USUHS_JA_MAGI_Final_Redacted.pdf

UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES

ACQUISITIONS DIRECTORATE

4301 JONES BRIDGE ROAD

BETHESDA, MARYLAND 20814-4799

www.usuhs.edu

Learning to Care for Those in Harm’s Way

Date: 19 August 2025

SUBJECT: Justification and Approval for Other than Full and Open Competition: “Meningococcal Immunization Against Gonococcal Infection (MAGI) Trial/ RV564”

REFERENCES: FAR Part 6.3

1. Identification of the agency and contracting activity:

The Contracting Activity responsible for this action is the Uniformed Services University (USU), 4301 Jones Bridge Road, Bethesda MD, 20814.

2. Nature and/or description of the action being approved:

This activity proposes to negotiate a non-competitive (sole source) Cost-plus Fixed Fee (CPFF) award Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) for collaborative studies that include a broad array of designs from double- blind, placebo-controlled randomized controlled trials of investigational products to observational cohort studies to understand the pathogenesis, clinical course, and outcomes of infectious diseases spanning multiple research areas, located both CONUS and OCONUS.

3. Description of the supplies or services required to meet the agency’s needs (including estimated value):

The contract shall provide execution of a phase II randomized, placebo-controlled study, to assess efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero©, GSK) in preventing gonococcal infection. This study supports the mission of the IDCRP by aiming to reduce the impact of infectious diseases in the military population through collaborative clinical research. The U.S. is currently experiencing a resurgence of sexually transmitted infections (STI) with pathogens such as gonorrhea playing a significant role.

The anticipated Period of Performance: 30 September 2025 – 29 September 2027. Anticipated Total Value: approximately $1,233,000.

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

10 U.S.C. 2304(a)(5) as implemented in Federal Acquisition Regulation (FAR) 6.302-5(a)(2)(i), contracting for these services without providing for full and open competition is authorized by statute.

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

10 U.S.C. 178 (enacted under PL 98-36) established the “Foundation for the Advancement of Military Medicine”, later renamed the “Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) and, under section (g)(1), authorized it to “enter into contracts with the Uniformed Services University of the Health Sciences for the purpose of carrying out cooperative enterprises in medical research, medical consultation, and medical education, including contracts for provision of such personnel and services as may be necessary to carry out such cooperative enterprises.” This authority is being exercised because the required simultaneous execution of multiple observational and epidemiological protocols for USU is solely available from the source that held the previous award with USU. The Henry M. Jackson Foundation is the only source that can provide the required services and award to any other source would result in unacceptable delays.

6. Description of efforts made that were to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by FAR 5.2 and, IF NOT, which exception under FAR 5.202 applies:

Not applicable, in accordance with FAR 5.202(a)(10), the proposed contract action is made under conditions described in 6.302-5. As noted above, USUHS has statutory authorization to contract on a sole-source basis with HJF, which is also the only source capable of continuing these on-going studies.

7. A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable:

The CO will determine that costs proposed are fair and reasonable using Cost Analysis techniques in accordance with FAR 15.404-1(c). Certified cost or pricing data will be required due to this being a non-competitive, non-commercial act exceeding the threshold for obtaining certified cost and pricing data established in FAR 15.403-4(a)(1).

8. Description of market research conducted and the results, or a statement of the reason market research was not conducted:

Prior to the award of contract no. W81XWH-22-C-0154 in September 2022, USU and USAMRAA conducted extensive market research to identify potential sources that could meet the Government’s requirement by querying online search engines, attendance of scientific conferences, examination of historical contracts, and discussions with key collaborators and trusted Government and academic contacts.

This market research indicated that various sources exist in the marketplace that could execute multiple research protocols, however this is only relevant if the Government were soliciting to execute these protocols from the beginning. The subject requirement is not for the execution of protocols at the starting stage but rather for the execution of ongoing and interrelated observational and epidemiological protocols. Therefore, award of the subject requirement to any source except for the Henry M. Jackson Foundation would result in unacceptable delays to the Government.

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

All of the pre-existing study sites, populations, existing enrolled subjects, and existing collected research data and specimens interrelated observational and epidemiological protocols were previously supported on a sole-source basis with the Henry M. Jackson Foundation under Contract No.: W81XWH-22-C-0154 (expires 29 Sep 2025) and Cooperative Agreement No.:

HU00012020083.

10. Listing of the sources, if any, that expressed, in writing, an interest in the acquisition: No other sources have expressed interest in the acquisition, nor is there need to solicit or identify more (see item 6. above).

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

Certifications

Technical/Requirements Personnel:

Sarah A. Jenkins, PhD

LCDR, MSC, USN

Deputy Director, Infectious Disease Clinical Research Program (IDCRP)

As evidenced by the signature below, the technical/requirements personnel have certified that any supporting data contained herein which is their responsibility is both accurate and complete.

Sarah A. Jenkins, PhD Deputy Director, IDCRP

Contracting Officer: Alycia K. Armbruster

I hereby certify that the justification is accurate and complete to the best of my knowledge and belief, and I have determined that the anticipated cost to the Government will be fair and reasonable

Alycia K. Armbruster Contracting Officer

Competition Advocate: Victoria Cunningham, Director, Procurement and Assistance Policy & Small Business.

Victoria A. Cunningham Director, Procurement and Assistance Poli...