B08-HT9427-26-R-E001-Attachment-A-SOO-Final-20260114-rev1.pdf

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Compact Oxygen Generation Medical Devices: Compact Oxygen Generation, Medical (COGM) and Compact Oxygen Generation, Medical – At Altitude (COGM-A)
Solicitation number
HT9427-26-R-E001
Issued by
Not on record

About this file

This is a Statement of Objectives (SOO) for the development of compact oxygen generation medical devices under the Defense Health Agency (DHA) Operational Medical Systems program. The effort focuses on two distinct device types: Compact Oxygen Generation, Medical (COGM) for Role 1 forward care with a target regulatory approval by 2029 and procurement by 2031, and Compact Oxygen Generation, Medical – At Altitude (COGM-A) for aeromedical evacuation platforms with regulatory approval targeted by 2030 and procurement by 2032. Both devices must generate United States Pharmacopeia oxygen at 93% ± 3% purity (99% desired), with COGM requiring 3–7 liters per minute (LPM) minimum and 15 LPM desired, and COGM-A requiring 3–15 LPM with high-pressure output for ventilators. Additional requirements include weight not exceeding 24 pounds (15 pounds desired), FDA clearance, airworthiness certifications, 95% operational availability (98% desired), and compliance with Military Standard 810-H for environmental testing. Devices must be serviceable by Biomedical Technicians, feature button-based interfaces with visual displays, include rechargeable batteries providing 2 hours of operation (3 hours desired), and operate across 110/220 VAC, 60–400 Hz, and 10–28 VDC power sources.

The solicitation anticipates multiple awards under each focus area, with a planned performance period of up to 24 months for COGM and 36 months for COGM-A. Six mandatory objectives structure the work: Management (progress reporting and cost/schedule tracking), Prototype Development/Technical (delivering 10 initial prototypes for government testing), Manufacturing (establishing Quality Management Systems compliant with 21 CFR Part 820 and ISO 13485), Regulatory (developing FDA regulatory strategy and submitting pre-submission packages), Maintenance and Sustainment (training and repair plans), and an In-Process Review at 75% completion. An optional seventh objective permits continued development funding. Deliverables include monthly reports with project management plans, regulatory submissions and FDA correspondence, technical summary reports, manufacturing and commercialization plans, maintenance and training materials, and software bills of materials. The performer must conduct device development at their location while government testing and evaluation occur at Department of Defense installations, with one to three performer personnel potentially required for site visits and technical demonstrations.

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Attachment A – Statement of Objectives (SOO)

Statement of Objectives (SOO) For

Compact Oxygen Generation Medical Devices

Requiring Activity: Defense Health Agency (DHA) Operational Medical Systems (OPMED), Warfighter Expeditionary Medicine and Treatment Project Management Office (WEMT PMO), Fort Detrick, MD

1.0 PURPOSE

The Defense Health Agency (DHA) needs to provide medical oxygen solutions in austere environments to treat service members with compromised lung function or injuries requiring oxygen therapy. The WEMT PMO is developing multiple oxygen generation and delivery systems through its Portable Oxygen (O2) program. This program aims to support casualties across all care settings, including evacuation platforms (Roles of Care 1-3 and en route).

Development and approval of candidate solutions will adhere to the Department of Defense (DoD) Acquisition System, the U.S. Food and Drug Administration (FDA), and other relevant regulatory and industry best practices.

This effort focuses on developing two expeditionary, easy-to-maintain, and portable oxygen generation devices meeting Joint Enroute Care Equipment Test Standard (JECETS) and airworthiness standards:

FOCUS AREA #1: Compact Oxygen Generation, Medical (COGM)

• Priority: High

• Primary Use: Role 1 (but still usable across all Roles, including en route care)

• Capabilities: Adjustable flow rate (3-7 lpm minimum, 15 lpm desired) for use with nasal cannulas, face masks, and nebulizers.

• Target Timeline: Regulatory approvals by 2029, procurement by 2031 (shorter timeline preferred)

FOCUS AREA #2: Compact Oxygen Generation, Medical – At Altitude (COGM-A)

• Primary Use: Aeromedical evacuation platforms

• Capabilities: Similar performance parameters to COGM, but with adjustable flow up to

15 lpm and high-pressure output for ventilators.

• Target Timeline: Regulatory approvals by 2030, procurement by 2032 (shorter timeline preferred)

The solicitation may result in multiple awards (i.e. Other Transaction Agreements [OTA]) under each focus area. The goal is development of FDA-approved devices that meet or exceed O2 program standards, ideally starting at Technology Readiness Level (TRL) 4. While a single device for both portability and aeromedical evacuation is preferred, the WEMT PMO acknowledges this may be unrealistic in the near future.

2.0 BACKGROUND

Future Large-Scale Combat Operations (LSCO) in Joint All-Domain Operations (JADO) environments are anticipated to result in significantly higher casualty rates than in recent counterinsurgency operations, potentially reaching levels not seen since World War II. This reality necessitates a robust and adaptable medical response capability. Medical personnel across all specialties (Medics to Physicians) require equipment (like the COGM and COGM-A) that is both easy to use and maintain, ensuring prolonged care capabilities as far forward as Role 1 and during transport.

Reliable medical oxygen availability is crucial in these resource-limited settings to prevent organ damage and facilitate recovery. A common, interoperable solution across all services is critical for seamless patient movement within the continuum of care. Loss of air superiority in future conflicts could significantly impact evacuation timelines, leading to longer holding times in lower Roles of Care and increased logistical strain, with a greater reliance on users or Biomedical Medical Technicians (BMET) for in-theater repair and maintenance. Equipment must therefore be designed for functionality in extreme environments and sustainability in austere conditions without climate control, including during storage.

3.0 SCOPE OF EFFORT

The scope of this effort covers activities needed to develop a prototype device that can:

1. Generate and deliver medical grade oxygen to the Joint Forces in military-relevant environments.

2. Be maintained, repaired, and serviced by DoD personnel.

3. Obtain FDA clearance with an indication that meets the DHA requirement and meets all other performance parameters.

4. Have production capacity in accordance with FDA regulations. The prototype system or device shall be Trade Agreements Act (TAA) Compliant and in accordance with DFARS 252.225-7021.

The final device shall be able to:

• Deliver reliable oxygen to patients within specifications defined in attributes.

• Interoperable and able to connect to or interface with standard ventilators and/or oxygen masks, nasal cannula, and standard associated accessories. The device will not have unique or proprietary fittings or accessories.

• Present visual indicators of flow rate, pressure, battery life, and remaining oxygen volume and alert/alarm when operations faults/failures occur.

• Have user agnostic accessibility (no individual user log-in credentials required), if applicable.

• Any software updates, as needed, must include regression testing and allow users to determine timing for adoption of updates. The device cannot be rendered inoperable if the software has not been updated to the latest available software version.

• Enable/disable active communications, if any (i.e. ability to turn off electronic signature).

• Ruggedized to function in far-forward extreme environments.

• Obtain airworthiness/safe-to-fly certifications for all hardware items during patient movement (i.e. carry-on medical devices).

• Achieve FDA clearance and commercial-scale manufacturing in accordance with (IAW)

FDA regulations.

Proposed devices with a technical maturity of approximately Technology Readiness Level (TRL) 4 are preferred in order to feasibly satisfy the target timelines.

The DHA requires 6 objectives to be reflected in any proposed Statements of Work.

• Objective 1, Management: Monitor and report on award progress/schedule for timely deliverable submission.

• Objective 2, Prototype Development/Technical: A prototype meeting technical parameters.

https://www.govinfo.gov/content/pkg/CFR-2010-title48-vol3/pdf/CFR-2010-title48-vol3-sec252-225-7021.pdf https://www.govinfo.gov/content/pkg/CFR-2010-title48-vol3/pdf/CFR-2010-title48-vol3-sec252-225-7021.pdf

• Objective 3, Manufacturing: Manufacturing plans and processes for FDA approval and commercial production.

• Objective 4, Regulatory: A regulatory strategy and testing plans for FDA and other relevant approvals. Initiate communication with regulatory agencies.

• Objective 5, Maintenance and Sustainment: Device maintenance, repair, and training plans.

• Objective 6, In Progress Review (IPR): Present a summary of work completed and additional work needed to achieve an FDA-cleared, DoD-compliant device.

The DHA may elect to execute the objective below for continued development upon successful completion of initial proposed work:

• Optional Objective 7: Proposal for continued development of Objectives 1-6.

4.0 OBJECTIVES

Objective 1: Management The Performer shall:

• Document progress and deviations from cost, schedule, and performance plans.

• Demonstrate management plans supporting device development, schedule tracking, and risk management.

• Conduct a kick-off meeting with the Government and provide meeting minutes

(Deliverable 1).

• Provide monthly reports, including updates to the Project Management Plan (PMP)

(Integrated Master Schedule, Staffing Plan, Risk Management Plan, and Spend Plan) or other strategic plans (testing, regulatory, manufacturing, maintenance/sustainment, commercialization) (Deliverables 2, 3).

• Submit monthly invoices (Deliverable 4) via Wide Area Workflow.

• Participate in recurring status meetings and provide minutes (Deliverable 5).

• Host annual and additional, if needed, Government site visits (Deliverable 6).

The Performer shall include all needed tasks in their Statement of Work and milestones.

Objective 1 is considered achieved when all progress reports, plan updates, and deviation documents have been submitted.

Objective 2: Prototype Development/Technical The Performer shall:

• Develop and deliver prototype devices that can meet device requirements as outlined in Section 8.0.

• The DoD will assess prototypes for functionality and potential to meet desired performance standards. Prototypes, along with all necessary accessories and consumables, will be delivered for government testing, including environmental, operational, and cybersecurity evaluations (Deliverable 7). Initially, 10 prototypes will be needed for testing and more may be requested by the Government.

o Prototypes will be assessed for suitability in military environments, and any necessary modifications will be identified.

o Prototypes will undergo expert assessment and rigorous testing under military-relevant environmental and physical conditions in accordance with Military Standard (MIL-STD) 810-H(1), Department of Defense, Test Method Standard, Environmental Engineering Considerations and Laboratory Tests (Attachment K).

• The Performer will collaborate with the government to develop and complete the Medical Device and Equipment Risk Assessment (MDERA) form (Attachment I, Deliverable 8).

• Finally, a Technical Summary Report (Deliverable 9) will be submitted, detailing the device design, testing results, feasibility assessments, and verification studies.

Objective 2 is considered achieved when:

• The Performer demonstrates that minimum device requirements are met.

• Prototypes are delivered for government testing and evaluation.

• Findings are summarized in the final technical summary report.

Objective 3: Manufacturing The Performer shall:

• Establish and maintain current Good Manufacturing Practices (cGMP) and a Quality Management System (QMS) compliant with 21 CFR Part 820 and ISO 13485 throughout the entire manufacturing process, from initial pilot production to commercialization.

• Demonstrate compliance through a Quality Management Plan (Deliverable 10) outlining the establishment and maintenance of the QMS.

• Develop a pilot manufacturing process for pre-production devices, leading to a process for fully manufacture-ready devices.

• Revise Manufacturing and Commercialization Plan (Deliverable 11) detailing timelines for establishing necessary manufacturing lines. The plan will include, at minimum:

o Manufacturing processes o Interim and final testing requirements o Raw material sourcing o Bill of Materials (BOM) and required spare parts o A detailed plan for making devices and spare parts available for procurement in both military and civilian markets o Rough Order Magnitude Product Unit Cost Estimates (CDRL A002).

• Define and track manufacturing and commercialization risks within the overall risk management plan (Deliverable 2).

Objective 3 is considered achieved when:

• The Quality Management System (QMS) is established.

• The initial pilot manufacturing process produces pre-production devices.

Objective 4: Regulatory The Performer shall:

• Develop and maintain a Regulatory Strategy (Deliverable 12) following MRMC Data Item Description (DID) DI-TCSP-82040, Research and Development of Medical Projects Regulated by the U.S. Food and Drug Administration (Attachment H, CDRL A001), with a schedule ensuring regulatory submission by 2029 for COGM or 2030 for COGM-A.

The strategy should target FDA clearance for an indication usable by military populations while meeting minimum performance attributes.

• Prepare and submit Pre-Submission packages to the FDA, verifying the regulatory strategy and informing required testing.

• Submit draft regulatory submission materials (Deliverable 13) to the government for review, including final materials (Deliverable 14), FDA responses (Deliverable 14), and meeting summaries to the FDA (Deliverable 14). The Performer will include at least two DoD Government representatives in all FDA meetings.

• Submit all draft and final test reports (Deliverable 15), including protocols and results for verification, validation, and Good Laboratory Practices (GLP)/non-GLP testing.

• Obtain approval from the appropriate regulatory body (Institute Animal Care and Use Committee (IACUC) and U.S. Army Medical Research Command (USAMRDC) Animal Care and Use Review Office (ACURO); or Institutional Review Board (IRB) and USAMRDC Office of Research and Regulatory Compliance (ORRC)) for all animal or human study protocols before their initiation (Deliverable 16).

• Define and track regulatory risks within the overall risk management plan (Deliverable 2).

Objective 4 is considered achieved when all FDA submissions and feedback are received, and test reports are submitted.

Objective 5: Maintenance and Sustainment The Performer shall:

• Develop plans supporting Government training, repair, maintenance, and sustainment of devices.

• Ensure device design aligns with MIL-STD-810H for operation, transport, and storage in military environments.

• Record failure data.

• Deliver the following:

o Deliverable 17: Maintenance and Sustainment Plan outlining user training, device repair, parts replacement, and software updates (if applicable).

o Deliverable 18: Training Materials and User Manuals, to include quick-start guides.

o Deliverable 19 (If applicable): Software Bill of Materials (SBOMs) for all delivered code, software components, and services (including firmware, OS, applications, and cloud-based software) following DI-SESS-82433, Cybersecurity Supply Chain Risk Management (C-SCRM) Software (CDRL A003).

Objective 5 is considered achieved upon delivery of a sustainment plan, initial manuals and guides, and applicable SBOM.

Objective 6: In Progress Review At approximately 75% Period of Performance (PoP) completion and with Objectives 1-6 on track for cost, schedule, and performance, the Government shall conduct an in-person (at Fort Detrick, MD) or hybrid In-Process Review (IPR) (travel constraints permitting).

The Performer shall:

• Attend and participate in the IPR.

• Provide a summary of the effort to date.

• Submit Deliverable 20: In Process Review Brief

Successful completion of Objectives 1-6 within the POP may lead to follow-on work (Objective

7) if milestones are met such as (but not limited to):

• Demonstration that the prototype has met technical parameters.

• Received feedback from FDA regarding the regulatory strategy and relevant testing plans.

• Draft maintenance and repair manuals.

• Testing of prototypes in relevant environments.

Optional Objective 7: Proposal for Continued Development Following the IPR, the Government may elect to fund the continued development of Objectives 1-6.

The Performer shall submit Proposal Volumes (Deliverable 21) for continued development that may include:

• Additional development and testing, to include regulatory testing, to meet the device specifications

• Final device specifications, instructions for use, and labeling.

• FDA and other applicable clearances, approvals, or certifications.

• Final maintenance and repair manuals, with training plans.

• Established production line.

• Commercialization and Distribution Plans.

In Process Review Brief (Deliverable 20) will inform the Government's intent to request Proposal Volumes (Deliverable 21) for continued development and subsequent PoP award recommendations.

5.0 PERIOD OF PERFORMANCE

The Government plans to fund Focus Area 1 (COGM) up to 24 months and Focus Area 2 (COGM-A) up to 36 months. Faster completion of either Focus Area is highly desirable, but the Government acknowledges that follow-on work may be needed to reach overall device goals.

6.0 PLACE OF PERFORMANCE/LOCATION

COGM and COGM-A device development shall be conducted at Performer location.

DoD Testing and Evaluation (T&E) will occur at DoD installations. The government may request the performer's on-site presence during T&E to provide instruction and observe.

7.0 TRAVEL

The Performer shall be authorized travel expenses consistent with the substantive provisions of the applicable travel regulations and the limitation of funds specified in the agreement.

Arrangements for all travel, transportation, meals, lodging, and incidentals are the responsibility of the Performer. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the Government. The Government shall not pay for business class or first-class travel. The Agreements Officer’s Representative (AOR) will approve travel prior to any trip.

Travel of one to three Performer personnel (ex: project manager and technical developers) may be required to support technical demonstrations and training at DoD facilities in the United States. Travel to locations may be required for prototype demonstrations and meetings, to professional and DoD conferences, and to qualify or audit a component or material supplier.

8.0 CONSTRAINTS

Research under this award involving the use of animals, shall not begin until the Animal Care Use and Review Office (ACURO) provides authorization that the research may proceed. Written approval to begin research shall be issued from ACURO, under separate notification to the recipient. Written approval from ACURO is also required for any sub-awardee that shall use funds from this award to conduct research involving animals.

Research under this award involving the use of human subjects, to include the use of human tissues or identifiable private information, shall not begin until ORRC provides authorization that the research may proceed. Written approval to begin research shall be issued from ORRC, under separate notification to the recipient. Written approval from ORRC is also required for any sub-awardee that shall use funds from this award to conduct research involving human subjects or human tissues.

Specific Requirements Providing medical oxygen near the point of injury and throughout casualty care will be crucial in future conflicts, especially in contested environments. Oxygen delivery capabilities will enable prolonged care, potentially reducing logistical and resupply burdens. Devices must be lightweight, reliable, minimize power consumption, and function in austere forward operating environments with limited infrastructure.

Device Requirements: COGM and COGM-A Oxygen Generators These requirements outline the required and desired attributes and performance objectives for two oxygen generator devices: COGM and COGM-A. Attributes apply to both unless otherwise specified.

1. General Attributes:

• FDA Clearance: Must be designed to obtain FDA-clearance

• Oxygen Purity: Must generate United States Pharmacopeia (USP) oxygen at 93% ± 3% purity, with a desired purity of 99%.

• Adjustable Flow Rate:

o COGM: Must have 3-7 liters per minute (LPM), with a desired range of 3-15 LPM.

o COGM-A: Must have 3-15 LPM.

• Size:

o COGM: Must fit securely in a space 4.3 inches in diameter and 19 inches long.

o COGM-A: Must fit securely in a space 5 inches in diameter and 20 inches long.

• Weight: Must be less than or equal to 24 pounds, with a desired weight of less than or equal to 15 pounds.

• Power: Must have 110/220 VAC, 60-400 Hz, and 10-28 VDC.

• Interface: Must be button-based physical interface and visual display showing flow rate, pressure, battery life, remaining volume, and time-to-empty at the current flow rate.

• Battery: Must have rechargeable battery providing 2 hours of operation at room temperature on battery power, with ability to utilize vehicle power. Battery must recharge without interrupting oxygen production. A rechargeable, hot-swappable battery providing 3 hours of operation at room temperature on battery power, with ability to utilize vehicle power is desired. Battery must recharge without interrupting oxygen production.

• Outlet Pressure (COGM-A only): Must have 55 ± 5 pounds per square inch (psi).

2. Functional Attributes:

• Operational Availability: Must have at least 95% according to service guidelines (e.g., Army Regulation (AR)-220-1, Army Unit Status Reporting and Force Registration – Consolidated Policies (Attachment J)), 98% is desired.

• Airworthiness/Safe to Fly: Must be designed to attain airworthiness release on Service aeromedical evacuation aircraft.

• Reliability/ Mean Time Between System Abort (MTBSA): Must have 87% probability of completing a 72-hour operation (48.75 run-time hours) without System Abort, or a MTBSA of 350 hours. A 90% probability of completing a 72-hour operation (48.75 run-time hours) without System Abort, or a MTBSA of 462 hours is desired.

• Oxygen Recapture: For products prone to oxygen supply depletion through natural off-gassing; the device must have the option or ability to capture and reuse oxygen released through off-gassing to reduce waste. The ability to completely eliminate waste is desired.

• Surface Temperature (COGM-A only): External surface temperature and user interfaces must remain between 32°F and 120°F during prolonged contact (2+ minutes).

Surfaces outside this range must be guarded.

3. Interoperability Attributes:

• Standard Fittings; Modular Open System Architecture (MOSA):

o COGM: Must utilize standard fittings and tubing for oxygen generation and supply. Able to integrate with Aeromedical Evacuation devices/systems as needed (e.g., ventilators, etc.).

o COGM-A: Must utilize standard fittings and tubing for oxygen generation and supply and enable integration with aeromedical evacuation systems via wired connections only, both wired and wireless connections desired.

• Closed-Loop Control Integration (COGM-A only): Must have technical capability and option to interface with closed loop control systems through an input/output (I/O) port and existing on-board hardware through external software controller(s). Interface through built-in software is desired.

• Net Ready (COGM-A only): Must have ability to interface with closed loop control systems on a local network by a wired connection. Ability to interface with closed loop control systems on an open network by a wireless connection that can be switched on and off is desired.

4. Maintainability Attributes:

• Serviceability: Must be serviceable and maintainable by Biomedical Technicians

(BMETs) with standard training following the OEM’s Service Manual and initial OEM specific training. However, not needing specialized OEM training for BMETS (and without voiding the warranty), or standard training following the OEM’s Service Manual, is desired.

• Repair Time: Must have a maximum Time to Repair for 90% of unscheduled field-level maintenance (MaxTTR-90) is within 2 hours, with a desired time of 1 hour.

• Replaceable Parts: Expendable maintenance parts (e.g., filters, batteries) must be BMET replaceable. User-level replacement is desired.

• Software Updates: System software that may require modification must be upgradable in the field by BMETs without changing hardware components. Updates must be regressions tested not render existing devices non-functional if installed. Software upgradable in the field by end users is desired.

• Support: Parts, consumables, supplies, and software updates must be available for purchase.

o COGM: Supported for the determined lifecycle.

o COGM-A: Supported for at least 7 years after the last system sale, with a desired support period of 8 years.

5. Storage Attributes:

• Shelf Life: Must have a minimum 12-month useful life in open storage with standard care. A shelf-life if 18 months is desired.

• Environmental Tolerance: Devices and components must withstand storage, transit, and operation in 95% humidity at 106°F for 24 hours without degradation. The ability to withstand for 72 hours with no degradation is desired.

9.0 GOVERNMENT FURNISHED PROPERTY

This requirement will not use Government Furnished Property.

10.0 DELIVERABLES

Method of Delivery: Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS Word, MS Excel, MS PowerPoint, MS Project, or MS Access format), unless otherwise specified by the Defense Health Agency (DHA) Agreement Specialist (AS) or Agreements Officer’s Representative (AOR). Electronic submission shall be made via email, unless otherwise agreed to by the DHA AOR. The Performer shall make use of commercial best practices in the packing and shipment of packages.

Item/ Deliverable

SOO

Reference Distribute to Format Initial Subsequent

1. Kick-Off Meeting & Minutes Obj 1 AS and AOR Virtual/

Electronic

NLT 10 days after the award.

Minutes NLT 7 days after the meeting occurs

N/A

2. Project Management Plan (includes IMS, Staffing Plan, Risk Management Plan, Spend Plan, and Quality Management Plan)

Obj 1, 3, 4 AS and AOR Electronic Upon proposal submission

As needed as part of monthly reports

3. Monthly Reports including any updates to the PMP and Strategic Plans

Obj 1, 3, 4 AOR Electronic The 1st day of the 3rd month Monthly

4. Monthly Invoices Obj 1 AOR Electronic Last day of the month Monthly

5. Recurring Status Meetings and Minutes

Obj 1 AOR Virtual/ Electronic

NLT 30 days after the 1st monthly report submission

Minutes NLT 7 days after the meeting occurs

Monthly

6. Site visits Obj 1 AOR In person Prior to end of 1st year Annually

7. Prototype Devices for Government Testing and Evaluation

Obj 2 AOR Physical Delivery

Target 12 months after award

As requested

SOO

Reference Distribute to Format Initial Subsequent

8. MDERA Form Draft Obj 2 AOR Electronic

Target 12 months after award

As requested

9. Final Technical Summary Report Obj 2 AOR Electronic

Draft within 6 months of project completion.

Final report within 2 weeks of project completion.

10. Quality Management Plan Obj 3 AOR Electronic Upon proposal submission Updated annually

11. Manufacturing and Commercialization Plan

Obj 3 AOR Electronic Upon Proposal Submission

Draft within 6 months of project completion.

Final report within 2 weeks of project completion.

12. Regulatory Strategy; IAW DID

# DI-TCSP-82040

Obj 4 AOR Electronic Upon Proposal Submission

Updated annually

13. Draft Regulatory Submissions Materials

Obj 4 AOR Electronic 2 weeks prior to FDA submission N/A

14. Final FDA submissions materials, responses and minutes; IAW DID

# DI-TCSP-82040

Obj 4 AOR Electronic Upon FDA acceptance of minutes

N/A

15. Draft and Final Test Reports Obj 4 AOR Electronic Draft results in monthly reports /

Final Reports 60 days post study completion

16. ACURO and/or ORRC Approvals Obj 4 AOR Electronic

Due before any animal or human studies

Due before any animal or human studies

17. Maintenance and Sustainment Plan

Obj 5 AOR Electronic Upon Proposal Submission

Updated Annually

18. Training Materials and User Manuals

Obj 5 AOR Electronic Target 12 months after award

Updated Annually

19. Software Bill of Materials IAW DI- SESS-82433, if applicable, CDRL A003

Obj 5 AOR Electronic Target 12 months after award

Updated Annually

SOO

Reference Distribute to Format Initial Subsequent

20. In Process Review brief Obj 6 AOR Electronic

2 weeks prior to In Process Review Brief

N/A

21. Proposal Volumes

Optional Obj 7 AOR Electronic Upon request N/A

11.0 ABBREVIATIONS

Abbreviation Definition ACURO Animal Care and Use Review Office AOR Agreements Officer’s Representative AS Agreement Specialist BMET Biomedical Medical Technician BOM Bill of Materials cGMP Current Good Manufacturing Production COGM Compact Oxygen Generation, Medical COGM-A Compact Oxygen Generation, Medical – At Altitude COIN Counter Insurgency DHA Defense Health Agency DoD Department of Defense FDA U.S. Food and Drug Administration GLP Good Laboratory Practices IACUC Institute Animal Care and Use Committee IMS Integrated Master Schedule IPR In-Process Review JADO Joint All-Domain Operations JECETS Joint Enroute Care Equipment Test Standards LPM Liters per minute LSCO Large Scale Combat Operations MDERA Medical Device and Equipment Risk Assessment MOSA Modular Open System Architecture MTBSA Mean Time Between System Abort O2 Portable Oxygen OEM Original Equipment Manufacturer OPMED Operational Medical Systems ORRC Office of Research and Regulatory Compliance OTA Other Transaction Agreement PDR Preliminary Design Review PMO Project Management Office PMP Project Management Plan PoP Period of Performance QMS Quality Management System QSR Quality System Regulation SBOM Software Bill of Materials SOO Statement of Objectives T&E Test and Evaluation TRL Technology Readiness Level TTR Time to Repair

Abbreviation Definition USP United States Pharmacopeia WEMT Warfighter Expeditionary Medicine and Treatment

10.0 DELIVERABLES

File details come from the government source that posted it. Updated .