Justification and Approval.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 Center (NMRC), Silver Spring, MD, on behalf of the Navy to meet Naval Medical Research and Development mission.

The Wound Infections Department (WID), within the Infectious Diseases Directorate (IDD), is located at NMRC in Building 503. The WID lab is located in 3W20.

2. Nature and/or description of the action.

The proposed action is for a contract that (1) identifies an anti-Staphylococcus aureus, bacteriophage encoded lysin with no activity for Staphylococcus epidermidis and (2) determines the optimal pH and salt conditions for maximal enzymatic activity of the identified lysin. The Government intends on awarding a one year contract to the proposed source. The proposed source is Dr. Vincent Fischetti and his laboratory at Rockefeller University. Specifically, Dr.

Fischetti’s laboratory will execute studies to screen his library of anti-S. aureus bacteriophage for specific activity against S. aureus and without activity against S. epidermidis. The lysin from bacteriophage will be purified and characterized for subsequent studies at NMRC.

3. Description of Supplies or Services:

The Naval Medical Research Center (NMRC) Wound Infections Department was awarded a Military Infectious Disease Research Program (MIDRP) project based on a proposal submitted for Fiscal Years 2020-2021. Fiscal Year 2020 funds in the amount of $86,270 will be used to support the research.

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.

Dr. Vincent Fischetti and his laboratory are leaders in the field of lysins and their application as therapeutics. Dr. Fischetti was a co-author of the proposal “Evaluation of Natural and Chimeric Phage Lysins against Staphylococcus aureus” submitted and funded by MIDRP for FY20-21. Dr.

Fischetti is uniquely capable of conducting the proposed work based on his lab’s experience with lysin discovery, purification, and applicability in animal models. Dr. Fischetti has been studying lysins for almost 50 years and his laboratory was the first lab to report the use of a phage derived lysin as a therapeutic. Additionally, Dr. Fischetti’s group has been able to successfully use lysins from gram positive and gram negative bacteria for therapeutic purposes. Dr. Fischetti and his years of experience will be required to complete the milestones set forth in the MIDRP contract.

His contribution to the study will primarily be required during the first year of the study but consultation with him might be required to overcome any unforeseen events that might occur during the study. Dr. Fischetti’s lab is fully prepared to execute the work immediately upon an awarded contract.

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

Due to the nature of this being a research project, a literature search on NCBI PubMed was conducted for comparable studies and lab capabilities. While this is a rapidly growing field with publications by multiple groups, Dr. Fischetti is the leader in the field of lysins as therapeutics.

His group was the first to show that lysins could be used as therapeutics, the first group to show that lysins were effective at clearing systemic infections, and the first group to develop a rapid high-throughput method to identify lysins from uncultured bacteriophage. The knowledge and expertise that Dr. Fischetti holds will be required to execute the aims of this research project, to troubleshoot issues during the study, and analyze/interpret data derived from our animal models.

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.

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 conducted by technical experts during the initial conception of this research project and again in April 2020. The research consisted of reviews of potential collaborators/scientists conducting research on lysins and their use as therapeutics. From the market research, it is evident that Dr. Fischetti has been at the forefront of this field and the prime candidate for this contract. Dr. Fischetti’s lab at Rockefeller University is the only source that can meet the government’s requirements as proposed in the research plan and within the timeframe of the period of performance.

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

If other suitable vendor(s) became available, a full and open competition may be considered.

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, NMRC has no plans at this time to compete future contracts for the types of supplies/services 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 Center, Silver Spring, MD, regarding the contents of the sole source justification is Diane M. Fox, who may be reached at (301) 319- 6481.

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

301-319-7428

08 May 2020 Name: CDR Mark Simons Phone Date Title: Department Head Department/Command: Wound Infections Department, Naval Medical Research Center

Requirements Cognizance

301-319-7428 Name: CDR Mark Simons Phone Date Title: Department Head Department/Command: Wound Infections Department, Naval Medical Research Center

CONTRACTING OFFICER CERTIFICATION

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

Diane M. Fox Phone Date Contracting Officer