Army Contracting Command Aberdeen Proving Ground

Edgewood Contracting Division, Fort Detrick Request for Project Pre-Proposal

RPP # W911SR-26-R-PPBC

Agency: Department of the Army Office: Army Contracting Command, Edgewood Contracting Division Location: Fort Detrick, MD, USA Program Office: Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE CBRN Defense), Joint Project Manager for CBRN Medical (JPM CBRN Medical) RPP Number: W911SR-26-R-PPBC Date Issued: 2 June 2026 Proposals Due: 15 June 2026 4:00PM ET

1. Through this Request for Project Pre-Proposal (RPP), the Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense’s (CPE CBRN Defense) Joint Program Manager for Chemical, Radiological, and Nuclear Medicine (CBRN Medical) seeks to identify a single contractor to provide expert program management and subcontract administration in support of the Broadening Enabling Acquisition of Chemical Operational Needs (BEACON) program's mission, as described in the attached Statement of Objectives (SOO) (Attachment 1). The Government is hereby requesting formal submission of preproposals to execute a formal agreement under 10 U.S.C. § 4022, Other Transaction Authority (OTA) for the prototype project described below.

Upon receipt of a preproposal submitted in response to this RPP, the next steps are as follows:

- The Government will evaluate the preproposal.

- Discussions among the parties, whether verbally or in writing, will occur as appropriate.

- The Government may request a full proposal from the offeror.

- Additional discussions will occur as necessary.

- Award may be made after evaluation and selection of a successful submission.

(Note: Awards are dependent upon the availability of funds.)

2. This RPP is issued to request project proposals in compliance with 10 U.S.C. § 4022 and is being issued for planning purposes only. It is not to be construed as a commitment by the Government to award an agreement, nor will the Government pay for the information solicited.

3. The CPE CBRN Defense, through the BEACON program, is accelerating the identification and screening of chemical threat medical countermeasure (MCM) candidates through a data-driven approach. The awardee's primary role will be to obtain Government-identified MCM candidates and execute the Government's defined testing plan by rapidly awarding and managing subcontracts with testing performers. Any resultant award will be issued as a prototype Agreement under the authority of 10 U.S.C. § 4022.

4. The Government will review/evaluate the submitted preproposals and if there is Government interest, the Agreements Officer may issue a request for full proposal (RFFP) in response to this RPP. The Government may award an agreement based on the submission or may require submission of additional details. The award of Prototype agreements shall be for the development of prototypes that are directly relevant to enhancing the mission effectiveness of personnel of the Department of War and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of War, or for the improvement of platforms, systems, components, or materials in use by the Armed Forces. Only a warranted Agreements Officer may obligate the U.S. Government to the expenditure of funds for awards under this Announcement.

5. Evaluation will be performed by CPE-CBRND personnel, other Federal Agency

Representatives, or combinations thereof to enable the selection of the best preproposal submission, and/or subsequent full proposal submission. After evaluation and selection, an award may be made to the successful offeror(s).

Subsequent awards depend upon the availability of funds and fulfillment of requirements and priorities determined to exist at the time of award. In some cases, funding priorities may change as certain scientific tasks are addressed and new mission assignments arise. Award may also be dependent upon demonstration by the offeror that they have adequately addressed the requirements.

6. The U.S. Government does not fund preparation of proposals or support work efforts or tasks that are inferred from discussions with technical project officers. The Offeror will not be reimbursed for any costs incurred prior to the effective date of the agreement. There are certain post-employment restrictions on former Federal officers and employees as defined in 18 USC 207 and FAR 3.104-3(d). If an offeror believes a post-employment restriction or conflict of interest exists, notification should be sent to the Agreements Officer prior to initiating efforts on a full proposal.

7. The Freedom of Information Act (FOIA) (5 USC 552) provides a statutory basis for public access to official U.S. Government records. “Records” are defined to include documentation received by the U.S. Government in connection with the transaction of public business. Certain types of information submitted to the Government in a process having the potential for award of an OT may be exempt from disclosure requirements of FOIA for a period of five (5) years from the date the Government receives the information. The types of information listed above may continue to be exempted, in whole or in part, from disclosure after the expiration of the five (5) year period if it falls within an exemption to the FOIA such as trade secrets and commercial or financial information obtained from a person that is privileged or confidential. It is the Offeror’s responsibility to adequately mark any submitted information in accordance with the FOIA.

8. The Government is prohibited from soliciting and awarding actions to awardees that have engaged or are suspected to have engaged in criminal, fraudulent, or seriously improper conduct.

9. Prospective awardees shall complete electronic annual representations and certifications at https://sam.gov. By submission of an offer, the Offeror acknowledges the requirement that prospective awardees MUST be registered in the System for Award Management (SAM) database prior to award and through final payment of any contract resulting from this RPP. Offerors that are not registered should consider applying for registration immediately upon receipt of this solicitation.

To remain registered in the SAM database after the initial registration, the Offeror is required to review and update, on an annual basis from the date of initial registration (or subsequent updates), its information in the SAM database to ensure it is current, accurate and complete.

10. Data submitted that cannot be disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall be marked appropriately on the title page and/or specific data sheets.

11. Questions regarding this announcement may be submitted by email to Joseph McCaffery (joseph.w.mccaffery2.civ@army.mil) and Alex Mayatte (alexander.z.mayatte.civ@army.mil) prior to 5 business days of the closing date.

12. The Government may award a follow-on production contract or Other Transaction (OT) for any OT awarded under this RPP if: (1) that participant in the OT successfully completed the entire prototype project provided for in the OT; and (2) the OT provides for the award of a follow-on production contract or OT to the participant.

13. Proposals, Brochures, or other descriptions of general organizational or individual capabilities will not be accepted as a preproposal. An email will acknowledge receipt of a proposal. Generally, the Project Manager of the submitting organization should receive a decision letter or email upon completion of the evaluation and determination.

14. Administration: The Government will retain comments and information received in response to this RPP. Do not use Government security classification markings. All written responses must be received by the due date. Submission should be identified mailto:joseph.w.mccaffery2.civ@army.mil mailto:alexander.z.mayatte.civ@army.mil with a Subject Line of the Responding Organization and RPP Title. Material that is advertisement only in nature is not desired. Late submissions will not be considered.

15. Requirements: See attached Statement of Objectives (SOO) (Attachment 1).

16. Submissions:

Submissions must include sufficient detail to warrant a decision or otherwise will not be considered. Submissions cover page must identify appropriate POC’s in addition to company address, UEI, and CAGE codes. If the offeror is not listed in SAM.gov, then the extent of their submission package to SAM should be documented. Cover page, Rough Order of Magnitude (ROM), and Work Breakdown Structure (WBS) will not be considered in the total page count. Any additional pages exceeding 14 pages will not be considered.

The ROM should show management services for a one year period assuming 5 candidates per year and 1-4 tests per candidate, assuming early pre-clinical work (in vitro and in vivo).

Submissions must be delivered by the date and time expressed in announcement or will not be considered.

17. Evaluation Factors: Proposals received will be evaluated per CBRND-BAA-22-01.

The evaluation will assess the Offeror’s understanding of the requirements and the feasibility of their approach. The primary factors, in descending order of importance, are:

1. Technical Approach: Feasibility and merit of the proposed approach for program and subcontract management, technical oversight, and regulatory compliance.

The qualifications of the proposed Program Manager are a key element.

2. Past Performance and Relevant Experience: Demonstrated corporate experience managing government contracts of similar scope and complexity, particularly in medical/drug development and subcontractor management.

18. Selection for Award: See CBRND-BAA-22-01.

19. If an agreement award is made, the Awardee agrees that all obligations entered under this agreement shall be transferrable and assignable to a potential successor awardee as directed by the Agreements Officer. The Awardee shall enter good faith negotiations with any successor awardee and the Agreements Officer to execute a tri-party agreement that transfers, assigns, and/or identifies responsibilities for existing obligations. If, at the completion or termination of this Agreement, the Agreements Officer does not direct the Awardee to transfer or assign obligation(s) to a potential successor awardee, the Awardee shall be liable, responsible, and accountable for closing out and liquidating such obligations, or for taking such other action as the Agreements Officer may direct. The Awardee shall remain liable to the Government and responsible for any unallowable costs which it incurred, or caused to be incurred, in performance of this Agreement, regardless of whether they arise out of, or relate to, any obligations transferred or assigned to the successor awardee or to another entity.

ATTACHMENT 1

Statement of Objectives (SOO) for BEACON

1.0 PROJECT TITLE

CWMD-XX-XX: BEACON – Medical Countermeasure (MCM) Candidate Integration and Subcontractor Management

2.0 BACKGROUND/DESCRIPTION

The Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE CBRN Defense), through the BEACON program, is accelerating identification and screening of chemical threat medical countermeasure (MCM) candidates through a data-driven approach.

BEACON will conduct targeted non-clinical, clinical, and Chemical, Manufacturing, and Controls (CMC) testing of MCM candidates to reduce the risk of failure in advanced development.

BEACON will also perform studies targeting operationally relevant parameters to demonstrate effectiveness in a simulated operational environment. BEACON will establish and maintain a robust pipeline, seamlessly transitioning successful candidates to continued advanced development. BEACON benefits the warfighter by proactively maintaining a resilient and innovative MCM portfolio, ensuring access to effective medical countermeasures and mitigating the risk of delays in fielding critical capabilities.

3.0 SCOPE

The scope of this effort is to identify a single contractor to provide expert program management and subcontract administration in support of the BEACON program's mission. The contractor shall be responsible for the efficient execution of Government-defined testing plans for Government-selected MCM candidates.

3.1 Roles and Responsibilities

Under this program, the Government will be solely responsible for:

• Identifying and selecting all MCM candidates for evaluation

• Defining the specific nonclinical, clinical, and CMC testing to be performed

The awardee's primary role will be to obtain Government-identified MCM candidates and execute the Government-determined testing by rapidly awarding and managing subcontracts with testing performers. The awardee will be responsible for overseeing study planning and execution, managing cost and schedule, identifying programmatic risks, and ensuring the on-time delivery of all required data packages to the Government. The awardee will be responsible for establishing and maintaining comprehensive program orchestration, serving as the single point of accountability to drive stakeholder alignment, cross-functional coordination, and consensus.

4.0 PROGRAM OBJECTIVES

4.1 Program Management Objectives

• Program Manager Expertise: The awardee's proposed Program Manager shall have demonstrated experience managing complex government contracts, preferably within the medical or drug development field. The proposed individual is designated as Key Personnel for this effort and, upon selection, may not be substituted without the prior written consent of the Contracting Officer.

• Planning and Execution: On a monthly basis, the awardee shall develop and maintain a detailed Integrated Master Schedule (IMS) for the entire program, inclusive of all subcontractor activities. The IMS must detail timelines, milestones, deliverables, and critical path activities.

• Reporting and Communication: The awardee shall establish effective communication channels and a regular meeting rhythm with the Government. This shall include, at a minimum, leading biweekly Programmatic meetings to discuss cost, schedule, and risks, as well as separate biweekly technical meetings to review study progress and data.

These meetings will serve as the primary forum for the Government to assess progress against program objectives and to communicate any necessary adjustments or required improvements. For these meeting series, the awardee shall be responsible for generating and distributing agendas, preparing and presenting status updates via presentation slides, and delivering detailed meeting minutes for the Government’s approval. The awardee shall also provide monthly, quarterly, and annual reports covering technical, schedule, and cost performance. The awardee shall also develop, maintain, and report a detailed program Spend Plan. At the conclusion of the program, the awardee will deliver a detailed final report that includes all Government-specified data elements and summarizes the program’s outcomes, challenges, and successes.

• Risk Management: The awardee shall develop and submit a Risk Management Plan for Government approval. Upon approval, the awardee shall implement and maintain the plan throughout the period of performance. This plan will identify, assess, and mitigate program risks.

• Government Oversight and Access: The Government reserves the right to conduct on-site audits, inspections, and observations at the awardee's and any subcontractor's facilities with reasonable notification. This right includes, but is not limited to, facility inspections, on-site data audits to ensure data integrity and quality, and the observance of critical program events, such as key experiments or animal challenge studies. The awardee shall be responsible for facilitating this access for Government personnel and their designated representatives across all performance locations.

4.2 Candidate Selection Objectives

• Candidate Selection and Review: Under the BEACON program, the Government is responsible for managing and facilitating the solicitation, review, and down-selection of new MCM candidates. The awardee's primary role is to manage and execute the subsequent technical testing for these Government-selected candidates. To support this Government-led process, the awardee shall facilitate the collection of standardized data packages from subcontractors and ensure all required data is available for the Government's technical evaluation. The Government retains final authority over the down-selection process and may direct the testing of specific candidates at any time to meet programmatic goals.

4.3 Candidate Testing Objectives

• The awardee shall manage and ensure the successful execution of the following technical activities through its network of subcontractors:

o MCM Candidate and Materials Procurement: Manage the procurement of MCM candidates, test agents, and all necessary animals and materials for non-clinical, clinical, and CMC studies. This includes the responsibility for ensuring agent Quality Control (QC) testing is performed upon receipt to verify the identity, purity, and concentration of all chemical warfare agents prior to their use in any study.

o Non-Clinical and Clinical Testing: Oversee a range of studies including, but not limited to, in vitro and in vivo efficacy studies, proof-of-concept studies, and safety/toxicology studies. Where applicable, efficacy studies shall test MCM candidates against a minimum of three nerve agents, selected by the Government based on the proposed intended use and/or previous candidate data. Ensure performers utilize adequate animal models (at least two, where applicable) for product development under the U.S. Food and Drug Administration (FDA) Animal Rule. The studies shall be designed to support regulatory submissions. The awardee shall be responsible for overseeing the development of detailed study protocols for Government approval prior to the initiation of any work.

o Chemical, Manufacturing, and Controls: Manage the development of validated, scalable manufacturing processes for promising MCM candidates. The awardee must ensure formulation requirements are met and will oversee stability testing programs.

o Operational Relevancy Studies: The awardee shall oversee the execution of nonclinical studies, as directed by the Government, to determine the operational impact of MCM treatment in a nerve agent-contaminated environment.

These studies will evaluate the ability of an MCM candidate to preserve or restore key functions post-exposure. Evaluated tasks must be relevant to Warfighter duties and may include motor skills, cognitive function (e.g., memory, learning), goal-oriented behaviors, or other such studies deemed necessary to determine operational relevance.

The awardee and/or the awardee’s subcontractor shall be responsible for defining the quantitative metrics for these evaluations and the analytical methods for interpreting the results.

The interpretation of results must correlate the behavioral outcomes to mission-relevant tasks. The final study reports must clearly articulate how the preservation of a specific function by an MCM could translate to improved Warfighter performance, safety, or mission success in an operational setting.

4.4 Regulatory Objectives

• Regulatory Sponsor: The awardee must indicate a willingness to collaborate with Government-identified drug developers who will serve as the Regulatory Sponsor and/or be willing to collaborate with drug developer-selected Regulatory Sponsor.

• Regulatory Strategy and Compliance: For each MCM candidate, the awardee shall obtain and maintain a comprehensive Regulatory Strategy. This strategy will outline the specific non-clinical, clinical, and CMC pathway required for FDA approval1. The awardee will ensure all subcontracted work complies with applicable regulations, including FDA Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), and animal welfare regulations (Animal Care and Use Review Office [ACURO]/ Office of Research and Regulatory Compliance [ORRC]).

• Targeted Product Profile: The awardee shall obtain and maintain a Target Product Profile (TPP) for each MCM candidate. The TPP shall define the key characteristics of the product from a regulatory, clinical, and operational perspective and will be used to guide development and decision-making throughout the product lifecycle. At a minimum, the TPP must define the target criteria for:

o Efficacy (e.g., survival percentage, reduction in symptoms) o Route of Administration (e.g., intramuscular, oral) o Shelf-life and Stability Requirements o Duration of Protection from a single dose o Booster requirements, if any o Time to effectiveness after administration

• Letter(s) of Authorization: Obtain letter of authorization from candidate sponsor.

• FDA Engagement: Support all communications with the FDA. This includes meetings, briefing packages, and facilitating Government participation.

• Submissions: Oversee the preparation, review, and submission of regulatory packages, including Investigational New Drug (IND) applications. Ensure final data reports are

1 Candidates will not be FDA approved under Beacon but should be developed with this end goal in mind.

formatted for FDA submission (e.g., Standard for Exchange of Non-clinical Data [SEND] format).

• Government Review and Approval: The Government reserves the right to review and approve all formal regulatory submissions, briefing packages, and significant correspondence prior to their submission to the FDA.

4.5. Data Generation and Management

• Intellectual Property, Data Management, and Security: It shall be explicitly understood that the original owner of an MCM candidate retains all background intellectual property rights and ownership of their compound. The awardee shall be responsible for establishing the necessary legal framework to support this, including the execution of Non-Disclosure Agreements (NDAs) from candidate owners to permit the Government-funded work. The awardee shall manage foreground intellectual property and data rights generated under this effort in accordance with the terms of the agreement. The awardee shall also implement a comprehensive Data Management Plan and ensure the security of all project data, including Controlled Unclassified Information (CUI) and potential Secret Information.

• Data Generation and Management: Ensure the generation of all required technical data from studies. The awardee shall manage the direct and timely entry of all study data into the Government-specified data repository by the MCM candidate owner. All data shall be quality-controlled to ensure reproducibility.

• Use of Artificial Intelligence: The awardee shall acknowledge that the Government's evaluation process utilizes a data evaluation framework, which employs artificial intelligence (AI) to analyze and assess candidate data.

5.0 DATA DELIVERABLE(S)

The following is a summary of deliverables described throughout the SOO. Additional detailed deliverables will be outlined in the Statement of Work (SOW).

• IMS

• Meeting Agendas, Slides, and Minutes

• Monthly, Quarterly, and Annual Reports

• Spend Plan

• Final Report

• Resource Management Plan

• Study Protocols

• Study Reports including Government-specified Data

• Regulatory Strategy

• TPP

• Letter(s) of Authorization

• FDA Communications, Correspondence, Briefing Packages, and IND Applications

• Data Management Plan

6.0 PROTOTYPE DELIVERABLE(S)

The prototypes for this effort are the data packages and assessments for Government-identified MCM candidates that demonstrate technical feasibility and military utility.

7.0 PERIOD AND PLACE OF PERFORMANCE

The anticipated Period of Performance for this effort is estimated to be 60 months (5 years) from the date of award. Specific dates are to be negotiated. The primary place of performance will be the awardee's facilities, with significant work performed at various subcontractor facilities.

8.0 AGREEMENTS OFFICER REPRESENTATIVE (AOR)

Name: Amy Sands

Telephone: 520-706-0082

E-mail: amy.l.sands4.civ@army.mil

Agency Name/Division/Section & Office Symbol: CPE CBRN Defense/JPM CBRN Medical/ SAAL-

CBD-MED-CDP

9.0 SPECIAL REQUIREMENTS

9.1 Regulatory Product Development Requirements

The Offeror agrees to the following:

• Regulatory Submissions: The Offeror will provide the Government with all data funded by the agreement and offer the Government the opportunity to review and comment on all draft regulatory submissions. The Offeror will keep the Government apprised of all FDA meeting outcomes.

• Communications: The Offeror shall invite Government representatives to all formal and informal FDA meetings and provide the Government with copies of all communications to or from the FDA regarding the funded technology.

• Sponsor Authorization: The Offeror shall submit a fully executed sponsor authorization letter to the Government within thirty (30) days of award, enabling the FDA to disclose information to the Government and its support contractors.

• Audits and Inspections: The Offeror shall accommodate quality audits by the Government and provide copies of all FDA inspection reports (e.g., FDA Form 483, Establishment Inspection Report) and proposed corrective actions.

• These requirements shall be flowed down to all subcontractors and will survive the expiration of the agreement.

9.2 Required Compliance for Use of Laboratory Animals

The Offeror is forbidden to use or subcontract for the use of laboratory animals without the express written approval of the US Army Medical Research and Development Command, Animal Care and Use Review Office (ACURO).

9.3 Required Compliance for Use of Human Subjects, Specimens, and Data

Research involving human subjects, data, or specimens may not begin until approved by the U.S. Army Medical Research and Development Command’s Office of Human Research Oversight (OHRO).

9.4 Other Government Contracts

The Offeror shall disclose all other Government contracts that relate to the proposed development effort to avoid duplication of effort.

9.5 Production Follow-On

The Offeror agrees that for any follow-on production, no customer shall receive a greater discount for the production model of the Prototype than the DoW for like purchase quantities.

9.6 Security and Classified Data

Information developed under this effort may be Controlled Unclassified Information (CUI) or Secret. All work shall be performed in accordance with the DD Form 254, “Department of Defense Contract Security Classification Specification.”

9.7 Data Rights

The resultant Agreement shall provide for the Government to receive at least Government Purpose Rights to all data, software, and inventions generated under this effort.