A03-JA17196_REDACTED_Malaria_Vaccine_(Bridge_for_SMMRS_TO_126)_cnb_v2_lapt.pdf

For Official Use Only

Control No: JA17196

Justification and Approval for Other Than Full and Open Competition

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Description of Action: Approval is requested for a 2-month extension of the current task order, W81XWH-11-D-0021-0126, under FAR clause 52.217-8. The estimated total cost of the extension is $405,807.38. Purchase request number 11044744 is submitted to incrementally fund the requirement with RDT&E funds in the amount of $386,000.00.

3. Description of Services: The mission of the Walter Reed Walter Reed Army Institute of Research (WRAIR) is to conduct biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers lifes aving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the war fighter.

This requirement is to perform and support malaria vaccine research and development.

The work requires an expert understanding of molecular biology, protein biochemistry, biotechnology, parasitology, virology and immunology. The work to be performed includes vaccine development and regulatory services, antigen discovery research, research logistics services, parasitology research, molecular biology research, clinical services, Malaria serology laboratory research, immunological testing of animal and human samples, in vitro and in vivo research to generate malaria vaccine antigens in pre-clinical and clinical vaccine trials, preclinical vaccine evaluation, testing and evaluation of immunogenicity and efficacy of malaria vaccine candidates, supporting CHMI clinical trials, and providing support and technical expertise to MVB’s core capabilities.

4. Authority Cited: Pursuant to FAR 6.302-1 and 10 USC 2304 (C)(1): When the supplies or services required by the agency are available from only one responsible source, or, for DoD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

5. Reason for Authority Cited: The 2-month extension is required to complete the on-going competition and source selection without creating a break in service.

The current contractor, Clinical Research Management, has the necessary personnel in place with the unique knowledge of regulatory requirements, procedures, and protocols and skills to conduct medical research in a Department of Defense environment.

Attempting to have another vendor perform this short, 2-month period will create an unnecessary duplication of cost. The amount of time it would take a new vendor to ramp up to perform would exceed the 2-month extension.

A break in service will be extremely detrimental to the WRAIR research mission, MVB’s research in its several laboratories, and on-going protocols and clinical trials such as the high visibility translational work on the ongoing WRAIR - GSK RTS,S/AS01B vaccine clinical trial (MAL092) funded by PATH MVI, and the development of second generation malaria vaccine candidates to improve efficacy (MSP1, AMA1, CelTOS, CSP). A break in service would have significant negative impact on MVB’s abilities to meet contractual obligations, proposal objectives and milestones, and continue its partnership with USAID.

Currently, there are insufficient numbers of civilians or military personnel to maintain these services in the case of a break in contract services. There is a contract already in place for similar services, providing REDACTED full time equivalents. Since there is a contract already in place for similar services, awarding this extension to another vendor places an unnecessary burden on the Government and jeopardizes the on-going research protocols.

6. Efforts to Obtain Competition: A Request for Information (RFI) was conducted 20 January 2017 on GSA’s OASIS vehicle where several potential offerors submitted their capabilities statements for assessment.

7. Actions to Increase Competition: The full requirement is currently being competed and is currently in negotiations with the offerors. The Government has full confidence that this competition and award will complete within the 2-month extension.

8. Market Research: Market research was completed on the full requirement identifying several potential offerors and contract vehicle.

9. Interested Sources: Under the OASIS contract vehicle the following potential offerors submitted capabilities statements assessed as capable of performing:

• REDACTED

10. Other Facts:

• The original solicitation for the current IDIQ contract was competed full and open in 2010.

• The current task order is a cost plus fixed fee. FAR Clause 52.217-8 holds the contractor to the current rates. A bilateral modification shall be initiated.

11. Technical Certification: I justify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

REDACTED

12. Requirements Certification: I certify that the following data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. Prices will based based upon current pricing and current provisional rates. This modification does not meet the threshold for certified cost and pricing data submission.

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.