
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
