Redacted_J&A.docx

Control Number: JA17082 Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: The Contracting Activity responsible for this action is US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD on behalf of the Walter Reed Army Institute of Research (WRAIR).

2. Description of Action: Approval is being requested for a six-month extension to the firm-fixed price contract, W81XWH-14-P-0113 under the authority of 52.217-8, Extension of Services Clause, to allow for the continuation of services providing in vitro and in vivo metabolism and disposition studies in support of antimalarial drug discovery and development efforts. The dollar value of requested extension is $48,000.00 . Purchase Request number 10977716 was provided in the amount of $48,000.01.

3. Description of Supplies/Services:

The contract is for research biology support to provide assistance in the development of new anti-malarial drugs; analysis of cell and/or enzyme based assays; lead the design and implementation of permeability studies involving the maintenance of cell lines and the use of related cell cultures under aseptic conditions; assessing in vitro permeability and the potential for drug metabolism in hepatocytes; collaborate in the development and validation of analytical methods for the identification of candidate new drugs and putative metabolites using HPLC with UV/VIS, fluorescence, electrochemical detection, radioactive monitor analyses, and/or mass spectrometry as needed; analyze data and prepare reports in support of Investigational New Drugs and New Drug Applications through the FDA using standardized computer applications and relevant software; prepare and present novel research projects as abstracts and/or for submission for the peer review publication process; Provide in vitro metabolism and disposition experimental support to include the design and implementation of high-throughput cell-based assays in efforts related to discovery and development of new antiparasitic drugs. Implement analytical methods for candidate drugs and metabolites using liquid chromatography coupled with mass spectrometry, in support of metabolic profiling and preclinical drug pharmacokinetic studies. Assess in vitro permeability and the potential for drug metabolism in hepatocytes.

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(2). The FAR citation is 6.302-2, unusual and compelling urgency.

5. Reason for Authority Cited:

The Requiring Activity approached the Contracting Office regarding the potential of a 6-month extension on or about 08 December 2016. The Request for Service Contract (RSCA), Purchase Request, and Sole Source documentation did not arrive at the Contracting Office until approximately 18 January 2017. This award ends 29 January 2017. There is insufficient time to exercise the extension in accordance with Army Federal Acquisition Regulation Supplement (AFARS) requirement of having a signed RSCA prior to contract modification, and Federal Acquisition Regulation (FAR) requirement to post a Notice of Intent to sole source before this award expires. The services of this award are necessary to forward the Military Malaria Research Program. Dr. Xiannu Jin, the incumbent contractor, is currently in place and performing services as defined. The Government would be unduly harmed in the continuing area of malaria research without this contract.

6. Efforts to Obtain Competition: A Request for Information was published in the Federal Business Opportunities on 20 January 2017 and closed on 23 January 2017. There was no response to the Request for Information (RFI).

7. Actions to Increase Competition: The Requiring Activity will continue to analyze Industry to determine if there are any changes in the competitive environment.

8. Market Research: A RFI was issued under W81XWH-14-P-0113. The RFI resulted in no response. As a result it was determined that only the current vendor is capable of continuing the services seamlessly and that no other vendor could finish the final 6 months of the services without duplication of costs and delays in service.

9. Interested Sources: No other sources were asked for new information.

10. Other Facts: N/A