
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
