Sources Sought Notice

Sources Sought Notice

This Sources Sought Notice (SSN) is for market research, information, and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Defense Health Agency Contracting Activity (DHACA), on behalf of Portfolio Acquisition Executive for Medical Products (PAE MP), Warfighter Protection and Acute Care Project Management Office (WPAC PMO).

DHACA, on behalf of the WPAC PMO, 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.

The applicable North American Industry Classification System (NAICS) code for this requirement is 541715 -- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology).

Westat Inc. conducted the Phase 1 clinical trial used for EZPLAZ licensure and has developed the protocol and Statistical Analysis Plan for the current clinical trial evaluating the safety of EZPLAZ and conventional plasma products in adult patients.

The Government intends to negotiate and award the modification under the statutory authority of 10 U.S.C. 3204(a)(1) as implemented in Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) 6.103-1, only one responsible source and no other supplies or services will satisfy agency requirements.

This SSN is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and rough order of magnitude, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed five (5) pages, 8.5 x 11 inches using a font size no smaller than 10-point. The Government will consider all capability statements received by the due date of this notice. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract modification.