SOLE_Source_Georgia_State_University_Justificfation_Redacted.pdf

Control No. JA16030

Justification and Approval for Other Than Full and Open Competition

Contract Issuance to Georgia State University Research Foundation

1. Contracting Activity: US Army Medical Research Acquisition Activity (USAMRAA), on behalf of the US Army Institute of Surgical Research (USAISR).

2. Description of Action: Approval is being requested for a new Firm Fixed Price contract to support neuromusculoskeletal injuries research. The type of funds being used are Defense Health Program (3 Year Appropriation).

3. Description of Services: The services being procured under this action will support the translation of regenerative and rehabilitative therapies to the USAISR. Initial funding for the research was provided via competitive intramural funding under the Defense Medical Research and Development Program, Grant No. MR140099. A non-competitive award will be issued to Georgia State University Research Foundation Inc., 30 Courtland Street SE, Atlanta, GA. The specific service required is construction of specialized miniature neural electrical stimulators and expertise in implanting and operating the stimulators in rats and pigs. The total estimated value of the award is $225,000. This estimated value includes a one year performance period and two option years of performance.

4. Authority Cited: Statutory authority permitting other than full and open competition is 10 U.S.C. 2304 (c)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(B), Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited: USAISR was originally awarded a grant No. MR 140099, “Combining clinically available rehabilitative and regenerative strategies to improve functional outcomes after sever extremity trauma”, which was co-authored by a researcher at Georgia State University Research Foundation.

A. This contract will be a subward from ISR to Georgia State University to carry out the co-authored research. No other source is available to perform the co-authored work selected under the Defense Medical Research and Development Program. To compete this action would be a duplication of effort, in which competition costs would not be recouped. As part of the approved research for the Clinical and Rehabilitative Medicine Research Program/Joint Program Committee 8, the awardee will design, construct, and program neural electrodes and miniature stimulators for rehabilitation studies in rats and pigs at GSU. Initial validation and reliability performance testing in simulated systems will also be performed at the research foundation. These activities will be performed continuously over the 3 year award period. Design parameters and functional performance standards will be determined in collaboration with USAISR.

B. The Principal Investigator (PI) at the research foundation is one of the foremost innovators in the design, construction and programming of neural electrodes and miniature stimulators in the nation. The PI also has developed and will instruct surgical implantation techniques customized for rat and pig rehabilitation programs.

C. Utilization of the miniature electrical stimulators provided and supported at the research foundation’s laboratory will allow for continuity of scientific research. Initiated methodologies in research studies, funded under Grant No. MR 140099, are being performed over a 3 year period from September 30, 2014 – September 29, 2017. The 3 years planned for this support service requirement are required to maintain continuity of neuromusculoskeletal injuries research.

6. Efforts to Obtain Competition: Only Georgia State University Research Foundation is capable of meeting this requirement. In accordance with Federal Acquisition Regulation (FAR) 5.2, a Notice of Intent to sole source this action was published in FedBizOpps. No responses to the notice were received.

7. Actions to increase Competition: It is the policy of USAMRAA to promote the use of competitive procedures whenever and wherever possible. However, this is a logical follow-on of support services to continue neuromusculoskeletal injuries research . Completive program announcements will be continued for similar research requirements in the future.

8. Market Research: ISR performed market research via the internet (Google Search: microstimulator AND rat AND pig AND implant AND rehabilitation AND skeletal muscle) and found no other source that has the specialized experience offered by the Georgia State University Research Foundation.

There are references of customized stimulators for various purposes to include neuromuscular stimulation within scientific literature. These papers demonstrate the utility of electrical stimulation but do offer commercial services. Moreover, these alternatives are not customized for the USAISR specified need of neural stimulation in rats and pigs indicated in Grant No.

MR140099, Additionally, no other source has been identified that can support surgical implantation and continue the existing neuromusculoskeletal injuries research as approved under the Defense Medical Research and Development Program.

9. Interested Sources: Not applicable. Initial sources were identified under a competitive program announcement.

10. Other Facts:

a. Procurement history

Initial program support funding for Neuromusculoskeletal Injuries Research was obtained by competitive the Program Announcement for the Defense Health Program, Defense Medical Research and Development Program, Department of Defense, Clinical and Rehabilitative Medicine Research Program/Joint Program Committee 8.

b. Other facts

Funding Opportunity Number: W81XWH-14-DMRDP-CRMRP-NMSIRA

11. Technical and Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

4 APR 16

12. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable based on price analysis and previously issued awards. Certified pricing data is not required per the exception at FAR 15.403-1.

14 APR 16

13. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based on the foregoing justification, I hereby approve the procurement of the research to further translate autologous minced muscle grafts to the clinic which was done in part by the award of grant No. MR140099. on an other than full and open competition is pursuant to the authority of 10 U.S.C. 2304 (c) (1) only one responsible source and no other supplies or services will satisfy agency requirements, subject to availability of funds and provided that the services and property herein described have otherwise been authorized for acquisition.

14 APR 16