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Categorical Exclusion under 21 CFR 25.31 (c) - Rotarix


Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality

To:STN BL 125265/0
From:Jonathan McInnis, HFM-676
Subject:Categorical exclusion under 21 CFR 25.31 (c)
Date::March 21, 2008

I have reviewed pertinent sections of the Biologics License Application Supplement (STN number 125265/0) from GlaxoSmith Kline Biologicals, for the manufacture of rotavirus vaccine and find that their request for a categorical exclusion from an environmental assessment under 21 CFR 25.31 (c) is justified as the product consists of components already present in the environment.


John A. Eltermann, Jr., R.Ph.,M.S.                                 Date
Division of Manufacturing Product Quality


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