To: Administrative File PAS 125385/0
From: Martha O’Lone, CBER/OCQB/DMPQ/MRBI
Subject: CSL Behring GmbH request for Categorical Exclusion under 21 CFR §25.31(c).
CSL Behring (US License number 1765) claims a categorical exclusion to the environmental analysis requirements in accordance with 21 CFR 25.31 (c) as follows:
(c) Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, for substances that occur naturally in the environment when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.
Factor XIII (Human) is composed of naturally occurring substances and therefore the manufacture of this product will not alter significantly the concentration or distribution of the substance, its metabolites or degradation products in the environment.
CSL Behring is not aware of any extraordinary circumstances that exist per 21 CFR 25.21 that would require the preparation of an environmental assessment or environmental impact
I have reviewed the pertinent sections of the Biologics License Application (STN 125385/0) from CSL Behring GmbH for manufacture of this new product Factor XIII (Human) in their currently approved Marburg, Germany location, and find that their request for categorical exclusion from an environmental assessment under 21 CFR 25.31(c) is justified as the product is composed of naturally occurring substances and that no extraordinary circumstances exist.
Division of Manufacturing Product Quality