Notice of Intent to Sole Source_Therapeutic Role of Soluble Adenylyl Cyclase Inhibition.pdf

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

INTRODUCTION

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

SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL

OR OPEN COMPETITION.

The National Institutes of Health (NIH), Office of Acquisitions and Logistics Management (OALM), Office of the Director (OD) on behalf of the Division of Intramural Research (DIR) intends to negotiate on a sole-source basis and award a purchase order without providing for full and open competition to the University of Illinois at Chicago (UIC), 809 S Marshfield Ave M/C 551, Chicago, IL 60612-4305 for preclinical animal research services to evaluate the therapeutic effects of soluble adenylyl cyclase (sAC) inhibition on pulmonary arterial hypertension (PAH).

NIH intends to solicit this requirement from UIC pursuant to FAR 13.106-1(b)(1) because the circumstances of the acquisition indicate that only one source is reasonably available. UIC currently maintains the established EC-Cav1 KO mouse colony required for this study. The required model is not known to be maintained by another laboratory. Establishing and validating the model at another institution would require colony establishment, breeding and expansion, genotyping, institutional approvals, and experimental validation and is estimated to require more than one year, which would significantly delay the planned research.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS Code 541715 – Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), 1,000 employees.

REGULATORY AUTHORITY

The resultant purchase order 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 FOR SINGLE SOURCE

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

NIH requires preclinical animal research services to evaluate the therapeutic effects of soluble adenylyl cyclase (sAC) inhibition on pulmonary arterial hypertension (PAH) using an established endothelial cell-specific Cav1 knockout (EC-Cav1 KO) murine model (Cdh5(PAC)CreERT2+/+; Cav1-lox+/+ treated with tamoxifen) and corresponding wild-type (WT) controls.

The study requires male and female, 3-month-old EC-Cav1 KO and WT control mice.

Two sAC inhibitors, KH7 and LRE1, will be compared with vehicle control treatment in mice exposed to either normoxia or chronic hypoxia (10% FiO2 for 28 days). KH7, LRE1, or vehicle control, as applicable, will be administered by subcutaneous osmotic pump for 28 days beginning at the onset of normoxia or hypoxia exposure.

The study consists of 144 animals, divided among male and female EC-Cav1 KO and WT control groups, with six animals per treatment group. Replacement animals will be required in the event of mortality or other study-related attrition.

Required services include animal breeding and colony maintenance; genotyping;

implantation of subcutaneous osmotic pumps; administration of KH7, LRE1, or vehicle control, as applicable; maintenance of hypoxia chambers at 10% FiO2;

baseline and Day 28 echocardiography; Day 28 right-heart catheterization;

euthanasia and necropsy; collection and embedding of lung and heart tissue for histological analysis; preparation of lung tissue for Western blotting and RNA-seq;

and collection and preparation of serum and plasma samples for Government analysis.

The Government will provide 200 mg of KH7 and 200 mg of LRE1 for use in the study. The compounds will be delivered directly to the Contractor from the manufacturer and shall be stored and handled in accordance with the manufacturer's instructions.

The anticipated award will be a firm-fixed-price purchase order with a period of performance of 12 months from the date of award.

BASIS FOR INTENDED SOLE SOURCE

UIC currently maintains the established EC-Cav1 KO mouse colony required for this study, and this model is not known to be maintained by another laboratory. Establishing and validating the required model at another institution is estimated to require more than one year due to the time required for institutional approvals, colony establishment, breeding and colony expansion, genotyping, and experimental validation. The resulting delay would adversely affect the study timeline and delay completion of the planned research.

Based on these circumstances, UIC is the only source reasonably available to provide the established model and associated research services required for this study.

CLOSING STATEMENT/RESPONSE INSTRUCTIONS

This notice of intent is not a request for competitive quotations. However, all responsible sources that believe they can satisfy the Government's requirements may submit a capability statement and/or quotation demonstrating their ability to provide the required services. All timely responses will be considered by the Government.

Responses shall provide sufficient information to demonstrate the respondent's ability to provide the required EC-Cav1 KO murine model and perform the preclinical animal research services described in this notice. Responses should include the entity's legal business name, Unique Entity Identifier (UEI), business size, point of contact information, relevant technical capabilities and experience, and sufficient information demonstrating the availability of the required animal model.

A determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government.

Information received will be considered for the purpose of determining whether to proceed with the intended noncompetitive acquisition or conduct a competitive procurement.

Responses must be received no later than 12:00 p.m. Eastern Time on Monday, September 21, 2026, and submitted electronically to Donna Cornish, Acquisition Specialist, donna.cornish@nih.gov and Jonathan Lear, Contracting Officer, john.lear@nih.gov.

The Government will not reimburse respondents for costs associated with preparing or submitting a response to this notice.

ANTICIPATED AWARD DATE

On or before September 30, 2026.

mailto:donna.cornish@nih.gov mailto:john.lear@nih.gov