A-03_JA18160_REDACTED.pdf

DEPARTMENT OF THE ARMY

US ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY

820 CHANDLER STREET

FORT DETRICK MD 21702-5014

Control No: JA 18-160

Justification Review Document for Other than Full and Open Competition

Program/Equipment: Limited User Test On Banyan Biomarkers, Inc.’s Brain Trauma Indicator (BTI™) For Traumatic Brain Injury (TBI)

Authority: 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1

Amount: $958,470.52

Prepared by:

Typed Name: Herbert Caj Keen DSN: 343-1011

Title: Contract Specialist Date: 6 August 2018_______

E-Mail: herbert.e.keen.civ@mail.mil___

Contracting Officer:

Typed Name: Samantha L. Connors DSN: 343-6979

E-Mail: samantha.l.connors.civ@mail.mil__ Date Reviewed: __________

Technical Representative:

Typed Name: CPT Sarah Sanjakdar DSN: 343-2973

Title: Assistant Product Manager Date Reviewed: _____________________

Requirements Representative:

Typed Name: LTC Kara Schmid DSN: 343-2670

Title: Project Manager Date Reviewed: _____________________

FOR OFFICIAL USE ONLY

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager/Project Manager/COR:

Typed Name: CPT Sarah Sanjakdar DSN: 343-2973

Signature: Date: ____________________

Legal Counsel:

Typed Name: R. Seth Higgs DSN: 343-2727

Signature: ____________________ Date: ____________________

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), in support of the Neurotrauma and Psychological Health Program Management Office (NPH PMO) of the U.S. Army Medical Materiel Development Activity (USAMMDA).

2. Description of Action: Approval is requested for a new Firm-Fixed-Price contract, on a sole source basis with Banyan Biomarkers, Inc. (Banyan) funded with fiscal year (FY) 18 Defense Health Program (DHP) Research Development Test, and Evaluation (RDT&E) funds.

3. Description of Supplies/Services: The government has a base requirement for 200 Banyan Brain Trauma Indicator (BTI™) assay kits, with an option for an additional quantity of 200 kits. Kits will be shipped to up to three (3) Continental United States (CONUS) installations to be identified by the Government from the following: Fort Bragg, Fort Carson, Fort Hood, Fort Benning, Joint-Base San Antonio, Camp Pendleton, Fort Bliss, Fort Campbell, and Camp Lejeune. Additionally, the government requires on-site BTITM protocol-specific training for use of the BTITM kits on Government-owned Synergy 2 software and hardware systems.

The estimated value of the contract, to include options, is $958,470.52. The estimated Period of Performance (PoP) is 1 September 2018 to 31 August 2019 with one additional 1-year option to supply and train two (2) subsequent installations from the nine (9) listed above, simultaneously, in the same manner described for the base period.

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1). The FAR citation is 6.302-1, titled ‘Only one responsible source and no other supplies or services will satisfy agency requirements.’

5. Reason for Authority Cited: On 14 February 2018, the U.S. Food and Drug Administration (FDA) granted Banyan’s De Novo request for the commercialization of Banyan BTI™, an in vitro diagnostic blood test to aid in the evaluation of patients with suspected traumatic brain injury (TBI). Banyan is the proprietary owner of the BTI™ kits and there are no authorized resellers or distributors.

In accordance with the FDA approval, the BTI™ kits can only be analyzed on a Biotek Synergy 2 plate reader system. The Banyan assay kits are the only FDA approved assays compatible with the Synergy 2 system.

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted to FedBizOpps on 31 May 2018 in accordance with DFARS PGI 206.302-1(d). Responses were due on 15 June 2018. Banyan submitted the only response. The Program Office found Banyan’s capability statement acceptable. No additional effort will be made to solicit offers as there is only one source capable of completing this requirement using the proprietary BTI™ kits.

a. Effective competition. No effective competition is anticipated for this acquisition.

b. Subcontracting competitition. Not applicable. No subcontracting opportunities are anticipated for this acquisition.

7. Actions to Increase Competition: Banyan is the patent-owner of the BTI™ kits.

Acquisition of these supplies can only be sourced through Banyan. As a result, there is no sourcing competition for this acquisition. USAMMDA conducts online research as part of its periodic market research efforts to locate other available sources that are capable of meeting these types of requirements in the future. Additionally, the Government may post an updated RFI for any future procurement to determine if there are sources available in the market place that can meet the Government’s need. If the RFI shows there are competitors in the market place, future acquisitions will be competed to the maximum extent practicable.

8. Market Research: USAMMDA performs regular market surveillance in this field. No other sources for the required supplies and services have been identified. Banyan’s BTI™ kit is the only commercialized, FDA-approved blood test for the detection of TBI. The Banyan BTI™ kits are the only supplies compatible with the government-owned hardware. Information was retrieved from the FDA database at the following location on 17 April 2018:

https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170045.pdf

As described in Paragraph 6, all information received in response to the RFI required by DFARS PGI 206.302-1 has been considered.

9. Interested Sources: A Notice of Intent to Sole Source synopsis was posted in accordance with FAR 5.201 on 18 June 2018. Responses were due on 3 August 2018, and no responses were received. To date, no other sources have written to express an interest in the requirement.

10. Other Facts:

a. Procurement history. The development of Banyan BTITM was supported by the U.S. Army Medical Research and Materiel Command under Contract No. W81XWH-10-C-0251. However, this contract only supported the development of the Banyan BTI™, not the acquisition of supplies and support services.

(i) Contract numbers and dates of the last several contracts for these same requirements. Not applicable.

(ii) Competitive status of these actions. Not applicable.

(iii) Authority previously cited if less than full and open competition was used. Not applicable.

(iv) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. Not applicable.

(v) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. Not applicable.

(vi) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not applicable.

(vii) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. Not applicable.

b. Other facts. None.

11. Technical Certification:

I certify 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.

Typed Name: _ CPT Sarah Sanjakdar ________ Date: ____________________________

Title: Assistant Product Manager ________ Signature: ________________________

12. Requirements Certification:

I certify 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.

Typed Name: __LTC Kara Schmid_______ Date: ____________________________

Title: Project Manager __________ Signature: ________________________

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable.

Basis for determination: The price reasonableness determination will be based on a comparison with the Independent Government Cost Estimate in accordance with FAR 15.404- 1(b)(2)(v) and analysis of data other than certified cost or pricing data provided by Banyan in accordance with FAR 15.404-1(b)(2)(vii). Certified cost or pricing data will not be required, as the estimated award value is below the $2 million threshold set forth in DoD Class Deviation 2018-O0015.

Typed Name: Samantha L. Connors_________ Date: __________________________

Title: Contracting Officer______________ Signature: ________________________

14. Contracting Officer Certification:

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

Typed Name: Samantha L. Connors _______ Date: __________________________

Title: Contracting Officer________________ Signature: ________________________

15. Legal Sufficiency Review:

Based on the information provided in this document, I hereby determine this justification for other than full and open competition to be legally sufficient.

Typed Name: R. Seth Higgs ___ Date: ___________________________

Title: Acquisition Attorney Signature: _______________________

Approval Special Advocate for Competition

Based on the foregoing justification, I hereby approve procurement of Banyan BTI™ (Brain Trauma Indicator) assay kits and BTI™ protocol-specific training on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1) FAR 6.302-1--Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: __________________________ Signature: ________________________