Categorical Exclusion under 21 CFR 25.31 (c) - Rotarix

Memorandum

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.

Concurrence:

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