WP1_RFP.pdf

RFP TABLE OF CONTENTS

NOTICE TO OFFERORS

PART I - THE SCHEDULE

SOLICITATION

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST :

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

SECTION M - EVALUATION FACTORS FOR AWARD

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A -

SOLICITATION/CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION

APPLICABLE TO THE CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO

UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

Proposals in Response to this solicitation are due on July 17th, 2026, by 3:00PM EST. The Price-Cost proposal shall be submitted separately from the technical proposal. Please provide searchable electronic copies only.

Interested parties are hereby notified that communications and submissions (e.g., proposals, solicitation questions, amendments, negotiation questions and responses, etc.) will be conducted via e-mail to Andrew Dinh, andrew.dinh@nih.gov and Melanie Suarez, melanie.suarez@nih.gov and via eCPS. See Attachment 1 for Proposal Submission instructions.

Proposal Intent

1. Contractors are asked to review this RFP and provide the below information via email to the Contracting Officer and Specialists/ emails (andrew.dinh@nih.gov and melanie.suarez@nih.gov) no later than close of business on June 22, 2026 . Choose one of the following options:

☐Do intend to submit a proposal

☐Do not intend to submit a proposal

If you do not intend to submit a proposal in response to this RFP, please state your reason(s) in your electronic response.

2. Include the following in your electronic response:

a. Solicitation Number and Title

b. Name of Contractor’s Organization

c. Name (First, Middle Initial, Last) of Contractor’s Representative

d. Title of Contractor’s Representative

Your expression of intent is not binding but will greatly assist us in planning for evaluation.

Requests for Clarification

1. Requests for clarification shall be submitted electronically via e-mail no later than July 29th, 2026 by 12PM EST.

2. When submitting requests for clarification, contractors must cite the relevant section, paragraph, and page number. Questions should be written in a way that enables clear understanding of the contractors’ issues or concerns. Statements expressing opinions, sentiments, or conjectures are not considered valid inquiries and will not be provided a response. Further, contractors are reminded that the Contracting Officer will not address hypothetical questions aimed at receiving a potential “evaluation decision.”

3. Contractors may submit no more than ten (10) questions for clarification.

4. Written responses to questions will be provided to all contractors by August 6th, 2026, by

3:00PM EST. Responses will not disclose proprietary information of the contractors.

mailto:andrew.dinh@nih.gov mailto:melanie.suarez@nih.gov mailto:andrew.dinh@nih.gov mailto:melanie.suarez@nih.gov

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The goal of this acquisition is for a single vendor to negotiate, award, and administer subcontracts or agreements resulting from the RADx Innovation Funnel. These subcontracts or agreements will cover validation and risk review as directed by the Government. Responsibilities will cover negotiations, award execution, post-award management and payments, and ongoing IT and legal resource support. Expertise in reviewing and negotiating milestones, budgets, and timelines for biomedical research and development awards is required, along with establishing terms & conditions, and execution of awards.

Resources for ongoing oversight and support for milestone-based award contracts are required, including financial management capabilities to process invoices and payment.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

ARTICLE B.3. PRICES/COSTS

1. This is an Indefinite Quantity contract as contemplated by RFO 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $200,000 (minimum) nor more than a total of $149,935,000 (maximum) for successful performance of this contract.

2. The costs set forth in this ARTICLE will cover the contract period August 18, 2026 through August 17, 2031.

3. The Government will issue Task Orders based on the work described in SECTION C of this contract.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

Invoice Processing Platform (IPP) NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). This award will transition to IPP in the future. The Contractor/Vendor shall use the attached NIH OFM Electronic Invoice Submission Instructions until the Contractor/Vendor has transitioned to IPP as specified on the OALM IPP website at https://oalm.od.nih.gov/IPP. It is the Contractor/Vendor’s responsibility to periodically check the OALM IPP website and be prepared to transition to IPP on the designated transition date. Questions concerning the transition to IPP should be directed to NIH- IPPinvoicing@mail.nih.gov. Questions concerning this award should be directed to the NIH Contracting Officer.

All IPP invoices must contain a Unique Entity Identifier (UEI) which is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

If this award is a parent indefinite delivery award or a Blanket Purchase Agreement Set-Up, then HHSAR 352.232-71 applies to all task/delivery orders or Blanket Purchase Agreement calls issued under this award.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. DESCRIPTION-SPECIFICATION- STATEMENT OF WORK

1. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated 2/25/2026, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports shall be submitted electronically to the Contracting Officer.

These reports shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents , "Create Accessible Documents."

[All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable.

a. Technical Progress Reports In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) no hard copies of these reports will be required.

[ X ] Monthly [ ] Quarterly [ ] Semi-Annually [ X ] Annually [ ] Annually (with a requirement for a Draft Annual Report) [ ] Final - Upon final completion of the contract [ X ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

b. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of racial and/or ethnic minority groups and their subpopulations (when appropriate) for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "Cumulative Inclusion Enrollment Report," which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.

In addition, the “NIH Policy and Guidelines on the Inclusion of Women and Members of Racial and/or Ethnic Minority Groups as Subjects in Clinical Research”, Amended effective, October 2001 August 16, 2025 also applies. If this contract is for Phase III clinical trials, see Section B of these guidelines. The Guidelines may be found at the following website:

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-131.html

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex, racial, and/or ethnic groups, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex, racial and/or ethnic groups.

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Health 6705 Rockledge Drive Bethesda, MD 20892-7902

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

RFO Clause 52.246-2, Inspection of Supplies - Fixed Price (August 1996).

RFO Clause 52.246-4, Inspection of Services - Fixed Price (August 1996).

RFO Clause 52.246-16, Responsibility for Supplies (April 1984).

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-131.html

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from August 18, 2026 through August 17, 2031.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule.

ARTICLE F.3. NOTIFICATION OF COMPLETION OF REPORTING IN ELECTRONIC RESEARCH

ADMINISTRATION (eRA) SYSTEM The Contractor shall submit data relevant to Human Subjects and Clinical Trial Information, including any required Inclusion Enrollment Reporting, into the NIH Electronic Research Administration (eRA) system.

These requirements are described further in SECTION H - REPORTING IN ELECTRONIC RESEARCH ADMINISTRATION (eRA) SYSTEM.

The Contractor shall submit the data within the NIH eRA system within fifteen (15) calendar days of receiving a prompt from the NIH to complete these activities, or sooner as instructed by the Contracting Officer (CO).

Following submission of data within the NIH eRA system as instructed, the Contractor shall send an e-mail notification verifying completion to the CO and the Contracting Officer’s Representative (COR).

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998).

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:

https://www.acquisition.gov/?q=browsefar. FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1)

CLAUSE:

52.242-15, Stop Work Order (August 1989).

Alternate I (April 1984) is applicable to this contract.

52.242-17, Government Delay of Work (April 1984).

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

TBD at the time of award

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule;

(4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015).

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days' notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause).

The following individual[(s)] [is/are] considered to be essential to the work being performed hereunder:

Name Title

TBD

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

b. Requesting Task Order Proposals

The Contracting Officer or a designated individual may solicit responses to requirements from Contractors within a technical area covered by a task order requirement in writing. A Task

Order Request for Proposals (TORFP) will be prepared and issued for each task order requirement.

Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained this contract shall be incorporated in the TORFP and the resultant task order. If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

Contractors are not required to propose on all TORFPs. Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit a proposal on or before the closing date and time established in the TORFP. An election not to propose on a given TORFP will not negatively affect or prohibit a Contractor from competing on future TORFPs. However, it may affect the Contractor's eligibility for continuations or extensions of the resultant Task Order.

c. Competitive Ordering Process

1. All Contractors within a technical area will receive e-mail notification advising of the availability of each proposed task order requirement. All proposed task orders will incorporate all terms of this contract unless otherwise specified in the proposed task order.

2. Contractors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order. Responses will not be considered a proposal as defined in RFO Part 15.

However, the Contractor shall provide information sufficient for consideration in accordance with RFO Part 16. Each TORFP will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated. Generally, the Contractor will be asked to demonstrate the following as appropriate:

• Understanding of the requirements;

• Experience and capability on similar tasks;

• Technical approach, methods and procedures for satisfying the requirements with a discussion of potential problems to be encountered and proposed solutions and/or risk mitigation strategies;

• Procedures for assuring quality of work, products, and deliverables;

• Plan for managing the task order, including meeting requirements and schedules, and performance measures (if applicable);

• Staffing plan with skill levels and level of effort for each individual proposed.

Generally, resumes will be required for proposed personnel (if not previously submitted);

• References to evaluate past performance; and

• Cost/Price to perform the task order.

d. Evaluation and Award of Task Order Proposals

The Government will evaluate the Task Order proposals against the requirements of the TORFP.

Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a Contractor for award. Generally, technical factors will be significantly more important than cost or price. However, each TORFP will specify how the award decision will be made.

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor whose proposal is most advantageous to the government.

The Contracting Officer will notify the Contractor(s) of the selection decision in writing.

e. Fair Opportunity

a) In accordance with RFO 16.507-2 each awardee will be given a fair opportunity to be considered for each order issued exceeding the micro-purchase threshold issued under multiple delivery-order contracts or multiple task-order contracts, except:

i. The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

ii. Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

iii. The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

iv. It is necessary to place an order to satisfy a minimum guarantee.

b) All awardees will be given a fair opportunity to be considered in accordance with the RFO

16.507-2 as follows:

i. For orders exceeding the micro-purchase threshold up to the simplified acquisition threshold, in accordance with RFO 16.507-3;

ii. ii. For orders exceeding the simplified acquisition threshold up to $7.5 Million, in accordance with RFO 16.507-4; and,

iii. iii. For orders exceeding $7.5 Million, in accordance with RFO 16.507-5.

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

The Contractor must submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer Name- Email Address-

Contracting Officer Representative Name- Email Address-

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@mail-cmp.niceincontact.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

1. The Contractor must submit invoices to the Department of Treasury’s Invoice Processing

Platform (IPP) at https://www.ipp.gov with a copy to the approving official for approval, as directed below and in accordance with the definitions of timeliness set forth in the invoice instructions included as an attachment in Section J of this Solicitation/Contract.

The contractor’s failure to submit timely invoice(s) to the Government waives the contractor’s rights to receive payment pursuant to this contract. In the event of this waiver, the Government is not obligated to make such payment, and the Contracting Officer shall have the authority to unilaterally deobligate the funds in accordance with the requirements at 31 U.S.C. 1552(a) and downwardly adjust the total amount of the award by the amount of the deobligation. The contractor shall be given an opportunity to request the excusal of a late invoice from the Contracting Officer. If excused, the Contracting Officer will respond in writing to confirm that the contactor’s right to receive payment has not been waived.

2. In addition to the requirements specified in RFO 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is R&D and Professional Services - Division B, OALM, Office of the Director, National Institutes of Health

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request.

The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer.

Note: The Contractor shall not include TIN if it is a Social Security Number.

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is: Rapid Acceleration of Diagnostics Award Management

g. Contract Line Items as follows:

Line Item # Line Item Description

TBD TBD

h. Inquiries regarding payment of invoices shall be directed to the designated billing office,

(301) 496-6452.

ARTICLE G.5. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, RFO

52.232-40 (Mar 2023).

(a) (1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with RFO Subpart 42.11. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on the anniversary date of the contract.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted sixty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address: https://www.cpars.gov.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. NOTICE TO OFFERORS – PROTECTION OF HUMAN SUBJECTS HHSAR 352.270-70 (MAR

2026) (RFO DEVIATION)

a) The Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR part 46, are available on the Office for Human Research Protections (OHRP) website at: http://www.hhs.gov/ohrp/index.html.

i. These regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of human subjects participating in research activities supported or conducted by HHS.

b) The regulations define a human subject as a living individual about whom an investigator

(whether professional or student) conducting research obtains data or identifiable public information through intervention or interaction with the individual, or identifiable private information. In most cases, the regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use.

c) Activities which involve human subjects in one or more of the categories set forth in 45 CFR 46.104(d)(1)-(8) are exempt from complying with 45 CFR part 46. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal.

https://www.cpars.gov/ http://www.hhs.gov/ohrp/index.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

e) In accordance with 45 CFR part 46, Offerors considered for award must file an acceptable Federal-wide Assurance (FWA) of compliance with OHRP specifying review procedures and assigning responsibilities for the protection of human subjects. The FWA is the only type of assurance that OHRP accepts or approves. The initial and continuing review of a research project by an institutional review board must ensure that: The risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result; selection of subjects is equitable; and informed consent will be obtained and documented by methods that are adequate and appropriate. Depending on the nature of the research, additional requirements may apply; see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 for additional requirements regarding initial and continuing review. HHS regulations for the protection of human subjects (45 CFR part 46), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information is available at the OHRP Web site (at http://www.hhs.gov/ohrp/assurances/index.html).

f) Offerors may consult with OHRP only for general advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. ONLY the contracting officer may offer information concerning a solicitation.

g) The Offeror must document in its proposal the approved or active FWA from OHRP, related to the designated Institutional Review Board (IRB) reviewing and overseeing the research.

i. If the Offeror does not have an approved FWA from OHRP, the Offeror must obtain an FWA before the deadline for proposal submission.

h) When possible, the Offeror must also certify the IRB's review and approval of the research. If the

Offeror cannot obtain this certification by the time of proposal submission, they must include an explanation in their proposal.

i) Never conduct research covered by 45 CFR part 46 prior to receiving certification of the research's review and approval by the IRB.

(End of provision)

Alternate I (MAR 2026) (RFO DEVIATION).

As prescribed in HHSAR 335.7004(a), substitute the following paragraph (g)(1) for paragraph (g)(1) of the basic clause.

(1) If the Offeror does not have an active FWA from OHRP, the Offeror must take all necessary steps to obtain an FWA prior to the proposal submission deadline. If the Offeror cannot obtain an FWA before the proposal submission deadline, the proposal must indicate the steps/actions the Offeror will take to obtain OHRP approval within (Contracting Officer insert a time period in which the FWA must be obtained). Upon obtaining FWA approval, submit the approval notice to the Contracting Officer.

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject http://www.hhs.gov/ohrp/assurances/index.html participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated August 25, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

ARTICLE H.3. INCLUSION OF WOMEN AND MEMBERS OF RACIAL AND/OR ETHNIC MINORITY

GROUPS IN CLINICAL RESEARCH

NIH-conducted and supported clinical research must conform to the NIH Policy and Guidelines on the Inclusion of Women and Members of Racial and/or Ethnic Minority Groups as Subjects in Clinical Research in accord with Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2. The policy requires that women and members of racial and/or ethnic minority groups and their subpopulations must be included in all NIH-conducted or supported clinical research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant NIH Institute/Center (IC) Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The Director, NIH, may determine that exclusion under other circumstances is acceptable, upon the recommendation of an IC Director, based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research.

All investigators proposing research involving human subjects should read the UPDATED “NIH Policy and Guidelines on the Inclusion of Women and Members of Racial and/or Ethnic Minority Groups as Subjects in Clinical Research”, published in the NIH Guide for Grants and Contracts, effective August 16, 2025, at the following website: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25- 131.html

When registering in Clincialtrials.gov, NIH-defined Phase 3 applicable clinical trials must specify outcomes on sex and race and/or ethnic group(s). For NIH-defined Phase 3 applicable clinical trials, submissions of results to ClinicalTrials.gov must include results of valid analyses by sex and race and/or ethnicity, as required based on prior evidence.

The NIH Inclusion Policy is complementary to requirements outlined in the Clinical Trial Registration and Results Information Submission regulation at 42 CFR Part 11 and the accompanying NIH Policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html on the Dissemination of NIH-Funded Clinical Trial Information (NO-OD-16-149). Applicable clinical trials are required to be registered in ClinicalTrials.gov not later than 21 calendar days after the enrollment of the first participant. Results information generally must be submitted no later than one year after the primary completion date, unless a certification of delay was submitted, a request for an extension for good cause was granted, or a request for a waiver of the requirements for submission of results information was granted.

ARTICLE H.4. INCLUSION OF INDIVIDUALS ACROSS THE LIFESPAN AS PARTICIPANTS IN RESEARCH

INVOLVING HUMAN SUBJECTS

Section 2038 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions requiring NIH to address the consideration of age as an inclusion variable in research involving human subjects, to identify criteria for justification for any age-related exclusions in NIH research, and to provide data on the age of participants in clinical research studies. The NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects applies to all NIH conducted or supported research involving human subjects, including research that is otherwise "exempt" in accordance with § 46.104 and 401(c) of 45 CFR 46 - Federal Policy for the Protection of Human Subjects.

Effective on all solicitations issued on or after January 25, 2019, individuals of all ages, including children (i.e. individuals under the age of 18) and older adults, must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them. The inclusion of individuals across the lifespan as subjects in research must be in compliance with all applicable subparts of 45 CFR 46 as well as with other pertinent federal laws and regulations.

The Contractor must address the age-appropriate inclusion or exclusion of individuals in the proposed research project. The Contractor must provide a description of plans for including individuals across the lifespan, including a rationale for selecting the specific age range justified in the context of the scientific question proposed. If individuals will be excluded from the research based on age, the contractor must provide acceptable justification for the exclusion.

The Contractor must submit cumulative data as prescribed in the Attachment Files - Section J “NIH Contracts Age Enrollment Report template” on participant age at enrollment in monthly progress reports. Investigators planning to conduct research involving human subjects should design their studies in such a way that de-identified individual level participant data on sex, race, and/or ethnicity, and age at enrollment may be provided in progress reports. The Contractor must submit cumulative de-identified individual level participant data on sex, race, and/or ethnicity, and age at enrollment annually. The template used for these submissions is https://www.era.nih.gov/sites/default/files/2020-05/ParticipantLevelData-Template.CSV

ARTICLE H.5. POSTING CLINICAL TRIAL INFORMED CONSENT FORMS TO CLINICALTRIALS.GOV

The Revised Common Rule sections 46.102(b) and 46.116(h) requires Contractors to post one IRB-approved version of an Informed Consent Form that has been used to enroll participants on a public federal website designated for posting such Consent Forms. Contractors shall post the Informed Consent Form to the National Institutes of Health's (NIH's) clinical trials registry and results database ClinicalTrials.gov . Note: ClinicalTrials.gov only accepts Informed Consent Forms written in English;

non-English language forms must be submitted to Regulations.gov . The Informed Consent Form must be posted after recruitment closes, and no later than 60 days after the final study visit. The https://www.era.nih.gov/sites/default/files/2020-05/ParticipantLevelData-Template.CSV

Contracting Officer (CO) and/or Contracting Officer Representative (COR) may permit or require redactions as appropriate.

ARTICLE H.6. REPORTING IN ELECTRONIC RESEARCH ADMINISTRATION (eRA) SYSTEM The Contractor shall submit data relevant to Human Subjects and Clinical Trial Information, including any required Inclusion Enrollment Reporting, into the NIH Electronic Research Administration (eRA) system.

More information is available at https://www.era.nih.gov/help-tutorials/era-training-hss.htm.

System Access The eRA system website may be accessed at: https://public.era.nih.gov/commonsplus.

Please note that if your organization does not currently have an account in eRA Commons, you will first need to register your organization at https://public.era.nih.gov/commonsplus/public/registration/initRegistration.era.

Once your organization is registered, your signing official is then able to create new eRA system user accounts (such as for a Project Director/Principal Investigator).

For information on how to create/manage accounts in the eRA system, please refer to:

https://www.era.nih.gov/register-accounts/create-and-edit-an-account.htm . [Note: You must be logged into the eRA system with appropriate role(s), in order to complete these activities.]

Refer to SECTION F - NOTIFICATION OF COMPLETION OF RESEARCH AND DEVELOPMENT DATA ENTRY IN ELECTRONIC RESEARCH ADMINISTRATION (eRA) SYSTEM for schedule and notification requirements related to data submission in the NIH eRA system.

ARTICLE H.7. PUBLIC HEALTH SURVEILLANCE EXCLUSION

The Contractor may request an exclusion from applicability of the "revised Common Rule"1 if it believes that the NIH-funded or -conducted activities associated with this contract should be considered "public health surveillance activities deemed not to be research" for the purposes of the revised Common Rule. All requests for exclusion from the revised Common Rule for NIH-funded research-whether conducted or supported-must receive NIH approval, as per the process outlined below, to be considered a public health surveillance activity deemed not to be research under the revised Common Rule's Sections §46.102(k), Public health authority, and §46.102(l)(2), Public health surveillance activities. NIH expects that NIH-supported or -conducted research will be determined to be a public health surveillance activity only in extremely rare cases. Please note that NIH will not consider any NIH-defined clinical trials for a public health surveillance exclusion request. In addition, NIH will not consider studies that contain any activity that does not meet the requirements for an exclusion for a public health surveillance determination, which includes any intent to store specimens and/or data for future use, for a request for exclusion.

Contractor shall provide a compelling justification as to why NIH-funded or -conducted activities should be considered public health surveillance activities deemed not to be research for the purposes of the revised Common Rule.

Contractor shall complete and submit the PHS Human Subjects and Clinical Trials Information Form, following instructions in the solicitation or contract, as applicable. Contractor should not assume that approval of an exclusion will be granted when completing the PHS Human Subjects and Clinical Trials Information Form.

Note that the proposed budget in the proposal must reflect all necessary/required costs for the full and proper conduct of research involving human subjects, in complete compliance with all applicable laws, protocols, rules, and/or regulations at all levels, without approval of any exclusion.

Contractor should not assume that approval of an exclusion will be granted when considering the costs to include in any proposed budget and therefore, must respond and price accordingly.

Notice of Approval or Disapproval of Request for Exclusion

Exclusion requests will be considered separate from the NIH peer review of technical proposals.

Offerors will be issued written notification of approval or denial by the NIH Contracting Officer of any request(s) for exclusion prior to award. Any decision by NIH on an Offeror's request for a Public Health Surveillance Exclusion shall be final.

If a Public Health Surveillance exclusion is approved, the Contracting Officer shall request that the Contractor revise its proposed costs during negotiations, in order to reflect any associated decreases in estimated costs, as a result of the exclusion being granted. The Contracting Officer shall also determine if any changes to the terms and conditions of the contract, as applicable, need to be made, based on the exclusion.

The cost proposal will then be adjusted accordingly at award if approval of an exclusion is granted by

NIH.

1 Code of Federal Regulations (CFR) Title 45, Public Welfare, Department of Health and Human Services, Part 46, Protection of Human Subjects, Revised 19 January 2017, Effective 19 July 2018, with a General Compliance Date of 21 January 2019 (45 CFR part 46)), and not its predecessor, the Pre-2018 Common Rule (Common Rule). The revised Common Rule is also known or referred to as the "2018 Requirements" or the "2018 Rule."

ARTICLE H.9. 2024 NIH PUBLIC ACCESS POLICY

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) electronic versions of all Author Accepted Manuscripts arising from this contract in whole or in part, upon acceptance for publication. NIH defines the Author Accepted Manuscripts as the author's final version that has been accepted for journal publication and includes all revisions resulting from the peer review process, including all associated tables, graphics, and supplemental material. NIH-funded investigators shall notify their Contracting Officers and Contracting Officer Representatives upon the acceptance of an Author Accepted Manuscript resulting from the contract, even if co-authored with those not using contract funds. Through execution of this contract, contractor, and through implementation of this provision by contractor to each of contractor’s investigators and subcontractor, and through implementation of this provision to each of subcontractor’s investigators, conducting work under this contract or a subcontract, respectively, hereby grants to NIH a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use for federal purposes and to authorize others to do so, all Author Accepted Manuscripts that result from this contract, which includes making Author Accepted Manuscripts publicly available in PubMed Central upon the Official Date of Publication, in accordance with the 2024 NIH Public Access Policy.