JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Command (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements.

The proposed contract action is for 1-Year maintenance of the 9 (nine) cryopreserved mouse lines at Charles River Laboratories (CRL). These mouse lines were originally produced and maintained in the WRAIR/NMRC vivarium and are used to generate human immune system humanized mice for research. This Humanized mouse model has been used as an in vivo surrogate model for developing medical countermeasures to prevent and treat infectious diseases of military relevance to enhance warfighter readiness and performance . The Government intends on awarding a Firm

Fixed Price contract. The proposed source is CRL, Wilmington, MA USA.

2. Nature and/or description of the action.

The proposed contract action is for 1-Year maintenance of the 9 (nine) cryopreserved mouse lines at CRL. These mouse lines have been generated and maintained in WRIR/NMRC vivarium in order to be used in the generation of human immune system Humanized DRAGA mouse model. This Humanized mouse model has been developed in 1997 and has since been used for in vivo surrogate model for testing vaccine and therapeutics development in the emerging infectious diseases ( i.e. HIV, Malaria, Dengue, SARS-Cov2, etc) research settings . The

Government intends on awarding a Firm Fixed Price contract. The proposed source is Charles

River (CRL) company, Wilmington, MA USA.

3. Description of Supplies or Services:

The Agile Vaccine and Therapeutics (AVAT) Department Humanized Mouse Core laboratory has a critical need to cryopreserve mouse embryos of nine humanized mouse strains produced at

NMRC for research to support the mission of developing and testing medical countermeasures to prevent and treat infectious diseases to enhance warfighter readiness and performance. This cryopreservation service will allow the Humanized Mouse Core to maintain valuable mouse strains in an off-site location that can be recovered in the event of disease outbreaks in the mouse colony in the WRAIR/NMRC vivarium, breeding cessation and other emergencies. AVAT

Department Fiscal Year 2026 funds in the amount of $3,346.20 will be used to procure a service contract with the vendor.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10

U.S.C. 2304(c)(1) and FAR 13.106-1(b)(1) soliciting from a single source.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The proposed contractor, CHARLES RIVER LABORATORIES (CRL), will provide all the necessary support and technical service to maintain nine different cryopreserved mouse lines

(strains) required by the AVAT Department. CRL already has the 9 lines of frozen embryos stored at Charles River Laboratories, Wilmington, Delaware. We recommend continuing to use their service for continuity and to avoid the additional cost and risks of shipping cryopreserved embryos from Charles River to another vendor.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was not performed, because we wish to continue maintaining the cryopreserved embryos at CRL for continuity and to avoid the additional cost and risks of shipping cryopreserved embryos from Charles River to another vendor.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the Charles River (CRL)’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Market research was not performed, because we wish to continue maintaining the cryopreserved embryos at CRL for continuity and to avoid the additional cost and risks of shipping cryopreserved embryos from Charles River to another vendor.

9. Other facts supporting the use of other than full and open competition.

Charles River is currently maintaining nine lines of cryopreserved mouse embryos from the NMRC

Humanized Mouse Core. We recommend continuing to use their service for continuity and to avoid the additional cost and risks of shipping cryopreserved embryos from Charles River to another vendor.

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

Sole source justification for using Charles Rivers Laboratories (CRL). CRL already has the cryopreserved mouse embryos. We recommend continuing to use their service for continuity and to avoid the additional cost and risks of shipping cryopreserved embryos from Charles River to another vendor.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

For the reasons set forth in Paragraph 5, NMRC has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements are feasible.

12. Point of Contact:

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification: Dr. Sofia Casares; sofia.a.casares.civ@health.mil and

Contracting Officers in the Material Management Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

SUNDARAM.APPAVU.K

ALYANA.1513194621

Digitally signed by

SUNDARAM.APPAVU.KALYANA.1513194621

Date: 2026.05.27 10:27:34 -04'00'

301-319-7199 05/27/2026

Name

Title Appavu K. Sundaram

Deaprtment Head

Phone Date

Department/Command

Requirements Cognizance

AVAT/IDD/NMR

Name Phone Date

Title

Department/Command mailto:sofia.a.casares.civ@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

CARTER.SHAMAI.

M.1624726649

Digitally signed by

CARTER.SHAMAI.M.1624726649

Date: 2026.05.27 13:07:40 -04'00'

(301) 319-9948 5/27/2026

Contracting Officer Phone Date