Synopsis of Proposed Contract Action_MM_JS 6.5.20 (002).pdf

Notice Type: Synopsis of Proposed Contract Actions

Date: June 5, 2020

Solicitation Number: 75A50120R00027

Project Title: OraQuick Coronavirus Rapid Antigen Test to 510(K)

Classification Code: AN13 – R&D Medical: Biomedical (Advanced Development)

NAICS Code: 541715 – Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

SUMMARY

This is a notice of a proposed contract action issued in accordance with FAR 5.203(a). The Government intends to issue a contract without providing for full and open competition to OraSure Technologies Inc.

(OTI), 220 E 1st St, Bethlehem PA 18015-1360. OTI is the only responsible source and no other supplies or services will satisfy agency requirements (see FAR 6.302-1). The Government plans to award this contract in July 2020.

DESCRIPTION

In December 2019, a novel (new) coronavirus known as SARS-CoV-2 was detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease COVID-19 that has now spread globally. The Secretary of HHS declared a public health emergency on January 31, 2020, under Section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19. On March 13, 2020, the President of the United States, pursuant sections 01 and 301 of the National Emergencies Act (52 U.S.C. 1601 et seq.) and consistent with Section 1135 of the Social Security Act, as amended (42 U.S.C. 1320b-5), proclaimed that the COVID-19 outbreak in the United States constitutes a national emergency.

Under the President’s Operation Warp Speed Mission, HHS is contributing to a public-private partnership to facilitate and accelerate the development, manufacture, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

To further the development, manufacture, and distribution of COVID-19 diagnostics, BARDA’s Detection, Diagnostics, and Devices Division is seeking to support organizations through contracting to obtain full 510(k) clearance from the US Food and Drug Administration (FDA).

OTI is currently working towards a FDA Emergency Use Authorization (EUA) for their SARS-CoV-2 Rapid Antigen Test (the Test) under BARDA contract number 75A50120C00061, a contract awarded using BARDA’s Division of Research Innovation and Ventures (DRIVe) Easy Broad Agency Announcement (EZ- BAA). The Government expects OTI to receive the EUA in August 2020.

The Test is a rapid Point of Care lateral flow test for the detection of SARS-CoV2 antigens. It leverages the OraQuick Ebola 510(k) device platform, which allows for both professional use and self-testing by lay users and is an in vitro diagnostic single-use immunoassay for the qualitative detection of antigens from SARS-CoV-2 in oral fluid in individuals who meet the COVID-19 clinical and/or epidemiological criteria.

The purpose of this planned contract is to fund the studies and clinical evaluations necessary for the Test to obtain full FDA 510(k) clearance which will allow for long-term sustainment and use of the Test.

Only OTI is capable of obtains full FDA 510(k) clearance for the Test because the Test is based on an OTI proprietary platform. In addition, any attempt of another organization seeking to replicate the Test would result in substantial duplication of cost to the Government and unacceptable delays in fulfilling the agency’s requirements.

RELEASE OF SOLICITATION

The Government intends to solicit a proposal directly from OTI using a Letter Request for Proposals (RFP) as allowed by FAR 15.203(e). The Government anticipates transmitting the Letter RFP via email on or after June 20, 2020.

The Letter RFP will not be made available through the Government Point of Entry. Interested parties may request the Letter RFP from the Primary Point of Contact.

Responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by BARDA.

CONTRACTING OFFICE ADDRESS

Biomedical Advanced Research and Development Authority (BARDA) Assistant Secretary for Preparedness and Response (ASPR) Department of Health and Human Services (HHS) Thomas P. O’Neill Federal Building 200 C Street SW Washington, DC 20024

POINTS OF CONTACT

Primary Point of Contact:

Keane Butts Contract Specialist Keane.butts@hhs.gov Phone: 202-205-8681

Secondary Point of Contract:

Jeffrey Brown Contracting Officer Jeffrey.Brown@hhs.gov phone: 202-730-8662