SAFE-PLASMA Protocol

The Defense Health Agency Contracting Activity, on behalf of Portfolio Acquisition Executive for Medical Products, Warfighter Protection and Acute Care Project Management Office, intends to issue a contract modification on a sole-source basis with Westat Inc. 1600 Research Blvd. Rockville, MD 20850. This modification will enable Westat Inc. to modify the current clinical trial design to comply with FDA recommendations and to conduct the Good Clinical Practices (GCP) compliant clinical trial in accordance with U.S. Food and Drug Administration’s requirements for EZPLAZ™ approval.