4.2 Sole Source Justification (SSJ) Updated_SW_DH1.pdf

The proposed action is for human subject research located at the Institute for Human and Machine Cognition (IHMC) concerning the familiarization, recognition, and reporting of hypoxia symptoms. The awarded study will advance the scientific understanding of the individual contributions of OBOGS warnings and hypoxic exposures on hypoxia symptom reporting and cognitive performance. This effort will provide training and personnel returns on investment by supporting revised aircrew training programs that focus on enhancing decision-making capabilities under stress, moving beyond the current emphasis on hypoxia symptom recognition training. The proposed testing location is IHMC 40 S Alcaniz St, Pensacola, FL 32502.

To combat the operational safety threat associated with Unexplained Physiological Events (UPEs) the U.S.

Navy and Air Force have developed an algorithm using integrated sensor data to provide real-time signal processing and data interpretation. Due to the prior work with IHMC, their testing facilities will be utilized in a similar manner to conduct the recruitment and data collection for the three participant visits.

Subcontractor (IHMC) will conduct a study using military flight students as participants to determine the effect of a warning light on respiration symptomatology with and without hypoxic exposure. Subcontractor (IHMC) will provide the following:

1. Provide input for IRB and HRPO protocols

2. Facilitate command approval from local military aviation training command for study participants from a population that serves military fixed wing tactical aviation

3. Conduct study as described in NAMRU-D approved protocol

4. Provide data analysis and technical reports

The study will consist of 3 sessions for 28 participants: the first being a hypoxia symptom recognition, with the remaining 2 as experimental sessions. During the experimental sessions, each participant will undergo two hypoxic exposure conditions, and 2 baseline conditions where they will perform the cognitive task.

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 Command (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements.

2. Nature and/or description of the action.

3. Description of Supplies or Services.

Table 1. .

Baseline 1 Exposure 1 Recovery 1 Baseline 2 Exposure 2 Recovery 2

6 minutes 12 minutes 10 minutes 6 minutes 12 minutes 10 minutes

Table 2. Counterbalancing simulated OBOGS warning and gas delivery conditions across two experimental sessions.

Experimental Session 1 Experimental Session 2

Group ID

Gas Delivery

Condition

Exposure 1 Warning

Light

Exposure 2 Warning

Light

Gas Delivery

Condition

Exposure 1 Warning

Light

Exposure 2 Warning

Light A Hypoxia On Off Normoxia Off On B Hypoxia Off On Normoxia On Off C Normoxia On Off Hypoxia Off On D Normoxia Off On Hypoxia On Off

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.

Use one of the following:

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

10 U.S.C. 2304(c)(2), Unusual and compelling urgency.

10 U.S.C. 2304(c)(3), Industrial mobilization; engineering, developmental, or research capability; or expert services.

10 U.S.C. 2304(c)(4), International agreement.

10 U.S.C. 2304(c)(5), Authorized or required by statute. 10 U.S.C. 2304(c)(6), National Security.)

Be sure to include the FAR cite as well. See attached FAR explanation sheet for J&A references FAR Part 13 FAR 13.106-1(b)(1) <$150K FAR 6.302-1, Only One Source (>$150K) FAR 6.302-2, Unusual and Compelling

10 U.S.C. 2304(c)(2), Unusual and compelling urgency.

10 U.S.C. 2304(c)(3), Industrial mobilization; engineering, developmental, or research capability; or expert services.capability; or expert services.

10 U.S.C. 2304(c)(4), International agreement.

10 U.S.C. 2304(c)(5), Authorized or required by statute. 10 U.S.C. 2304(c)(6), National Security.)

FAR 6.302-1, Only One Source (>$150K) FAR 6.302-2, Unusual and Compelling2, Unusual and Compelling

FAR 13.106-1(b)(1) <$150K

Market research was conducted by contacting knowledgeable individuals regarding testing requirements, reviewing recent market contracts, searching government databases, and communicating with industry personnel and potential customers. Eaton and the Institute for Human and Machine Cognition were the two companies with potential testing services. After more research, Eaton was found to not be able to provide the entirety of the testing required for the specific study on hypoxia research using an OBOGS system while performing a cognitive task similar to the flight environment. Therefore, IHMC is the only testing facility available to provide the required testing services.

1. Team must be led by an individual with expertise around fixed wing UPE issues and hypoxia.

2. Must have existing relations with military training command or a population that serves tactical fixed wing aviation.

3. Must possess a documented history of conducting human research using participants composed of military flight students and instructors.

4. There is a proximity to and agreement with the Student Naval Aviators (SNAs) in Pensacola to complete training at IHMC.

5. IHMC is in close proximity and a co-location of the SNAs within a certain range for exposure sequences and safety of participants

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. In addition, the Government anticipates that the negotiated contract price will

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

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

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the government point of entry in accordance with FAR 5.202.

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

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

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

Previous contracts from NAMRU-D have been awarded to IHMC for algorithm development and testing under the same setup (N3239819P0063 & N3239822P0601).

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

Not applicable

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.

For the reasons set forth in Paragraph 5, (contracting activity) has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMRC) will assess whether competition for future requirements are feasible.

12. Point of Contact:

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

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 POC

Name Title Department/Command

Department Head

Phone Date

Name Title Department/Command

Phone Date

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Phone Date

Stephanie Warner Biomedical Engineer Environmental Physiology

937-255-3871

937-938-3917 14 MAY 2025

14 MAY 2025

LT Mahamat Babagana Department Head Environmental Physiology