PR 1301210154-JNA-KOSigned-rev..pdf

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.

2. Nature and/or description of the action.

The need is for reagent component 10x Buffer with BSA 50mM Mg2Cl2. This reagent is manufactured by BioFire Diagnostics/BioFire Defense. The Government intends on awarding a Firm Fixed Price contract. The proposed source is BioFire Defense 79 West 4500 South, Suite 14, Salt Lake City, UT 84107.

3. Description of Supplies or Services:

The Molecular Diagnostics Department of Biological Defense Research Directorate, Naval Medical Research Command produces reagents for biological defense applications. These reagents are employed by a variety of Navy, Department of Defense, and other US Government agencies for the detection and identification of biological warfare agents. The development process for the production of these reagents included extensive testing of the reagent components to produce the best combination. Essential component, 10x PCR Buffer, is required.

RDT&E funds in the amount of $64,978.00 will be used to procure these reagent components.

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 6.302-1 sole source (including brand name) acquisitions or 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 10x PCR Buffer produced by BioFire Diagnostics/BioFire Defense is an essential component of reagents being produced by BDRD/NMRC for biological defense applications. This reagent is employed by a variety of Navy, Department of Defense, and other US Government agencies for the detection and identification of biological warfare agents. Additionally, this reagent is currently deployed globally for operational use. The development process included extensive testing of various reagent components to produce the best combination. The 10x PCR Buffer produced by BioFire Diagnostics/BioFire Defense is one of those components. Switching to another kit from another vendor would invalidate all previous optimization and evaluation efforts. Reagents produced with another vendor’s kit without a re-optimization and evaluation would result in reduced performance of the reagents. This is unacceptable to the agencies that employ the current reagents in ongoing operations.

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

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the government point of entry in accordance with FAR 5.202.

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 Biofire Defense 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.

See accompanying Market Research Memorandum.

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

As above, the only acceptable vendor for the component is Biofire Diagnostics/Biofire Defense.

Previous purchases include the following:

N32398-14-P-0341 totaling $ 48,141.00 N32398-15-P-0344 totaling $ 48,204.00 N32398-16-P-0252 totaling $ 134,830.00 N32398-17-P-0214 totaling $ 78,100.00

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

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.

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, (contracting activity) 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 are the 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

Name: Stephen Lizewski Phone 301-619-1507 Date: 04NOV24 Title: Department Head Department/Command: Molecular Diagnostics/NMRC

Requirements Cognizance

Name: Stephen Lizewski Phone 301-619-1507 Date: 04NOV24 Title: Department Head Department/Command: Molecular Diagnostics/ NMRC

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Phone Date mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil

Technical Cognizance