HT9425-25-RFI-TNM01-Obstructive-Sleep-Apnea.pdf

Request for Information (RFI)

1. RFI Number: HT9425-25-RFI-TNM01

2. RFI Title: “Acceleration of Deployment Readiness Through First Line Oral Appliance Therapy for Obstructive Sleep Apnea (OSA)”

3. Agency: Defense Health Agency (DHA)

4. Office: U.S. Air Force 59th Medical Wing, Science and Technology Office (59

MDW/ST)

5. Contracting Office: United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD.

6. Locations: Contractor’s facility.

7. Background: The U.S. Air Force 59 MDW/ST Office has a requirement for research and development services. This research study is titled, “Acceleration of Deployment Readiness through First Line Oral Appliance Therapy for Obstructive Sleep Apnea.”

Veteran Affairs (VA) and Department of Defense (DoD) guidelines recommend either Oral Appliance Therapy (OAT) or Positive Airway Pressure (PAP) therapy as first line options to manage OSA. However, little guidance is provided on when to favor one therapy over the other and many VA and DoD clinicians only prescribe PAP as first-line therapy. PAP therapy is not feasible for some environments, patients, or jobs.

8. Objectives:

The main objectives are summarized as follows:

• To determine the comparative effectiveness of the 2 first-line therapies at producing deployment readiness. Speed, efficacy, compliance, and medical deployability will be assessed as primary goals.

• To document OSA therapy status at 4 specific time points after initiation of therapy and determine if OAT reduces the time from initiation of therapy to full medical readiness/deployability with OSA versus standard positive airway PAP therapy. Thus, providing a medical readiness advantage over the commonly prescribed therapy (PAP) in terms of time, resources, and feasibility for patient use in any scenario.

9. Information Requested in Capability Statement:

• Confirm ability to conduct research in a manner that will meet the objectives listed above.

10. North American Industry Classification System (NAICS) Code: The NAICS code for this potential action is: AN13 and 541715 – Research and Development in the Physical, Engineering and Life Sciences (except Nanotechnology and Biotechnology)

11. Response Due Date: Interested parties should submit their RFI response electronically by 12:00 pm Eastern on 23 June 2025 via e-mail to Ms. Tammy McRae at tammy.n.mcrae.civ@health.mil.

12. Instructions to Responders:

12.1 The Government appreciates responses from all capable and qualified sources.

12.2 The Government welcomes input and will accept questions pertaining to this RFI;

however, the Government reserves the right to answer or not answer all questions pertaining to this RFI. Only one set of questions per vendor will be accepted. Telephone requests will not be entertained.

12.3 The subject header of the e-mail for submission of questions and/or the RFI response shall be: HT9425-25-RFI-TNM01.

12.4 Interested firms should submit a response (Capability Statement) that demonstrates the Offeror’s ability to meet the requirements identified in this RFI. The Capability Statement shall not exceed five typed pages; additional sheets for cover page, table of contents, tables, and charts will not be counted toward page limitation.

12.5 Fill in the below table when responding to this Sources Sought / RFI.

Question Answer RFI Number Company Name Company Address Point of Contact Phone Number E-mail Address Tax Identification Number (TIN) Cage Code

DUNS

Company Web Page Company Location(s) Company is / is not a Small Business Company is / is not SAM Registered Other Classifications (e.g. 8(a), HubZone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned)

If 8(a), date that the company graduates from the program.

mailto:tammy.n.mcrae.civ@health.mil

13. Disclaimer and Important Notes:

In accordance with Federal Acquisition Regulation (FAR) 15.201, "Exchange with industry before receipt of proposals," and FAR 52.215-3, "Request for information (RFI) or Solicitation for Planning Purposes (SFP)," this RFI is for information and planning purposes only, at this time, and shall not be construed as a solicitation or obligation on the part of the DHA. The purpose of this RFI notice is to gain market knowledge. This RFI is not expected to be a Request for Proposal or Invitation for Bid, nor does it restrict the Government to an ultimate acquisition approach. The Government is not obliged to award a contract or otherwise pay for the information provided in the responses received.

The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its responses are complete and sufficiently detailed to allow the Government to determine the organization's solution. Responders are advised that the Government is under no obligation to acknowledge receipt of the information received, or to provide feedback to respondents regarding any information submitted.

After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on SAM.gov. At this time, no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential vendor to monitor SAM.gov for the release of any solicitation or synopsis.

Responses to this notice will not be considered adequate responses to a solicitation.

14. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in submitted responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Original Point of Contact (POC): Tammy McRae; tammy.n.mcrae.civ@health.mil