JA-22-JCRD-119 - 500M Additional COVID Test Kits_Redacted.pdf

Control No: JA-22-JCRD-119

Class Justification and Approval

FAR 6.302-2 Other than Full and Open Competition Unusual and Compelling Urgency for COVID-19

1. Contracting Activity: U. S. Army Contracting Command – Aberdeen Proving Ground (ACC-APG), Joint COVID-19 Contracting Division (CCAP-CR), 4672 Integrity Court, Aberdeen Proving Ground, MD 21005.

2. Description of Action: The United States Government (USG or Government) has an urgent requirement for an estimated 1 Billion rapid Antigen (Ag)-based diagnostic tests indicated for non-prescription home use that are Food and Drug Administration (FDA) approved, 510(K)-cleared, or have Emergency Use Authorization (EUA) to detect the SARS-CoV-2 virus, which causes COVID-19. An initial estimated quantity of 500M of the total 1 billion requirement is being procured under a separate class J&A approved on 12 January 2022, reference JA-JCRD-22-0099. This additional requirement of an estimated 500M additional tests will be used to detect and combat the spread of COVID-19 within the United States. The Department of Defense (DoD) intends to pursue multiple contract awards with responsible suppliers under this class J&A in order to meet the total Government requirement as soon as possible but no later than by June 2022. The DoD intends to solicit a class of companies which are defined as:

Manufacturers and current authorized distributors of FDA approved, 510(k) cleared, or which have an EUA for COVID-19 rapid antigen tests. This class includes manufacturers who receive EUA approval through the National Institute of Health (NIH) Independent Test Assessment Program (ITAP) or Rapid Acceleration of Diagnostics (RADx) program prior to award of a contract.

These COVID-19 rapid tests will be provided upon request to individuals within the United States for home use to quickly detect exposure and infection of an individual with COVID-

19. Based upon current modeling data, the United States faces a continuing shortfall in the availability of COVID-19 tests through Summer 2022. These tests are critical for early identification of COVID-19 infection which is crucial to timely treatment and isolation of infected individuals; to reduce the widespread infection of the population in the United States; and to minimize the burden on the healthcare system to treat COVID-19 positive patients. Therefore, it is a public health imperative to reduce or eliminate the anticipated shortfall in availability of these tests.

The anticipated contract type for each contract is Firm Fixed Price. These efforts are entered into by the DoD and ACC-JCRD on behalf of the Assistant Secretary for Preparedness and Response (ASPR), Health and Human Services (HHS), in accordance with the Memorandum of Understanding between HHS and the DoD regarding DoD Acquisition Support, signed 20 May 2021; at the request of the Executive Office of the President by memorandum dated 21 December 2021, and by memorandum dated January 21, 2022. The DoD will be the contracting agency. This requirement will be fully funded utilizing Section 2401 of the American Rescue Plan Act (no year funds)

Contractor Name EUA Cleared (Y/N)

EUA

Pending?

(Y/N)

Product Meets Requirements (Y/N)

Manufacturing location

Y NA Y USA

Y NA Y China

N Y Y USA

Y Testing Y USA

Y N Y USA

Y N Y Australia N Y Y USA and South

Korea Y NA Y US and Hong

Kong

Y NA Y USA

Y NA Y China

N Y Y USA

N Y Y USA and Mexico N Y Y South Korea

Y NA Y USA

Y N Y USA

Y N Y Switzerland

N Y Y USA

Y N Y South Korea N Y Y Japan

9. Interested Sources: A Request for Information was posted on 22 December 2021 with 58 responses received and a limited sources competition was conducted through 4 January 2022 with 20 responses received. Some companies submitted multiple proposals offering different configurations of product, which is the reason there are 19 companies in the table in para 8. The FDA, HHS, and DoD reviewed the responses and incorporated that information into its market research. However, as discussed above, due to the extremely urgent nature of the requirement, the Government is unable to compete on a full and open basis for the requirements at this time. The Government continues to review industry feedback and interest to identify additional potential sources that can meet the Government's delivery schedule with acceptable product.

10. Other Facts:

a. Procurement History: Multiple contracts from prior competition: W58P05-22-C-0008, Abbott Health Labs; W58P05-22-C-0009, iHealth Labs; W58P05-22-C-0010, Roche Diagnostics; W58P05-22-C-0011, Siemens.

b. Other f acts. Not applicable.