Sole Source Justification Redacted.pdf

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 02 Effective Date: 11/15/23 Acquisition ID#: 36C249-23-AP-3307

Request for Sole Source Justification >SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C249-23-AP-3307

1. Contracting Activity:

VA Tennessee Valley Healthcare System Medical Center - Nashville Campus 1310 24th Avenue South Nashville, TN 37212-2637 Station 626 2237 No:

2. Nature and/or Description of the Action Being Processed:

This is a new Firm-Fixed-Price Award contract for research and development focused in the tuberculosis field.

3. Description of Supplies/Services Required to Meet the Agency�s Needs:

The purpose of this requirement is to identify and characterize vaccine candidates against tuberculosis. Vaccine candidates are antigens, which are substances made by pathogens to which the immune system reacts. Tuberculosis is a chronic, devastating disease caused by an infection with Mycobacterium tuberculosis (Mtb). Veterans are exposed to Mtb when they are on tour of duty where tuberculosis is highly prevalent.

The requested project contains three parts indicated as scopes: Antigen Discovery, Protective Antigen Discovery, and Nanoparticle Vaccine Validation. Rutgers University Medical School is the only Vendor with the required facilities and personnel to fulfill this requirement.

Base, February 15, 2024 to February 14, 2025 Option 1, February 15, 2025 to February 14, 2026 Option 2, February 15, 2026 to February 14, 2027 Option 3, February 15, 2027 to February 14, 2028

Estimated Total:

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

Request for Sole Source Justification >SAT

VHAPG Part 806.3 OFOC Page 2 of 4 Revision: 02 Effective Date: 11/15/23 Acquisition ID#: 36C249-23-AP-3307

5. Demonstration that the Contractor�s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Mtb is a highly virulent human pathogen. Work with Mtb requires a specialized, biological containment facility referred to as BioSafety Level 3 (BSL3). It also requires a specialized BSL3 facility for animals referred to as ABSL3. Work in a BSL3 & ABSL3 facility additionally require trained personnel.

The VAMC at TVHS Nashville Campus and Vanderbilt University Medical Center (VUMC) do not have an ABSL3 facility nor the trained personnel. The requirements must be outsourced to a university that has BSL3 & ABSL3 facilities and trained personnel to conduct experiments in these specialized facilities.

The only Vendor currently capable of fulfilling this requirement is Rutgers University Medical School.

Rutgers University Medical School 33 Knightsbridge Road, 2nd Floor, East Wing Piscataway, NJ 08854-3925

UEI: YVVTQD8CJC79

Accordingly, Rutgers University Medical School is the only firm capable of providing the supplies and services described in Section III above without the Veteran�s Health Administration experiencing unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

, and Rutgers University Medical School were each contacted about this requirement. All four research facilities have access to BSL3 & ABSL3 facilities.

Rutgers University Medical School expressed interest and stated they were able to take on the requirement. Additionally, Rutgers is uniquely qualified as their TB research will provide direct support to this requirement. The University provided preliminary experiment results for submission with the VA Merit application. The outcomes of the preliminary experiments assured the Government of the feasibility of the work.

Rutgers University Medical School is the only vendor that can fulfill this requirement.

Other Vendors were contacted for market research:

was interested in the line of research, however, after further discussions their project did not align with the program office�s specifications.

relayed they were incapable of completing this requirement as adequate personnel did not exist to undertake the project.

became non-responsive to requests for information and communications ended.

VHAPG Part 806.3 OFOC Page 3 of 4 Revision: 02 Effective Date: 11/15/23 Acquisition ID#: 36C249-23-AP-3307

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

This requirement is utilizing 38 U.S.C. 8153. However, in preliminary market research

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

This procurement will be sole sourced using 38 U.S.C 8153, VAAR 873.108 (b) and VA Directive 1663. Proposed sole source contractor is an institution affiliated with the VA.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Oral conversations were held, but when more formal inquiries took place in writing the discussions stalled.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

No follow-on contract is anticipated.

VHAPG Part 806.3 OFOC Page 4 of 4 Revision: 02 Effective Date: 11/15/23 Acquisition ID#: 36C249-23-AP-3307

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

NCO 09

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Branch Chief, Healthcare Team

NCO 09