RPP for HT9425-24-R-0005 RDS (22 Apr 2024).docx

Request for Prototype Proposal (RPP)

Solicitation Number: HT9425-24-R-0005 Prototype for Rapid Donor Screening

Issued by the:

United States Army Research Acquisition Activity (USAMRAA)

808 SCHREIDER ST

FORT DETRICK MD 21702

for the:

United States Army Medical Materiel Development Activity (USAMMDA)

Request Issue Date: 22 April 2024

Proposal Due Date: 22 May 2024

Table of Contents

RPP HT9425-24-R-0005 Prototype for Rapid Donor Screening

1. Executive Summary

1.1 Request for Prototype Proposal

This RPP is being issued by the U.S. Army Medical Research Acquisition Activity (USAMRAA), in support of the U.S. Army Medical Materiel Development Activity (USAMMDA) located in Frederick, Maryland at Fort Detrick. The requirement is needed by the Warfighter Protection and Acute Care Project Management Office (WPAC PMO) within in USAMMDA for prototype rapid blood screening.

This is a feasibility prototype development effort, to determine whether the needs of the Department of Defense (DoD) can be achieved.

This RPP will result in a single award to develop a rapid donor screening (RDS) technology that is U.S. Food and Drug Administration (FDA)-cleared with a donor screening indication. DoD is seeking multiplexed assays for HIV-1 and -2, Hepatitis B and C, blood type and Rh factor, that use a whole blood sample and provides results in 20 minutes or less. The RDS must ultimately support screening blood from the donors in conflict zones. The DoD requires technology that is rugged, lightweight, compact, and that it operates with no requirement for connectivity to a cloud domain. Therefore, technologies starting at a Technology Readiness Level (TRL) 3 or higher are preferred in order to achieve this goal. The ideal solution for the DoD must combine the infectious disease targets with blood type targets, but we understand that combining these into a single multiplex panel may not be technically feasible.

The proposal selected for award, as a result of this RPP, will be awarded under the authority of prototype Other Transaction Authority (pOTA) 10 U.S.C. 4022 (formerly 2371b).

Follow-on requirement for future expansion may be needed of the multiplex include targets of 10 or more. Examples include syphilis (T. pallidum), Human T-lymphotropic virus type 1 (HTVL I) and type II (HTLV II), Trypanosoma cruzi (Chagas disease) and low-titer O (defined as no greater than 1:250 anti-A and anti-B). However, this is not part of the scope for this requirement and is only intended to provide insight into potential future efforts.

1.2 Background

During military operations in conflict zones, the US military relies on blood products delivered from US blood donor centers to the greatest extent possible. However, when blood supply chain interruptions occur or the demand for blood products exceeds available supply, then Service Members on site are asked to donate blood as a contingency solution until blood deliveries are resumed. In the Iraq and Afghanistan conflicts stored blood products supplemented with Walking Blood Bank (WBB) collections were adequate to meet the demand for treatment. However, in future large-scale combat operations the demand for and supply of blood products must exceed historical volumes available in theater, and resupply must be challenged by near-peer adversaries. This must place greater demand on the WBB. Ensuring donated blood is free from HIV-1 and -2, Hepatitis B and C, and is a compatible blood type, is essential to safety and ultimately positive outcomes for the patients.

At present, all the Services (U.S. Army, U.S. Navy, U.S. Air Force, U.S. Marine Corps, and U.S. Special Operations Forces) use three (3) separate rapid tests for HIV, Hepatitis B, and C, which are approved as diagnostics; each takes 30 minutes or longer for results. Blood typing is accomplished using a separate assay (Eldon cards) and requires an experienced user to interpret the results accurately. Frequently, local nationals, enemy combatants, and Coalition Forces are treated by US medical providers alongside US Service Members, and their blood type is usually unknown. Having a single multiplex panel that provides easily interpreted results for HIV 1 & 2, Hepatitis B and C, and blood type must significantly increase efficiency of donor screening and blood collections.

1.3 Inclusion of Nontraditional Defense Contractors or Nonprofit Research Institutions

10 U.S.C. 4022 (formerly 2371b) authorizes Department of Defense organizations to carry out prototype projects that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting 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 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 C for additional details.

Definitions:

Non-Traditional Defense Contractor (NDC) –An entity that is not currently performing and has not performed, for at least one-year period preceding the solicitation 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. A nontraditional defense contractor is considered a nontraditional defense contractor 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 solicitation of the current OT opportunity. In order for an entity to qualify for NDC status, it would need to meet all elements of the prescribed definition within that time period. This includes performance of a DoD contract or subcontract subject to full CAS coverage within one year prior to solicitation of the Prototype 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 award type will be cost plus fixed fee (CPFF).

2.2 Period of Performance

The estimated period of performance (PoP) for Objective 1 is 24 months. The estimated PoP for Objectives 2 through 4 is 66 months. Total project performance is 90 months. If all objectives can be accomplished/completed in less time, it is highly desirable.

Objective 1 – 24 months Objective 2 (optional) – 12 months Objective 3 (optional) – 42 months Objective 4 (optional) – 12 months

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

USAMRAA will oversee submission of proposals submitted in response to this RPP. USAMRAA 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 a non-disclosure and conflict of interest documents.

2.5 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 Article 7 of the Agreement’s terms & conditions.

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 Ownership of Agreement Inventions

Ownership inventions for this award will be defined in the terms and conditions of the Agreement. As a starting reference point, the Government’s standard inventions terms have been provided. See Article 8 of the Agreement’s terms & conditions.

2.7 Data Rights

Data rights for this award will be defined in the terms and conditions of the Agreement. See Article 9 of the Agreement’s terms & conditions.

It is anticipated that any data delivered under this proposed effort will be jointly owned by the Parties. Prior to making an award, the presumptive awardee will be required to reach an agreement with the Government on the Government’s rights in all technical data and/or computer software required to be delivered under the resultant agreement (see the deliverables table in the SOO).

2.8 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 that have not submitted proposals 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 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 Offeror is a nontraditional defense contractor (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:

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 there all significant participants in the transaction, other than the Federal Government, are small businesses or nontraditional defense contractors.

(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.

NOTE: One statutory condition for the use of a Prototype OT is if the performing team does not include either a 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.

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.

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

(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 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 Cost Proposal Volumes and must be submitted in accordance with these General Instructions. If an Offeror fails to submit their proposal in accordance 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 solicitation. 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 that the requirements in these instructions contain an error, omission, or are otherwise unsound, the Offeror must immediately notify the USAMRAA Agreements Specialist, listed in this solicitation, 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

Technical Approach:

-Assay Development Strategy -Assay & Device Integration & Refinement, and -Testing Strategy 20 pages

Management Approach:

-Project Management Plan (PMP) (with Integrated Master Schedule & Risk Management Plan), -Regulatory Strategy, and -Commercialization Strategy for Rapid Donor Screening (RDS) 10 pages

Attachment E – Draft Agreement (Terms and Conditions), including filled out:

- Attachment 5 – Performer Background Intellectual Property, Technical Data, and Other Terms

- Attachment 6 – Foreign Disclosure Agreement 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 contacts 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 solicitation. The Offeror must not merely reiterate the objectives or reformulate the requirements specified in the solicitation.

Labeling To request protection from FOIA disclosure as allowed by 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 of the objectives outlined in the SOO. In addition to the written technical approach, the Offeror must also include an Assay Development Strategy, and Assay & Device Integration & Refinement, and Testing Strategy as well as a Statement of Work (SOW) with milestones.

Offerors must include technical and corporate experience that reflect the ability to execute the SOO. Any relevant experience achieving FDA clearance / approval and commercializing must also be included.

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

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

Assay Development Strategy The Offeror must describe and justify selection of assay antigen, antibody or nucleic acid target for each infectious agent, development of assay reagents, and development of multiplex panel. This section must include assay testing strategy that will achieve the Governments goals.

Assay & Device Integration & Refinement The Offeror must describe process for multiplex panel integration into device (if separate from multiplex panel), integration testing, modification approach (assay/device, if applicable), and refinement process to achieve the Government’s goal of a donor screening indication. A description of the steps in the assay method/protocol shall be included.

Testing Strategy The Offeror must describe assay validation procedures, assay (and device if required for operation) stability studies (under conditions described in the performance attributes table of the SOO), and clinical specimen study test plan to achieve FDA 510(k) clearance or PMA approval.

Attachment D - SOW – The Offeror must fill out and submit Attachment D - Statement of Work (SOW) template with milestones. The Offer must fill in the specific tasks to be completed for each objective (see last page of Attachment D). The SOW tasks must align to the assay development strategy, assay development integration & refinement, testing strategy, modification approach (if applicable), and project schedule. Attachment B – Objectives to Performance Attribute Crosswalk is provided in this RPP in an effort to assist Offerors in preparing their SOW. The Offeror’s SOW is the primary document detailing the tasks proposed.

3.4 Volume II: Management

Management Approach The Offeror must submit a written management approach which effectively demonstrates the Offeror’s clear understanding and approach to achieving all of the objectives outlined in the SOO. The management approach consists of: Project Staff selection, Project Management Plan (PMP), Regulatory Strategy, and Commercialization Strategy.

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

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

Project Management Plan (PMP) (Deliverable 3 of the SOO) The Offeror must provide a PMP detailing the approach to managing the project schedule, project risks, cost control, testing timeline and includes sufficient detail to allow the Government to assess overall management strategy and project control measures. The PMP must include an Integrated Master Schedule (IMS) and Risk Management Plan.

(a) Integrated Master Schedule (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 (CLIA waiver studies and full-rate manufacturing).

(b) 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.

Regulatory Strategy The Offeror must submit a regulatory strategy for FDA approval. 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.

Commercialization Strategy for Rapid Donor Screening The Offeror must submit a strategy for RDS commercialization. This must include identification of a non-US DoD customer base, marketing strategy, and plan to sustain markets into the future.

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 Offer must include a table of contents for this volume.

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

Attachment E – Draft Agreement (Terms and Conditions) The Offeror must submit a red line version (i.e. track changes) of Attachment E – Draft Agreement (Terms and Conditions) incorporating any proposed changes and revisions. If no proposed changes/language are needed, please indicate this by submitting a signed copy of Attachment E – Agreement (Terms and Conditions). Additionally, Offeror must fill out Attachment 5 “Performer Background Intellectual Property, Technical Data, and Other Terms” and Attachment 6 “Foreign Disclosure Agreement.”

Attachment F – Cost Sheet Template 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.

Cost estimate Offerors must submit both a written cost estimate and fill out and submit Attachment F – Cost Sheet Template. 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 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.

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.

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.

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.

Sub-performers. For each year, the Offeror must submit a complete breakdown of costs/pricing for all sub-performer 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 estimate (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.

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 what tasks/milestones the equipment is associated with.

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.

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 agency’s, name, email address, and telephone number MUST be provided.

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. The proposal will be evaluated on a “best value” basis.

Best Value - The Government will conduct the source selection based on the evaluation criteria and ratings contained within this RPP. The overall award decision will be based upon a Best Value determination and the final award selection will be made to the most advantageous offer. The Government reserves the right to negotiate and request changes to any or all parts of the proposal to include the SOW.

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

The evaluation of the proposal in response to this RPP will be based on a comprehensive review and evaluation of the proposal against all evaluation factors. Ratings consistent with the evaluation criteria will be derived from the Offeror’s demonstrated ability to perform the work in accordance with all aspects of requirements outlined in the RPP. The Government will evaluate each proposal against the evaluation criteria and assign an adjectival rating to the non-cost factors consistent with those defined in Table 1 “Non-Cost Rating Assessments.” The Government will evaluate the overall cost for realism, reasonableness, and completeness. The Offeror must clearly state how their proposal meets the objectives and, if possible, exceeds the RPP requirements. Mere acknowledgement or restatement of a requirement or objectives is not acceptable. The Government will evaluate proposals using the following criteria listed in descending order of importance:

Information required for each evaluation factor that is not found in its designated volume may not be considered in the evaluation of that factor or will be simply eliminated from competition.

Evaluation Factors

Table 1: Non-Cost Factor Ratings

Definition of General Terms used in Evaluations:

Significant Strength – An aspect of an Offeror's proposal that has appreciable merit or appreciably exceeds specified performance or capability requirements in a way that will be appreciably advantageous to the Government during award performance.

Strength – An aspect of an Offeror’s proposal that has merit or exceeds specified performance or capability requirements in a way that will be advantageous to the Government during award performance.

Weakness – A flaw in the proposal that increases the risk of unsuccessful award performance.

Significant Weakness – A flaw that appreciably increases the risk of unsuccessful award performance.

Significant Weakness – A flaw that appreciably increases the risk of unsuccessful award performance.

Deficiency – A material failure of a proposal to meet the Government’s requirement or a combination of weaknesses in a proposal that increases the risk of unsuccessful award performance to an unacceptable level.

4.3.1 Factor I – Technical Approach

The Offeror’s proposal will be evaluated to the degree it includes/addresses the required content/ information from Section 3.3 above and the degree to which the technical approach demonstrates:

· A clear understanding of the all the objectives outlined in the SOO and how it will be achieved, is comprehensive, realistic, mitigates risk, meets timelines as well as furthers the prototype’s maturity towards regulatory clearance, commercialization, and military relevance;

· Offeror proposes an achievable single multiplex assay that includes all of the listed targets OR Offeror proposes an achievable multiplex assay of no more than 2 for the prototype phase of development;

· Offeror proposes sound strategy for achieving the performance minimums stated in the SOO and includes the testing strategy and modification approach for assay development necessary for successful functioning in an operational environment;

· Offeror proposes a comprehensive SOW with milestones that includes tasks that align to the assay development strategy, assay development integration & refinement, testing strategy, project schedule (included in the Integrated Master Schedule), and Integrated Master Schedule; and

· Team and corporate experience reflect the ability to execute the SOO as well as relevant experience achieving FDA clearance / approval and commercialization.

4.3.2 Factor II – Management Approach

The Offeror’s proposal will be evaluated to the degree it includes/addresses the required content/information from Section 3.4 above and the degree to which the technical approach demonstrates:

· A clear understanding of all the objectives outlined in the SOO and how it will be managed, is comprehensive, realistic, mitigates risk, and meets timelines and deliverables as well as the approach to managing the prototype’s maturity towards regulatory clearance, commercialization, and military relevance;

· Is detailed and provides appropriate and effective management approach/strategy for maintaining project schedule, project risks, cost control, quality assurance, and testing timeline;

· Regulatory Strategy management approach/strategy is detailed, appropriate, mitigates regulatory risks and potential issues, and increases probability of success; and

· Includes a commercialization strategy for RDS that identifies non-US DoD customer base, marketing strategy, and plan to sustain markets into the future.

4.3.3 Factor III – Cost

The Offeror’s cost proposal and rationale/basis of estimate will be evaluated to determine whether the proposed cost is realistic, reasonable, and complete. To make this determination, the Government may use analysis techniques including, but not limited to, verification of cost data, evaluation of cost elements, comparison of costs proposed by the Offeror for individual cost elements with actual costs previously incurred by the same Offeror, previous cost estimates from the Offeror for the same services, and independent government cost estimates by government personnel. The Government will independently review and evaluate specific element of the Offeror’s proposed cost to determine realism, reasonableness, and completeness. The evaluation will include analysis of the proposed cost together with the supporting cost information.

Realism: Cost is “realistic” when they are neither excessive nor insufficient for the effort to be accomplished. Estimates must also be realistic for each objective when compared to the total proposed cost, reflects a clear understanding of the requirements, and are consistence with the technical and management Approaches.

Reasonableness: Cost must, in its nature and amount, represent a price to the Government that a prudent person would pay in the conduct of competitive business. The Offeror must show that sound, rational judgment was used in deriving and applying cost methodologies. Normally, price reasonableness is established through cost and price analysis.

Completeness: Cost must clearly and thoroughly document the rationale supporting the proposed cost and its compliance with the requirement of the solicitation. The proposal must clearly and thoroughly document the cost information supporting the proposed cost in sufficient detail and depth. Rate and pricing information is required to properly perform a cost analysis of the proposal.

5. Proposal Submission

RPP Questions Due: Submitted in writing no later than: 4:00 PM eastern, 30 April 2024

Proposals Due: 04:00 PM eastern, 22 May 2024

Questions and proposals must be submitted in writing to Mr. Chris Sult, USAMRAA Agreements Specialist via email at christopher.m.sult.civ@health.mil

6. Attachments

Attachment A – Statement of Objectives (SOO) Attachment B – Objectives to Performance Attribute Crosswalk (REFERNECE ONLY) Attachment C – Warranties and Representatives Attachment D – Statement of Work (SOW) Template Attachment E – Draft Agreement (Terms & Conditions) Attachment F – Cost Sheet Template Attachment G – Contract Data Requirements List (CDRL) (REFERENCE ONLY) Attachment H – Data Item Description (DID) No. DI-TCSP-8204 (REFERENCE ONLY)

(end of RPP)