ROCHE_J&A___2019_03_12_15_30_12.pdf

NMRC

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Center (NMRC), Silver Spring, MD, on behalf of the Navy to meet Naval Medical Research and Development mission.

2. Nature and/or description of the action.

The need is for reagent components LightCycler Faststart UNG and 12.5mM dNTP blend. Both of these are manufactured by Roche Diagnostics. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Roche Diagnostics, 9115 Hauge Road, Indianapolis, IN 46250.

3. Description of Supplies or Services:

The Molecular Department of the Biological Defense Research Directorate, Naval Medical Research Center produces reagents for biological defense applications. These reagents are employed by a variety of Navy, Department of Defense, and other US Government agencies for the detection and identification of biological warfare agents. The development process for the production of these reagents included extensive testing of the reagent components to produce the best combination. Essential components, LightCycler Faststart UNG and 12.5mM dNTP blend, are required.

RDT&E funds in the amount of $xxxxx will be used to procure these reagent components.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(l) and FAR 13.106-l(b)(l) soliciting from a single source.

5. Demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited.

LightCycler Faststart UNG and 12.5mM dNTP blend produced by Roche are both essential components of reagents being produced by BDRD/NMRC for biological defense applications.

These reagents are employed by a variety of Navy, Department of Defense, and other US Government agencies for the detection and identification of biological warfare agents.

Additionally, these reagents are currently deployed globally for operational use. The development process included extensive testing of the components to produce the best combination. The LightCycler Faststart UNG and 12.5mM dNTP blend produced by Roche are two of these components. Switching to another vendor would invalidate all previous optimization and evaluation efforts. Reagents produced with these components from another vendor without