B08-HT9427-26-R-E001-RPP-Amend-0001.pdf

Request for Prototype Proposal (RPP)

RPP Number: HT9427-26-R-E001, Amendment 0001 Compact Oxygen Generation Medical Devices

Issued by the:

Defense Health Agency Contracting Activity (DHACA)

Research and Development Contracting Division 2

808 SCHREIDER ST

FORT DETRICK MD 21702

for the:

Defense Health Agency (DHA) Operational Medical Systems (OPMED), Warfighter

Expeditionary Medicine and Treatment Project Management Office (WEMT PMO), Fort Detrick, MD

RPP Issue Date: 22 January 2026

Proposal Due Date: 11 March 2026

RPP HT9427-26-R-E001 – COGM/COGM-A

Table of Contents Request for Prototype Proposal 1 Executive Summary

1.1 Request for Prototpye Proposal

1.2 Background ................................................................................... Error! Bookmark not defined.

1.3 Inclusion of Nontraditional Defence Contractors or Nonprofit Research Institutions

1.4 System for Award Management (SAM) Registration

2 Requirement Overview

2.1 Award Type

2.2 Period of Performance

2.3 Frequency of funds obligated

2.4 Proprietary Information

2.5 Intellectual Property

2.6 Ownership of Agreement Inventions

2.7 Data Rights

2.8 Preliminary Screening & Eligibility

3 Proposal Preparation Instructions

3.1 General Instructions

3.2 Organization of Proposal

3.3 Volume I: Technical

3.4 Volume II: Management

3.5 Volume III: Administrative and Cost

4 Proposal Evaluation

4.1 General

4.2 Proposal Revisions

4.3 Evaluation Factors for Award

4.3.1 Factor I – Technical Approach

4.3.2 Factor II – Management Approach

4.3.3 Factor III – Cost

5. Proposal Submission

6. Attachments

1. Executive Summary

1.1 Request for Prototype Proposal

This Request for Prototype Proposal (RPP) is being issued by the Defense Health Agency Contracting Activity (DHACA), in support of the Defense Health Agency (DHA) Operational Medical Systems (OPMED) Project Management Office located in Frederick, Maryland, at Fort Detrick. The requirement is needed by the Warfighter Expeditionary Medicine and Treatment Project Management Office (WEMT PMO) within DHA OPMED for medical oxygen generation.

This is a prototype development effort, to develop a prototype that meets the minimum performance attributes to meet the needs of the Department of Defense (DoD).

The 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 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 oxygen generation devices meeting Joint Enroute Care Equipment Test Standard 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 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 RPP 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 aeromedical evacuation and portability is preferred, the WEMT PMO acknowledges this may be unrealistic in the near future.

The proposal(s) selected will be awarded under the authority of prototype Other Transaction

Authority (pOTA) 10 U.S.C. 4022.

If successful, at the end of the pOTA, the program will have an FDA-cleared device that meets DoD requirements, and the effort could lead to a production OT.

1.2 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.

1.3 Inclusion of Nontraditional Defense Contractors or Nonprofit Research Institutions

10 U.S.C. 4022 authorizes DoD organizations to carry out prototype projects that are directly relevant to enhancing the mission effectiveness of personnel of the Department of Defense or improving platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the armed forces. To use this authority for an agreement resulting from this RPP, one of the following conditions must be met:

(A) There is at least one (1) nontraditional defense contractor or one (1) non-profit research institute participating to a “significant extent” in the prototype project.

or

(B) All “significant” participants in the transaction, other than the Federal Government, are small businesses or nontraditional defense contractors.

or

(C) At least one-third (1/3) of the total cost of the prototype project is to be paid out of funds provided by parties to the transaction other than the Federal Government. NOTE: One statutory condition for the use of a Prototype OT is if the performing team does not include either a Non-

Traditional Defense Contractor (NDC) or a small business concern participating to a “significant extent” in the prototype project; when this occurs, it is then required to have at least 1/3 of the total cost of the prototype project to be paid by the parties, other than the Federal Government.

Please see RPP Section 3. “Proposal Preparation Instructions” and Attachment B for additional details.

Definitions:

Non-Traditional Defense Contractor (NDC) – An entity that is not currently performing and has not performed, for at least a one-year period preceding the RPP of sources by DoD for the procurement or transaction, any contract or subcontract for the DoD that is subject to full coverage under the cost accounting standards (CAS) prescribed pursuant to section 1502 of Title 41 and the regulations implementing such section (see 10 U.S.C. §3014). The phrase “the solicitation of sources” refers to the initial agreement solicitation only. An NDC retains its status for the duration of the prototype project/agreement’s period of performance, or for any in-scope work modified under the same agreement.

NOTE: Per the statutory definition, NDCs are all entities that have not performed under a narrowly defined set of circumstances within one year of RPP of the current OT opportunity. The effect of this narrow definition is that many entities will fall into the NDC category, including nearly all small business concerns, and even those firms that work exclusively with DoD. This is in part due to the exemptions to CAS coverage under 41 U.S.C. §1502 and FAR Part 30, which exempt commercial contracts, Firm Fixed Price contracts based on adequate price competition, and any contract or subcontract with a small business concern, among other exemptions. Further, even where an entity is not outright exempt from CAS coverage, the entity may not have been subject to “full” CAS coverage. This is because full CAS coverage applies only to firms that receive a single CAS-covered contract award of $50 million or more; or received $50 million or more in net CAS-covered awards during its preceding cost-accounting period.

Significant Extent – The Government will consider the totality of the circumstances for EACH proposed prototype project before making a determination as to the significance of expected NDC or nonprofit research institute participation. The government will weigh/consider elements such as, but not limited to, whether the NDC/nonprofit research institution will supply a new key technology, product, or process; supply a novel application or approach to an existing technology, product, or process; provide a material increase in the performance, efficiency, quality, or versatility of a key technology, product, or process; accomplish a significant amount of the prototype project;

cause a material reduction in the cost or schedule of the prototype project; or, provide for a material increase in performance of the prototype project. The following are some, but not all, examples of participation to a significant extent:

1. Supplying a new key technology, product or process.

2. Supplying a novel application or approach to an existing technology, product or process.

3. Providing a material increase in the performance, efficiency, quality or versatility of a key technology, product or process.

4. Accomplishing a significant amount of the prototype project.

5. Causing a material reduction in the cost or schedule of the prototype project

6. Providing for a material increase in performance of the prototype project.

Cost Sharing – Cost sharing occurs when a portion of the total cost of the project is paid out of funds provided by sources other than the Federal Government. Contributions can be in cash or non-cash form, and costs can be either direct or indirect, so long as they are allowable, allocable, reasonable, and consistently accounted for by the performer. Resource sharing may include labor, materials, equipment, IP rights, and facilities. Foregone fee or profit on another contract or agreement or cost of money is NOT consistent with general cost principles and will NOT be permitted. Profit or fee must NOT be included in resource-shared agreements. Types of cost sharing:

Cash Contribution - Any contribution of funds, services, or materials for which the Recipient is required to pay cash and which would normally be authorized for reimbursement as a direct or indirect charge to the Agreement. Examples include provision of direct labor, raw materials, and associated indirect costs. Cash contribution does not include foregone profit or fee.

In-Kind Contribution - Any contribution of equipment, facilities, intellectual property, etc. which is necessary for performance of the statement of work for which a usage or depreciation charge is normally assessed versus reimbursement of the actual costs for acquiring or providing the item.

Examples include costs associated with the provision or rental of real property, special tooling or test equipment, and foregone licensing fees for software where the Government has no pre-existing right to free use.

1.4 System for Award Management (SAM) Registration

SAM.gov is a centralized web-based tool used by the federal Government’s executive agencies as the authoritative source for federal awardee data. SAM’s Entity Information module maintains annually self-reported entity information including address and contact information, banking information, and representations and certifications.

Companies and other organizations who are prime awardees for OT agreements MUST register in SAM and maintain an active registration status throughout performance. The prime awardee MUST use its Unique Entity Identifier (UEI) from SAM (https://sam.gov). If NAICS code 541714 “Research and Development in Biotechnology (except Nanobiotechnology)” is not currently listed in the Performer’s SAM.gov account, it MUST be added prior to award.

2. Requirement Overview

2.1 Award Type

The Contractor shall propose award type.

2.2 Period of Performance

The Government's preference is that overall device goals can be achieved within 24 months for Focus Area 1 (COGM) and within 36 months for Focus Area 2 (COGM-A). The Government acknowledges that this may not be achievable and will consider proposals that require additional time to achieve the overall device goals.

2.3 Frequency of Funds Obligated

The pOTA is anticipated to be incrementally funded. An incremental funding schedule will be provided upon award.

2.4 Proprietary Information

DHACA will oversee submission of proposals submitted in response to this RPP. DHACA will take the necessary steps to protect all proprietary information and will not use such proprietary information for purposes other than the evaluation of an Offeror’s proposal and the subsequent agreement administration if the proposal is selected for award in accordance with Federal laws and regulations.

Additionally, all Technical Evaluation Panel participants will agree to and sign non-disclosure and conflict of interest documents.

2.5 Intellectual Property

Intellectual Property (IP) rights for this award will be defined in the terms and conditions of the Agreement. As a starting reference point, the Government’s standard IP terms have been provided.

See Articles 7, 8, and 9 of the Draft OTA for Prototype (Attachment B).

Once a successful Offeror has been determined, the presumptive awardee will be required to provide the Government with a list and brief description of any background IP related to the research and development activities contemplated under the proposed agreement, which will be incorporated into the Agreement. The list will include relevant IP such as:

(1) Relevant issued U.S. and foreign patents, which the presumptive awardee partially or wholly owns or is an assignee;

(2) All relevant pending U.S. patent applications, provisional patent applications, PCTs that have not yet expired, and any foreign patent applications, including national stage applications, which the presumptive awardee partially or wholly owns or is an assignee;

(3) Relevant copyrighted/copyrightable works/material in which the presumptive awardee has rights in;

(4) Relevant patent/copyright licenses that the presumptive awardee is party to;

(5) Any relevant patents, patent applications, and/or copyrights owned by third parties that the presumptive awardee has knowledge of; and

(6) Any license with a third party for technology that is or may be necessary for the presumptive awardee to use in order to perform or meet obligations under this Agreement.

2.6 Preliminary Screening & Eligibility

The Government will conduct a preliminary screening of submitted proposals to ensure compliance with the RPP submission instructions. As part of the preliminary screening process, proposals not submitted in accordance with the RPP instructions may be eliminated from the competition or additional information may be requested by the Government. Additionally, the Government reserves the right to request additional information or simply eliminate proposals that have not been proposed in accordance with the RPP submission instructions. One of the primary reasons for non-compliance or elimination during the preliminary screening is not properly demonstrating that the Offeror is an NDC, nonprofit research institution, or not cost sharing (if applicable).

The Offeror must submit Warranties and Representations (Attachment C) specifying the critical technologies being offered and/or the significant extent of participation of the NDC or nonprofit research institution or cost share (if applicable). The NDC may be an individual so long as he/she has a SAM.gov UEI and meets the requirements in the Warranties and Representations. The significance of the NDC’s or nonprofit research institution’s participation must be explained in detail in the signed Warranties and Representations.

To be eligible for award, a proposal must demonstrate that at least one (1) of the following conditions are met:

Rating Description

Pass

(A) Demonstrated that there is at least one (1) nontraditional defense or one (1) non-profit research institute participating to a significant extent in the prototype project.

or

(B) Demonstrated that all significant participants in the transaction, other than the Federal Government, are small businesses or nontraditional defense contractors.

or

(C) Demonstrated at least one-third (1/3) of the total cost of the prototype project is to be paid out of funds provided by parties to the transaction other than the Federal Government.

Rating Description

Fail

(A) Did NOT demonstrate that there is at least one (1) nontraditional defense or one (1) non-profit research institute participating to a significant extent in the prototype project.

or

(B) Did NOT demonstrate that all significant participants in the transaction, other than the Federal Government, are small businesses or nontraditional defense contractors.

or

(C) Did NOT demonstrate at least one-third (1/3) of the total cost of the prototype project is to be paid out of funds provided by parties to the transaction other than the Federal Government.

If cost sharing is proposed, then the Offeror must state the amount that is being proposed and whether the cost sharing is a cash contribution or in-kind contribution; provide a description of each cost share item proposed; the proposed dollar amount for each cost share item proposed; and the valuation technique used (e.g., vendor quote, historical cost, labor hours and labor rates, number of trips, etc.). Foregone fee or profit on another contract or agreement, or cost of money is not to be consistent with general cost principles and will NOT be permitted. Profit or fee must NOT be included in resource-shared agreements. The resources used as the share do not have to come from the lead or prime performer but can come from any of the performing team’s members or third-party resource-sharing. What is important for the Government team to know at the time of award is how the aggregate share will be split amongst the team or their financiers and whether the team has the authority to utilize and commit the resources they propose to share.

3. Proposal Preparation Instructions

3.1 General Instructions

This section provides general guidance for preparation of the proposal as well as specific instructions on the format and content of the proposal. The proposal submitted must contain three

(3) separate volumes. Volume I Technical, Volume II Management, and Volume III Administrative and Cost Volumes must be submitted in accordance with these General Instructions. If an Offeror fails to submit their proposal in accordance with these instructions, the Government may reject the entire proposal and may not be evaluated for award.

The Offeror’s proposal must include all requested data and information and must be submitted in accordance with the instructions in this RPP. Offerors who have not submitted proposals in accordance with the RPP instructions may be eliminated from the competition entirely or additional information may be requested by the Government. Additionally, the Government reserves the right to request additional information or simply eliminate proposals entirely that have not proposed in accordance with these Section 3.1 General Instructions.

The proposal must be clear, concise, and must include sufficient detail for effective evaluation and for substantiating the validity of stated claims. The proposal must not simply rephrase or restate the Government’s requirements but rather must provide convincing rationale to address how the Offeror intends to meet these requirements. The Offeror should assume that the Government has no prior knowledge of the Offeror’s capabilities and will base its evaluation solely on the information presented in the Offeror’s proposal.

Elaborate brochures or documentation, binding, detailed artwork, or other embellishments are unnecessary and not desired.

If the Offeror believes the requirements in these instructions contain an error, omission, or are otherwise unsound, the Offeror must immediately notify the DHACA Agreements Specialist, listed in this RPP, in writing, with supporting rationale.

3.2 Organization of Proposal

General The Offeror must prepare the proposal as set forth in the Proposal Organization Table below.

The titles and contents of each volume must contain the documents as indicated in the Proposal Organization Table. The three (3) separate and distinct volumes are:

Volume I: Technical Volume;

Volume II: Management Volume; and Volume III: Administrative and Cost

Proposal Organization Table

Volume Section Title Page Limit

Volume I: Technical

Cover Page (with POC contact information) 2 pages Table of Contents 1 page Technical Approach:

-Description of current state of the prototype technology and final end-state concept -Prototype Development Plan to include Design Refinement -Testing Plan -Regulatory Strategy -Maintenance and Sustainment Plan -Manufacturing and Commercialization Plan

20 pages

Attachment B – Draft OTA for Prototype (Terms and Conditions), Sub Attachment 1 - Statement of Work (SOW) with milestones

No page limit

Volume II:

Management

Cover Page 2 pages Table of Contents 1 page Management Approach:

-Project Management Plan (PMP) (with Integrated Master Schedule (IMS), Identification of Key

12 pages

Personnel, Risk Management Plan, Spend Plan, and Quality Management Plan) Teaming Agreement (if applicable) No page limit

Volume III:

Administrative and

Cost

Cover Page 2 pages Table of Contents 1 page Attachment B – Draft OTA for Prototype (Terms and Conditions) Review

N/A

Attachment C – Warranties and Representations N/A Attachment D – Cost Sheet Template with priced milestones

N/A

Written Cost Narrative (with support documentation) No page limit Accounting System capability & POCs for

DCMA/DCAA (if applicable) 1 page

Attachment L – Prohibition on Contracting with Malign Foreign Talent Programs

N/A

Submission Format Each volume must be submitted electronically in searchable PDF format. For the Project Management Plan (PMP) in addition to a high-level presentation in PDF format as part of the Volume I: Technical submission, the Offeror must submit an electronic copy in Microsoft Project with milestones and tasks. The files must be virus and malware free and must not be password protected. Files must not include hyperlinks. The electronic submission must be compatible with Microsoft Office and Adobe Acrobat.

Volume Content Each volume must be written on a standalone basis. Each volume must contain a cover page and table of contents. Each page must be numbered and include the RPP number and Offeror name. For Volume 1 Technical cover page, please be sure to include a point of contact and point of contact with the authority to negotiate on behalf of the Offeror. The information in each volume must be specific and complete as well as legible, clear, and concise. Per the instructions, the Offeror must provide as specifically as possible, the actual methodology it proposes to use to accomplish and satisfy all requirements. By submitting a proposal, the Offeror represents that it will be responsible for meeting the requirements specified in the RPP.

The Offeror must not merely reiterate the objectives or reformulate the requirements specified in the RPP.

Labeling To request protection from FOIA disclosure as allowed by Other Transaction Authority (pOTA) 10 U.S.C. 4021 (formally 10 U.S.C. §2371(i)), Offerors shall mark business plans and technical information with a legend identifying the documents as being submitted on a confidential basis.

3.3 Volume I: Technical

Technical Approach The Offeror must submit a written technical approach which effectively demonstrates the Offeror’s clear understanding and approach to achieving all the objectives outlined in the SOO. The Offeror must include a description of the current state of the prototype technology and the final end-state concept, a Prototype Development Plan to include Design Refinement, Testing Plan, Regulatory Strategy, Maintenance and Sustainment Plan, and Manufacturing and Commercialization plan. The Statement of Work (SOW) with milestones shall include tasks necessary and shall align to the

IMS.

Cover page The Offeror must include a cover page for this volume.

Table of Contents The Offeror must include a table of contents for this volume.

Description The Offeror must describe the current state of the prototype technology and final end-state concept.

Prototype Development Plan The Offeror must describe and justify an achievable single device that can meet goals of one focus area OR a single device that can meet goals of both focus areas. This section must include sound strategy for achieving the performance minimums stated in the SOO and the Governments goals.

Design Refinement The Offeror must describe process for design refinement process to achieve the Government’s goal of a COGM or COGM-A device that meets minimum performance attributes.

Testing Plan The Offeror must describe bench or third-party performance testing to achieve minimum performance attributes described in SOO. The Offeror must describe how design of device will be refined or modified as part of testing strategy.

Regulatory Strategy (Deliverable 12 of the SOO) The Offeror must submit a regulatory strategy for achieving FDA approval/clearance. The regulatory strategy must be described in sufficient detail to allow the Government to assess the appropriateness of the strategy, probability of success, and regulatory risks.

Maintenance and Sustainment Plan (Deliverable 17 of the SOO) The Offeror must submit a maintenance and sustainment strategy to support Government training, repair, maintenance and sustainment of devices. The plan will describe how the Offeror will design the device to function in Military relevant environments as defined in MIL-STD-810H.

Manufacturing and Commercialization Plan (Deliverable 11 of the SOO) The Offeror must submit a manufacturing strategy for initial pilot production of devices. The plan will describe compliance with current or establishing current Good Manufacturing Production (cGMP) requirements of the Quality Management System and must be described in sufficient detail to allow the Government to assess the appropriateness of the strategy, probability of success, and manufacturing risks.

The Offeror must submit a strategy for COGM and/or COGM-A commercialization. This must include a plan to ensure ongoing product availability at a reasonable price, market potential, marketing strategy, replacement part availability and plan to sustain markets in the future and must be described in sufficient detail to allow the Government to assess the appropriateness of the strategy, probability of success, and commercialization risks.

Attachment B, Draft OTA for Prototype (Terms and Conditions), Sub Attachment 1 - SOW – The Offeror must fill out and submit - SOW template with milestones. The Offeror must fill in the specific tasks to be completed for each objective. The SOW tasks must align to the product development plans, design refinement, testing plan, modification approach (if applicable), and project schedule. The Offeror’s SOW is the primary document detailing the tasks proposed.

3.4 Volume II: Management

Management Approach The Offeror’s Management Approach is essential to accomplishing the technical objectives. The Management Approach shall consist of a Project Management Plan (PMP) (with IMS, Identification of Key Personnel, Risk Management Plan, Spend Plan and Quality Management Plan). Offerors must include technical and corporate experience that reflect the ability to execute the SOO. Any relevant experience achieving FDA clearance / approval and commercialization must also be included.

Cover Page The Offeror must include a cover page for this volume.

Table of Contents The Offeror must include a table of contents for this volume.

Project Management Plan (PMP) (Deliverable 2 of the SOO) The Offeror must provide a PMP detailing the approach to managing the project schedule, project risks, cost control, testing timeline and include sufficient detail to allow the Government to assess overall management strategy and project control measures. The PMP must include an IMS, Staffing Plan, Risk Management Plan, Spend Plan, and Quality Management Plan.

(a) IMS The Offeror must provide a project schedule in Microsoft Project that includes summary tasks and a minimum of 3 levels of subtasks (summary, subtask, sub-subtask 1, 2, 3, etc.) that covers the scope of activities from project initiation through final activities.

(b) Identification of Key Personnel The Offeror must identify Key Personnel (e.g., Project Manager, Technical Lead, Regulatory SME, Manufacturing Lead, and Commercialization Subject Matter Expert). Key Personnel is defined as critical roles essential for project success and list their specific qualifications.

(c) Risk Management Plan The Offeror must provide a Risk Management Plan that identifies significant risks to project success, root cause of the risk, the impact and probability of risk realization, and mitigation strategies for each risk.

(d) Spend Plan

The Offeror must provide a Spend Plan that estimates the monthly disbursement of funds to perform proposed tasks to achieve the Government’s objectives and goals.

(e) Quality Management Plan The Offeror must provide a Quality Management Plan that outlines how they will 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.

Teaming Agreement (if applicable) The Offeror must include evidence (e.g., statement of intent to enter into a teaming agreement) of sub-performer/offeror relationships, if sub-performers/offerors are proposed.

NOTE: Offerors who propose consultants, subawardee(s) and/or contractual arrangements with foreign organizations or foreign collaborators must provide additional justification explaining why the foreign organization or foreign individual can carry out the scope of work more effectively than a U.S. organization or U.S. individual.

3.5 Volume III: Administrative and Cost Volume

Cover page The Offeror must include a cover page for this volume.

Table of Contents The Offeror must include a table of contents for this volume.

Attachment B – Draft OTA for Prototype (Terms and Conditions) This is a generic sample agreement for the Offeror’s awareness; terms are subject to change.

The Offeror is not required to submit a redline version (i.e. track changes). Terms and conditions are subject to negotiation following selection for award.

Attachment C - Warranties and Representations This volume must include complete Attachment C - Warranties and Certifications. (Reference Section 2.8 of the RPP).

Attachment D – Cost Sheet Template with priced milestones The Offeror must include all formulas and calculations for review. The cost sheet must show proposed dollar values for the entire effort, including all direct and indirect costs and fees, where applicable. All cost/budget information must be addressed ONLY in Volume III:

Administrative and Cost. Do not address cost in the Volume I Technical or Volume II Management. The cost proposal/budget submitted under Volume III: Administrative and Cost must include a Microsoft Excel file, showing all formulas and links, including applicable sub-performer/offeror costs/budget. Estimated levels of effort, labor hours, labor categories, consultant services, travel, material, quantities, etc. may be referenced/addressed in the other two Volumes, but no cost information may be used in Volume I Technical or Volume II Management.

Written Cost Narrative with Support Documentation This narrative must provide a detailed and comprehensive description of proposed labor, hours, direct, indirect, and other direct costs, estimating techniques used and allocation methods that correlate in sufficient depth with the tasks in the SOW. The Offeror must provide cost build up data for labor rates beginning with the unburdened labor rate through application of indirect and profit and/or fee. The Offeror must not propose labor rates that are derived from blending two or more separate Performers or sub-Performers. Proposed indirect must be based on Offeror’s current Forward Pricing Rate Agreement and/or three-year historical trend. The narrative must indicate how the proposed cost is realistic, reasonable, and complete. Rates and cost information is required for the Government to properly perform a cost analysis of the proposal. The Offeror must provide a copy of their current Forward Pricing Rate Agreement, or like documentation, that supports the proposed indirect rates.

Compliance with these instructions is mandatory and failure to comply may result in rejection of the Offeror’s proposal. Unrealistically low or unreasonably high proposed costs, initially or subsequently, may be grounds for considering the proposal unacceptable, either on the basis that the Offeror does not understand the requirement or has otherwise made an unrealistic or unreasonable proposal.

Supporting Cost Information:

Labor. For each year, the specific direct and indirect labor rates utilized to price the proposal must be identified and include labor hours, labor positions, employee names, and escalation rate. The same detailed support data must be furnished for all proposed sub-performers.

Direct labor rates/positions must identify the baseline (i.e. unburden rate) plus projected escalation for each year and the methodology for computing labor rates (i.e. composite) must be shown. For example: 3 months of FY24 + 9 months of FY25 divided by 12 = the average labor rates for the award period of performance. The Offeror and each proposed subcontractor must state their business fiscal year. The Offeror is advised that projected escalation must be applied to both exempt and non-exempt labor positions.

Indirect Rates. Provide current rates for Fringe, Overhead, Material Handling, General and Administration (G&A), and/or any other indirect costs for all efforts proposed. Provide forward pricing agreements, if applicable. If forward pricing agreements are not in place, include rate calculation methodology and historical trend for the last three-year period to assist with evaluating proposed rates. Please provide relevant rate agreements from cognizant government agencies.

Sub-performers. For each year, the Offeror must submit a complete breakdown of costs/pricing for all sub-performers proposed as well as the method by which the prime Offeror has determined subcontractor pricing fair, reasonable, and realistic.

Consultants. For each year, list proposed consultants by name, if known. For each consultant, describe: (1) nature of services (2) timeframe service will be provided, (3) tasks/milestones supported, (4) hourly rate/fee, and (4) and any other related cost (e.g., travel, per diem) as well as why the consultants needed, the method by which the Prime Offeror has determined consultant costs fair, reasonable, and realistic. Signed letters of commitment must clearly identify the

Consultant’s name, service provided, timeframe of service and agreed-to salary/hourly rate and other pertinent conditions (if applicable).

Materials and Supplies. For each year, provide a detailed listing of materials and supplies, quantity, unit price, and basis of estimates (e.g., vendor quotes, catalog pricing, subcontractor estimates).

Competitive historical price information of prior purchases is adequate. For all direct purpose/sole-sourced materials and supplies, provide a consolidated price summary of individual material quantities being proposed and the basis of estimate. If vendor quotes are the basis of estimate, please provide the quotes. If catalog pricing, please provide the business name and relevant inventory number.

Equipment. For each year, provide a list of all proposed equipment to be purchased in support of the Agreement. The list must include equipment description, manufacturer, manufacturer’s address, model and stock number, estimated unit price and with what tasks/milestones the equipment is associated.

Travel. For each year, provide the number of travelers, purpose, origin (from), destination (to), and duration of all travel, along with a detailed breakdown of pricing. All travel must be in accordance with federal travel and per-diem regulations.

Other Direct Costs. For each year, list direct costs not included in the above categories (e.g., special tooling, computer services, preservation, packaging, shipping, etc.). Provide the basis of estimate for each.

Accounting System Although the requirements of FAR 16.301-3(a) do not apply, an expenditure-based OT agreement that provides for payment based on amounts generated from the awardee’s financial or cost records require the awardee to have an accounting system capable of identifying the amounts/costs to individual agreements/contracts AND complying with Generally Accepted Accounting Principles (GAAP). The accounting system should have effective controls over all project funds, including Federal funds and any required resource share. The system should have complete, accurate, and current records that document the sources of funds and the purpose for which they are disbursed. The accounting system should have procedures for ensuring that the project funds are only for purposes permitted by the terms and conditions of this agreement. If the Offeror is currently performing under other expenditure-based (i.e., cost reimbursement) Federal procurement contracts OR assistance agreements/grants, the Offeror is subject to the SAME standards for financial management/accounting systems that apply to those other Federal awards.

The Offeror MUST describe how the capability of its accounting system meets these requirements.

If the Offeror has any active Federal contracts AND assistance agreements/grants, the cognizance Defense Contract Management Agency (DCMA) and Defense Contract Audit Agency (DCAA), or other Government agencies, name, email address, and telephone number MUST be provided.

Attachment L – Prohibition on Contracting with Malign Foreign Talent Programs

This volume must include a complete Attachment L – Prohibition on Contracting with Malign Foreign Talent Programs.

4. Proposal Evaluation

4.1 General

Potential award will be based on the Government’s proposal evaluation and subsequent exchanges with the Offeror (if needed). The Government reserves the right to reject the Offeror’s proposal, and to award no agreement at all, depending on the quality of the proposals submitted and the availability of funds. The proposal must be complete, arrive by the date and time indicated in this RPP, and be compliant with all RPP General Instructions.

4.2 Proposal Revisions

The Agreements Officer may request or allow proposal revisions to clarify and document understandings reached during negotiations. The Agreements Officer may establish a cut-off date only for receipt of final proposal revisions. The request for final proposal revision must advise the Offeror that the final proposal revision must be in writing and that the Government intends to make award without further revisions.

4.3 Evaluation Factors for Award

Every proposal will get a comprehensive review and evaluation in accordance with the evaluation factors. The Government will select the proposal/proposals that it determines to be most advantageous.

Evaluation Factors

Factor Number Evaluation Factors 1 Technical Approach 2 Management Approach 3 Cost

4.3.1 Factor I – Technical Approach

The Offeror’s technical approach will be evaluated to the degree it effectively demonstrates and addresses the required content/information from Section 3.2 and 3.3 above and effectively demonstrates a clear understanding and approach to achieving all the objectives outlined in the

SOO.

4.3.2 Factor II – Management Approach

The Offeror’s proposal will be evaluated to the degree it demonstrates and addresses the required content/information from Section 3.2 and 3.4 above and overall demonstrates appropriate and an effective management approach/strategy for maintaining project schedule, project risks, price control, and quality management.

4.3.3 Factor III – Administrative and Cost

The Offeror’s proposal will be evaluated to determine whether the proposed Warranties and Representations, Cost Sheet Template, Written Cost Narrative and Prohibition on Contracting with Malign Foreign Talent Programs are realistic, reasonable, and complete.

5. Pre-Proposal Meeting

The Government intends to hold a virtual Pre-Proposal Meeting to provide potential offerors with an opportunity to obtain clarification on any aspects of the RPP for which they have questions.

Offerors choosing to participate do so at their own expense, including any associated costs for preparation or attendance. To request attendance, interested offerors must submit an email to the points of contact listed in Section 6 Proposal Submission no later than Friday, 30 January 2026. A Microsoft TEAMS meeting invitation will be sent to all offerors who successfully register by the deadline.

6. Proposal Submission

RPP Questions Due: Submitted in writing no later than: 6 February 2026

Proposals Due: 11 March 2026

Questions and proposals must be submitted in writing to Timothy Kelly, DHACA Agreements Specialist via email at timothy.j.kelly169.civ@health.mil and Katherine Ramsburg, DHACA Agreements Specialist via email at katherine.j.ramsburg.civ@health.mil, and Shannon Lertora, DHACA Agreements Officer via email at shannon.p.lertora.civ@health.mil.

7. Attachments

• Attachment A – Statement of Objectives (SOO)

• Attachment B – Draft OTA for Prototype (Terms & Conditions) o Sub Attachment 1 – Statement of Work (SOW)

• Attachment C – Warranties and Representatives

• Attachment D – Cost Summary Sheet

• Attachment E – Contract Data Requirements List (CDRL) A001 FDA Regulatory Data

(REFERENCE ONLY)

• Attachment F – CDRL A002 ROM Production Costs (REFERENCE ONLY)

• Attachment G – CDRL A003 Software Bill of Materials (REFERENCE ONLY)

• Attachment H – Data Item Description (DID) No. DI-TCSP-82040, Research and

Development of Medical Products Regulated by the U.S. Food and Drug Administration

(REFERENCE ONLY)

• Attachment I – Medical Device and Equipment Rik Assessment (MDERA) (REFERENCE

ONLY)

• Attachment J – Army Regulation (AR)-220-1, Army Unit Status Reporting and Force Registration – Consolidated Policies (REFERENCE ONLY)

• Attachment K – MIL-STD-810H, Department of Defense Test Method Standard, Environmental Engineering Considerations and Laboratory Tests mailto:timothy.j.kelly169.civ@health.mil mailto:katherine.j.ramsburg.civ@health.mil mailto:shannon.p.lertora.civ@health.mil

• Attachment L – Prohibition on Contracting with Malign Foreign Talent Programs

(end of RPP)