Justification and Approval - Other Than FAO.pdf

Pursuant to the requirements of the Competition in Contracting Act (CICA) as implemented by the

Federal Acquisition Regulation (FAR) in accordance with the requirements of FAR 6.303-1. The justification for the use of the statutory authority under FAR Subpart 6.3 is based on the following facts and rationale required under FAR 6.303-2 as follows:

1. Agency and Contracting Activity.

The Department of Health and Human Services, 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 on a basis of other than full and open competition.

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

(a) Type of action: Cost Reimbursement contract with firm fixed price option CLIN for test kits.

(b) Amount of the current J&A: $10,893,317.90

(c) Brief Description: DCMA intends to procure, on a sole source basis, services to improved the OraQuick® Ebola Rapid Antigent Test. The OraQuick® Ebola Rapid

Antigen Test is the only FDA cleared test for Ebola infection from cadavers. However, the test has low sensitivity, short shelf life, a reliance on limited supply critical reagents and is manufactured on a manual line. This procurement will support improvements to the test to increase test sensitivity and shelf life, development of sustainable and key test reagents by OraSure to eliminate reliance on limited supply reagents and speed up test production in response to an outbreak, provide support for moving the test production to an automated manufacturing line to improve test quality, and will be used to purchase two lots of approximately 10,000 tests each.

OraSure Technologies, Inc.

220 East First Street

Bethlehem, Pennsylvania

18015-1360, United States

3. Description of Supplies/Services.

This requirement is to improve the OraQuick® Ebola Rapid Antigent Test. The OraQuick®

Ebola Rapid Antigen Test 510(k) was cleared by FDA in October 2019. As of June 2022, there is limited supply of critical reagents (both control and diagnostic antibodies) used in the

Ebola 510(k) cleared device. The Government seeks to make the Ebola 510(k) cleared device independent of the aforementioned critical reagents, improve manufacturing capabilities, sensitivity and shelf in order to better respond to public health emergencies.

Therefore, the project scope will be expanded beyond preliminary device performance testing, with a goal to improve the quality of the test performance and stability. New FDA

Emergency Use Authorization (EUA) and 510(k) clearance will be required. Further, the scope will include transitioning test manufacturing to an automated line, thus improving test quality and shortening test manufacturing time. This procurement will deliver two, approximate 10,000 unit lots, of the improved OraQuick® Ebola Rapid Antigen Test 510(k) or EUA.

These services are required to facilitate rapid response to future Ebola public health emergencies. Currently, the limited supply of critical reagents and manufacturing challenges have hindered the ability to respond to ongoing Ebola public health emergencies.

4. Identification of statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is 41 U.S.C. §3304 as implemented by:

☒ FAR Subsection 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements.

☐ 6.302-2: Unusual and compelling urgency.

☐ 6.302-3: Industrial mobilization; engineering, development, or research capability; or expert services.

☐ 6.302-4: International agreement.

☐ 6.302-5: Authorized or required by statute.

☐ 6.302-6: National security.

☐ 6.302-7: Public interest.

5. Demonstration that the nature of the acquisition requires use of the authority cited.

On April 23, 2022, the Ministry of Health in the Democratic Republic of the Congo declared an outbreak of Ebola virus disease in Mbandaka health zone, Equateur Province. This is the

14th EVD outbreak in DRC and marks the third in a series of outbreaks in Equateur province since 2018.

OraSure Technologies is uniquely qualified because their product is the only test that meets all of the following salient characteristics:

• For point of care use

• Handheld

• Lateral flow, rapid antigen test for Ebola virus

• Either emergency use authorized or Section 510(k) cleared by the U.S. Food and

Drug Administration (FDA)

• Sample oral fluid from cadavers

• For use on individuals or suspected to have recently died from the Ebola virus disease

Alternative tests will not work because the Government will be unable to assess infection with the Ebola Virus in individuals and cadavers.

Because there are currently no other FDA cleared tests for use in cadavers, it would take significantly longer for another company to obtain FDA clearance on a new test than it would to improve OraSure’s already cleared test and obtain new FDA clearance.

Developing a new test would significantly delay the Government’s ability to assess infections, therefore jeopardizing HHS’ public health mission in a way that would result in unacceptable risks to the health of the public.

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

☒ DCMA intends to publicize this requirement, prior to award, as required by subpart 5.2 by posting a notice on the Governmentwide Point of Entry (GPE) on June 30, 2022.

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

The contracting officer has determined that the anticipated price(s) will be fair and reasonable based on comparison with:

• OraSure’s published commercial pricelist for the test kits;

• The independent government cost estimate and;

• Prices paid under previous acquisitions for similar work.

8. Description of market research.

In accordance with FAR Part 7.102(a) and FAR Part 10, market research was conducted. Market research was conducted using internet searches in November 2020, December 2020, March

2021, and June 2022, to determine the landscape of FDA-approved rapid diagnostic testing available for Ebola infection from both the living and recently deceased (cadavers). Internet searches used the following keywords: Ebola diagnostic assay or test, rapid Ebola diagnostic assay or test, FDA/ Ebola/diagnostic, Ebola/diagnostic/cadaver, and

FDA/EUA/Ebola/diagnostic.

The only FDA 510(k) cleared test is the OraQuick Ebola Rapid Antigen Test by OraSure

Technologies, and the test can be used on whole blood from living patients suspected of exposure to the virus and on oral fluid from the recently deceased. 510(k) clearance was announced by the FDA on 10OCT2019. Two non-FDA 510(k) cleared rapid tests were found. In addition to not being FDA cleared, neither of these tests can use samples from cadavers.

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

Not applicable.

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

A Notice of Intent to Sole Source was posted to the GPE on 6/30/2022 requesting that parties express their interest in writing to the Contracting Officer. No other companies expressed interest in this acquisition.

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.

BARDA is in the process of amending its’ Broad Agency Announcement to include a new Area of Interest for Molecular Ebola Diagnostics. This will allow additional developers with similar products to obtain BARDA funding for their Ebola cadaver test kits, eliminating the need for subsequent sole sole acquisitions to this vendor.

☒ After award of this action, HHS intends to post the approved/signed justification pursuant to 6.305.

☐ After award of this action, HHS does not intend to post the approved/signed justification in accordance with 6.305(f).

12. 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

13. 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