Notice_of_Intent_co_review_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 The Johns Hopkins University, 3400 N Charles St Baltimore, MD 21218-2608 for a service contract for collection of biospecimens and associated clinical data from patients with Pulmonary Arterial Hypertension.

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 The intramural pulmonary vascular lab is focused on understanding the molecular mechanism leading to endothelial dysfunction in pulmonary arterial hypertension (PAH).

One area of focus is identifying therapeutic targets that can ameliorate inflammatory vascular remodeling in PAH. In the cellular model of caveolin-1 (CAV1) deficiency associated PAH, NHLBI observed increased interferon signaling, similar to what is seen in systemic sclerosis-associated PAH (SSc-PAH). NIH has recently been awarded a Bench-to-Bedside and Back Award to further investigate CAV1 deficiency in a pre-clinical animal model as well as in circulating immune cells from PAH patients. An essential part of the study will be supported by work performed by collaborators at the Johns Hopkins Hospital (JHH), which is a Pulmonary Hypertension (PH) Center of Excellence. Drs. Paul Hassoun and Stephen Mathai currently have an IRB approved protocol to facilitate sample collection from PAH patients. They will provide peripheral blood mononuclear cells (PBMCs) which will allow NHLBI to investigate the role of CAV1 in both SSc-PAH and idiopathic PAH (IPAH).

Purpose and Objectives The purpose of this acquisition is to procure a service contract for collection of biospecimens and associated clinical data from patients with Pulmonary Arterial Hypertension.

Period of Performance Base Period: 12 Months

Project Description Scope of Work

Contractor Requirements:

• The Johns Hopkins Pulmonary Hypertension Program is formally accredited as a Pulmonary Hypertension Comprehensive Care Center by the Pulmonary Hypertension Association. The Program is staffed by 5 physicians, three pulmonary medicine trained post-doctoral fellows, two research coordinators, and two dedicated PH nurses.

• There are approximately 1,200 visits per year to the PH clinic, with about five new patients seen every week.

• These patients are well-characterized from a clinical and hemodynamic standpoint.

• All patients undergo routine initial clinical evaluations (e.g., 6 minute walk testing, chest imaging, blood tests, echocardiographic assessment, and hemodynamic assessment of pressures with vasodilator challenge).

• Hence, JHH PH center, has the necessary patient cohort and the infrastructure to collect the appropriate patient clinical data, hemodynamics, blood draws, sample processing, and storage.

• Additionally, Drs. Paul Hassoun and Stephen Mathai have a well-established PBMC collection, processing, and storage protocol.

• There is no additional educational or certifications needed for their team to perform the required services.

General Contractor Responsibilities

• The objective is to obtain de-identified samples of PBMCs and associated, de-identified clinical data from patients with SSc-PAH (n=10), SSc without PAH (n=10), and IPAH (n=10)

• Based on the referral pattern at the JHH PH clinic and their historical accrual rate of research samples over the past year, obtaining samples from approximately 2 patients per month is anticipated.

Description of sample collection and processing:

• Subjects will be enrolled in an IRB-approved protocol at JHH. Following informed consent subjects will undergo blood sample collection. Associated clinical and demographic data will also be collected as specified in the IRB-approved protocol following informed consent.

• Venous blood is collected by simple venipuncture under aseptic conditions.

• All blood samples are processed within two hours of collection to minimize variations associated with longer sample incubation times.

• PBMCs are per the Standard Operating Procedures of Dr. Hassoun’s Lab.

• Isolated PBMC aliquots will be cryopreserved according to standard procedures and stored in liquid nitrogen.

• De-identified PBMC samples will be transferred to the NHLBI (Dr. Elinoff’s Lab) once sample collection has been completed in all subjects.

• In addition, de-identified clinical data associated with each sample will be securely shared with the NHLBI (Dr. Hersi and Dr. Elinoff)

• The de-identified clinical and demographic data that will be collected by JHH

PH clinic and securely shared with the NHLBI includes but is not limited to:

• Age, sex, race, ethnicity, height and weight (at time of blood collection)

• WHO/NYHA functional classification (within 3 months of blood collection)

• 6-minute walk distance, pulmonary function testing

• Echocardiogram (within 6 months of blood collection)

• Hemodynamics (within 1 month of blood collection)

• BNP or proBNP (within 1 month of blood collection)

• Estimated GFR (within 6 months of blood collection)

• Current medications (at time of blood collection)

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 The Johns Hopkins University 3400 N Charles St Baltimore, MD 21218-2608

Other Important Considerations None

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION

(INCLUDING BRAND-NAME) DETERMINATION

The Johns Hopkins University is uniquely positioned to provide collection of biospecimens and associated clinical data from patients with Pulmonary Arterial Hypertension. Funding for the research that will be completed with the patient samples obtained through this contract is from the 2024 Bench-to-Bedside and Back Award program to the lab. This award was based on a research proposal that specified the JHH Pulmonary Hypertension Program as the clinical collaborator. Therefore in order to maintain the integrity of the research plan and adhere to the proposed work that received funding, NHLBI must limit competition for this project.

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 09/04/2026 at 10:00am EDT. Responses must be submitted via email to James Hawkins james.hawkins3@nih.gov and Natalie Bruning Natalie.bruning@nih.gov.

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

http://www.sam.gov/