Categorical Exclusion Memo - Bivigam
To: Administrative File, BL STN 125389/0, Immune Globulin Intravenous (Human) Biotest Pharmaceuticals Corporation (US License No. 1792)
From: Destry Sillivan, Acting Branch Chief, OCBQ/DMPQ/MRB II, HFM-676
Subject: Categorical Exclusion under 21 CFR § 25.31(c)
Biotest Pharmaceutical Corporation requested categorical exclusion from an environmental assessment pursuant to 21 CFR 25.31 (c), which applies to a biologic product containing substances that occur naturally in the environment when the introduction of the product does not alter significantly the concentration or distribution of the substances, their metabolites, or degradation products in the environment.
I evaluated the request for categorical exclusion and concluded that this request is justified as the product meets the applicable exclusion criteria in 21 CFR Part 25, and that there is no information indicating that extraordinary circumstances exist.
Destry Sillivan, Acting Branch Chief Date
Division of Manufacturing and Product Quality, MRBII
John A. Eltermann, Jr., R.Ph., M.S. Date
Division of Manufacturing and Product Quality