PAR240033_NMRC J and A_1.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 Unit SOUTH (NAMRU SOUTH), in Lima Peru, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements.

2. Nature and/or description of the action.

The proposed action is for a Firm Fixed Price single contract to Fundacao de Desenvolvimento da Pesquisa, Av. Antonio 6627 Unidad ADM II Belo Horizonte MG 31270, Brazil. To support the project “Tropical parasitic disease surveillance in endemic regions of Brazil”.

3. Description of Supplies or Services:

A key mission of the Department of Parasitology of NAMRU SOUTH is the execution of surveillance activities in the Americas. Brazil is the biggest country in South America and is strategic for SOUTHCOM. Establishing the surveillance capacity in Brazil requires the services of an on/site institution that provide samples and conduct laboratory experiments.

The services provided are related to project management, provision of clinical samples, execution of in-vitro assays, shipment of samples and reporting. The contractor shall obtain all ethical and regulatory permits for collecting specimens in Brazil and shipping them to NAMRU SOUTH. The contractor should collect a minimum of 250 specimens from endemic sites in Brazil and perform laboratory molecular testing using PCR and other methods in response to NAMRU SOUTH requirements. In addition, the contractor shall provide demographic, clinical and laboratory test results in a de-identified manner to NAMRU SOUTH. The contractor shall perform local shipments of samples between study sites and from Brazil to NAMRU SOUTH headquarters in Lima, Peru.

The contract will have one delivery period within a 12-month time frame with optional extension period for two additional years.

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.

Market research, based on NAMRU SOUTH scientific staff, prior procurements, e-mail and telephone conferences between January and March 2024 to validate interest, capabilities and availability of resources to provide the research services needed for surveillance in Brazil. We found only one institution capable of performing this activity which is FUNDEP. FUNDEP has demonstrated that they have the capability for executing this project due to their demonstrated management capacity of research projects across Brazil in an efficient manner and prior execution of similar projects during previous fiscal years. In addition, FUNDEP is familiar with the Brazilian regulatory policies for execution of research activities been a reference institution for execution of research projects in Brazil.

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

Market research was conducted to ascertain if multiple sources existed in the marketplace that could meet the Government’s requirement. Market research conducted using Internet searches, and prior procurement history produced no other sources that could meet the Government’s requirements except for FUNDEP.

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 in January - March 2024 timeframe. This research consisted of reviews of previous procurements for this type of service and a market survey through search engines such as Google. Consequently, the Government’s technical experts determined that FUNDEP is the only source that can meet the Government’s requirements.

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

FUNDEP has been conducting malaria and leishmaniasis surveillance activities under a prior contract with NAMRU SOUTH and demonstrated capacities for providing this service on contracts as detailed

N3239819P0413 - PAR190416

N3239822P0414 - PAR227020.

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, Parasitology 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, (NMRC) will assess whether competition for future requirements is feasible.

The Government (or Program Office) expects to obtain a technical data package that will support competition for future acquisitions of the same or similar items.

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.

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

Name: CDR Kimberly Edgel Phone: 511-6144141 Date:

Title: Acting Department/Command: Parasitology/NAMRU SOUTH

Requirements Cognizance

Name Phone Date Title Department/Command

CONTRACTING OFFICER CERTIFICATION

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

Deborah M. Sharpe Phone Date Contracting Officer

Edilberto P. Calma Phone Date Contracting Officer timothy.daniels Cross-Out timothy.daniels Cross-Out

Technical Cognizance