A--Testing of an additional four thousand specimens for a rapid transfusiontransmitted disease detection (RT2D2) device pre-Investigational Device Exemption (IDE) package to the FDA.

The United States Army Medical Research Acquisition Activity intends to solicit a proposal and enter into a contract modification with MEDMIRA Inc, Halifax, NS, Canada. The statutory authority for this sole-source is 10 U.S.C. 2304(c)(1). The FAR citation is 6.302-1(a)(2)(ii). The NAICS code for this action is 541712. This requirement is for a rapid transfusiontransmitted disease detection (RT2D2) device pre-Investigational Device Exemption (IDE) package to the FDA. Upon review of the IDE package, FDA determined that the proposed clinical trial must be expanded, which will require the drawing and testing of approximately four thousand more specimens than were initially proposed. Both the newly required and originally planned specimen testing must be accomplished with the same RT2D2 device, which is only available from MedMira as it is still under development. USAMRAA requires that all contractors doing business with the Acquisition Office must be registered with the SAM and to be eligible to receive an award from this acquisition office, all offerors must have a DUN & Bradstreet Number. A DUN & Bradstreet Number may be acquired free of charge by contacting DUN & Bradstreet on line at https://www.dnb.com or by phone at (800) 333-0505.