RPPV 26-07-ASSURE.docx

Biomedical Advanced Research and Development Authority (BARDA) Rapid Response Partnership Vehicle (RRPV)

Request for Project Proposals (RPP) Solicitation Number: RRPV 26-07-ASSURE

“Assay development for Superior Understanding of Response and Efficacy (ASSURE)”

Request Issue Date: 14 November 2025 Due Date: 18 December 2025 by 1pm Eastern

Biomedical Advanced Research and Development Authority (BARDA) Contracts Management & Acquisition (CMA) 400 7th Street, SW, Washington, DC 20024 MedicalCountermeasures.gov

Contents

1. Executive Summary

1.1 Rapid Response Partnership Vehicle Consortium

The Rapid Response Partnership Vehicle (RRPV) Consortium is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities, in cooperation with the Center for the Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services (HHS).

The RRPV will help fortify national health security by developing medical countermeasure products prior to and during a pandemic or public health emergency. The RRPV will focus on the acceleration of products and technology development, regulatory approval, commercialization, and sustainment to address pandemic influenza, emerging infectious diseases, and other biological threats.

Advanced Technology International (ATI) has been awarded an Other Transaction Agreement (OTA) by BARDA to serve as the Consortium Management Firm (CMF) for the RRPV.

RRPV is openly recruiting members to join a broad and diverse biomedical consortium that includes representatives from all organizations who work within stated technical focus areas. For more information on the RRPV mission, refer to the RRPV website at RRPV.org. For entities interested in joining the RRPV Consortium and responding to this solicitation, please visit http://www.rrpv.org/how-to-join.

1.2 Background

For the majority of licensed vaccines, measurement of serum antibody concentrations or neutralization activity remains the gold standard for immunogenicity assessment. To evaluate vaccines that elicit robust immune responses beyond humoral immunity, new assays are needed.

Although antibody responses may be a critical component of the protective immune response to infection and/or vaccination, other aspects of the immune system (e.g., cell mediated immunity, mucosal immunity, innate immunity, etc.) may significantly contribute to effective protection against infection, disease pathology and severe outcomes. Assays that are relatively simple to use and can represent the breadth and complexity of immunogenicity are needed. Such assays may require sample types beyond commonly collected serum, which adds complexity to the requirements for sample collection, volume, storage and processing. Thereby, the Assay development for Superior Understanding of Response and Efficacy (ASSURE) program aims to enhance our ability to comprehensively evaluate the immune response to vaccination or infection, with specific interest on assays that capture markers of cell-mediated immunity and/or mucosal immunity.

1.3 Purpose

The ASSURE program aims to develop innovative, multiplexed, high-throughput, scalable and sample-sparing assays that provide comprehensive evaluation of an individual’s immune status as a response to either infection or vaccination.

This program seeks to de-risk the development of novel assay platform technologies with the ultimate goal of establishing new, qualified assays primarily for BARDA and vaccine developers to comprehensively assess the immune response and status elicited by vaccines and/or infection due to CBRN threats, pandemic influenza, or other emerging infectious diseases. Some of these assays may lead to support of new correlates of protection.

2. Administrative Overview

2.1 RPP Approach

A multi-stage approach will be employed to streamline the process for preparation, submission, evaluation, and notification. A down selection will occur between Stages 1 and 2. Participation in Stage 1 does not guarantee the opportunity to submit a Full Technical and Cost Proposal in Stage 2, and submission of a Full Technical and Cost Proposal in Stage 2 does not guarantee an award. Each stage of this solicitation process is competitive. Offerors will be invited to participate in the next stage of the process via email from the RRPV Consortium Management Firm (CMF) following the results of the evaluation. Only selected Stage 1 offerors will be invited to submit a Full Technical and Cost Proposal in Stage 2.

The solicitation stages are as follows:

Stage 1 - Abstract In Stage 1, Offerors will submit an Abstract (not to exceed 5 pages) and a 1-page Quad Chart. Abstracts submitted under this RPP shall follow the mandatory templates provided in Attachment 1. BARDA will evaluate the Stage 1 Abstracts to determine which proposed solutions best meet the evaluation criteria as well as BARDA’s current technology priorities and program objectives. Those Offerors will be invited to proceed to Stage 2. Offerors who are not invited to proceed into Stage 2 will be notified.

Stage 2 - (By Invitation Only) Full Technical Proposal & Cost Proposal The successful Stage 1 Offeror(s) will receive an invitation letter from the CMF to submit a full technical proposal and cost proposal. Stage 2 is anticipated to require a Technical Proposal, Cost Proposal Narrative, Cost Proposal Template, and Statement of Work. Further instructions will be provided to successful Stage 1 Offerors in the invitation letter.

Following review of Full Technical Proposal and cost Proposal, selected offerors may be invited to present (virtual format) their proposed project to BARDA in a slide presentation, which will be followed by a Question-and-Answer session. The presentations will allow BARDA to efficiently evaluate Stage 2 proposals, determine their respective alignment with the ASSURE program goals, and engage directly with the Offeror to address technical questions or concerns. Instructions, including slide template, content due date, presentation time and date, and technical questions, will be provided to the Offerors in advance when they receive an invitation to present.

2.2 Order of Precedence

Each proposal selected for award under this RPP will be executed as a Project Award under the RRPV Base Agreement 75A50123D00005. The same provisions will govern this Base Agreement as the OTA between the U.S. Government (USG) and ATI (“RRPV Base”) unless otherwise noted in the Project Award.

2.3 Period of Performance and Funding

2.3.1 Period of Performance

The period of performance for Performer(s) should be commensurate with the amount of work proposed. The period of performance for Performer(s) should take into consideration risk of unforeseen challenges associated with R&D, industry practices, market conditions, and business concerns. BARDA anticipates that initial projects will require up to 24 months, but this is flexible, depending on scope and range of work proposed.

2.3.2 Funding

The total USG funding amount anticipated to be available for Project Awards is approximately $8M. Four to five awards are anticipated, and subject to change, dependent upon priorities and proposed proposal scope. Resource/cost sharing is encouraged to support costs that may exceed what is possible by BARDA. Award and funding from the Government is contingent upon the availability of federal funds for this program.

2.4 Expected Award Date

Offeror should plan on the period of performance beginning during the third quarter of calendar year 2026. Government reserves the right to change the proposed period of performance start date through negotiations via the RRPV CMF and prior to issuing a Project Award.

2.5 Proprietary Information

The RRPV CMF will oversee submission of abstracts, proposals, and presentation materials submitted in response to this RPP. The RRPV CMF shall take the necessary steps to protect all proprietary information and shall not use such proprietary information for purposes other than proposal evaluation and agreement administration. Please mark all Confidential or Proprietary Information as such. An Offeror’s submission of a response under this RPP indicates concurrence with the aforementioned CMF responsibilities.

2.6 Mandatory Eligibility Criteria

In order to be eligible for consideration, Offerors must be RRPV members when their Abstract is submitted. Prospective Offerors may join the consortium at www.rrpv.org/how-to-join.

Abstracts found to not meet minimum eligibility criteria as detailed above may be removed from consideration, no further evaluation will be performed, and feedback will not be provided to these Offerors.

2.7 Cost Sharing

Cost sharing is defined as the resources expended by the Project Awardee on the proposed Statement of Work (SOW). Cost sharing is encouraged, if possible, as it leads to stronger leveraging of Government-Performer collaboration.

2.8 Intellectual Property and Data Rights

Intellectual Property (IP) rights for RRPV Project Awards will be defined in the terms of a Project Awardee’s Base Agreement. The RRPV CMF reserves the right to assist in the negotiation of IP, royalties, licensing, future development, etc., between the Government and the Project Awardees during the entire award period.

The Offeror shall comply with the terms and conditions defined in the RRPV Base Agreement regarding Data Rights. It is anticipated that anything delivered under this proposed effort would be delivered to the Government with unlimited data rights as defined in the RRPV Base Agreement unless otherwise specified in Attachment 1, Abstract, and agreed to by the Government. All proposed data rights are subject to Government review and approval. Rights in technical data agreed to by the Government will be incorporated into the Project Award.

3 Submissions

3.1 Question and Answer Period

Key dates related to this RPP are provided below. Please submit questions to Ms. Rebecca Harmon (rrpv-contracts@ati.org). Answers will be posted publicly to the RRPV website.

3.2 General Instructions

The formats provided in this RRPV RPP are mandatory and shall reference this RPP number. At the time of the submission, Offerors must certify on the cover page of their Abstract that, if selected for award, they will abide by the terms and conditions of the latest version of the RRPV Base Agreement. Offerors may request a current copy of the RRPV Base Agreement terms and conditions by emailing RRPV-contracts@ati.org. Base Agreements are typically not executed until Offeror is selected for award.

Offerors are encouraged to contact the Point of Contact (POC, see Section 6), identified herein up until the submission date/time to clarify requirements.

Abstracts and Quad Chart shall reference this RPP number. The Abstract and Quad chart is mandatory and shall remain valid for 180 days unless otherwise specified by the Offeror in the submission. Offerors are encouraged to contact the RRPV CMF with any questions so that all aspects are clearly understood by both parties.

All eligible Offerors shall submit Abstracts and Quad charts for evaluation according to the criteria set forth in this RPP. Offerors are advised that only ATI, as the RRPV’s CMF, with the approval of the Other Transaction Agreements Officer, is legally authorized to contractually bind or otherwise commit funding for selected Project Awards as result of this RPP.

3.3 Abstract and Quad Chart Submission

Abstracts and Quad Charts shall be submitted by the date and time specified on the cover page to the BARDA Digital Resource (BDR) portal website at https://rrpv.hhs.gov/. Abstracts received after the date and time specified may not be evaluated.

Offerors will be required to register for a BDR portal account before a response can be submitted. A BDR account can be requested by contacting ATI at RRPV@ati.org. The account request process is simple but may take several days for approval and access. Upon confirmation of a BDR portal account, the Offeror will login using the prescribed two-factor authentication method.

Offerors are strongly encouraged to access the BDR Portal well in advance of the submission due date to verify their ability to log in, confirm account validity, and ensure full access to the submission system. Failure to submit on time for any reason (e.g., due to late registration in BDR portal) will result in the submission not being considered for award. Offerors will be provided an automated confirmation of successful submission.

Do not submit any classified information in the Abstract or Quad Chart submission.

3.4 Preparation Cost

The cost of preparing Abstracts, Quad Charts, and/or Proposals in response to this RPP is not considered a direct charge to any resulting award or any other contract.

3.5 Submission Format

Stage 1 submissions shall consist of a written Abstract of no more than five (5) pages and a Quad Chart of no more than one (1) page, prepared in accordance with the template and formatting instructions in Attachment 1. Submissions exceeding the page limits or not adhering to the prescribed format may be rejected without further review.

4 Technical Requirements

4.1 Introduction

The Offeror shall clearly state how it intends to meet and, if possible, exceed the technical requirements. Mere acknowledgement or restatement of the requirements is not acceptable, unless specifically stated otherwise. The Offeror may submit to one or multiple areas providing that the scope of the proposed project remains realistic and commensurate with resources, expertise and projected timelines as feasible. Teaming is encouraged for submissions to individual and multiple areas.

4.2 Scope

Submission areas:

1) Assay Innovation:

Develop, and clinically evaluate assays that capture comprehensive information on the quality, breadth, and durability of protection conferred by vaccination and/or infection. The project focus is on the assay development and not on biomarker discovery. Such assays must have a clear clinical or product development use case (i.e., accurately predict vaccine efficacy or response to natural infection) and be adaptable to a diversity of pathogen targets. Developers should take into consideration the use case in alignment with laboratory setting, clinically relevant assay turnaround times, etc. BARDA is particularly interested in novel technologies that measure cellular and mucosal immunity elicited in response to exposure to the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) or vaccination against such pathogens (including vaccines in development), but other threats relevant to BARDA’s mission space will be considered for the purposes of assay development under this program.

2) Sample Collection and Processing Innovation to Support Novel Assays Developed Under 1:

Assay Innovation is the priority of this requirement, however simplified sample collection, transport, and processing are of interest to enable these assays. However, it is desired to have assays that can process multiple samples in a high throughput manner from large (>10,000 participant) trials.

Advances in sample collection and processing technologies compatible with novel assays developed under area #1 should support reproducible measurements on the assay with consideration for small sample volumes, collection method and ease of collection, ease and time for handling and processing, stability and storage requirements as well as high throughput capabilities. Such sample sparing approaches will need to be developed in coordination with the assay; development of sample sparing approaches alone will not be considered in scope.

3) Sample Collection and Processing Innovation Compatible with Existing Commercial Assays that measure the immune response:

These advances should improve efficiency in sample collection (including sample type), handling, and processing, with an emphasis on ability to scale or multiplex analysis. Similar to above, it is desired to have assays that can process multiple samples in a high throughput manner from large (>10,000 participant) trials.

4.3 Performance Requirements

The abstracts for novel immune assays should include the following:

1. Description of immune markers (e.g., innovative measure of functional T cells, mucosal immunity, etc.) to be measured, based on scientific premise and the clinical relevancy.

2. Discuss the number of biomarkers able to be currently measured. Discuss potential ability to measure multiple biomarkers either sequentially or simultaneously and potential scaling capabilities that may be needed to support measuring multiple biomarkers. Description of ability of assay to be compatible for high throughput.

3. Description of compatibility of assay to scale to allow rapid analysis of large numbers of patient samples (e.g., >1000 samples per run), if relevant to the use case.

4. Propose reasonable performance metrics (e.g., time to results, cost, breadth of biomarkers, etc.) to allow for the technology to be transferable to a commercial partner, commercially viable, and support adoption.

5. Generate reproducible results with specificity and sensitivity in line with commercial and regulatory considerations.

6. Be compatible with different sample types, for example, minimally invasive sample collection of capillary whole blood, dried blood spots, mucosal secretions such as respiratory tract fluid, salivary, lacrimal, mammary gland, or stool specimens, and support analysis of, including but not limited to, serum, plasma, PBMC, etc.

7. Provide a sample to result timeframe relevant to the intended use.

8. Validate assays with clinically relevant samples.

9. Provide rationale for novel endpoints, if achieved

It is of interest for abstracts to also:

1. Demonstrate correlation and provide justification for the immune response, and vaccine or infection induced immune protection

2. Describe how the technology can be pivoted to measure immune responses to different PHEMCE threats, including viral, bacterial, or fungal pathogens, or their vaccines.

3. Describe the potential ability of the technology to measure the immune status longitudinally beyond the initial acute phase of the response and provide information on the breadth, quality, and durability of the response over time.

Sample collection and processing technology proposals are expected to:

1. Demonstrate that sample processing capabilities are compatible with novel immune assays developed under this solicitation and:

a. Support reproducible measurements on the coupled assay.

b. Allow for small sample volumes, ease of collection, ease and appropriate or reduced handling and processing time.

c. Rely on minimally invasive collection techniques (e.g., whole blood, dried blood spots, serum, plasma, PBMC, mucosal secretions (e.g., respiratory tract, salivary, lacrimal, or mammary gland, stool)).

d. May improve sample handling, processing, stability and storage compared to current standards.

2. Or demonstrate that sample processing capabilities be compatible with existing commercial assays and, in addition to the above:

a. Improve efficiency in sample collection and processing compared to existing methods.

b. Allow for ability to tech transfer to commercial partners and scale. Evidence of a partnership with a commercial assay developer is highly desired.

c. Allow for multiplex analysis.

Additionally, proposed projects are expected to:

1. Include future commercialization plans, planned regulatory engagement if required, planned clinical validation or qualification, and anticipated timeline for development and transition plan beyond the work proposed in response to this solicitation. Note that BARDA is also interested in understanding, but not limited to, assay deployment, reagents required, maintenance, and long-term use.

2. Describe what clinical samples will be leveraged for the proposed scope of work. Note that BARDA is interested in assays that measure immune responses to influenza and emerging infectious diseases within BARDA’s mission space if identified as appropriate use cases.

3. Consider assay designs and sampling processes that are cost-effective.

4. Consider sample sparing approaches (described above) that may be compatible with pediatric and immunocompromised subjects/populations.

4.4 Out of Scope Topics

Abstracts will be considered out of scope if:

· Focused primarily on research questions and biomarker discovery, without consideration for a product driven / clinical management approach.

· Lacking a defined intended use or proposing an intended use not relevant to the BARDA mission related pathogens (i.e., CBRN threats that can cause infections, pandemic influenza, emerging infectious disease, and/or clinical trials monitoring)

· Lacking preliminary data.

· Focused on direct pathogen or pathogen-based biomarker detection/quantification.

Abstracts determined to be out of scope as detailed above may be removed from consideration, no further evaluation will be performed, and feedback will not be provided to these Offerors.

5 Selection/Evaluation

5.1 Compliance Screening

The RRPV CMF will conduct a preliminary screening of submitted Abstracts to ensure compliance with the RPP requirements. As part of the preliminary screening process, submissions that do not meet the requirements of the RPP may be eliminated from the competition or additional information may be requested by the RRPV CMF. The Government reserves the right to request additional information, perform a pre-award audit, or eliminate from further consideration Abstracts that do not meet these requirements.

5.2 Evaluation Process

Following the preliminary screening, the Government sponsor will perform source selection using the evaluation factors detailed below. The Government will conduct an evaluation of all qualified Proposals.

Qualified Proposals will be evaluated by a panel of subject matter experts (SMEs) who will make recommendations to a Source Selection Authority.

This process may involve the use of contractors as SME consultants or reviewers. Where appropriate, the USG will employ non-disclosure agreements to protect information contained in the RPP. An Offeror’s submission of an Abstract and/or Proposal under this RPP indicates concurrence with the aforementioned use of contractors and SMEs.

5.2.1. Stage 1 and 2:

Following the preliminary screening by the CMF for compliance with the RPP requirements, BARDA will perform an evaluation of all eligible Stage 1 Abstracts and Stage 2 Proposals.

Evaluation of Stage 1 Abstracts and Stage 2 Proposals will be based on an independent, comprehensive review and assessment of the work proposed. The Government will evaluate each Abstract and Proposal against the evaluation factors detailed below and assign one of the following adjectival ratings in order to determine the best value to the Government.

· Outstanding

· Good

· Acceptable

· Marginal

· Unacceptable

Stage 1 Abstract and Stage 2 Proposal evaluation factors are as follows:

Evaluation Factor 1 - Technical Approach: This factor evaluates the relevancy, thoroughness, completeness, and feasibility of the proposed approach and the feasibility of proposed schedule.

Evaluation Factor 2 – Relevant Experience: This factor evaluates the offeror’s demonstrated organizational experience, as well as the technical and management experience of the proposed team to perform the proposed work. The Government may also consider information in Contractor Performance Assessment Reporting System (CPARS), and the Federal Awardee Performance and Integrity Information System (FAPIIS) or similar systems.

Evaluation Factor 3 – Cost Reasonableness: Assessment of the cost of the project to determine i) whether the project cost is within the available funding limits, and ii) the ability and/or likelihood of the offeror to successfully execute the proposed project within the financial resources proposed.

5.3 Cost/Price Evaluation

Successful Stage 1 Offerors will be invited to submit full proposals. If a proposal is selected for award, the RRPV CMF will evaluate the estimated cost proposed by the Offeror for performing all requirements outlined in this RPP. Evaluation will include analysis of the proposed cost together with all supporting information. The RRPV CMF will request additional information or clarification as necessary. The RRPV CMF will assess the reasonableness and completeness of the cost estimates and then provide a formal assessment to the Government. The Government will review this assessment and make the final determination that the project value is fair and reasonable, subject to final Government negotiations.

Proposals will be evaluated using the understanding of cost realism, reasonableness and completeness as outlined below:

a) Realism. Proposals will be evaluated to determine if Costs are realistic for the work to be performed, reflect a clear understanding of the requirements, and are consistent with the various elements of the Offeror's schedule proposal.

Estimates are “realistic” when they are neither excessive nor insufficient for the effort to be accomplished. Estimates must also be realistic for each phase of the proposed project when compared to the total proposed cost.

The RRPV CMF will make a determination by directly comparing proposed costs with comparable current and historical data, evaluator experience, available estimates, etc. Proposed estimates will be compared with the corresponding technical proposals for consistency.

b) Reasonableness. The Offeror’s cost proposal will be evaluated to determine if it is reasonable. For a price to be reasonable, it must represent a price to the Government that a prudent person would pay in the conduct of competitive business. Normally, price reasonableness is established through cost and price analysis.

To be considered reasonable, the Offeror’s cost estimate should be developed from applicable historic cost data. The Offeror should show that sound, rational judgment was used in deriving and applying cost methodologies. Appropriate narrative explanation and justification should be provided for critical cost elements. The overall estimate should be presented in a coherent, organized and systematic manner.

Costs provided shall be clearly attributable to activities or materials as described by the Offeror. Costs should be broken down in the Cost Proposal Format. An optional template is located on the Members-Only RRPV website.

c) Completeness. The RRPV CMF will evaluate whether the proposal clearly and thoroughly documents the rationale supporting the proposed cost and is compliant with the requirements of the solicitation.

The proposal should clearly and thoroughly document the cost/price information supporting the proposed cost in sufficient detail and depth. The RRPV CMF will evaluate whether the Offeror’s cost proposal is complete with respect to the work proposed. The RRPV CMF will consider substantiation of proposed cost (i.e., supporting data and estimating rationale) for all elements.

Rate and pricing information is required to properly perform the cost analysis of the proposal. If the Offeror is unwilling to provide this information in a timely manner, the proposal will be lacking information that is required for proper evaluation and the proposal may not be selected for award.

5.4 Best Value

The Government will conduct the source selection based on the evaluation criteria and ratings listed above. The overall award decision will be based upon a Best Value determination by considering and comparing factors in addition to cost or price. Funding recommendations depend on various factors and programmatic relevance. Based on the evaluation of the Technical Approach, Relevant Experience, and Cost/Price, the Government reserves the right to negotiate and request changes to any or all parts of the SOW. Offerors will have the opportunity to concur with the requested changes, propose further changes and revise cost proposals, as necessary.

5.5 Evaluation Results

Following the evaluation of the Stage 2 proposals, the Source Selection Authority may recommend the following for the CMF’s consideration:

0. Select the proposal (or some portion of the proposal) for award;

0. Place the proposal in the Basket if funding currently is unavailable; or

0. Reject the proposal (will not be considered for award and will not be placed in the Basket)

The Government does not guarantee a minimum or maximum number of awards resulting from this solicitation.

5.6 Basket Provision

The electronic “Basket” is an innovative acquisition tool. Stage 2 Full Technical and Cost Proposals rated as Acceptable through Outstanding, but not immediately selected for award, will be placed in the Basket for 2 years and eligible for award during that time. Proposals rated as below Acceptable will not be placed in the Basket and will not be eligible for future award. If awarding from the Basket, the Government reserves the right to award whichever proposal best meets its needs.

6 Points of Contact Questions related to this RPP should be directed to Ms. Rebecca Harmon (rrpv-contracts@ati.org).

All technical questions must be submitted by November 26, 2025, to allow for Government response. The Government will respond to questions at its discretion. All questions and responses will be posted to the RRPV Solicitation webpage https://www.rrpv.org/opportunities/. Questions received after the stated deadline are not guaranteed a response.

Once an Offeror has submitted a submission under this RPP, the Government and the RRPV CMF will not discuss evaluation/status until the evaluation results have been provided to the Offerors.

ATTACHMENT 1 – ABSTRACT TEMPLATE

General Instructions The Abstract must address the technical requirements described in the RPP in sufficient detail to permit evaluation from a technical perspective in accordance with the evaluation factors set forth in the RPP. Offerors are strongly encouraged to use pictures and graphics to succinctly represent proposed ideas, organization, etc.

The Abstract shall be limited to 5 pages and Quad Chart limited to 1 page; however, the Cover Page and the Data Rights Assertions are not included in the page count. Pages in excess of this limitation may not be considered. Offerors are advised that the number of pages should be commensurate with the degree of complexity of the proposed effort.

The following formatting requirements apply:

· 12-point font (or larger), single-spaced, single-sided, 8.5 by 11 inches

· Smaller type may be used in figures and tables, but must be 8-point font (or larger)

· Margins on all sides (top, bottom, left, and right) should be at least 1-inch

· Submit files in Microsoft Word, Adobe Acrobat (PDF – portable and searchable document format) formats. ZIP files and other application formats are not acceptable. All files must be print-capable and without a password required. Filenames shall contain the appropriate filename extension (.docx.pdf). Filenames should not contain special characters. IOS users must ensure the entire filename and path are free of spaces and special characters. Movie and sound file attachments or other additional files, will not be accepted.

To ensure Abstracts receive proper consideration, the format shown below is mandatory. If there are any items which are not applicable to a specific Abstract, include the section topic in the Abstract with a short explanation as to why it is not applicable.

· Cover page (not included in page count)

· Executive Summary

· Technical approach overview

· Teaming/subcontractors

· Facilities and personnel qualification

· Budget estimation

· Period of Performance/Schedule

· Data Rights Assertions (not included in page count)

· Quad Chart (not included in page count, 1-page limit)

[Name of Offeror] [Address of Offeror] [Phone Number and Email Address of Offeror]

Unique Entity Identifier (UEI) #: [UEI #] CAGE code: [CAGE code]

RRPV 26-07-ASSURE

[Title of Abstract]

[Offeror] certifies that, if selected for selected for an Award, the Offeror will abide by the terms and conditions of the RRPV Base Agreement.

[A proprietary data disclosure statement if proprietary data is included. Sample: This Abstract includes data that shall not be disclosed outside the RRPV Consortium Management Firm and the Government and shall not be duplicated, used, or disclosed, in whole or in part, for any purpose other than to evaluate this Abstract and negotiate any subsequent award. If, however, an award agreement is a result of, or in connection with, the submission of this data, the RRPV Consortium Management Firm and the Government shall have the right to duplicate, use, or disclose these data to the extent provided in the resulting agreement. This restriction does not limit the RRPV Consortium Management Firm and the Government's right to use the information contained in these data if they are obtained from another source without restriction. The data subject to this restriction is (clearly identify) and contained on pages (insert page numbers).]

[Title of Abstract]

0. Executive Summary

· Provide the background and the Offeror’s understanding of the problem.

· Provide a description of the technology/process.

· Emphasize how the proposed technology/process meets the overall objective specified in this RPP.

0. Technical Approach Overview

· Identify which submission area(s) you are responding to.

· Demonstrate how your proposed solution currently meets the Technical Requirements described in Section 4.

· Include any previous studies or preliminary data [non-clinical and/or clinical] that support the feasibility of the proposed technology solution.

0. Regulatory and Commercialization Strategy

· Briefly describe your regulatory strategy.

· Discuss how you plan to commercialize the technology including plans for fundraising and partnerships.

0. Teaming/Subcontractors

· Describe any current or potential partnerships or collaborations that may be of use when developing this process/technology.

0. Facilities and Personnel Qualification

· Describe the qualifications and expertise of the key personnel and organizations associated with the proposed solution.

· Detail any past performance(s) that demonstrate relevance to the program objective and solution requirements.

· Identify any key facilities, equipment, and other resources relevant for the solution being proposed.

0. Budget Estimation

· Provide rough order of magnitude (ROM) and any pertinent assumptions for the proposed work.

0. Period of Performance/Schedule

· Identify the proposed Period of Performance (PoP) in months and describe the overall schedule.

0. Data Rights Assertions

· It is anticipated that anything delivered under this proposed effort would be delivered to the Government with unlimited data rights. If this is not the intent, then you should discuss any restricted data rights associated with any proposed deliverables. If applicable, complete the below table for any items to be furnished to the Government with restrictions. An example is provided. This section is not part of the page count.

Objective: Clear, concise (two to three sentences) description of the objectives and methodologies of the effort.

Description of effort: A bullet list (2-3) of the primary scientific challenges being addressed

Picture or Graphic that Illustrates the research or concept (e.g., data figures, molecule illustrations or processes)

Benefits of Proposed Technology:

Challenges:

Maturity of Technology:

Bullet list of the major goals/milestones by:

Project Year Proposed Funding (Rough Order of Magnitude Estimate)

Your quad chart must contain the following information and be positioned in a landscape view. Any quad chart submitted that exceeds the one-page limit will not be read or evaluated.

PROJECT TITLE, RPP#, TECHNICAL/ADMINISTRATIVE POC (NAME, EMAIL, PHONE), COMPANY NAME & ADDRESS Quad Chart Template image1.png image2.png image3.png