FAR 13.5_SSJ_Certain Commercial Items_Draft Redacted.pdf

SOLE SOURCE JUSTIFICATION: SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS EXCEEDING SAT, INCLUDING BRAND NAME

Pursuant to the requirements under the authority of simplified procedures for commercial items at 41 U.S.C. 1901 as implemented by Federal Acquisition Regulation (FAR) Subpart 13.501 and consistent with the content requirements of FAR 6.303-2.

1. Agency and Contracting Activity.

The Department of Health and Human Services (HHS), Office of the Assistant Secretary for

Preparedness and Response, Biomedical Advanced Research & Development Authority, Division of Contracts Management & Acquisition (DCMA), proposes to enter into a contract on behalf of the Division of Detection, Diagnostics, & Devices Infrastructure (DDDI) on a basis of other than full and open competition.

2. Nature and/or description of the action being approved.

(a) Type of action: Firm-fixed price contract

(b) Amount the current J&A is justifying:

(c) Brief Description: DCMA intends to procure, on a sole source basis, the required clinical and development work to obtain U.S. Food and Drug Administration (FDA) Section

510(k) clearance of Luminex Corporation’s combined ARIES ® Flu A/B/RSV +

Coronavirus (SARS-CoV-2 test using simplified acquisition procedures. FDA 510(k) clearance will allow Luminex to commercially market their combined SARS-CoV-2, influenza A, influenza B, and Respiratory syncytial virus (RSV) diagnostic test that operate on the proprietary ARIES® platform. This action is being taken pursuant to the authority of FAR 13.501. The vendor listed below is the only company that can provide the required services as the ARIES® PCR system is proprietary to Luminex Corporation.

Luminex Corporation

12212 Technology BLVD.

Austin, Texas 78727-6100

3. Description of Supplies/Services. Describe the supplies or services to be acquired.

Provide the estimated total value (including options, if any).

The purpose of this requirement is to fund the necessary clinical evaluations and 510(k) submission so that in the future the ARIES® SARS-CoV-2 Assay combined with the influenza A, influenza B, and RSV assays can be cleared by the FDA to support testing beyond the emergency use authorization period—obtaining a full FDA 510(k) clearance that would allow for long-term sustainment and use of the ARIES® combined Flu A/B/RSV +

SARS-CoV-2 test. These services are required to facilitate DDDI’s key initiative to focus on expanding the US domestic capacity and capability to develop and deploy medical countermeasures to diagnose and detect infectious disease threats.

Period Time Price Total

Base 12 mos.

4. Identification of the authority.

This action is being taken under the authority of Simplified Procedures for Commercial

Items, 41 U.S.C. 1901 as implemented by FAR 13.501.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

On March 11, 2020, the World Health Organization declared the COVID-19 pandemic, and on March 13, 2020, the United States issued a Presidential Proclamation declaring the

COVID-19 pandemic to be a national emergency.

The mission to respond to the community spread of COVID-19 throughout the United States and the mission to repatriate individuals who have been exposed to the virus are both ongoing and growing. The COVID-19 pandemic has evolved at a fast pace, resulting in an urgent and compelling need to rapidly procure supplies and services to support the containment of and recovery from the outbreak throughout the country and world.

On March 21, 2020, HHS issued a “Class Justification for Other Than Full and Open

Competition COVID-19 Response” (“Class Justification”) which authorized HHS, due to unusual and compelling urgency, to enter into sole source awards for “all contract actions to facilitate the recovery efforts necessary to address the 2019 Novel Coronavirus (COVID-

19).”

As a result, contract number 75A50121P00025 was awarded to Luminex Corporation on a sole source basis under the authority of the Class Justification for 12 months, in accordance with the express terms of the Class Justification and applicable regulations. See 48 C.F.R. §

6.302-2(d)(ii).

Contract 75A50121P00025 authorized development of the Luminex ARIES Flu A/B/RSV +

SARS-CoV-2 test, a targeted panel test for molecular detection of 4 respiratory pathogens using a sample – to – answer (hands-off) platform which offers simplicity for users. The final deliverable of this non-severable, firm fixed price contract was FDA 510(k) clearance of the test.

However, development of the ARIES panel test was delayed due to the FDA recommendation for three comparator tests; an increase from two comparators originally contemplated for this award. Therefore, FDA 510(k) clearance could not be obtained prior to the expiration of contract 75A50121P00025. While, in accordance with FAR 6.302-

2(d)(2)(ii), a determination of exceptional circumstances was pursued and granted to extend the contract, the additional time granted under this determination still did not allow Luminex

Corporation enough time to submit their FDA 510(k) clearance package.

As such, it is in the best interest of the Government to award a new contract to Luminex

Corporation to continue the development of the Luminex ARIES Flu A/B/RSV + SARS-

CoV-2 test and obtain FDA 510(k) clearance. 510(k) clearance of this test is critical to the

Agency’s ability to combat the pandemic and allows for the increased ability to detect SARS-

CoV-2 antigens and antibodies in individuals throughout the United States. No other vendor is authorized to develop or pursure 510(k) clearance of the ARIES Flu A/B/RSV + SARS-

CoV-2 test.

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

☒ DCMA intends to make this justification publically available pursuant to FAR 6.305 on

FedBizOpps on MM/DD/YY.

7. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

The contracting officer determines that the anticipated price(s) will be fair and reasonable based on prices paid under previous acquisitions for similar services as well as comparison with the independent government cost estimate.

8. Description of market research.

Market research was conducted by inquiring with the vendor whether or not any other company is authorized to perform development of the ARIES. Luminex Corporation does not authorize any other vendor to develop the ARIES as it is proprietary to Luminex.

9. Any other facts supporting the justification.

Not applicable.

10. A listing of the sources, if any that expressed, in writing, an interest in the acquisition.

A synopsis was issued on FedBizOpps on 7/12/2022 requesting that parties express their interest in writing to the Contracting Officer. No other vendors expressed interest in this requirement.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for supplies or services required.

Once the combined test obtains 510(k) clearance and becomes commercially available to combat the global COVID-19 pandemic, BARDA will no longer require these services from

Luminex Corporation and will eliminate the need for any subsequent limited source acquisition to this vendor.

12. HHS intends to post the requirement pursuant to FAR 13.501(a)(1)(iii) and 6.305(a)

13. Contracting Officer’s Certification.

I certify that the data supporting the recommended use of other than full and open competition is accurate and complete to the best of my knowledge and belief.

Contracting Officer Date

14. Technical/Requirements Personnel Certification.

I certify this requirement meets the Government’s minimum need and that the supporting data, which forms a basis for this justification, is complete and accurate.

Technical Representative/COR Date

15. Approval.

Procuring Activity Advocate for Competition Date