NMRC JA_LT_Babagana_19OCT2023_Redacted.pdf

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 Navy Expeditionary Medical Research requirements.

2. Nature and/or description of the action.

Naval Medical Research Unit – Dayton (NAMRU-D) investigators require a research support team capable of 1) assisting to generate single cell population from lab mice (e.g., C57B6J) brain tissue for single cell RNA (scRNA) library generation and sequncing, 2) assisting in bioinformatics analysis of scRNA data, 3) conducting animal biotelemetry surgery and 4) performing animal thermal stress experiments to identify relevant spatial and temporal physiological responses to thermal stress.

Additionally, NAMRU-D requires the use of a gentleMACS™ Dissociator with Heaters and animal heating/cooling equipment for experimental use.

3. Description of Supplies or Services:

The Naval Medical Research Unit Dayton (NAMRU-D) is conducting a funded study that includes research support from a team with a background in and/or access to scRNA sequencing expertise, bioinformatic analysis, animal thermal stress, and pathway delineation experience.

This study requires a combination of unique equipment including an automated animal brain processer,and animal husbandry facilities. Funding has been provided to NAMRU-D from the

Defense Health Agency under the FY23 Interservice Restoral Program.

The project discussed is titled: Reducing Operational and Training-Related Heat and Cold Stress

Injuries: Identifying Novel Pharmaceutical Targets– Period of performance beginning with awarding of contract (received on JUN2023) and ending 30 APR 2025.

The objectives are to identify cell-type specific physiological responses to thermal stress which will allow for a deeper understanding of the novel pathways engaged during mild and intense thermal stress. The desired outcome is a knowledge product describing results of the study, which may take the form of conference abstract(s) and/or peer-reviewed publication(s).

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)(1) and FAR 6.302-1 sole source (including brand name) acquisitions or FAR 13.106-

1(b)(1) soliciting from a single source.

10 U.S.C. 2304(c)(1), Only one responsible source.

FAR 13.106-1(b)(1) <$250K

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

There is only one team known, currently at Roswell Park Comprehensive Cancer Center

(RPCCC), with the capabilities to perform scRNAseq analysis, animal thermal stress experimentations, animal biotelemetry surgeries, animal health assessments, and provide the unique single cell dissociation equipment (e.g., gentleMACS™ Dissociator with Heaters).

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Experts in scRNA sequencing and analysis, animal thermal stress experimentations, animal biotelemetry surgeries, with animal health assessments with the necessary facilities and equipment were sought through discussions with colleagues in government and academia and through a search of relevant publications performed on pubmed.gov. Only one research group was found to have the necessary combination of skills and resources, led by Dr. Eugene Kandel at the RPCCC. Dr. Kandel was contacted by e-mail to discuss their capabilities and interest in this project. RPCCC provided a Proposal to perform the work within the time frame required. No other proposals were received.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Contacted knowledgeable individuals in government and industry regarding market capabilities to meet the requirement.

9. Other facts supporting the use of other than full and open competition.

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

RPCCC, Dr. Eugene Kandel, To date, no other sources have written to express an interest.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point of Contact.

The point of contact at the Naval Medical Research Center, Silver Spring, MD, regarding the contents of the sole source justification is , Deborah M. Sharpe, who may be reached at (301)

319-6471.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

937-938-3921 5/7/19

Name (PI) Phone Date

Title

Department/Command

Requirements Cognizance

Name (Dept Head, Director or Deputy) Phone Date

Title

Department/Command

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

Deborah M. Sharpe Phone Date

Contracting Officer

Edilberto P. Calma Phone Date Contracting Officer