A02-Portable-Oxygen-Carrier-COGM-RFI-Attach2-SOO.pdf

STATEMENT OF OBJECTIVES (SOO)

Original Date:

Revised Date:

Title: PORTABLE OXYGEN (O2) – COMPACT OXYGEN GENERATION MEDICAL (COGM)

DEVELOPMENTAL EFFORTS

Requiring Activity/Agency Name: Defense Health Agency (DHA), Program Executive Office Operational Medical Systems (OPMED), Warfighter Expeditionary Medicine and Treatment Project Management Office

(WEMT PMO)

Program Name: O2 - COGM

1. PURPOSE

The purpose of this SOO is to obtain oxygen generation devices that meet (i.e. Threshold level) or exceed (i.e.

Objective level) technical performance standards of the Portable Oxygen (O2) program, to provide solutions for oxygen concentration or generation and delivery for Joint Services’ requirements Roles 1-3 and en route care, providing approximately three (3) -to-seven (7) liters per minute (lpm) of medical oxygen to patients.

Improvements over existing fielded systems will include size, weight, power and reliability considerations, as well as efficiencies in varied operational environments, including temperature variability and conditions with limited infrastructure capability. The effort under this SOO will develop an approved medical device to achieve defined performance criteria, will address all relevant Regulatory criteria, will provide documentation as defined in deliverables, and will deliver prototype units for independent Government test and evaluation activities.

Portable Oxygen devices will satisfy the need for a Compact Oxygen Generation Medical (COGM) capability.

COGM capability development will be conducted in two phases:

a) Phase I. Phase I efforts will satisfy the Technology Maturation and Risk Reduction (TMRR) acquisition phase. As such, at the time of award, proposed devices should be at a technical maturity of approximately Technology Readiness Level (TRL) 4. During Phase I, developmental efforts will mature devices to TRL

6. Phase I efforts mayinclude: Develop and provide prototype devices and related documentation to support Governmental testing and evaluation (T&E) activities, planning for Food and Drug Administration (FDA) approval or clearance, and initiate certification and/or qualification efforts for all other relevant Regulatory compliance (ex. Compressed Gas Association [CGA], Department of Transportation [DOT], Occupational Safety and Health Administration [OSHA], and National Fire Protection Association [NFPA]). During this phase, T&E activities will include environmental testing (ET), an early operational assessment (OA), an initial logistics evaluation, and initial cybersecurity or Risk Management Framework (RMF) evaluation. If FDA approval or clearance is pending, the performer’s strategy will be defined and Pre-Submission documentation completed. Documentation supporting all other Regulatory compliance needed will be provided. The Government may award one or multiple contracts for the COGM. If multiple awards are made, a down-select decision will be made prior to award of the next phase.

b) Phase II. Optional award for further development of successful candidate systems from Phase I. Phase II efforts will satisfy the Engineering and Manufacturing Development (EMD) acquisition phase. As such, at the time of award (i.e. option exercise), proposed devices should be at a technical maturity of approximately TRL 6. During Phase II, developmental efforts will mature devices to TRL 8. Phase II efforts can include: Procure updated, more mature prototype devices and associated documentation updates to implement any changes needed per Phase I evaluations, and complete system validation and qualification for full compliance to all performance capabilities as demanded for deployment to military use cases. FDA clearance or approval shall be obtained within this phase if not already obtained in the previous phase, for an indication for use which addresses the entire planned patient population. Full compliance with all other applicable Regulatory requirements (ex. CGA, DOT, OSHA, NFPA) must be achieved and Airworthiness/Safe-to-Fly criteria shall be met. Governmental T&E and cybersecurity evaluation/authority to operate (ATO) will be concluded, allowing the Government to proceed to a production and deployment (P&D) decision.

c) Procurement of Production and Deployment (P&D) systems will not be included under this SOO.

However, following successful completion of Phase II efforts, the Government intends to separately award contracts for to-be-determined-quantity procurements of deployable COGM capabilities, if proper authorization and funding are in place.

The COGM will be designed for use primarily at Role 1 and en route care; however, it may be used throughout the care continuum. It must be designed for expeditionary medical use, meaning small, lightweight, durable in harsh environments, easy to maintain, highly reliable, and able to operate on batteries or other approach which precludes a need for wall power. Size, weight and power consumption are important considerations and should be minimized.

Any COGM device connectivity to a network must be capable of disconnect by users, with no degradation in delivery of oxygen to patients. Modularity of device components for ease of maintenance is a plus; for example, to allow providers to change out filters or batteries in far-forward deployed conditions. The COGM must be FDA approved and certified as airworthy/safe to fly for all hardware items, which will remain with patients during patient movement (i.e. carry on medical devices).

2. BACKGROUND

In contrast to recent Counter Insurgency (COIN) Operations, future Large-Scale Combat Operations (LSCO) conducted during Joint All-Domain Operations (JADO) will generate casualties in numbers not seen since World War II. Medical providers with varied medical expertise, ranging from Medics to Nurses or Medical Doctors, must be able to easily employ and maintain the COGM in support of prolonged care as far forward as Role 1 and en route care. Reliable availability of medical oxygen will facilitate patients’ recovery and prevent potentially irreversible vital organ damage in resource-constrained environments. A common solution across the Joint Services will facilitate patient movement and patient hand-offs between Services throughout the care continuum.

3. SCOPE/MISSION

The Consolidated Performance Parameters (CPPs) define the end state capability the COGM must be able to achieve, following all developmental activities. Throughout developmental phases for the COGM, the Performer will conduct effort required for the end state capability. Details within this SOO regarding Phases I and II are intended to characterize anticipated efforts, however, they should be read as “may include but not limited to”, rather than as finite constraints. All effort under Phase I which is needed to mature capability from TRL 4 to TRL 6 is considered in scope. All effort under Phase II which is needed to mature capability from TRL 6 to TRL 8 is considered in scope. Should the Performer identify tasking needed to achieve these ends, which are not overtly stated in language under this section, it may be proposed.

A) Phase I of this effort will support TMRR. The minimum TRL for entry into this phase is approximately 4, i.e.

proof-of-concept and safety of candidate devices/systems must be demonstrated, and a design history file initiated to support an eventual submittal to the FDA, such as 510(k) or de novo. The prototype system or device must continue maturing toward:

• Reliable delivery of oxygen to patients within specifications defined in performance parameters

• Ability to connect to or interface with ventilators and/or oxygen mask, nasal cannula, or the like

• Visual indicator of flow rate, pressure, battery life, and remaining oxygen volume

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

• Planning for any software updates, as needed, must include regression testing, and will allow users to determine timing for adoption of updates and precluding rendering devices inoperable if they have not been updated to the latest available software revision

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

• Ruggedization to function in far-forward extreme environments

Additional effort in the Phase I:

• Planning for FDA approval or clearance, including toward a Submission package

• Planning for other Regulatory (ex. CGA, DOT, OSHA, NFPA) compliance and/or certifications, as applicable

• Initial documentation to support development of Government sustainment planning, including training and maintenance

• Initial documentation to support initiation of cybersecurity compliance verification

• Rough Order Magnitude (ROM) production cost estimates, in accordance with Contract Data Requirements

List (CDRL)

• Submission of any inventions/Intellectual Property (IP) claimed under this contract via iEdison

• Meetings and reporting per defined deliverables

The performer(s) shall deliver prototype devices. Independent Government T&E will confirm progress toward operational and transport/storage capability in accordance with Services’ needs and per testing conditions as defined in MIL-STD-810H. Initial evaluation of cybersecurity considerations will confirm suitability to operate within military domains and/or identify modifications needed for compliance; any modifications to the design may be accomplished in Phase II. The Government will conduct an early User and Maintainer operational assessment to evaluate suitability for use in all anticipated environments, such as hot/cold, lit/unlit, wet/dry, powered/unpowered, and including alert or warning indicators, protective gear compatibility and other criteria, as needed. All T&E activities will inform further development efforts needed under Phase II, EMD activities.

Supporting documentation from the manufacturer/performer shall include:

• Initial sustainment planning documentation, including planned maintenance, draft user and maintainer manuals, quick-start guide, availability of replacement parts, software update planning, if applicable, and initial training development

• Documentation regarding FDA Regulatory clearance/approval in accordance with Data Item Description (DID) # DI-TCSP-82040, Title: RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA). Reference DID found in references appendix, at ASSIST-QuickSearch Document Details (dla.mil)

• Documentation regarding other Regulatory requirements (ex. CGA, DOT, OSHA, NFPA), as needed

• Test and evaluation summary reports

Please note, the above bulletted list is expected to be initial or preliminary as of Phase I; final revisions will be included as effort under Phase II.

At the end of the Phase I, the system or device must achieve a minimum TRL of 6, i.e. a fully functional prototype, demonstrated to interface with any supporting systems, and compliant with a simulated operational environment.

During Phase I, all effort necessary to mature the end item toward eventual compliance with performance parameters identified in the CPPs document is considered in scope, and may be proposed. Also note, the performer should propose efforts across Phases I and II in a way that is logical and most efficient from a perspective of its product; if a detail in Phase I planning partially addresses maturing the product to a TRL higher than 6, this would not render that effort out of scope. The TRL guidelines are not absolutes, and tailoring is appropriate.

If more than one contract was awarded for the COGM, the Government will down-select prior to awarding the Phase II efforts.

B) The Phase II, optional, phase of this effort will support EMD and will be awarded following a successful Milestone B decision. Efforts during this phase will further develop prototypes completed during Phase I, refining device functionality, form factor, ruggedization, and any needed improvements for final design. The performer(s) will deliver updated prototype devices. Supporting documentation will be updated, including guides, manuals and drawings, and all other supporting documentation as noted in Phase I details. Additionally, training and software update development and plans will be finalized, and planning for a Configuration Control Board will be required.

Independent Government T&E will confirm final compliance with all performance parameters, environmental and cybersecurity standards, airworthiness/safe to fly (in accordance with Joint Enroute Care Equipment Test Standards [JECETS] and AR 70-62), a logistics evaluation, and suitability for use via an operational assessment. Finalized FDA submission will be completed and clearance/approval must be obtained and manufacturability demonstrated.

All other relevant Regulatory compliance (ex. CGA, DOT, OSHA, NFPA) requirements must be completed and https://quicksearch.dla.mil/qsDocDetails.aspx?ident_number=281528 documented. The COGM must achieve a minimum TRL of 8, i.e. a final product proven to work in its final form and under expected conditions. An ATO will be requested for all scenarios in which the items will be employed.

All effort which serves to achieve the above goals is appropriate, and may be proposed.

C) Following a successful EMD Phase II, the Government intends to separately contract for production quantities of COGM, if proper authorization and funding are in place. Production is not included in scope for this solicitation.

4. PERFORMANCE OBJECTIVES – BASE TASKING – TMRR PHASE I

4.1 Developmental Effort

Provide program management, engineering, quality management, regulatory and other expertise required to achieve the Scope as defined in section 3, (A) Phase I, including device capabilities, additional efforts and supporting documentation. Ensure adequate time is planned for expertise in providing detailed support and iterative responses related to documentation requirements. Estimates for expertise should pay particular attention not only to engineering developmental activities for design and test of items, but should also include focus on cybersecurity/RMF documentation, FDA and/or other regulatory documentation and other data or reporting requirements.

4.2 Performance Parameters

Reference document titled, “Portable Oxygen (O2) Consolidated Performance Parameters (CPPs)” for detailed critical and desired performance parameters. This referenced document is part of this solicitation package.

4.3 FDA Regulatory Concerns

FDA clearance/approval is a critical parameter and must be achieved as of conclusion of all developmental activities. Documentation regarding FDA Regulatory clearance/approval shall be provided in accordance with DID # DI-TCSP-82040, Title: RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA). Reference the DID found in the references appendix, at at ASSIST-QuickSearch Document Details (dla.mil) During Phase I, efforts which must be completed are:

• An Indication for Use which suffices device use in the referenced care continuum (Roles 1-3, en route care), for adults (age 18-65) and all demographics in Military populations.

• The Performer shall be the FDA regulatory sponsor in accordance with Code of Federal Regulations (CFR) Title 21 Food and Drugs, and shall designate the Government as a co-sponsor.

• The Performer should submit a high-level draft FDA Regulatory Strategy in accordance with (IAW) MRMC DID DI-TCSP-82040 (Deliverable 3) with the proposal and update as requested. The Regulatory Strategy should include a schedule with corresponding regulatory activities.

• The Performer shall prepare a Pre-Submission package to the FDA for a Good Laboratory Practices (GLP) protocol, intended to support the clearance/approval of their product. The package, at a minimum, should include: protocol, questions for the FDA, applicable bench studies and data, as well as a validated animal model, if applicable. The GLP protocol, and the facility executing the protocol, shall be in compliance with 21 CFR Part 58. The Pre-Submission packet shall be provided to DHA OPMED for review, and the Performer shall make adjustments as necessary.

• Document and provide detail plans for any clinical trials needed to demonstrate safety and efficacy, all documentation needed in support of clinical trials, and a timeline to accomplish approval no later than 2029.

• The Performer shall include the DHA OPMED Contract Officer’s Representative (COR), or his/her designee, in all meetings both formal and informal with the FDA. It is the intention of the Government to be present (physically whenever possible or via Performer-provided teleconferences) for all meetings and discussions with the FDA. Whether the Government can or cannot attend, detailed notes will be provided to the Government by the Performer. Copies of notes and regulatory communications from the FDA shall be sent to the COR within three (3) days of occurrence or receipt. The Performer shall provide copies of all communications, to include meeting minutes, emails, and letters, to the FDA within five (5) business days (Deliverable 13). If submissions have occurred prior to contract award, the Performer shall provide copies of any submissions to date.

• Provide copies of formal minutes from all FDA meetings or calls.

https://quicksearch.dla.mil/qsDocDetails.aspx?ident_number=281528

• For any/all clinical trials and/or studies, apply for approval from the Office of Human and Animal Research Oversight (OHARO) to ensure compliance with all protocols; trials or studies shall not commence in advance of formal approval.

• Plan for and initiate compliance with current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) per 21 CFR Part 820, in preparation for eventual production capability.

• In the event that data from the GLP animal studies or feedback from the FDA requires additional studies and/or data, the Performer may propose the necessary work.

During Phase II, full execution of the FDA Regulatory Strategy must be completed, including updates to all relevant documents from Phase I, and FDA clearance/approval must be obtained.

4.4 Other Regulatory Compliance

Documentation shall be provided to the Government for all additional Regulatory compliance, as needed (ex. CGA, DOT, OSHA, NFPA). Planning, status updates and estimated completion timelines shall be documented and submitted as part of the monthly reports deliverable.

4.5 Cybersecurity Compliance

As part of its cybersecurity assessment, the Government will evaluate device cyber risks. During Phase I, feedback from the assessment will be provided to the performer to allow for any corrections needed. During Phase II, any corrections must be implemented and verified, for the Government to be able to obtain an ATO. If the Government is unable to obtain an ATO, the end items will not be fieldable, and procurement of production quantities will not follow. As such, expertise to provide iterative feedback to the Government, as well as to implement any corrections, must be included as part of both the Phase I and Phase II efforts.

Note, documentation submitted shall include drawings/schematics and data flow diagrams sufficient for cybersecurity assessment, in accordance with the Medical Device and Equipment Risk Assessment (MDERA) (see Attachment 5). Reference the MDERA for additional details surrounding expected compliance considerations.

If applicable, the Performer shall generate and deliver Software Bills of Materials (SBOMs) for all code, software components and subcomponents, and software-based services delivered under this contract, including firmware, operating systems, applications, and application services, including cloud-based software. Full details that include the scope, inventory and reporting, emerging threats and self-attestation can be found in References, Software Bills of Material.

4.6 Logistics and Sustainment Capabilities

Provide logistics and training expertise required to achieve the Scope of Effort as defined in section 3, (A) Phase I.

Documentation shall include:

• Initial user guide,

• Initial quick start guide,

• Initial maintenance and repair manual defining maintenance actions and intervals, as well as step-by-step trouble-shooting guidelines, schematics, and identification of high-failure parts (if any),

• Initial user training development,

• Initial maintainer training development, including any OEM or other certifications needed by Government maintainers,

• Release for Government to duplicate and/or post training materials to Government websites for use by

Government users, maintainers and/or repair technicians,

• Recommended maintenance and repair kits, including estimated costs and any minimum buys,

• Shelf life estimate of any consumables and/or maintenance parts,

• Life expectancy of the devices based on wear and tear and/or repair part obsolescence

• Summary plan for OEM support, identifying capabilities which will be planned for long-term support (i.e.

this planning would include efforts such as repair capability, technical support, etc.),

• Initial parts catalog or other ordering methodology for consumables, maintenance and repair parts, including part numbers

• Defined software update methodologies, if applicable, including anticipated intervals for updates,

• Release for Government to post software updates on CECOM and/or other Government website, to allow for field updates of software releases,

• Mean Time Between Failure (MTBF) and Mean Time to Repair (MTTR) data, if available,

• Initial user and maintainer manuals, and device quick start guide shall be submitted for review and comment. Updates shall be made to address comments.

4.7 T&E – Performer Activities

Test and evaluation summary reports shall be included with monthly reports. Performer format is acceptable.

4.8 Government T&E

Government T&E activities will include ET, an early OA, an initial logistics evaluation, and initial cybersecurity or RMF evaluation. The Government will not share the detailed reports with the Perfomer. However, information from the reports will be summarized and provided to the Performer to the extent needed for the Performer to understand any shortfalls with respect to expected compliance for this effort.

4.9 Monthly Meetings and Reports

A) The Performer shall provide monthly reports and monthly program update meetings for the Government.

Performer format is acceptable; however, note, minimum content shall include:

• Technical status and plans

• Regulatory status and plans

• Integrated master schedule (in electronic format), to a level sufficient for demonstrating feasibility of achieving required delivery dates

• Financial status and monthly billing estimate to the end of the period of performance (PoP)

• Summary of all deliverables, including actual or estimated delivery dates and documented Government acceptance dates

• Summary of issues and mitigation plans

Monthly meetings shall generally be via MS Teams or alternate application which allows remote verbal, video and screen-sharing capability, and which is accessible by Government participants. The Performer shall be available to host Government monthly meetings at its site a minimum of two times per year.

Read-ahead monthly reports shall be provided to the Government a minimum of two work days prior to the scheduled meetings. Following all monthly meetings, the Performer shall provide draft minutes to the Government within five work days after the meetings. Performer format is acceptable; however, content shall include an agenda of topics covered, a summary of attendees including organization and functional role for each, a summary of discussions, and action items. The minutes shall not be considered final until approved by the Government.

B) Preliminary Design Review (PDR) A one-time PDR shall be conducted, as an in-person meeting at the Performer’s facility, to evaluate the feasibility of the design, and to identify any potential issues or challenges that may need to be addressed.

4.10 TAA Compliance

All end items must be TAA Compliant/Comply with Trade Agreements Act. Reference DFARS 252.225-7021 Trade Agreements/federal government procure only “U.S.-made or designated country end products.” To be TAA compliant, a product or service must be made or “substantially transformed” in the U.S. or a designated/approved country. Link: DFARS 252.225-7021

4.11 Inventions/Intellectual Property (IP) Reporting

Any inventions and/or IP claimed under this contract must be reported via iEdison, at https://www.nist.gov/iedison.

Also, provide a brief summary of any submittals in the Monthly Report.

4.12 Rough Order Magnitude (ROM) Production Unit Costs

Following delivery of Prototype devices, Performer shall submit estimated ROM costs for production of COGM devices as well as any subcomponents or parts requiring replacement as part of regular maintenance (ex. filters, sieve beds, batteries). Estimates should be provided in current year dollars, with a fidelity of +/- 20%.

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

4.13 Optional Complementary Equipment

The Offeror may propose any optional equipment which complements its device, to enhance COGM usability, sustainment, and/or maintainability. Such optional offering shall be included on its own CLIN, and shall be costed separately from other efforts and deliverables. This allows for offering novel approaches which would optimize use of the COGM generator capabilities, is completely optional, and if left blank will not count as a failure to meet other requirements, nor as a weakness.

COGM Deliverables – TMRR Phase I Item Description Quantity or

Frequency Due** Government

Review Period

Final Updates Due

1 Prototype COGM Devices * 8 Target 9 mo.

after award n/a n/a

2 Initial Operator User Manual 1 (electronic)

Target 9 mo.

after award

30 days 30 days

3 Initial Maintenance and Repair Manual

(electronic)

Target 9 mo.

after award

30 days 30 days

4 Initial Quick Start Guide 1 (electronic)

Target 9 mo.

after award

15 days 15 days

5 Drawings and Schematics to support cybersecurity assessment

(electronic)

Target 9 mo.

after award

30 days 30 days

6 Completed MDERA form 1 (electronic)

Target 9 mo.

after award

30 days 30 days

7 Listing of high usage and/or high failure parts, including projected replacement intervals, part numbers and pricing, shelf life, device product useful life, any minimum buys;

including recommended maintenance kit and repair parts kit

(electronic)

Target 12 mo.

after award

30 days 30 days

7 Software update methodology and plan, if applicable

(electronic)

Target 9 mo.

after award

30 days 30 days

8 Monthly Report – reference sections 4.10, 4.7, 4.4, and 4.11 for minimum required content

Monthly 2 workdays prior to monthly meeting

5 working days

5 working days

9 Monthly Meeting Monthly Beginning approx. 1 mo.

after award n/a n/a

10 Meeting Minutes Monthly 5 workdays after each monthly meeting

10 working days

10 working days

11 Inventions/IP reporting, in accordance with section 4.11

As needed Final report due one month prior to PoP end

30 days 30 days

12 Development of initial user and maintainer training

(electronic)

18 mo. after award

30 days 30 days

13 CDRL A001: FDA Pre-Submission documentation and plan, in accordance with DID DI-TCSP-82040

As needed per CDRL/

DID

As needed per

CDRL/DID

30 days 30 days

14 CDRL A002: ROM Production Unit Cost Estimates

(electronic)

18 mo. after award

10 working days

10 working days

15 CDRL A003: Software Bill of Materials

(electronic)

Target 9 mo.

after award

30 days 30 days

16 Optional: Complementary Equipment, in accordance with section 4.13

8 Target 9 mo.

after award n/a n/a

* Prototype COGM Device includes (i.e. configuration for each item):

- Fully configured oxygen generator for medical purposes

- Reusable, ruggedized shipping container, if applicable

- Twelve (12)-month supply of any consumables required for use

- Cables, power cords and other such equipment items necessary for power, network connectivity, recharging batteries, and any proprietary cables or connectors needed to operate or maintain the device

- Equipment quick-start guide

- Proprietary equipment or tools, if any, required to maintain or repair device Note that any Optional Complementary Equipment items should be separately defined in the system configuration, and should be separately costed in the cost section of the proposal.

** All dates noted are preliminary and/or targets; due dates and timelines will change according to proposed, and will be reflected in awarded contracts.

5. PERFORMANCE OBJECTIVES – OPTIONAL TASKING – EMD PHASE II

Note: If the Performer had been awarded Phase I tasking for COGM capabilities, the Government may choose to exercise optional tasking for the EMD Phase II. However, the Government may choose to not award Phase II.

5.1 Developmental Effort

Provide program management, engineering, quality management, regulatory and other expertise required to achieve the Scope as defined in section 3, (B) Phase II, including device capabilities, additional efforts and supporting documentation. Ensure adequate time is planned for expertise in providing detailed support and iterative responses related to documentation requirements. Estimates for expertise should pay particular attention not only to engineering developmental activities for design and test of items, but should also include focus on cybersecurity/RMF documentation and FDA and/or other regulatory documentation.

5.2 Performance Parameters

Reference document titled, “Portable Oxygen (O2) Consolidated Performance Parameters (CPPs)” for detailed critical and desired performance parameters. This referenced document is part of the solicitation package.

5.3 Regulatory Concerns

FDA approval/clearance is a critical parameter and must be achieved. During Phase II, all efforts begun under Phase I must be successfully completed, resulting in FDA clearance/approval. Reporting to be completed includes:

• A final indication for use

• Documented completion of all items within the Regulatory Strategy

• A finalized FDA Submission package, in accordance with DID # DI-TCSP-82040, Title: RESEARCH

AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG

ADMINISTRATION (FDA).

• Documented completion of any clinical trials needed to demonstrate safety and efficacy, all documentation needed in support of clinical trials, and a timeline to accomplish approval no later than 2029.

• The Performer shall include the DHA OPMED COR, or his/her designee, in all meetings both formal and informal with the FDA. It is the intention of the Government to be present (physically whenever possible or via Performer provided teleconferences) for all meetings and discussions with the FDA. Whether the Government can or cannot attend, detailed notes will be provided to the Government by the Performer.

Copies of notes and regulatory communications from the FDA shall be sent to the COR within three (3) days of occurrence or receipt. The Performer shall provide copies of all communications, to include meeting minutes, emails, and letters, to the FDA within five (5) business days (Deliverable 13). If submissions have occurred prior to contract award, the Performer shall provide copies of any submissions, to date.

• Provide copies of formal minutes from all FDA meetings or calls.

• For any/all clinical trials and/or studies, any updates to protocols or plans must be approved by the

OHARO in advance of formal approval or implementation.

• Documented compliance with cGMP and QSR per21 CFR Part 820, in preparation for eventual production capability.

• In the event that data from the GLP animal studies or feedback from the FDA requires additional studies/data, the Performer may propose the necessary work.

During Phase II, full execution of the Regulatory Strategy must be completed, including updates to all relevant documents from Phase I, and FDA clearance/approval must be obtained.

5.4 Other Regulatory Compliance

Documentation shall be provided to the Government for all additional Regulatory compliance, as needed (ex. CGA, DOT, OSHA, NFPA). Planning, status updates and estimated completion timeline shall be documented and submitted as part of the monthly reports deliverable. Fully documented compliance must be achieved by 2029.

5.5 Cybersecurity Compliance

As part of its cybersecurity assessment, the Government will evaluate device cyber risks. During Phase II, any risk mitigation corrections must be implemented and verified, for the Government to be able to obtain an ATO. If the Government is unable to obtain an ATO, the end items will not be fieldable, and procurement of production quantities will not follow. As such, expertise to provide iterative feedback to the Government, as well as to implement any corrections, must be included as part of both the Phase I and Phase II efforts.

Note documentation submitted shall include drawings/schematics and data flow diagrams sufficient for cybersecurity assessment, in accordance with the MDERA (see Attachment 5). Reference the MDERA for additional details surrounding expected compliance considerations.

If applicable, the Performer shall generate and deliver SBOMs for all code, software components and subcomponents, and software-based services delivered under this contract, including firmware, operating systems, applications, and application services, including cloud-based software. Full details that include the scope, inventory and reporting, emerging threats and self-attestation can be found in References, Software Bills of Material.

5.6 Logistics and Sustainment Capabilities

Provide logistics and training expertise required to achieve the Scope as defined in section 3, (B) Phase II.

Documentation shall include:

• Finalized user guide,

• Finalized quick start guide,

• Finalized maintenance and repair manual defining maintenance actions and intervals, as well as step-by-step trouble-shooting guidelines, schematics and identification of high-failure parts (if any),

• To obtain finalized versions of user and maintainer manuals, and device quick start guide, documents shall be submitted to the Government for review and comment. Updates shall be made to address comments.

• Finalized user training development,

• Finalized maintainer training development, including any OEM or other certifications needed by

Government maintainers,

• Release for Government to duplicate and/or post training materials to Government websites for use by

Government users, maintainers and/or repair technicians,

• Recommended maintenance and repair kits, including estimated costs and any minimum buys,

• Shelf life of any consumables and/or maintenance parts,

• Life expectancy of the devices based on wear and tear and/or repair part obsolescence,

• Finalized summary plan for OEM support, identifying capabilities which will be planned for long-term support (i.e. this planning would include efforts such as repair capability, technical support, etc.),

• Parts catalog or other ordering methodology for consumables, maintenance and repair parts, including part numbers,

• Defined software update methodologies, including anticipated intervals for updates,

• Release for Government to post software updates on CECOM and/or other Government website, to allow for field updates of software releases, if applicable,

• MTBF and MTTR data, if available,

• Finalized configuration control board planning, including a provision for Government participation (see

5.7),

• User and maintainer manuals, and device quick start guide shall be submitted for review and comment.

Updates shall be made to address comments.

5.7 Configuration Control Board (CCB) Planning

Following completion of all RDTE activities, the Government intends to field equipment items (Note: procurement and fielding are not included in scope of this solicitation.) Over the duration of long-term equipment item usage, configuration changes may result from parts obsolescence, safety considerations, software updates, performance improvements, materials changes, or any number of reasons for engineering change proposals (ECPs). Class 1 ECPs are those which would change form, fit or function of the end items. Class II ECPs are for all other changes.

The Government shall have the following authorities with respect to ECPs:

• Concur/non-concur with designation as Class I or Class II

• Approval authority for all Class I changes

During the RDTE phase, the Performer shall submit its finalized plan for the CCB.

5.8 T&E – Performer Activities

Test and evaluation summary reports shall be included with monthly reports. Performer format is acceptable.

5.9 Government T&E

Government T&E activities will include ET, an OA, a logistics evaluation and cybersecurity or RMF evaluations.

The Government will not share the detailed reports with the Perfomer. However, information from the reports will be summarized and provided to the Performer to the extent needed for the Performer to understand any shortfalls with respect to expected compliance for this effort. All efforts required to achieve compliance with required system performance is considered in scope.

5.10 Monthly Meetings and Reports

A) The Performer shall provide monthly reports and monthly program update meetings for the Government.

Performer format is acceptable; however, note minimum content shall include:

• Technical status and plans

• Regulatory status and plans

• Integrated master schedule (in electronic format), to a level sufficient for demonstrating feasibility of achieving required delivery dates

• Financial status and monthly billing estimate to the end of the PoP

• Summary of all deliverables, including actual or estimated delivery dates and documented Government acceptance dates

• Summary of issues and mitigation plans

Monthly meetings shall generally be via MS Teams or alternate application which allows remote verbal, video and screen-sharing capability, and which is accessible by Government participants. The Performer shall be available to host Government monthly meetings at its site a minimum of two times per year.

Read-ahead monthly reports shall be provided to the Government a minimum of two work days prior to the scheduled meetings. Following all monthly meetings, the Performer shall provide draft minutes to the Government within five work days after the meetings. Performer format is acceptable, however, content shall include an agenda of topics covered, a summary of attendees including organization and functional role for each, a summary of discussions, and action items. The minutes shall not be considered final until approved by the Government.

B) Critical Design Review (CDR) A one-time CDR shall be conducted, as an in-person meeting at the Performer’s facility, prior to finalization of design files.

5.11 Item Unique Identification (IUID)

For any items which meet or exceed thresholds defined in Defense Federal Acquisition Regulation Supplement (DFARS) 252.211-7003 Item Unique Identification and Valuation, the Performer shall provide its plan for implementation of IUID marking and registry.

5.12 TAA Compliance

All end items must be TAA Compliant/Comply with Trade Agreements Act. Reference DFARS 252.225-7021 Trade Agreements, federal government procure only “U.S.-made or designated country end products.” To be TAA compliant, a product or service must be made or “substantially transformed” in the U.S. or a designated/approved country. Link: DFARS 252.225-7021

5.13 Inventions/Intellectual Property (IP) Reporting

Any inventions and/or IP claimed under this contract must be reported via iEdison, at https://www.nist.gov/iedison.

Also, provide a brief summary of any submittals in the Monthly Report.

5.14 Rough Order Magnitude (ROM) Production Unit Costs

Following delivery of Prototype devices, Performer shall submit estimated ROM costs for production of COGM devices as well as any parts requiring replacement as part of regular maintenance (ex. filters, sieve beds, batteries).

Estimates should be provided in current year dollars, with a fidelity of +/- 10%.

5.15 Manufacturing Scale-Up Plan

Following CDR the Performer shall submit a Manufacturing Scale-Up Plan. Contractor format is acceptable;

however, minimum content is to reflect:

• Places of performance, including status of any personnel and facilities certifications needed

• Supply management plan, including sources for all unique and/or critical parts

• Estimated timeline for staffing, including hiring (if needed), staff training, and what effort will be out-sourced

• Estimated timeline for quality system planning and implementation

• Estimated timeline for test/evaluation/certification capabilities to support production volumes

Further details surrounding this planning shall be discussed by the Performer and Government team at the CDR;

Government will provide estimated volumes and timeline needs at the CDR.

5.16 Optional Complementary Equipment

The Offeror may propose any optional equipment which complements its device, to enhance COGM usability, sustainment, and/or maintainability. Such optional offering shall be included on its own CLIN, and shall be costed separately from other efforts and deliverables. This allows for offering novel approaches which would optimize use of the COGM generator capabilities, is completely optional, and if left blank will not count as a failure to meet other requirements, nor as a weakness.

COGM Deliverables – EMD Phase II

Frequency Due** Government

Review Period

Final Updates Due

1 Prototype COGM Devices * (for T&E)

8 Target 9 mo.

after award n/a n/a

2 Final form COGM Devices * (for A/StF testing)

4 Target 18 mo.

after award n/a n/a

3 Final Operator User Manual 1 (electronic)

Target 9 mo.

after award

30 days 30 days

4 Final Maintenance and Repair Manual 1 (electronic)

Target 9 mo.

after award

30 days 30 days

5 Final Quick Start Guide 1 (electronic)

Target 9 mo.

after award

15 days 15 days

6 Drawings and Schematics to support cybersecurity assessment

(electronic)

Target 9 mo.

after award

30 days 30 days

7 Completed MDERA form 1 (electronic)

Target 9 mo.

after award

30 days 30 days https://www.govinfo.gov/content/pkg/CFR-2010-title48-vol3/pdf/CFR-2010-title48-vol3-sec252-225-7021.pdf https://www.nist.gov/iedison

COGM Deliverables – EMD Phase II

Frequency Due** Government

Review Period

Final Updates Due

8 Listing of high usage and/or high failure parts, including projected replacement intervals, part numbers and pricing, shelf life, device product useful life, any minimum buys;

including recommended maintenance kit and repair parts kit

(electronic)

Target 12 mo.

after award

30 days 30 days

9 Software update methodology and plan, if applicable

(electronic)

Target 12 mo.

after award

30 days 30 days

10 Monthly Report – reference sections 5.10, 5.8, 5.4 and 5.13 for minimum required content

Monthly 2 workdays prior to monthly meeting

5 working days

5 working days

11 Monthly Meeting Monthly Beginning approx. 1 mo.

after award n/a n/a

12 Meeting Minutes Monthly 5 workdays after each meeting

10 working days

10 working days

13 Inventions/IP reporting, in accordance with section 5.13

As needed Final report due one month prior to PoP end

30 days 30 days

14 Configuration Control Board plan, in accordance with section 5.7

(electronic)

Target 12 mo.

after award

30 days 15 days

15 Development of user and maintainer training

(electronic)

Target 18 mo.

after award

30 days 30 days

16 CDRL A001: FDA Pre-Submission documentation and plan, in accordance with DID DI-TCSP-82040

As needed per CDRL /

DID

As needed per

CDRL/DID

30 days 30 days

17 CDRL A002: ROM production unit cost estimates

(electronic)

Target 12 mo.

after award

10 working days

10 working days

18 CDRL A003: Software Bill of Materials

(electronic)

Target 9 mo.

after award

30 days 30 days

19 Optional: Complementary Equipment, in accordance with section 5.16

8 Target 9 mo.

after award n/a n/a

20 Item Unique Identification (IUID) Plan

(electronic)

Target 12 mo.

after award

30 days 30 days

21 Manufacturing Scale-Up Plan 1 (electronic)

TBD mo. after CDR/TBD mo.

prior to PoP end

30 days 30 days

22 Optional: Final Form Complementary Equipment, in accordance with section

5.16 (for A/StF testing)

4 Target 18 mo.

after award n/a n/a

* Prototype COGM Device includes (i.e. configuration for each item):

- Fully configured oxygen generator for medical purposes

- Reusable, ruggedized shipping container, if applicable

- Twelve (12)-month supply of any consumables required for use

- Cables, power cords, and other such equipment items necessary for power, network connectivity, recharging batteries, and any proprietary cables or connectors needed to operate or maintain the device

- Equipment quick-start guide

- Proprietary equipment or tools, if any, required to maintain or repair device

Note that any Optional Complementary Equipment items should be separately defined in the system configuration, and should be separately costed in the cost section of the proposal.

** All dates noted are preliminary and/or targets; due dates and timelines will change according to proposed, and will be reflected in awarded contracts.

6. PERIOD AND PLACE OF PERFORMANCE

The estimated period of performance for this task order is:

COGM:

Phase I – June 2025 – June 2027 Phase II – June 2027 – March 2030

COGM

Phase I: Initial or Base Period – Date of Award through 24 months of performance.

Phase II: Option Period 1– Expiration of Base Period through 30 months of performance.

The base task must be completed in order to trigger exercising the optional task. Additionally, T&E results must indicate product maturity at TRL 6 or higher (see references appendix for further details on TRL criteria). During the TMRR Phase I, the Government will use T&E and TRL results to indicate whether risk has been successfully mitigated to move into EMD, i.e. to award Phase II.

The place of performance is expected to be Offeror facilities and other locations, as needed by the Offeror, to support efforts such as clinical trials. The Offeror is to determine the place of performance in its Technical proposal.

Government T&E activities will be conducted at locations to be determined by the Government.

7. OPERATING CONSTRAINTS

The Government does not anticipate research to involve human anatomical substances or human cadavers.

The Government does anticipate research to involve human subjects.

The Government does not anticipate research to involve research involving animals.

The Offeror should articulate in the proposal whether any of the above research constraints are needed for its efforts.

CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

A CPARS assesses a contractor's performance and provides a record, both favorable and unfavorable, on a given contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Performance evaluations are transmitted into the Past Performance Information Retrieval System (PPIRS) which is used by government agencies to assess contractor past performance for future acquisitions. The contractor shall appoint a Contractor Representative (CR) and provide this information to the KO (KO) within 10 calendar days of award. The contractor POC shall have the authority to comment on the CPAR assessment on behalf of its company and within the timeframes established.

A CPARS assessment must be completed within 120 calendar days after the evaluation. Evaluations are sent to PPIRS within 14 calendar days after the government Assessing Official (AO) has submitted the rating. If the CR has not concurred/non-concurred with the rating; PPIRS will show the government evaluation as “Contractor Comment Pending Review”. The CR has a total of 60 calendar days to concur/non-concur with the assessment.

After 60 days, the CR can either concur/non-concur. The CR has the authority to: access the Government evaluation; review/comment/concur or non-concur with the assessment within 60 calendar days after notification of the government’s assessment. The CR has the right to request a meeting (in writing) with the government within 7 calendar days of notification of an assessment. Once the government and the CR complete the evaluation; an automatic update will be sent to PPIRS and visible for Source Selection. If the CR fails to respond within 60 days, the assessment will be finalized. Training for CPARS can be found on the CPARS website:

https://www.cpars.gov/index.htm.

To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate.

KEY PERSONNEL

a. Solicitation Requirement:

(1) The Government has identified the following two positions to be filled by Key Personnel. The offeror may propose alternate and/or additional positions as Key personnel.

Position Title: a) Principal Investigator (for FDA clearance/approval), b) Program Manager

(2) For all Key Personnel positions, provide an attachment naming the individuals proposed to fill Key Personnel positions along with a description of the portion of the solicitation’s Performance Work Statement that each individual is being proposed to perform.

(3) A resume is required for all individuals proposed to fill Key Personnel positions. Do not submit resumes for all labor proposed, only for those Key Personnel identified above. A signed a letter of intent is required for those individuals proposed as Key Personnel who are not current employees of the prime contractor responding to this requirement. This includes letters of intent for key personnel proposed by subcontractors, teaming partners and consultants. A letter of intent is not required for individuals proposed as key personnel who are current employees of the prime contractor.

(4) The resumes must provide thorough and detailed documentation of the…