Justification and Approval UMD_Signed.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 Navy Expeditionary Medical Research requirements.

2. Nature and/or description of the action.

The proposed action is to assess the effects of military-relevant exposure to blast on visual physiology and testing a therapeutic drug for the mitigation of blast-induced visual deficits. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Dr. Mary Johnson at the University of Maryland (UMD) located at 419 W. Redwood Street, Baltimore, MD 21201.

3. Description of Supplies or Services:

The Neurotrauma Department at NMRC has a critical need to use Dr. Mary Johnson’s (University of Maryland) services to assess vision loss in subjects exposed to military-relevant explosive blasts as part of a pre-clinical study. This project will (1) assess the effects of exposure to blast on visual physiology and function and tissue levels of various biomarkers and (2) assess a therapeutic for the mitigation of blast-induced visual deficits. Dr. Johnson invented a protocol that allows for measuring vision loss caused by horizontal cells in the retina. No other researcher or company can perform this work.

Navy Operation and Maintenance Fiscal Year 2023 interservice restoral funds in the amount of $87,104 will be used to procure services from Dr. Johnson at UMD. These funds will also allow for purchase of supplies and travel as needed for her portion of our study.

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),FAR 6.302-1 sole source (including brand name) acquisitions OR FAR 13.106-1(b)(1) soliciting from a single source, and FAR 6.302-2.

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

Dr. Mary Johnson at the University of Maryland (UMD) is a subject matter expert in the effects of traumatic injury, including injury resulting from exposure to explosive blasts, on the visual system in human subjects and animal models. Dr. Johnson owns novel resources, capabilities, and technical expertise to transition the results of Naval research and development for public use.

Fiscal year 2023 restoral funding was procured to assess strategies to prevent vision loss resulting from blast-related traumatic brain injury using techniques invented by Dr. Johnson to assess visual loss. No other researcher or company on the market performs these assessments.

Completion of the study will not be possible if the contract is not awarded to Dr. Johnson at the University of Maryland leading to loss of the awarded funds.

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.

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.

(Once this determination is made, paragraph 7 need only contain the above statement. No additional information is required.)

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 in the May 2023 timeframe. This research consisted of a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Yahoo, MSN, and GSA Advantage using the following search words: retina horizontal cell electroretinogram measurements. Dr. Johnson at UMD is the only researcher who developed the protocol and can perform the work. Consequently, the Government’s technical experts determined that UMD is the only source that can meet the Government’s requirements. The results of the market research are attached. There are no other researchers, vendors or companies who can perform retinal horizontal cell electroretinograms.

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

The requirement for conducting assessments of vision loss caused by exposure to explosive blasts depends on a method invented by Dr. Johnson to assess the physiological activity of horizontal cells in the retina. No other researcher has expertise to apply this protocol or provide this service to NMRC. Restoral funding in the amount of $87,104 will be used towards a contract with UMD. The total amount of the restoral award procured to perform the study is $452,874.

Failure to award this contract will prohibit performing the work for this project.

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.

For the reasons set forth in Paragraph 5, The Neurotrauma Department 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, The Neurotrauma Department at 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 Deborah M. Sharpe, who may be reached at (301) 319- 6471 or Edilberto Calma 301-319-6481.

University of Maryland SAM.gov # is their UEI #: Z9CRZKD42ZT1 and it is good until 4/17/24.

Stacey Boyd is the POC. Her contact info is: sboyd001@umaryland.edu 410-706-0639

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

301-319-7480 05/18/2023 Stephen T. Ahlers, PhD Phone Date Director mailto:sboyd001@umaryland.edu

Operational and Undersea Medicine Directorate Acting Department Head The Neurotrauma Department

Requirements Cognizance

301-319-7480 05/18/2023 Stephen T. Ahlers, PhD Phone Date Director Operational and Undersea Medicine Directorate Acting Department Head The Neurotrauma Department

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Phone Date

Technical Cognizance