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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Categorical Exclusion Memo - Berinert, October 5, 2009

To:BL STN 125287, C1 Esterase Inhibitor (Human)   
CSL Behring GmbH, Marburg, Germany
Lic. # 1765
From: David Doleski, Team Leader, CBER/OCBQ/DMPQ/MRB2, HFM-676
Subject:Categorical Exclusion under 21 CFR 25.31(c)

 

CSL Behring GmbH has submitted a request for a categorical exclusion to omit preparation of an Environmental Assessment, under 21 CFR 25.31(c) as part of the Biologics License Application 125287-0 for C1 Esterase Inhibitor (Human) manufactured at Marburg, Germany.  This regulation states that the submission does not alter significantly, the concentration or distribution of the substance, its metabolites, or degradation products in its environment.  The undersigned DMPQ/CBER reviewer on this committee has evaluated the request for categorical exclusion and has concluded that this request is justified as the product meets the applicable exclusion criteria in 21 CFR 25.31(c), and that there is no information indicating that extraordinary circumstances exist. 

 

________________________________________

David Doleski                                       Date

Team Leader, Branch 2, DMPQ

 

 

________________________________________

Chiang Syin                                         Date

Branch Chief, Branch 2, DMPQ