Notice_of_Intent_1.docx

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 Metabolon, Inc., 617 Davis Dr STE 400 Morrisville, NC 27560-7171 for a service contract for Metabolomic Analysis of the Effects of Phenylbutyrate (PB) in Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 621511 - Medical Laboratories, Small Business Size, $41.5 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 Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic multisystem disorder that causes significant disability worldwide. It has been estimated to affect ~1% of the general population in the United States according to the Center for Disease Control and Prevention (CDC). Based on recent findings, NHLBI plans to investigate the potential therapeutic use of the ER stress inhibitor sodium phenylbutyrate (PB) in patients with ME/CFS. To characterize the effects of sodium phenylbutyrate (PB) in patients with ME/CFS, this metabolomic study will: (1) identify plasma metabolites that differ between patients with ME/CFS and healthy volunteers, and (2) determine whether PB treatment can correct or improve the abnormal metabolic changes observed in patients with ME/CFS.

Purpose and Objectives The purpose of this acquisition is to procure a service contract for Metabolomic Analysis of the Effects of Phenylbutyrate (PB) in Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

Period of Performance Base Period: 9/30/2026 to 9/29/2027

Project Description

Contractor Requirements:

To characterize the effects of sodium phenylbutyrate (PB) in patients with ME/CFS, this metabolomic study will: (1) identify plasma metabolites that differ between patients with ME/CFS and healthy volunteers, and (2) determine whether PB treatment can correct or improve the abnormal metabolic changes observed in patients with ME/CFS.

Product Specifications/Features/Salient Characteristics Untargeted metabolomic profiling and bioinformatic analysis will be performed by Metabolon, Inc. using plasma samples collected from patients with ME/CFS before and after PB treatment. Baseline plasma samples from healthy volunteers will serve as controls. The goal of this project is to assess the effect of PB treatment on abnormal plasma metabolites in patients with ME/CFS and to generate insight into the therapeutic potential and metabolic impact of PB in this patient population.

General Contractor Responsibilities This clinical metabolomics study will analyze plasma samples from 30 patients with ME/CFS and 15 healthy volunteers. Plasma samples from patients with ME/CFS will be collected at two time points: prior to initiation of PB treatment and after eight weeks of PB treatment. Metabolon, Inc. will be responsible for performing untargeted metabolomic profiling on all 75 plasma samples and conducting the following comparisons for the identified compounds:

1. Baseline ME/CFS vs. healthy controls To identify plasma metabolites and metabolic pathways that are abnormal in patients with ME/CFS.

2. Post-PB treatment vs. baseline ME/CFS To determine which metabolites are significantly altered after PB treatment.

3. Post-PB treatment ME/CFS vs. healthy controls To evaluate whether PB treatment corrects or partially normalizes ME/CFS-associated metabolic abnormalities.

Evaluation of the Contractor The NHLBI Clinical Director will evaluate the performance of the Contractor. The NHLBI Clinical Director may request reports and performance evaluations from the Contractor to assess its overall qualifications and expertise.

Location of Services Metabolon, Inc.

617 Davis Drive, Suite 400 Morrisville, NC 27560

Other Important Considerations None

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The Government requires the new metabolomic data to be directly comparable to the existing ME/CFS dataset previously generated using Metabolon’s proprietary untargeted metabolomics platform. This requirement is therefore not for general metabolomics testing, but for analytical continuity with the existing dataset.

Use of a different vendor or analytical platform would introduce methodological variability and potential batch effects resulting from differences in sample preparation, instrumentation, metabolite identification, data normalization, and bioinformatics. Such differences could compromise valid comparison of the new PB intervention data with the existing dataset.

Because Metabolon’s proprietary platform and methodology were used to generate the existing ME/CFS dataset, Metabolon is the only source reasonably available to provide the analytical consistency and compatibility required for scientifically valid cross-dataset comparisons.

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 09/08/2026 at 10:00am EDT. Responses must be submitted via email to James Hawkins james.hawkins3@nih.gov and Tara Knox tara.knox@nih.gov.

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