Notice_of_Intent_1.pdf

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT

PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Health (NIH), Office of Acquisitions and Logistics Management

(OALM), Office of the Director (OD) on behalf of the National Heart, Lung and Blood

Institute (NHLBI) intends to negotiate and award a purchase order without providing for full and open competition to Vanderbilt University Medical Center, 1161 21st Ave. S.

Suite D3300 MCN Nashville, TN 37232-001 to provide clonal hematopoiesis of indeterminate potential (CHIP) – Target assay.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541990 – All Other

Professional, Scientific and Technical Services, Small Business Size, $19.5 Million.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01 effective date 03-13-2026.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13—

Simplified Acquisition Procedures at an amount not exceeding the SAT.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation

(FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold.

Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements.

DESCRIPTION OF REQUIREMENT

Background

With the advent of high-throughput DNA sequencing, it has become increasingly evident that the human genome is dynamic and that somatic mutations in the nuclear and mitochondrial genomes accumulate with age. Researchers hypothesize that integrative multi-omics approaches can be used to characterize clinically impactful changes in the human genome and provide insights into the molecular underpinning of these changes.

Specifically, researchers posit that elucidating the transcriptomic (including splice variation), DNA methylation, and proteomic signatures of deleterious somatic mutations in the nuclear and mitochondrial genomes will advance mechanistic understanding of a substantial subset of age-related heart, lung, and blood diseases that are linked to nuclear and mitochondrial somatic mutations.

Purpose and Objectives

Cardiovascular disease (CVD) is the leading cause of death and serious illness in the

United States. The objective of the Framingham Heart Study (FHS) is to identify the common factors or characteristics that contribute to CVD by following its development over a long period of time in a large group of participants who had not yet developed overt symptoms of CVD or suffered a heart attack or stroke. The FHS continues to make important scientific contributions by enhancing its research capabilities and capitalizing on its inherent resources.

In light of new National Institutes of Health (NIH) emphasis, researchers need to conduct ‘Gold standard Replication and reproducibility studies’ to help restore the process of ‘replication’ as a foundational pillar of science at NIH. There is a need for a follow-on requirement to run a targeted CHIP replication assay to confirm the initial results obtained via work that has been in progress for three (3) years via previous awards 75N92024P00272 and 75N98026P00647.

Period of Performance

Base Period: 12 months

Project Description

I. Contractor Requirements:

a. Access FHS data and WGS data from TOMPMED

b. Perform targeted Clonal Hematopoiesis Targeted Sequencing Assay on

11,000 samples

c. The team will collaborate with the NHLBI intramural team on subsequent analyses and publications.

d. Data transfer of all data to NIH via google cloud or other suitable means determined at complete of the collection of data

II. Government Responsibilities

a. NHLBI will provide DNA materials for both initial time point and second serial WGS sequencing data.

Reporting Requirements and Deliverables by vendor

Contractor will provide following upon completion of study:

A. Statistical analyses of the CHIP reads from all samples

Program Management and Control Requirements

No special management or control systems are required under this contract.

Evaluation of the Contractor

Reports and performance evaluations may be requested from the Contractor to assess its overall qualifications and expertise.

Location of Services

Vanderbilt University Medical Center

1161 21st Ave. S. Suite D3300 MCN

Nashville, TN 37232

Other Important Considerations

None

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION

(INCLUDING BRAND-NAME) DETERMINATION

It is being recommended that this requirement be sole-sourced to Vanderbilt

University Medical Center (VUMC) as a follow-on requirement for work that has been in progress for three (3) years from previous awards 75N92024P00272 and

75N98026P00647. Data needs to be replicated using orthogonal technology that is only provided by the BICK Lab at VUMC which will ensure the data are consistent, formatting allows for easy integration with existing data and most importantly to be able to compare the original data to the newly generated data in the fastest means possible. The BICK Lab has developed a targets CHIP sequencing assay that will be applied in this data set as a completely orthogonal and independent data set that will be measured on the exact same samples to verify the original Whole Genome

Sequencing (WGS) generated CHIP data. The DNA samples reside at VUMC.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier (UEI), the

Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by 09/14/2026 at 10:00am EDT. Responses must be submitted via email to Kierre Person kierre.person@nih.gov and Roxane Burkett roxane.burkett@nih.gov.

All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.

http://www.sam.gov/