S26-117 Request for Proposal.pdf

P.O. Box B, Frederick, MD 21702-1201 • 301-846-1000

A subsidiary of

RFP No. S26-117 June 3, 2025 - Revision 3

SOLICITATION/RFP NUMBER: S26-

117 DATE ISSUED: 1/22/2026

ISSUED BY:

Leidos Biomedical Research, Inc.

Research Contracts Department P.O. Box B 1050 Boyles Street Frederick, MD 21702

ADDRESS OFFERS TO/FOR INFORMATION REGARDING THIS

SOLICITATION CONTACT:

Cody Wenner/cody.wenner@nih.gov

IMPORTANT:

To be considered for award, offers must be received at the location specified above by 4 PM EST, 3/5/2026. Offers must be clearly identified with the Solicitation/RFP Number listed above.

The cover letter shall acknowledge that your transmission of an offer in response to this Solicitation is valid for a period of 120 days from date of submission.

A. Introduction

This Solicitation is issued by Leidos Biomedical Research, Inc. (Leidos Biomed), a wholly owned subsidiary of Leidos Corporation under its Prime Contract with the National Cancer Institute (NCI/Government) at Frederick. The provisions and clauses contained herein and attached are influenced by and reflect the relationship of the parties in said Prime Contract, which was awarded and is administered under the provision of the Federal Acquisition Regulation (FAR).

B. Anti-Kickback Act of 1986

The Anti-Kickback Act of 1986 as referenced in FAR 52.203-7 is hereby incorporated into this Solicitation and any subsequent award(s) as a condition of acceptance. If you have reasonable grounds to believe that a violation, as described in paragraph (b) of FAR 52.203-7, may have occurred, you should report this suspected violation to the Leidos Ethics Hotline at (855) 753-4367 or via the internet at www.leidos.ethicspoint.com.

C. Solicitation Package

This Solicitation Package consists of two documents: (i) this one, which is referred to as the Request for Proposal (RFP) Document and (ii) Subcontractor’s Representations and Certifications.

http://www.leidos.ethicspoint.com/

RFP No. S26-117 June 3, 2025 - Revision 3

D. Contract Type

The resulting Subcontract will be a Firm-Fixed-Price contract providing for a price that is not subject to any adjustment on the basis of contractor’s cost experience in performing the contract.

E. Instructions to Offerors

E.1. General Information

IMPORTANT – ELECTRONIC SUBMISSION:

OFFERS MUST BE SUBMITTED ELECTRONICALLY IN EITHER SEARCHABLE ADOBE ACROBAT, MICROSOFT WORD, OR MICROSOFT EXCEL FORMATS AS APPLICABLE. SAVED FILES MUST NOT EXCEED 15 MB IN SIZE;

THIS MAY REQUIRE THAT A DOCUMENT BE BROKEN INTO TWO OR MORE SEPARATE FILES.

ALL OFFERS MUST BE RECEIVED BY 4 PM EST, 3/5/2026. OFFERS SHALL BE SUBMITTED TO CODY WENNER

AT CODY.WENNER@NIH.GOV.

All offer submissions must be clearly identified to include the Offeror’s name, Principal Investigator’s name (or Project Manager’s name), and Solicitation/RFP Number.

Late offers will not be considered for award.

E.2. Questions Regarding this Solicitation

IMPORTANT:

ALL QUESTIONS OR REQUESTS FOR CLARIFICATION MUST BE EMAILED TO CODY WENNER AT

CODY.WENNER@NIH.GOV NO LATER THAN 4 PM EST, 2/12/2026.

Questions shall be provided in one concise submission with references to the relevant sections(s) of this Solicitation. The questions submitted will be compiled with responses into one document that will be incorporated as an amendment to this Solicitation and distributed to all Offerors.

Questions or requests directed to any other individual other than the individual named in this section will not be considered valid, nor will there be a response provided. If deemed necessary or desired by the Leidos Biomed Subcontracts Administrator, a second round of questions may be solicited.

E.3. Offerors’ Teleconference - RESERVED

E.4. Offeror Site Visit - RESERVED

F. Proposal Instructions to Offeror

To be considered responsive to this Solicitation, the Offeror must provide and/or complete the following requirements:

RFP No. S26-117 June 3, 2025 - Revision 3

- Volume 1 – Request for Proposal Document

- Volume 2 – Technical Proposal

- Volume 3 – Price (Cost) Proposal

- Subcontractor’s Representations and Certifications (provided as a separate document with this Solicitation Package).

- An IRS Form W-9. All Offerors MUST be registered with the System for Award Management (SAM).

Offerors may register with SAM at https://www.sam.gov/SAM/. The address included on the W- 9 MUST match the address registered at SAM, and/or included with Subcontractor’s Representations and Certifications. FOR INTERNATIONAL, ALL OFFERORS MUST COMPLETE W- 8BEN-E IN PLACE OF W-9. LINK MAY BE FOUND AT http://www.irs.gov/pub/irs-pdf/fw8bene.pdf

F.1. VOLUME 1 – RFP Document

This Volume shall contain the RFP Document with all items completed as required below and submitted as prescribed in E.1. General Information above and be clearly named Volume 1 – RFP.

Requirements:

• Complete Section J. Certifications

• Complete Section K. Offeror Representatives

• Complete Section L. Offeror Signature

F.2. VOLUME 2 – TECHNICAL PROPOSAL

This Volume shall contain the Technical Proposal Document with all items completed as required below and submitted as prescribed in E.1. General Information above and shall be clearly named Volume 2 – Technical Proposal.

IMPORTANT:

Technical Proposals shall not include cost or pricing information.

Technical Proposals must include page numbers on all pages, including all appendices and attachments.

There must also be a cover page that lists all appendices and attachments.

https://www.sam.gov/SAM/ http://www.irs.gov/pub/irs-pdf/fw8bene.pdf

RFP No. S26-117 June 3, 2025 - Revision 3

Requirements:

The Offeror must provide Technical Proposals that clearly demonstrate the Offeror’s current capabilities to meet each of the various requirements as established in RFP Attachment 1: Statement of Work and in accordance with the guidelines set forth below. Responses shall be focused, succinct, and free of extraneous data or information responding solely to the requirements contained in the RFP Attachment 1: Statement of Work. Additionally, Technical Proposals shall be formatted in such a way to clearly cross-reference the relevant sections in the RFP Document.

Provided below is the outline of specific information to be addressed in the Technical Proposal and for maximum page limitations for each of the required sections.

F.2.a. Executive Summary

The summary shall contain the most important elements from sections below but should at a minimum clearly specify the following elements:

• Brief identification and qualifications for this Solicitation of your organization/team, including any lower-tier subcontractors and their roles.

• The purpose and anticipated end result of this Technical Proposal.

• Technical and management approach discriminators.

The summary shall be on separate pages or include a section break before the rest of the Technical Proposal.

F.2.b. Technical Approach

Understanding

Provide your understanding of what needs to be done, the scope of the work, the estimated length of time for the work to be finished, the challenges, and how you are going to address those challenges.

Approach

Describe a sound technical approach to the proposed work and critical technology challenges required for accomplishing proposed tasks. Describe any unique aspects of the approach, and why you believe it will be the most efficient and effective way of achieving project objectives. Describe how this approach will meet both project and overall objectives as described in RFP Attachment 1: Statement of Work.

F.2.c. Team and Key Personnel

Introduction

Introduce your organization and/or team here; give an overview of the capabilities brought to address this effort.

RFP No. S26-117 June 3, 2025 - Revision 3

Organization and/or Team

Describe your organization and show chain of command and lines of communication.

Describe each proposed individual’s role, the percentage of their time that is being bid, and a brief description of their qualifications. Fuller experience descriptions may be included in the Appendix.

Personnel

A minimum of two key personnel are required, and shall be clearly indicated.

All key personnel shall be clearly indicated. Resume summaries for key personnel shall be included in this section, and full resumes in the Appendix. The percentage of time each key person is proposed should be clearly indicated here.

F.2.d. Experience and Past Performance

Describe the teams overall experience with development, processes, and technologies similar to those described in the RFP Attachment 1: Statement of Work. Clearly indicate which organization on your team is providing this experience.

Provide a description of at least three projects successfully performed in the past that indicate the ability to perform on this effort. At least one of these projects should have been performed for an organization other than Leidos Biomed. Clearly indicate who on your team performed, what role was played on each of these projects, and the success criteria that were used to judge the project. Summaries shall be given here, and more complete descriptions may be included in the Appendix.

F.2.e. Project Plan and Work Breakdown Structure

Describe in summary form the set of tasks that will be performed in order to accomplish project objectives.

Detail the methods for producing deliverables, allocation of staff, and other resources necessary to produce deliverables, and timelines.

Provide a draft project plan in MS Excel or PDF format as a separate attachment (no page limit). This document should contain tasks that demonstrate how objectives described in the RFP Attachment 1:

Statement of Work will be accomplished. The draft project plan shall show tasks, dependences, and milestones, any milestone reviews as requested in RFP Attachment 1: Statement of Work, as well as any requested Offeror-supplied dates for deliverables.

F.2.f. Management Approach

Controls

Describe your project management approach and what control mechanism you can put in place to track progress and ensure project schedules will be met in according to agreed-upon schedules.

RFP No. S26-117 June 3, 2025 - Revision 3

Risk Management

Describe your overall risk mitigation strategy.

Provide an initial risk table. This table should include a list of project risks, an estimation of the severity of the risk (H,M,L), and a risk mitigation approach for that risk.

Subcontractor Management

Describe management controls to be put in place for lower-tier subcontractor management if lower-tier subcontractors are a part of the proposed team.

Financial Tracking

Describe the mechanism you will use to control budget and cost.

F.2.g. Appendix (no page limit)

F.3. VOLUME 3 – COST (OR PRICE) PROPOSAL

This Volume shall contain the Cost (or Price) Proposal Document with all items completed as required below and submitted as prescribed in E.1. General Information above and shall be clearly named Volume 3 – Cost (or Price) Proposal.

Requirements:

Offerors shall submit Cost (or Price) Proposals that provide a budgetary estimate for the project proposed.

The Cost (or Price) Proposal shall include the information required in Sections One and Two below. Budget estimates provided in response to this Solicitation will be used for planning and evaluation purposes. Any requests from Offerors to revise the original budget estimate, as the result of changes requested to the original technical approach during Subcontract negotiations, may be considered but these requests from Offerors must be accompanied by a detailed explanation of the nature and impact of the change and the need for monetary adjustment.

F.3.a. Section One – Cost (or Price) Proposal

The Cost (or Price) Proposal shall contain sufficient information to allow Leidos Biomed to perform an analysis of the proposed cost (or price) of the work proposed. This information shall include the amounts of the basic elements of the proposed cost (or price) including, but not limited to, labor hour rates, travel, materials, and lower-tier subcontracts.

In preparing your Cost (or Price) Proposal, the following shall be considered:

FAR 52.215-17 Waiver of Facilities Capital Cost of Money is incorporated in this Solicitation;

therefore, Facilities Capital Cost of Money is an unallowable cost under any resulting Subcontract.

RFP No. S26-117 June 3, 2025 - Revision 3

As prescribed in HHSAR 331.101.70 Salary rate limitation, in response to this Solicitation/Request for Proposal, the Offeror cannot use any resulting Subcontract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding is obligated.

Offeror is to prepare their Cost (or Price) Proposal using RFP Attachment 2: Cost (or Price) Template and submit with Offer in Microsoft Excel format.

Costs shall be broken out by task where possible.

A milestone payment schedule shall be provided, if applicable. Milestones shall be identified by number, title and description. Provide amount of milestone and if applicable, include unit of measure, quantity and unit price.

Offerors shall provide substantive detail regarding the cost (or price) proposed to enable reviewers to objectively determine the reasonableness. Failure to provide a level of detail to facilitate this determination may result in the offer being considered nonresponsive.

F.3.b. Section Two – Cost (or Price) Justification and Documentation

In this section, provide justifications and explanations of all proposed costs. This INCLUDES explanation of the processes by which extended costs were derived and a basis for why the proposed costs should be considered reasonable. The supporting information to be provided includes, but is not limited to:

Labor costs: Provide labor categories and a description of the position’s planned role on the project. If the proposed positions have not been filled or are to be named or hired, provide description of anticipated position and estimated labor category and rate.

Demonstration of the reasonableness of any proposed lower-tier subcontractor costs, including demonstration that the proposed rates/costs are in keeping with those normally charged for the work to be performed.

G. Proposal Evaluation Criteria

G.1. Basis for Award

Leidos Biomed intends to award a Subcontract(s) resulting from this Solicitation to the responsible organization(s) whose offer(s) conforming to this Solicitation will be of the best value to Leidos Biomed, price and other factors considered. Although technical factors are of paramount consideration in the award of a Subcontract, cost and/or price is also important to the overall award decision.

G.2. Potential Award Without Discussions

Leidos Biomed reserves the right to award a Subcontract without discussions if the Leidos Biomed Subcontracts Administrator determines that the initial offer(s) are fair and reasonable and that discussions

RFP No. S26-117 June 3, 2025 - Revision 3 are not necessary. Therefore, the Offeror’s initial offer should contain the Offeror’s best terms from a price and technical standpoint. However, Leidos Biomed reserves the right to conduct discussions if later determined by the Leidos Biomed Subcontracts Administrator to be necessary. Leidos Biomed may reject any or all offers; accept other than the lowest priced offer; and waive informalities and minor irregularities in offers received.

The assessment of the offers received in response to this Solicitation will be carefully considered against the needs of Leidos Biomed and the Government. This assessment is not intended to be a solely mechanical or mathematical analysis of an offer, but rather the product of both objective and subjective measurements and judgments of the source selection officials after consideration of the relevant information.

H. Proposal Evaluation Factors

Evaluation of the offers submitted will be considered against the following evaluation factors.

General Evaluation Criteria

H.1. Technical Approach (40%)

The Offeror demonstrates good understanding of the scope, objectives, and challenges of this project.

The proposed approach is capable of meeting project objectives as stated in the RFP Attachment 1: Statement of Work.

The proposed approach is capable of supporting the requirements for the initiative.

The solution proposed is within the scope of the effort.

H.2. Team and Key Personnel (25%)

Project Organization covers all skills needed to execute this project.

Key Personnel have demonstrated experience in the technical evaluation factors given above that are applicable to their role.

Evidence has been provided that Key Personnel have performed successfully in the past in the role proposed.

Key Personnel are bid at a level of effort commensurate with their proposed role.

H.3. Experience and Past Performance (10%)

The Offeror has demonstrated experience in the technologies and procedures required to execute this project.

RFP No. S26-117 June 3, 2025 - Revision 3

Past performance examples are for projects of similar size, scope, and technical objectives.

Evidence of successful performance on these projects has been provided.

H.4. Project Plan and Work Breakdown Structure (10%)

The project plan is sufficient to meet the objectives in the RFP Attachment 1: Statement of Work.

Project schedule is reasonable given the tasks proposed.

Milestones are consistent with the RFP Attachment 1: Statement of Work guidance.

H.5. Management (5%)

Mechanism by which budget and costs are controlled has been described.

Project risks have been identified and risk mitigation strategies have been identified.

Lower-tier subcontractor roles are defined, and management controls are adequate.

H.6. Cost (or Price) Reasonableness (10%)

Costs (or prices) proposed are commensurate with the technical tasks bid.

I. RFP Attachments

The following are considered attachments to this RFP Document:

Attachment No. Document Description

1 Statement of Work

2 Cost (or Price) Template

The following is provided as a separate document in this Solicitation Package:

Subcontractor’s Representations and Certifications

J. Certifications

J.1. Organizational Conflicts of Interest (OCI)

This certification is required to ensure OCIs do not exist for the anticipated performance of the Subcontract or that any potential OCI is identified, neutralized or mitigated when:

Offeror hereby certifies that Offeror’s performance of its obligations under any Subcontract that may be issued as a result of this Solicitation will not be biased because of its financial, contractual, RFP No. S26-117 June 3, 2025 - Revision 3 organizational or other interests which relate to the proposed work; Offeror will be able to render impartial, technically sound, and objective assistance or advice; and Offeror will not obtain any unfair competitive advantage over other parties by virtue of its performance of the proposed Subcontract.

Offeror hereby certifies that the circumstances as to why it cannot make the foregoing “No OCI Representation” certification are fully disclosed in the attached pages (Offeror to provide as a separate document in advance of full proposal) and reflect:

- The category of conflict (organizational, contractual and/or financial);

- The company, agency, organization in which you have a past, present, or currently planned interest or activity (financial, contractual, organizational, or otherwise);

- A brief description of the relationship, period of relationship and the extent of relationship (e.g., value of financial interest of work; percent of total holdings, total work, etc.).

Offerors who have a real or potential conflict of interest must notify Leidos Biomed in writing and provide a mitigation plan addressing the conflict at least 2 weeks prior to the submittal due date for offers.

If this direction is not followed, Offeror will be disqualified from the competition.

J.2. Place of Performance (FAR 52.215-6)

In performance of any Subcontract resulting from this Solicitation, the Offeror certifies that it:

Does not intend to use one or more plants or facilities located at a different location from the Offeror’s primary performance address as proposed in this RFP Document.

Intends to use one or more plants or facilities located at a different location from the Offeror’s primary performance address as proposed in this RFP Document, and provides the following information for the other plants or facilities where work will be performed below:

RFP No. S26-117 June 3, 2025 - Revision 3

Place of Performance Street Address, City, State, County, Zip Code

Name and Address of Owner/Operator of Plant/Facility if Other than Offeror/Respondent

J.3. FAR 52.215-22 Limitations on Pass-Through Charges

Select one:

The proposal excludes excessive passthroughs.

The offeror/subcontractor intends to subcontract to a lower-tier subcontractor more than 70 percent of the total cost of work to be performed under its subcontract, the offeror/subcontractor has identified in their proposal, (i) The amount of the subcontractor’s indirect costs and profit/fee applicable to the work to be performed by the lower-tier subcontractor(s); and (ii) A description of the added value provided by the subcontractor as related to the work to be performed by the lower-tier subcontractor(s).

The offeror/subcontractor shall complete the following representation and certification providing the percentage of effort that would be conducted by your employee personnel during the execution of the Statement of Work as provided herein including any optional tasks/periods, if applicable.

By submission of this signed offer, Insert Organization Name hereby certifies that:

% of the effort expended in the execution of the Statement of Work as provided by Leidos Biomed in Solicitation/RFP Number will be conducted by employees of this organization.

J.4. FAR 52.215-23 Limitations on Pass-Through Charges

Select one:

The offeror/subcontractor does not certify

The offeror subcontractor does certify

Required reporting of performance of work by the offeror/subcontractor. The offeror/subcontractor shall notify the cognizant LBR Subcontract Administrator in writing if:

The offeror/subcontractor changes the amount of lower-tier subcontractor effort after award such that it exceeds 70 percent of the total cost of the work to be performed under its subcontract. The

RFP No. S26-117 June 3, 2025 - Revision 3 notification shall identify the revised cost of the subcontract effort and shall include verification that the subcontractor will provide added value as related to the work to be performed by the lower-tier subcontractor(s).

J.5. Utilization of Small Business Concerns

In accordance with the terms of its Prime Contract, under which a resulting Subcontract will be issued, Leidos Biomed is committed to maximizing small business subcontracting opportunities to the greatest extent practicable.

Any lower-tier subcontractor effort shall be detailed in the Offeror’s Technical Proposal.

Small Business Subcontracting Plan (FAR 52.219-9)

Select One:

Not applicable, the offeror/subcontractor is a small business.

Not applicable, the offeror/subcontractor is other than a small business and the award is not expected to exceed the threshold specified in FAR 19.702(a) at date of subcontract award.

Not applicable, the offeror/subcontractor is other than a small business and the award will be performed entirely outside of the United States and its outlying areas.

OR

RFP No. S26-117 June 3, 2025 - Revision 3

If the offeror/subcontractor selects this option, both boxes must be checked:

Not applicable at time of award, the offeror/subcontractor is other than a small business and certifies that they do not anticipate any subcontracting opportunities.

Should subcontract opportunities exist in the future the offeror/subcontractor will comply with the requirements in FAR 52.219-9.

OR

Applicable, the offeror/subcontractor is other than a small business and is providing a small business subcontracting plan in accordance with FAR 52.219-9. The Leidos Biomed Subcontracting Plan template can be found at:

https://frederick.cancer.gov/sites/default/files/2025- 06/LBR%20Subcontracting%20Plan%20Template.pdf

J.6. Certificate of Minimum Labor Category Requirements

In order to be considered for a Time and Materials, Labor Hour or Level-of-Effort type subcontract, the Offeror must agree to maintain minimum labor qualification standards and requirements.

Select one:

Offeror/Subcontractor is exempt because the proposal being submitted is for other than Time and Materials, Labor Hour or Fixed Price Level-of-Effort.

The Offeror/Subcontractor certifies that it does and will conduct and maintain records of all employees’ background verifications (employment education, licensing and professional certifications) performing under the anticipated Subcontract resulting from this Solicitation and such documented verifications will be provided to Leidos Biomed immediately upon request.

The Offeror/Subcontractor certifies that it does not and will not conduct and maintain records of all employees’ background verifications (employment education, licensing and professional certifications) performing under the anticipated Subcontract resulting from this Solicitation.

J.7. Health and Human Services Acquisition Regulation – 352.231-70 Salary Rate Limitation

The Offeror/Subcontractor Certifies or Does not Certify that the “direct salary” as defined in 352.231-70 and as proposed in response to this RFP/solicitation is compliant with 352.231-70.

https://frederick.cancer.gov/sites/default/files/2025-06/LBR%20Subcontracting%20Plan%20Template.pdf https://frederick.cancer.gov/sites/default/files/2025-06/LBR%20Subcontracting%20Plan%20Template.pdf

RFP No. S26-117 June 3, 2025 - Revision 3

J.8. Office of Laboratory Animal Welfare (OLAW) Certification

Select One:

Offeror is exempt as the solicitation and the contemplated subcontract does not involve animals.

Offeror is not exempt as the solicitation and the contemplated subcontract does involve animals.

Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Any award made using Public Health Service funding for the use of laboratory animals must comply with Public Health Service Policy.

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) establishes several requirements for research activities involving animals. Before award may be made to an Offeror, the Offeror shall file, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC).

Note: OLAW Assurance is required regardless of location animal work is performed (i.e., if Offeror proposes a lower-tier subcontractor to perform the animal work, Assurance is still required [this scenario would require an Inter-institutional type of Assurance]).

In accordance with the PHS Policy, Offerors must establish an Institutional Animal Care & Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution's animal program, facilities, and procedures. Offerors are required to provide verification of IACUC approval prior to release of a subcontract involving live vertebrate animals. No award involving the use of animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to Leidos Biomed. Prior to award, Leidos Biomed will notify Offeror(s) selected for projects that involve live vertebrate animals that an Assurance and verification of IACUC approval are required. Leidos Biomed will request that OLAW negotiate an acceptable Assurance with those Offeror(s) and request verification of IACUC approval. For further information contact OLAW, at NIH, 6700B Rockledge Drive, Suite 2500, MSC 6910, Bethesda, MD 20892 (E-mail: olawoad@mail.nih.gov; Phone: 301-496-7163). The PHS Policy is available on the internet at:

https://olaw.nih.gov/policies-laws/phs-policy.htm.

mailto:olawoad@mail.nih.gov https://olaw.nih.gov/policies-laws/phs-policy.htm

RFP No. S26-117 June 3, 2025 - Revision 3

If animal work is being conducted at multiple organizations, please provide the below Assurance details for all organizations.

Link to Animal Welfare Assurance guidance and sample assurance:

https://olaw.nih.gov/guidance/obtaining-an-assurance.htm

Select One:

Offeror’s organization has an approved Assurance by the Office of Laboratory Animal Welfare (OLAW); our Assurance number is . The Assurance expiration date is: .

Offeror’s organization does not have an approved Assurance by the Office of Laboratory Animal Welfare (OLAW).

J.9. Protection of Human Subjects – Federal Wide Assurance (FWA)

Select One:

Offeror is exempt as the solicitation and the contemplated subcontract does not involve human subjects.

Offeror is not exempt as the solicitation and the contemplated subcontract does involve human subjects.

Offeror agrees that the rights and welfare of human subjects involved in research under this potential Subcontract shall be protected in accordance with 45 CFR part 46 and with the Offeror’s current Federal Wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Offeror further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

Offeror shall bear full responsibility for the performance of all work and services involving the use of human subjects under any Subcontract resulting from this Solicitation and shall ensure that work is conducted in a proper manner and as safely as is feasible.

Offerors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Offeror’s FWA via designation as agents of the institution or via individual investigator agreements see OHRP website at: https://www.hhs.gov/ohrp/

Select One:

Our organization has an approved Federal Wide Assurance on file with the Office of Human Research Protections, Department of Health and Human Services; our FWA number is .

The FWA expiration date is: .

Our organization does not have an approved Federal Wide Assurance with the Office of Human Research Protections.

https://olaw.nih.gov/guidance/obtaining-an-assurance.htm https://www.hhs.gov/ohrp/

RFP No. S26-117 June 3, 2025 - Revision 3

J.10. Restrictions on Use of Human Subjects Select One:

Offeror is exempt as the solicitation and the contemplated subcontract does not involve human subjects or projects related to human subjects requiring the Offeror to obtain local Institutional Review Board (IRB) approval.

Offeror is not exempt as the solicitation and the contemplated subcontract does involve human subjects or projects related to human subjects requiring the Offeror to obtain local Institutional Review Board (IRB) approval.

Pursuant to 45 CFR part 46, Protection of Human Research Subjects, the Offeror shall not expend funds under any Subcontract resulting from this Solicitation for research involving human subjects or engage in any human subjects’ research activity prior to Leidos Biomedical’s receipt of a certification that the research has been reviewed and approved by the Institutional Review Board (IRB) registered with the Office for Human Research Protections (OHRP). This restriction applies to all collaborating sites, whether domestic or foreign, and subcontractors at all tiers. The Offeror must ensure compliance by their collaborators and lower-tier subcontractors.

Select One:

Offeror certifies the research will be reviewed and approved by the IRB registered with OHRP.

IRB Number: _____________________________________

[Insert IRB Number Above.]

Offeror does not certify that research will be reviewed and approved by the IRB registered with

OHRP.

RFP No. S26-117 June 3, 2025 - Revision 3

K. Offeror Representatives

K.1. Offeror Authorized Representative

The following individual is the designated representative of the Offeror; this will be the Official authorized to obligate your organization and sign the resulting Subcontract:

Name

Title

Organization

Address Line 1

Address Line 2

City, State, and ZIP Code

Phone

Email

K.2. Offeror Key Personnel

The following individual(s) are considered to be essential to the work being performed hereunder, and shall not be re-assigned, removed or substituted without the concurrence of the Leidos Biomed Subcontracts Administrator:

Name Title Email Address

K.3. Offeror Invoice Representative

The following individual is the designated representative to submit invoices:

Name

Title

Organization

Address Line 1

Address Line 2

RFP No. S26-117 June 3, 2025 - Revision 3

City, State, and ZIP Code

Phone

Email

K.3.a. Offeror Invoice Remittance Address

Organization

Address Line 1

Address Line 2

City, State, and ZIP Code

K.4. Offeror Regulatory Affairs Representative, if applicable

The following individual is the designated representative handling all matters pertaining to Regulatory Affairs:

Name

Title

Organization

Address Line 1

Address Line 2

City, State, and ZIP Code

Phone

Email

L. Offer Signature

By signing of this document, I hereby affirm that I am duly authorized on behalf of my organization to submit this offer and all information including Subcontractor’s Representations and Certifications submitted to be accurate and complete.

By:

Title:

Signature:

Date:

RFP No. S26-117 June 3, 2025 - Revision 3

Attachment 1: Statement of Work

A. Background

A.1. General

The Frederick National Laboratory for Cancer Research (FNLCR) http://ncifrederick.cancer.gov/ is seeking a digital automation solution to enhance process efficiency at its Materials Management receiving dock and internal delivery operations. The goal is to reduce errors and backlogs while increasing productivity and accountability through a real‑time delivery status tracking system and digital documentation.

FNLCR is a Health and Human Services (HHS) Federally Funded Research and Development Center (FFRDC), operating as a government‑Owned, Contractor‑Operated facility. Leidos Biomedical Research, Inc. (LBR), a wholly owned subsidiary of Leidos, Inc., currently provides operations and technical support for FNLCR under prime contracts 75N901900024 and HHSN2612015000031.

The provisions and clauses contained herein and attached to any future agreements are influenced by and reflect the relationship of the parties in the prime contract agreements, which were awarded and are administered under the provision of the Federal Acquisition Regulation (FAR). There is no privity of contract between the Seller of the Materials management Receiving software application solution (Goods and Items receipts and Delivery Status Tracking) and implementation provider and the Government.

A.2. Project Background

FNL currently receives all inbound shipments at its receiving docks located in Building 1050, ATRF, and the VCMP facility. At each location, the logistics support and compliance teams manage the full receiving process, including pre‑receiving checks, posting receipts into ERP systems, delivery coordination and delivery, and return processing. Shipments may arrive against purchase orders, pre‑approved purchase cards, or as general items without purchase orders. There are virtual receipts processing for materials received at offsite locations occasionally. FNL’s materials management items and goods include FNL assets, scientific study materials, alcohol, materials, items requiring special handling, compressed gases, large equipment, and packages destined for internal delivery to employees and stakeholders, with package status tracked internally.

At present, FNL/LBR operates with a mixture of manual (paper-based documentation) and digital procedures for receiving at docks and delivering to end users, resulting in bottlenecks with validation at receipt docks, congestion at staging areas, and lack of real-time visibility of incoming goods and the subsequent delivery. Materials management begins with shipping manifest from shipper validated and documented at dock, followed by pre‑receiving checks and validations, transaction validation and posting to ERP, delivery note preparation, to warehouse or driver delivery to stakeholders, and return processing. Process improvements and digital transformation

RFP No. S26-117 June 3, 2025 - Revision 3 are expected to significantly enhance goods receipt and internal delivery tracking, providing visibility at multiple control points across the enterprise and digital documentation.

Currently, the process of storing paper documentation (physical folders and cabinets) and digital documentation (ECMS Hyland OnBase) including shipping manifests, packing slips, purchase orders, delivery notes, and related materials — are cumbersome and inefficient. Modernizing these processes through digital solutions is the logical next step, particularly to ensure compliance with electronic documentation and federal regulations.

B. Scope of Work

Leidos Biomed is seeking a digital solution to support and modernize our current receiving processes. The project is referred to as the Receiving Process Improvement and Digital Transformation. The Scope of Work for the selected Vendor includes:

• Assessment and review of FNL/Leidos BioMed’s current receiving processes

• Design, Plan, Install and Configuration of software solutions to meet FNL/Leidos BioMed’s use cases and business processes and requirements.

• End User, System Administrator and System Owner Training

• Go-Live and Operational Support Services

C. Objectives

This project aims to enhance the receiving process by minimizing delivery errors, staging congestion, and dock backlogs. It seeks to improve transparency, accountability, productivity, and efficiency in materials receipt, internal delivery, and return processing through modern digital technologies and streamlined electronic documentation.

LBR seeks a state-of-the-art enterprise level solution, with features to include mobile barcode scanning, label printing, digital driver delivery queue tracking, digital signatures at delivery and real-time status visibility. LBR expects to deploy this new system in accordance with industry best practices and Federal regulations at all our receiving docks, including three locations -VCMP, Building 1050 and ATRF.

Table 1 provides the processes and high-level requirements that are to be included, but not limited to:

Table 1- Receiving Processes and High-Level Requirements

Scope

ID

Category Technical Assumption (s) and/or Customer functional Requirements

Required

RP-01 Receipt Processing 60% PO-based and about 40% non-PO receipts x

RFP No. S26-117 June 3, 2025 - Revision 3

RP-02 Receipt Processing Ability to process barcoded and non-barcoded packages, including perishable and non-perishable scientific materials x

SP-01 Special Receiving Scenarios

Virtual receipts for remote office and oversized items delivered at yards x

SP-02 Special Receiving Scenarios

End-user delivery by receiving staff or internal drivers along pre-determined routes, that can be delivered with digital signatures on mobile iPads, and status tracked x

INT-

ERP Integration (Costpoint A/P)

Receipt posting, RMA, charging, shipping & Return processing x

OP-01 Operations and Tracking

Full or partial receipts, validations and repacking x

OP-02 Operations and Tracking

Ability to print Barcoding, Label printing, delivery and return tracking x

OP-03 Operations and Tracking

Proof of delivery and automated end-user notification via email etc.

x

PERF-

Performance and Visibility

Real-Time dashboards for receipts and deliveries x

PERF-

Performance and Visibility

About 500 minimum package transactions per location per day x

MOB-

Mobile Features Native out of the box mobile app of the Core Application with industry compliant barcode scanning x

MOB-

Mobile Features Label printing capabilities from Mobile devices x

MOB-

Mobile Features Compatible with Windows Laptops, Apple IOS end point devices x

DEP-

Deployment Preferences

For Vendor solutions Cloud hosted SaaS/PaaS, the Cloud Security compliance with Federal Government standards hosting for Government data, FISMA and FedRAMP mandatory for SaaS/PaaS x

RFP No. S26-117 June 3, 2025 - Revision 3

DEP-

Deployment Preferences

For Vendor solutions On-Prem, needs to be compliant with SAM.GOV requirements, and preferred to have a clear SaaS/PaaS roadmap x

AUD-

Audit Tracking Supports ability for system administrators to access the applicable audit logs in a user-friendly format.

x

CON-

Configuration Custom Fields - Ability to create unlimited custom fields that are not impacted by system upgrades x

CON-

Configuration Ability to access metadata properties or tags, search control of metadata fields x

CON-

Configuration Vendor should provide implement the solution / provide full support of implementation with adequate training, documentation, knowledge transfer and knowledgeable project managers with experience implementing the proposed software and solution.

x

D. Project Description and Requirements

Vendor Project Management:

Vendor shall provide a Project Manager to work with the Leidos Biomed TPM for the execution of the project. The Vendor’s Project Manager shall have experience with similar projects.

Vendor Project Team:

Vendor Project Team members should have experience with similar projects.

Assessment of FNL/Leidos Biomed Research’s current Receiving and delivery process and detailed discovery

Leidos Biomed will collaborate with the Vendor to arrange meetings with key stakeholders and subject matter experts to review future state requirements at FNL. Through these meetings and detailed requirement analysis, the Vendor will deliver a solution based on SaaS, PaaS, or FNL’s on-premises infrastructure. This will include configuration and design documentation, an implementation plan, and support that integrates with existing ERP systems, meeting and exceeding FNL’s needs.

The Requirements/Configuration/Design documentation shall also provide all the necessary information needed to support Leidos BioMed’s Enterprise System Security Plan.

Installation, Configuration and customization identified Receiving process Solution (SaaS or PaaS or on-premises):

RFP No. S26-117 June 3, 2025 - Revision 3

Vendor will be responsible for installing, configuring and customizing their solution on FNL’s environment, establishing interfaces with existing systems and migrating data (if needed) from existing systems in accordance with the approved Configuration/Design Document. Solution shall support the requirements and user stories outlined in attachment (User Stories requirements Matrix) - Detailed list of requirements for detailed requirements/user stories.

Vendor shall develop a Testing Plan and Test Scripts to validate Leidos Biomed requirements are met. The project will establish three distinct application environments – Development, Test, and Production.

Training:

Vendor will be responsible for providing training and training documentation for the following audiences:

• End User (Trainees)

• Train the Trainer, Business Process Owners, Business Side Application Admins, SME and System Administrators

Go-Live and Transition Operational Support Services:

• Go Live and Transitional Operation Support Services – Vendor implementation team will support to FNL during User Testing and the 4-week Post Go period

• Error Classification & Response time – Vendor implementation team will provide support during client User Testing and the 4-week Post Go Live support period

E. Conformance and Compliance: Program Policies and Practices

• For SaaS / PaaS products, vendor to provide all certifications and/or accreditations with preference for FedRAMP

• If products(s) are SaaS / PaaS, provide LBR-controlled interfaces and ensure LBR retains ownership of all documents stored within the SaaS product(s), including ensuring LBR can access and download documents at any time needed.

• Venders solutions must support SAML2 integration for Authentication and authorization.

• Provide encryption of data-at-rest and in-transit, including attached documents.

• If on premise installation, the product(s) must be able to run in a virtualized environment.

• Allow for customizable user access in the form of role-based access control.

• Application environments include Development, Test and Production Environments.

F. Deliverables

The following table contains a list of deliverables with notification of due dates. All days identified are intended to be normal business days unless otherwise specified. The Subcontractor may suggest an

RFP No. S26-117 June 3, 2025 - Revision 3 alternative due date for any or all deliverables in their offer. The final schedule will be agreed to by the Leidos Biomed TPM and the Subcontractor based on the Subcontractor’s proposed cost and proposed delivery schedule.

F.1. Deliverable Summary and Due Dates – Phase 1 – CLM and document management system implementation.

Deliverable Due Date Acceptance Criteria

Project Plan, Schedule with Deliverables 14 days after award

Schedule identifies all task required to meet the SOW and clearly identifies dependencies and task owners.

Meeting Minutes 2 days after meeting. See General Acceptance Criteria

Bi-weekly Status Reports : Up on award /Kick-Off See General Acceptance Criteria, See section G1

Technical, Solution deliverables

• Requirements Traceability

Matrix / Agile Stories /

• Application Configuration /

Design Document / Wireframes and Input forms

• Proposed process flow diagrams and Activity summary documentation

• System and database Technical Architecture Blueprints /

• Security hardening documentation, Infosec compliance and

• Software license or subscription documentations.

45 days after award

See General Acceptance Criteria

UAT Test Plan and Test Scripts 60 days after award Defines testing plan and scripts.

Proof of Concept demonstration 90 days after award Demonstrated to entire stakeholders

Fully configured Environments (Total 3 environments expected Development /Test and Production)

6 months after approval of Configuration/Design Document

Test scripts validations and stakeholder acceptance completed, and any issues resolved

Final Test Report Prior to Go-Live All test scripts completed, and issues resolved before Go-Live

Training Plan and Schedule 60 days after award Defines training plan and schedule for trainings.

RFP No. S26-117 June 3, 2025 - Revision 3

Deliverable Due Date Acceptance Criteria

Final Report After Go-Live See General Acceptance Criteria

F.2. Deliverable Descriptions and Acceptance Criteria

F.2.a. Descriptions and Specific Acceptance Criteria

The deliverables noted above shall be developed in this project. The Vendor’s proposed Project Plan should clearly contain all tasks and milestones required to produce these deliverables.

F.2.b. General Acceptance Criteria

• In addition to specific acceptance criteria listed above, general quality measures, as set forth below, will be applied to each delivery received from the Subcontractor under this Statement of Work.

• Accuracy – Deliverables shall be accurate in presentation, technical content, and adherence to accepted elements of style.

• Clarity – Deliverables shall be clear and concise. Any/all diagrams shall be easy to understand and be relevant to the supporting narrative.

• Consistency to Requirements – All deliverables must satisfy the requirements of this Statement of Work.

• Timeliness – Deliverables shall be submitted on or before the due date specified in this Statement of Work or the PMP or submitted in accordance with a later scheduled date determined by the Government.

G. Reporting Requirements

G.1. Bi-Weekly Status Report

The Subcontractor shall document the efforts performed in the completion of each task in a detailed bi-weekly status Report, due on or before the first and mid-month working days. It is expected that this report will include, but not be limited to:

• Program status, to include objectives met, work completed and work outstanding

• Notable achievements

• Issues or obstacles impeding progress and recommended solutions

• Status of deliverables/milestones

RFP No. S26-117 June 3, 2025 - Revision 3

• Issues and resolutions

• Resource planning/status

• Description of work completed and plans for next month including anticipated travel

G.2. Final Report

Subcontractor shall submit a Final Report within 30 days of subcontract completion and shall include the following:

• Subcontractor Name and Address

• Name of Person Submitting the Report

• Subcontract Number

• Report Date

• Period Covered by the Report

• A comprehensive Summary of Work performed during reporting period

H. Place of Performance

Most of the work will be performed at the vendor’s facilities; however, Leidos Biomed TPM may ask that specific tasks, such as testing and demonstrations, proof of concepts, trial runs be performed at LBR locations.

I. Government Furnished Data, Materials, or Equipment

None

RFP No. S26-117 June 3, 2025 - Revision 3

Attachment 2: Cost or Price Template

Item/ MS # Title/Description/Requirements Unit of

Measure Qty Unit Price Extended Amount

Note: MS means Milestone

Price Proposal Form

TOTAL PRICE