ja1.docx

Control No: 16375

JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity:

The contracting activity for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD, in support of the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) at Aberdeen Proving Ground- Edgewood Area, MD.

2. Description of Action:

This approval is being requested for the issuance of a Research & Development (R&D) contract to the University of Utah. The award is in support of the National Institutes of Health (NIH) Interagency Agreement (IAA) research funding in the area of Chemicals affecting the Nervous System for the project entitled “Evaluation of novel anticonvulsants to treat nerve agent- and pesticide-induced seizures and prevent brain damage in pediatric rats.” A firm fixed-price award will be issued to the University of Utah with a base year of performance and an optional year for performance. Fiscal Year 2016 Public Health funding is being transferred to USAMRICD for procurement of this research project.

3. Description of Supplies/Services:

USAMRICD has a requirement to issue an R&D contract as part of a Memorandum of Agreement (MOA) and related IAA with the NIH. In addition, the University of Utah will contribute to the NIH IAA project by providing propriety EEG telemetry modules for use in pediatric animals as well as providing basic research into the effectiveness of experimental anti-convulsant drugs in protecting pediatric rats from seizures and brain damage elicited by the organophosphate pesticide compound diisopropylfluorophosphate (DFP). The total estimated value for this R&D effort is $1,027,831. Year 1 estimated value is $505,574 and Year 2 estimated value is $522,257.

4. Authority Cited:

The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1) as implemented by FAR 6.302-1, “Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited:

This is a collaborative requirement in support of the NIH Countermeasures Against Chemical Threats (CounterACT) program. CounterACT research is within the established IAA, in which directed research projects were submitted by USAMRICD, which included specific academic collaborators designated by NIH. These projects were evaluated, and selected to sponsor a network of collaboration amongst government and academic researchers. The University of Utah possesses propriety, electrographic (EEG) analytical software to evaluate the effectiveness of the novel test compounds that is not available elsewhere and is considered state-of-the-art by the NIH. It is neither cost effective nor realistic to expect another contractor to perform the requirements of the collaboration established.

NIH is the primary biomedical facility for research on infectious, immunologic, and allergic diseases, including research on emerging and re- emerging infectious diseases, HIV/AIDS, and potential agents of bioterror. The University of Utah has been identified by NIH and USAMRICD as the only source for the project titled “Rat models of organophosphate and nerve agent intoxication to evaluate delayed treatment with novel anticonvulsants/neuroprotectants.” The University of Utah has a long history of independently evaluating test compounds for anticonvulsant potential and is unique in that seizure models of the organophosphate pesticide DFP were developed there and are currently used to evaluate novel anticonvulsants in a standardized fashion that is virtually identical to the ones used by their collaborators at USAMRICD in their nerve agent seizure model.

6. Efforts to Obtain Competition:

A sources sought notice was published in FedBizOpps.gov on September 11, 2016 with a closing date of September 14, 2016. As a result of the notice, one corporation expressed interest in future CounterACT collaborative projects.

Under the IAA, sixteen proposals were initially selected for funding by NIH, with only six proposals making the final funding approval. This procurement is for one of the six NIH competitively selected projects.

7. Actions to Increase Competition:

It is the policy of USAMRAA to promote the use of competitive procedures to the maximum extent practicable. However, this research support is unique to the University of Utah, making efforts to increase competition very difficult. USAMRICD and the contracting office will review upcoming R&D solicitations for competitive acquisition opportunities. These efforts will include posting specific research projects via a Broad Agency Announcement (BAA).

8. Market Research:

The University of Utah possesses propriety techniques to develop and implement drug screening rat models for nerve agents and organophosphates induced status epilepticus in the pediatric population. The research will involve collaborative, preclinical experiments using OPs and NAs. The recordings will be performed using a novel, miniature telemetry system developed at the University of Utah.

The following facts are derived from literature searches performed in August 2016 and prior to that, using PubMed, Athens, and EduServe databases. No examples of other efforts on the effectiveness of various anticonvulsant treatments, either benzodiazepines or other drugs used clinically to stop status epilepticus have been found. Only the University of Utah can meet the agency’s research requirement for evaluation of novel anticonvulsants to treat nerve agents.

9. Interested Sources:

A Notice of Intent to award this project on a sole basis was announced in FedBizOpps.gov on September 19, 2016 with a closing date of September 23, 2016. No responses were received as a result of the published notice.

10. Other Facts:

a. Procurement History:

Previous collaboration between the University of Utah and USAMRICD has included a contract for similar research.

(1) Contract Number and date of award:

W81XWH-14-C-0093 – Pediatric Susceptibility of Induced Seizures in Rats, Period of Performance: 26 SEP 14 – 25 SEP 16

(2) Competitive status of these actions:

Competitive proposal through Broad Agency Announcement

(3) Authority previously used for less than full and open competition: N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. N/A

(5) If any prior award was accomplished by full and open competition , provide a detailed explanation of the changed circumstances.

The previous acquisition was selected through full and open competition through the USAMRAA BAA. Current acquisition requires University of Utah propriety EEG analytical software to evaluate the effectiveness of the novel test compounds that is not available elsewhere and is considered state-of-the-art by the NIH.

(6) An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive urgent buys. N/A

(7) If justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes. N/A

b. Other Facts:

The NIH maintains the following website that addresses the IAA and CounterACT research categories for consideration with USAMRICD. See the section on Contracts, Inter-Agency Agreements, and Other Resources at:

http://www.ninds.nih.gov/research/counterterrorism/counterACT_researchers _projects.htm