NOI_PCA-NHLBI-01737.pdf

PRE-SOLICITATION NON-COMPETITIVE –

Notice of Intent to Sole Source

1. SOLICITATION NUMBER: PCA-NHLBI-01737

2. TITLE: Mouse Colony Breeding Service

3. RESPONSE DATE: March 26, 2026, at 9 A.M. Eastern Daylight Time (EDT)

4. PRIMARY POINT OF CONTACT:

Nicholas Capobianco 301-496-1318 nicholas.capobianco@nih.gov

I. INTRODUCTION:

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

CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-

NAME).

The National Heart, Lung, and Blood Institute (NHLBI) intends to negotiate and award a purchase order without providing for full and open competition to Ozgene (Bentley, WA, Australia). The purpose of this acquisition will be to provide National Heart, Lung, and Blood Institute (NHLBI) with mouse models carrying the human δ-globin gene that can be used to evaluate the impact of the KLF1–GATA1 fusion protein and candidate compounds on SCD and β-thalassemia phenotypes.

II. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE

STATUS

NAICS Code 112990 - All Other Animal Production - $2.75 Million SBA Size Standard. This acquisition is NOT set aside for small businesses.

III. REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2024-07 dated 08-29-2024.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13.5— Simplified Procedures for Certain Commercial Items and FAR subpart 12—Acquisition of Commercial Items at an amount exceeding the SAT and not exceeding $7 million.

IV. STATUTORY AUTHORITY

This acquisition is for a commercial item or service and is conducted under the authority of the FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items and the statutory authority of FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 3304 (a)(1).

V. DESCRIPTION OF REQUIREMENT:

A. PURPOSE AND OBJECTIVES:

The purpose of this requirement is to provide the National Heart, Lung, and Blood Institute (NHLBI) with the mouse colony breeding service, which is an ongoing project involving our transgenic HBB, HBBS, and HBBE knock-in mice at Ozgene. The previous order was PO # 75N92023P00254. These transgenic mice will be crossed with the Townes mouse model to generate fully humanized mice carrying only human hemoglobin with or without mutation.

B. PERIOD OF PERFORMANCE:

NHLBI anticipates a firm fixed price purchase order. This requirement shall consist of mouse colony breeding service which will take 12-15 months starting on June 1, 2026 – May 31, 2027, and performed at Ozgene (3 Parker Place, Bentley, WA 6102, Australia).

C. PROJECT REQUIREMENTS:

The contractor will perform the mouse colony breeding service following the below procedures.

For HBB [HBB(Dash)] humanized mice Step 1: expand wt/KI(HBB) line Step 2: cross Townes to homozygous KI(HBB)mice Step 3: intercross wt/HBA(Townes), HBB(Townes)/HBBKI Step 4: intercross HBA/HBA (Townes), HBB (Townes)/HBBKI(HBB)

For HBE [HBB(Mirage)] humanized mice Step 1: expand wt/KI(HBE) line Step 2: cross Townes to homozygous KI(HBE)mice Step 3: intercross wt/HBA(Townes), HBB (Townes)/HBE Step 4: intercross HBA/HBA(Townes), HBB (Townes)/HBE

Reporting Requirements and Deliverables

Humanized HBB model:

• 5 HBA/HBA, HBB(Dash)/HBB(Dash) males, 6-8 weeks old

• 5 HBA/HBA, HBB(Dash)/HBB(Dash) females, 6-8 weeks old

Humanized HBBE model

• 5 HBA/HBA, HBB(Mirage)/HBB(Mirage) males, 6-8 weeks old

• 5 HBA/HBA, HBB(Mirage)/HBB(Mirage) females, 6-8 weeks old

Project officer of NHLBI and Dr. Jianqiong Zhu of MCHB shall be responsible for issuing service requests to the Contractor. Dr. Jianqiong Zhu will assess the quality of services rendered by the Contractor. Staff shall immediately inform the Government’s Project Officer for this requirement of any inconsistencies and/or shortcomings in the Contractor’s performance.

VI. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING

BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Ozgene is the only vendor in the marketplace that can provide the services required by NHLBI. This requirement supports an ongoing research project involving transgenic HBB and HBE knock-in mouse lines generated by Ozgene. These mouse lines are currently maintained as an established breeding colony at Ozgene’s facility. The project requires continued breeding and colony maintenance, including crossing these lines with the Townes mouse model to generate fully humanized mice expressing either normal human hemoglobin (HBB) or hemoglobin with a thalassemic mutation (HBE). Because the founder animals and established colony are currently housed at Ozgene, transitioning this work to another vendor would require transferring or re-deriving the lines and re-establishing the colony. This would result in substantial duplication of cost to the Government and unacceptable delays to the ongoing research program. In addition, transferring the colony may introduce scientific risks, including genetic drift and disruption of lineage integrity. Therefore, Ozgene is the only source reasonably available to continue the required services while maintaining the integrity of the existing mouse lines and research data.

In accordance with FAR part 10, extensive market research was conducted to reach this determination. Additionally, contacts with knowledgeable individuals both in industry and Government, as well as reviews of available product literature, revealed no other sources.

Finally, a review of the GSA Advantage, Dynamic Small Business Search, and previous government acquisitions returned no results that meet all of the requirements. Therefore, only Ozgene is capable of meeting the needs of this requirement.

The intended source is:

Ozgene 3 Parker Place Bentley, WA 6102 Australia

VII. 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.

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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response.

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.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, PCA-NHLBI-01737. Responses must be submitted electronically to Nicholas Capobianco, Program Specialist, nicholas.capobianco@nih.gov.