Tab_A16_J A_Fed_Biz_Opps.docx

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity:

The Justification and Approval (J&A) is executed by the Naval Medical Logistics Command (NMLC), 693 Neiman Street, Fort Detrick MD 21702 on behalf of the requesting agency: Naval Medical Research Unit-6 (NAMRU-6), Lima, Peru.

2. Description of the Action Being approved:

The proposed action is to provide for the delivery of 57 FilmArray Respiratory Panel IVD, 30-Pouch Kits. The Government intends on awarding a Firm Fixed Price contract to Bio Fire Defense LLC, 79 West 4500 South Suite 14, Salt Lake City, Utah 84107.

3. Description of the supplies or services required to meet the agency's needs:

This requirement is for 57 FilmArray Respiratory Panel IVD, 30-Pouch Kits that are compatible with the FilmArray PCR system. Each kit should contain individually packaged FilmArray Respiratory Panel pouches, Single use (0.5 mL) sample buffer vials, single use (1.5mL) hydration solution vials, individually packaged transfer pipettes, individually packaged sample loading syringes with attached cannula and individually packaged pouch hydration syringes with attached cannula. The following organism types and subtypes should be identified using the FilmArray RP: Adenovirus, Bocavirus, Coronavirus 229, Coronavirus HKUl, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype HI, Influenza A subtype H3, Influenza A subtype 2009 HI, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus and Respiratory Syncytial Virus. FilmArray Respiratory Panel IVD is a multiplexed nucleic acid test intended for use with the FilmArray instrument for the simultaneous qualitative detection and identification of multiple respiratory viral (17 viruses) and bacterial nucleic acids (3 bacteria) in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections.

The contract is anticipated to have multiple delivery dates over a 12-month period. The type of funds being utilized for this requirement is FY 2015 Navy Research, Development, Test and Evaluation (RDT&E).

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

10 U.S.C. 2304 (c)(1) (as implemented by FAR 6.302-1); Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Rationale Justifying Use of Cited Statutory Authority:

BioFire Defense is the only manufacturer and vendor that can provide the 57 FilmArray Respiratory Panel IVD, 30-Pouch Kits that are compatible with the FilmArray PCR system. BioFire Defense has developed the FDA-cleared multiplex PCR system that integrates all molecular steps to include sample preparation, amplification and detection and analysis. BioFire Defense currently holds more than 85 patents related to the PCR system which is directly related to work that will be performed by this requirement.

Each of these FilmArray Respiratory Panel IVD, 30-Pouch Kits should contain individually packaged FilmArray Respiratory Panel pouches, Single use (0.5 mL) sample buffer vials, single use (1.5mL) hydration solution vials, individually packaged transfer pipettes, individually packaged sample loading syringes with attached cannula and individually packaged pouch hydration syringes with attached cannula. BioFire Defense is the only contractor capable of delivering the items with the specifications listed above.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable:

A sources sought notice was synopsized on the Federal Business Opportunities (FBO) website on 31 August 2015 and only BioFire Defense expressed an interest in this requirement. No additional market research was conducted because it is not practicable for the reasons discussed in paragraph 5 above, for any company other than BioFire Defense to perform the required work. Additionally, a notice of intent to award was synopsized on the FBO website on 06 September 2015 and no companies submitted a capability statement for this requirement.

7. Determination of Fair and Reasonable Cost:

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by the J&A to be fair and reasonable by conducting an appropriate price analysis.

8. Actions to Remove Barriers to Future Competition:

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the type of supplies/services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible. If future requirements exist that do not involve the same research efforts, the Government will solicit through full and open competition to remove barriers.