PR 1301151187 JA_redacted.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 SuperScript III (SSIII) 1-Step QRT-PCR kits and custom probes. All of these are manufactured by Life Technologies Corporation. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Life Technologies Corporation

XXXXXXX. Grand Island, NY 14072.

3. Description of Supplies or Services:

The Molecular Department of the Biological Defense Research Directorate, Naval Medical

Research Center produces over 50 different molecular testing kits for biological defense applications. These test kits 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 testing kits included extensive testing of various reagent components to produce the best combination. The development and optimization of these assays have been ongoing for over 20 years. Essential component SSIII 1-Step QRT-PCR Kits and

Custom probes are required for these test kits.

RDT&E funds in the amount of $XX,XXX.XX 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 SSIII 1-Step QRT-PCR Kits and custom probes produced by Life Technologies are a component of reagents being produced by NMRC/BDRD 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.

Additionally, these reagents are currently deployed globally for operational use. The development process included extensive testing of various reagent components to produce the best combination.

The SSIII 1-Step QRT-PCR kits and custom probes produced by Life Technologies are some of those components. Switching to another vendor would invalidate all previous optimization and evaluation efforts. Reagents produced with these components from another vendor without extensive re-optimization and evaluation would result in reduced and scientifically questionable 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.

These specific reagent components must be produced by Life Technologies. This purchase requirement will be posted to NECO and/or FedBizOpps in accordance with FAR 5.202.

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 Life Technologies/Invitrogen 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 components is Life Technologies/Invitrogen.

Previous purchases include the following:

N32398-15-P-0243 $114,117.50

N32398-15-P-0258 $147,305.34

N32398-16-P-0227 $6,180.00

N32398-16-P-0246 $149,917.50

N32398-17-P-0227 $149,987.50

N32398-18-P-0216 $149,976.50

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.

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.

For the reasons set forth in Paragraph 5, NMRC has no plans at this time to compete future contacts for the reagent components covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements is 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

LIZEWSKI.STEPHEN.EU

GENE.1272396309

Digitally signed by

LIZEWSKI.STEPHEN.EUGENE.1272396309

Date: 2024.02.21 15:41:32 -05'00' 301-619-1507 21FEB2024

Name

Title

LCDR Stephen Lizewski Phone Date

Department/Command

Requirements Cognizance

Name Phone Date

Title

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

Contracting Officer

CONTRACTING OFFICER CERTIFICATION

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

4/18/2024

Phone Date