Compact Oxygen Generation Medical Devices: Compact Oxygen Generation, Medical (COGM) and Compact Oxygen Generation, Medical – At Altitude (COGM-A)

Form / Attachment / Pricing Sheet

This document, "Attachment C: Warranties and Representations," outlines the requirements for offerors regarding the use of Other Transaction Agreements (OTAs) for prototype projects, as authorized by 10 U.S.C. 4022. It requires offerors to provide specific warranties and representations concerning their status as a nontraditional defense contractor or their proposed use of such contractors.

• Authority for OTA: Details the conditions under which an OTA can be used for prototype projects, focusing on the significant participation of nontraditional defense contractors, small businesses, or non-profit research institutes, or significant cost-sharing by non-Federal parties.
• Nontraditional Defense Contractor Definition: Provides the definition used for this agreement, specifying that such contractors have not performed on a Department of Defense contract subject to full Cost Accounting Standards (CAS) for at least one year prior to the proposal issuance date.
• Offeror Representations: Requires the Prime Offeror to state whether they are a nontraditional defense contractor.
• Information for Nontraditional Contractors: If the Prime Offeror is a traditional defense contractor, specific details are required for each proposed nontraditional defense contractor, including legal name, DUNS number, address, and point of contact.
• Significant Contribution Details: Offerors must select and describe the significant contributions of any proposed nontraditional defense contractors, categorized by:
  • Supplying new key technology, product, or process.
  • Novel application or approach to existing technology.
  • Material increase in performance, efficiency, quality, or versatility.
  • Material reduction in cost or schedule.
  • Material increase in the performance of the prototype project.
• Additional Information: Requires details on any other necessary capabilities of the nontraditional contractor, the tasks/phases where they will be used, and their total estimated cost.

This attachment is critical for bidders to understand the eligibility criteria related to Other Transaction Agreements and the specific requirements for identifying and detailing the participation of nontraditional defense contractors. Bidders must accurately complete these representations and provide the requested information to be considered compliant with the solicitation's requirements for utilizing OTAs and engaging nontraditional partners.

Amendment / Modification

This document is Amendment 0001 to the Request for Prototype Proposal (RPP) HT9427-26-R-E001 for Compact Oxygen Generation Medical Devices.

• The RPP Issue Date is listed as 22 January 2026.

• The Proposal Due Date is listed as 11 March 2026.

• The proposal due date remains 11 March 2026.

• The RPP questions due date is 6 February 2026.

Questions & Answers / Clarifications

This document provides responses to questions submitted by potential vendors regarding Solicitation HT9427-26-R-E001, Amendment 0001, concerning Compact Oxygen Generation Medical Devices (COGM and COGM-A).

• Attachment F (ROM Production Unit Cost Estimates): This attachment is a Contract Data Requirements List (CDRL), not a document containing production quantities or a period of performance. Vendors experiencing download issues are advised to try a different browser or download to their local drive.

• Device Type: The requirement can be met by either an oxygen concentrator or an oxygen generator. For Focus Area #1 (COGM), devices must provide an adjustable flow rate of 3-7 LPM. For Focus Area #2 (COGM-A), devices must provide 3-15 LPM. Both must deliver 93±3% oxygen purity.

• Form Factor & Dimensions: The device does not need to be a fixed cylinder. For COGM, dimensions must fit within 4.3" dia x 19" length. For COGM-A, dimensions must fit within 5" dia x 20" length. Batteries are included within these dimensions.

• Flow Rate: Continuous flow is the minimum requirement, but alternative flow modes may be proposed. For COGM-A, a minimum of 93% ± 3% purity is required, with a desired flow up to 15 LPM.

• Funding: Estimated funding per award is approximately $3.2M for COGM and $4.4M for COGM-A. The government anticipates multiple awards for each focus area.

• Proposal Submission: Proposals must be submitted via email to the addresses listed in RPP Section 6.

• Airworthiness: Both COGM and COGM-A technologies need to be rated for airworthiness.

• Power Requirements: Devices must be designed for all specified power options (110/220AC, 60-400Hz, and 10-28VDC) as they will be used across multiple roles of care.

• Amendment 0001 has been issued to address industry questions and includes an adjustment to the proposal due date.

• The RPP and Attachment C have been revised to clarify eligibility requirements, including the role of non-profit research institutes.

• The government anticipates awarding by the end of the fiscal year.

Form / Attachment / Pricing Sheet

This document outlines the "Prohibition on Contracting with Malign Foreign Talent Programs" as mandated by Section 10631 of the Chips Act of 2022. It requires performers to certify that covered individuals are aware of and comply with this prohibition. This form is a mandatory submission for proposals.

• Certification Requirement: Performers must certify that no "covered individual" is participating in a malign foreign talent recruitment program.
• Disclosure Questions: Bidders must answer eight detailed questions regarding potential affiliations with foreign countries of concern, foreign talent programs, and foreign ownership or investment. Specific details must be provided if the answer is "Yes."
• Performer Information: Requires Unique Entity ID (UEI), Point of Contact Name, Phone Number, and Email.
• Signature: The form must be signed by an authorized individual.
• Definitions: Provides definitions for "Covered Individual," "Foreign Affiliation," "Foreign Country of Concern," and "Malign Foreign Talent Recruitment Program."

Failure to submit this form correctly, or providing incomplete/inaccurate information, will result in the proposal being deemed noncompliant and not evaluated. Bidders must carefully review the definitions and disclosure questions to ensure accurate and timely completion. This document is critical for proposal eligibility and compliance.

Form / Attachment / Pricing Sheet

This document, MIL-STD-810H, provides comprehensive guidelines and laboratory test methods for evaluating the effects of environmental conditions on materiel. It ensures materiel is designed and tested for all pertinent environmental conditions it may encounter throughout its service life. Part Two specifically details environmental laboratory test methods, including procedures for various conditions such as temperature, humidity, solar radiation, salt fog, sand and dust, and mechanical vibrations. Method 522.2 provides detailed procedures for ballistic shock testing, outlining test procedures, conditions, and analysis methods to evaluate materiel performance under ballistic shock.

• Part One: Environmental engineering program guidelines, applicable documents, definitions, and general program guidelines.
• Annexes A, B, C: Detailed task descriptions, program management guidance, and environmental tailoring guidelines.
• Part Two: Environmental laboratory test methods for numerous environmental conditions.
• Method 522.2 (Ballistic Shock): Six distinct procedures for simulating ballistic shock, guidance on test levels and conditions, data acquisition requirements, test execution steps, and analysis of results.

This standard is critical for bidders as it defines the environmental conditions and testing methodologies that materiel must withstand. Understanding these requirements is essential for designing and manufacturing products that meet durability, reliability, and performance standards. Bidders must pay close attention to specific methods, procedures, and parameter levels relevant to their materiel's intended operational environments to ensure compliance and avoid costly redesigns or failures. The ballistic shock testing procedures (Method 522.2) inform bidders about rigorous testing requirements, specific equipment, and analysis methods used to evaluate performance and survivability under ballistic impact, increasing their chances of successful bids.

Other / Unclassified

This document is Army Regulation 220-1, titled "Army Unit Status Reporting and Force Registration-Consolidated Policies." It establishes fundamental Army policies for readiness reporting and force registration, synchronized with the Army Readiness Portal and the Defense Readiness Reporting System-Army (DRRS-A).

This regulation is highly relevant to bidders as it outlines the comprehensive framework for how Army units report their readiness status. Understanding this document can provide insight into the operational context and requirements that may influence future opportunities or the evaluation of contractor performance related to Army readiness and force structure. It details the systems, processes, and responsibilities involved in readiness reporting, which are critical for understanding the Army's operational posture and planning capabilities.

Form / Attachment / Pricing Sheet

This document is the Medical Device and Equipment Risk Assessment (MDERA) Questionnaire, Version 6. It is a mandatory pre-procurement selection tool required for vendors to complete as part of the Request for Offer (RFO)/Risk Management Framework (RMF) Change Control Board (CCB) review process. The questionnaire aims to ascertain security compliance with US Federal Government, DoD, and DHA policies and directives for all medical systems/devices, regardless of network connection.

• Vendor Information: Requires primary and technical POC details, including contact information and signatures.
• System Identification: Details about the medical device/equipment, including title, version, description, model, regulatory certifications (e.g., FDA 510K), contract information, DoD/DHA authorization status, physical testing location, mode of operation (standalone, peer-to-peer, client/server, web-based, host-based, cloud-based), implementation method (hardware/software, software-only, virtual), network interfaces (LAN, wireless), and connected systems.
• Technical Information: Comprehensive details on system hardware/firmware, operating systems (including EOL dates and support), installed applications (including EOL dates), migration paths for unsupported software, user account types and authentication methods, system architecture diagrams, endpoint protection (antivirus/HBSS/HIPS) capabilities, vulnerability scanning limitations, vulnerability management/patching policies, remote access capabilities, wireless capabilities (Wi-Fi, Bluetooth), and mass storage usage (USB drives).
• Data Processing Capabilities: Information on data processing functions (receive, process, store, transmit, display), handling of Electronic Protected Health Information (ePHI)/Personally Identifiable Information (PII), specific ePHI/PII elements processed, DoD information persistence, data input methods, data workflow, data at rest encryption, and data in transit encryption.

Completion of this questionnaire is critical for vendors proposing medical devices or equipment. Failure to provide complete and accurate information can result in the system being ineligible for purchase or lead to contract breach and cancellation. The detailed technical and security information required helps bidders understand the cybersecurity requirements and compliance expectations for medical devices within the DHA environment. Vendors must submit the completed MDERA to the designated POC or the CYBERLOG org box.

Form / Attachment / Pricing Sheet

This document is a Data Item Description (DID) titled "RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)". It is published by the U.S. Army Medical Research & Materiel Command (USAMRMC) to define the technical data required to support the research and development of drugs, biologics, and medical devices regulated by the FDA. This DID is intended to be used in conjunction with the Contract Data Requirements List (CDRL) to specify data deliverables for solicitations or contracts.

This DID outlines the format, content, and intended use for data deliverables. It covers a wide range of requirements for both drugs/biologics and medical devices, including:

• Drugs and Biologics: Product Development Planning Documents (Regulatory Strategy, RDP, Pre-clinical Development Plan, Clinical Development Plan, Manufacturing Development Plan), FDA Interactions (Meetings, Communications, Submissions, Inspections), Pre-clinical Testing and Trials, Clinical Trials, and Manufacturing.
• Medical Devices: Product Development Planning Documents (Regulatory Strategy, RDP, Pre-clinical Development Plan, Clinical Development Plan, Manufacturing Development Plan), FDA Interactions, Pre-Clinical Testing and Trials, Clinical Trials, Manufacturing, System Engineering, and Quality Assurance.
• General Requirements: Administrative details such as classification, format, font size, language, acronyms, appendices, and page numbering.
• References: Lists applicable Federal Statutes, DoD and Army Regulations, and FDA Regulations, as well as ICH Guidance Documents.
• Acronyms: A comprehensive list of acronyms used throughout the document.

This DID specifies the detailed technical data and documentation that contractors will be required to provide as part of a contract. Bidders should review this document to understand the extensive documentation requirements related to the research, development, testing, manufacturing, and regulatory submission of drugs, biologics, and medical devices. It helps in assessing the scope of work and the necessary resources for compliance with FDA and DoD regulations.

Form / Attachment / Pricing Sheet

This document is identified as "Attachment G - CDRL A003 - Software Bill of Materials" and is likely a form or template required for bidders to complete. It pertains to the software bill of materials (SBOM) for the opportunity.

• The document is a Software Bill of Materials (SBOM) template.
• Bidders are expected to provide a list of all software components, including their versions and licenses.

Bidders must complete and submit this Software Bill of Materials (SBOM) as part of their proposal. This document is crucial for demonstrating compliance with software supply chain security requirements and for the government's assessment of the software being proposed.

Form / Attachment / Pricing Sheet

This document is an attachment titled "B08-HT9427-26-R-E001-Attachment-F-CDRL-A002-ROM-Production-Unit-Cost-Estimates.pdf". It appears to be a template or form for providing Rough Order of Magnitude (ROM) production unit cost estimates.

• The document is intended for bidders to provide cost estimates for production units.
• Specific fields or categories for cost estimation are likely included within the PDF, though not detailed in the provided metadata.

Bidders will need to complete and submit this form as part of their proposal preparation to provide the required cost estimates for production units. This directly impacts the evaluation of their pricing.

Other / Unclassified

This document is a placeholder or error message indicating that the PDF viewer could not properly display the document content. It suggests upgrading to the latest version of Adobe Reader and provides links for download and assistance.

This document does not contain substantive information relevant to the SAM.gov opportunity. It indicates a potential issue with accessing the actual document content.

Form / Attachment / Pricing Sheet

This document, "Attachment D - Cost Summary Sheet," is a pricing sheet intended for bidders to provide cost breakdowns for the opportunity HT9425-26-R-E001. It details the structure for reporting costs across different CLINs (Contract Line Item Numbers) and performance periods.

• CLINs: The sheet breaks down costs by CLIN, including CLIN 0001 (Labor - COGM), CLIN 0002 (Other Direct Costs - COGM), CLIN 0003 (Labor - COGM-A), and CLIN 0004 (Other Direct Costs - COGM-A).
• Cost Categories: Costs are categorized into "Labor" and "Other Direct Costs (ODCs)" for each CLIN.
• Periods: Costs are presented for the "Base Period."
• Optional Objective 7 Pricing: A note indicates that if required, pricing for "Optional Objective 7" would be requested with Proposal Volume 2 (Deliverable 21) if the Government chooses to fund the continued development of Objectives 1-6.
• Zero Values: All cost fields (Labor, ODCs, Total Cost) are currently populated with 0.0, indicating no costs have been entered or are required at this stage for the base period.

Bidders must use this attachment to structure and submit their cost proposals. While currently showing zero values, it outlines the required format for labor and other direct costs for the base period and any potential future optional objectives. Bidders should pay close attention to the note regarding Optional Objective 7 pricing, as it may require a separate submission later.

Form / Attachment / Pricing Sheet

This document, "Attachment C: Warranties and Representations," outlines the required warranties and representations that offerors must provide when responding to the Request for Prototype Proposal (RPP). It details the criteria for utilizing Other Transaction Authority (OTA) for prototype projects, specifically focusing on the participation of nontraditional defense contractors.

• Authority for Other Transaction Agreement: Explains the conditions under which OTA can be used for prototype projects, requiring significant participation from nontraditional defense contractors, small businesses, or substantial non-governmental cost sharing.
• Offeror Warranties and Representations: Requires the prime offeror to declare whether they are a nontraditional defense contractor.
• Nontraditional Defense Contractor Definition: Provides the definition of a nontraditional defense contractor, emphasizing a lack of significant DoD contracts for at least one year prior to the RPP issue date.
• Information for Nontraditional Contractors: If the prime offeror is a traditional contractor, specific details are required for each participating nontraditional defense contractor, including legal name, DUNS number, address, and point of contact.
• Significant Contribution Details: Offerors must describe the significant contributions of nontraditional contractors, selecting from categories such as new key technology, novel application, performance/efficiency increase, cost/schedule reduction, or prototype project performance increase. Detailed descriptions are required for each selected category.
• Additional Information: Further questions address any additional capabilities of the nontraditional contractor, the specific tasks/phases where they will be used, and the total estimated cost associated with their participation.

Bidders must carefully review this attachment to understand the requirements for defining their status as a traditional or nontraditional defense contractor. If proposing with nontraditional partners, detailed information and justification for their significant contributions are mandatory for proposal submission. This document directly impacts proposal preparation and compliance with the terms of the Other Transaction Agreement.

Other / Unclassified

This document is a draft "Other Transaction Agreement for Prototype" (OT) between ABC, Inc. (Performer) and the Defense Health Agency (Government). It outlines the terms and conditions for a prototype development project authorized under 10 U.S.C. § 4022. The agreement is not a procurement contract, grant, or cooperative agreement, and the Federal Acquisition Regulation (FAR) generally does not apply.

Key sections cover:

• Scope of the Agreement: Defines the purpose as a prototype development program and clarifies it's an OT, not a traditional contract.
• Term and Termination: Outlines the agreement's duration and conditions for termination by either party.
• Program Management: Details responsibilities for project governance, communication, and reviews.
• Agreement Administration: Identifies points of contact and requires performer registration in the System for Award Management (SAM).
• Financial Matters: Addresses funding, payment structures (fixed-price or expenditure-based milestones), and travel.
• Intellectual Property (IP) and Data Rights: Defines ownership and licensing of background IP and inventions created under the agreement.
• Regulatory Rights: Addresses FDA clearance processes and potential remedies for product development failures.
• Cybersecurity: Includes terms related to safeguarding covered defense information and reporting cyber incidents.

This document provides a template and framework for a prototype Other Transaction Agreement. Potential bidders should review the scope, deliverables (Attachment 1), reporting requirements (Attachment 2), milestone schedule (Attachment 3), and terms related to IP, data rights, and regulatory processes. It highlights the specific nature of an OT agreement, which differs from standard FAR-based contracts. The document also details administrative requirements like SAM registration and payment procedures via Wide Area Work Flow (WAWF).

Statement of Objectives (SOO)

This Statement of Objectives (SOO) outlines the requirement for the development of two expeditionary, easy-to-maintain, and portable medical oxygen generation devices: Compact Oxygen Generation, Medical (COGM) and Compact Oxygen Generation, Medical – At Altitude (COGM-A). The goal is to provide medical oxygen solutions for service members in austere environments, meeting Joint Enroute Care Equipment Test Standard (JECETS) and airworthiness standards. The solicitation may result in multiple awards (e.g., Other Transaction Agreements [OTA]) for the development of FDA-approved devices, ideally starting at Technology Readiness Level (TRL) 4.

The effort requires developing prototype devices capable of generating medical-grade oxygen in military environments, being maintained by DoD personnel, obtaining FDA clearance, and having production capacity. Key device attributes include:

• COGM: Primarily for Role 1 care, adjustable flow rate (3-7 lpm minimum, 15 lpm desired), for use with nasal cannulas, face masks, and nebulizers. Target regulatory approval by 2029, procurement by 2031.
• COGM-A: Primarily for aeromedical evacuation platforms, similar performance to COGM but with adjustable flow up to 15 lpm and high-pressure output for ventilators. Target regulatory approval by 2030, procurement by 2032.

Six core objectives are defined for the work:

1. Management: Project oversight, reporting, and schedule adherence.
2. Prototype Development/Technical: Design and delivery of prototypes meeting technical parameters, including government testing and evaluation.
3. Manufacturing: Establishment of cGMP and Quality Management System (QMS), pilot manufacturing process, and commercialization plans.
4. Regulatory: Development of a regulatory strategy, FDA submissions, and testing plans.
5. Maintenance and Sustainment: Plans for government training, repair, maintenance, and sustainment.
6. In Progress Review (IPR): Summary of work completed and future needs.

Devices must meet specific requirements including:

• General Attributes: FDA clearance, oxygen purity (93% ± 3% USP, 99% desired), adjustable flow rates, specific size and weight limits (e.g., COGM <=24 lbs, 15 lbs desired), power requirements, button-based interface with visual display, rechargeable battery (2 hrs operation, 3 hrs desired).
• Functional Attributes: Operational availability (95% minimum, 98% desired), airworthiness/safe-to-fly certification, reliability (MTBSA of 350 hours, 462 hours desired), oxygen recapture capability, and environmental tolerance.
• Interoperability Attributes: Standard fittings (MOSA), integration with aeromedical evacuation systems, closed-loop control integration (COGM-A only), and network readiness (COGM-A only).
• Maintainability Attributes: Serviceable by Biomedical Technicians (BMETs), maximum repair time (2 hours, 1 hour desired), BMET-replaceable parts, field-upgradable software, and product support for specified lifecycles.
• Storage Attributes: Minimum 12-month shelf life (18 months desired) and environmental tolerance (e.g., 95% humidity at 106°F for 24 hours, 72 hours desired).

Key deliverables include kick-off meeting minutes, monthly reports, prototype devices, technical summary reports, quality management plans, regulatory strategies, maintenance plans, training materials, and in-process review briefs.

• Period: COGM development up to 24 months; COGM-A development up to 36 months. Faster completion is preferred.

• Place: Device development at the Performer's location. DoD Testing and Evaluation will occur at DoD installations.

• Adherence to DoD Acquisition System, U.S. FDA, and other relevant regulatory and industry best practices.

• Devices must be Trade Agreements Act (TAA) Compliant and comply with DFARS 252.225-7021.

• Prototypes with TRL 4 are preferred.

• Compliance with MIL-STD-810H for operation, transport, and storage in military environments.

• No Government Furnished Property will be provided.

• Research involving animal or human subjects requires prior approval from ACURO or ORRC, respectively.

• Travel may be required for technical demonstrations, training, and audits.

Solicitation / RFP / RFQ

This Request for Prototype Proposal (RPP) is issued by the Defense Health Agency Contracting Activity (DHACA) for the Defense Health Agency (DHA) Operational Medical Systems (OPMED) Project Management Office. The requirement is for the development of expeditionary, easy-to-maintain medical oxygen generation devices to treat service members in austere environments. The effort aims to develop prototypes that meet minimum performance attributes for the Department of Defense (DoD), with a goal of FDA-approved devices.

Two focus areas are defined:

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

  • Priority: High
  • Primary Use: Role 1 (also usable en route)
  • Capabilities: Adjustable flow rate (3-7 lpm minimum, 15 lpm desired) for nasal cannulas, face masks, and nebulizers.
  • Target Timeline: Regulatory approvals by 2029, procurement by 2031.

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

  • Primary Use: Aeromedical evacuation platforms
  • Capabilities: Adjustable flow up to 15 lpm and high-pressure output for ventilators.
  • Target Timeline: Regulatory approvals by 2030, procurement by 2032.

• The RPP may result in multiple awards using Other Transaction Agreements (OTA).

• The effort is anticipated to be incrementally funded.

• The government's preference for period of performance is 24 months for COGM and 36 months for COGM-A, but longer periods will be considered.

• Proposals must be submitted in three volumes: Technical, Management, and Administrative/Cost.

• Key deadlines:

  • Pre-Proposal Meeting Registration: 30 January 2026
  • RPP Questions Due: 6 February 2026
  • Proposals Due: 6 March 2026

• Evaluation Factors for Award:

  1. Technical Approach
  2. Management Approach
  3. Administrative and Cost

• The RPP is issued under Other Transaction Authority (POTA) 10 U.S.C. 4022, which encourages participation from nontraditional defense contractors or nonprofit research institutions.

• To be eligible for award, proposals must demonstrate one of the following:

  • At least one nontraditional defense contractor or nonprofit research institute participating to a significant extent.
  • All significant participants are small businesses or nontraditional defense contractors.
  • At least one-third of the total project cost is paid by parties other than the Federal Government.

• Offerors must register in SAM.gov.

• Intellectual Property (IP) rights will be defined in the agreement terms.

• A list of 11 attachments is provided, including SOO, Draft OTA, SOW, Warranties and Representations, and Cost Sheet Template.