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Vaccines, Blood & Biologics

Categorical exclusion under 21 CFR 25.31(c) - RECOTHROM

Memorandum

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality

Date: 06 December 2007
To: BLA STN No. 125248/0
From: Nancy Waites, OCBQ/DMPQBI/ HFM-675
Subject: Categorical exclusion under 21 CFR 25.31(c)

I have reviewed pertinent sections of the Biologics License Application Supplement (STN number 125248/0) from ZymoGenetics, Inc. (ZGI), for the manufacture of Thrombin (recombinant), and find that their request for a categorical exclusion from an environmental assessment under 21 CFR 25.31(c) is justified since the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment. Thrombin also occurs naturally in the environment.

                                                                                               

                                                                                      

___________________________________________________________
Nancy Waites                                                       Date
Committee Member
Division of Manufacturing Product Quality

 

Concurrence:

                                                                                               

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

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