JA-22-JCRD-094 - COVID Test Kits_Redacted.pdf

Control No: JA-22-JCRD-094-R

FAR Part 6 Class Justification and Approval for Other than Full and Open Competition

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

2. Description of Action: The United States Government (USG) has an urgent requirement for approximately 60 Million rapid Antigen (Ag)-based COVID-19 diagnostic tests indicated for non-prescription home use that are U.S. Food and Drug Administration (FDA) approved, 510(K)-cleared, or have Emergency Use Authorization (EUA) which will be used to detect and combat the spread of COVID-19 within the United States. The Department of Defense (DoD) intends to award contracts with three suppliers who have been identified as having stock on hand that can ship within 14 days of award; Medea Inc., Pleasanton, CA, and Atlantic Trading LLC, Austin, TX, and Revival Health, Manhattan Beach, CA

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 shortfall in availability of an estimated 500 Million COVID-19 tests by approximately 21 January 2022. This instant procurement will provide an initial allocation to meet urgent requirements and begin the logistics and shipping pipeline of tests to individuals within the United States. Early identification of COVID-19 infection is crucial to timely treat and isolate infected individuals and to reduce the widespread infection of the population in the United States.

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 Biomedical Advanced Research and Development Authority, in accordance with the Memorandum of Understanding between the Department of Health and Human Services (HHS) and the DoD regarding DoD Acquisition Support, signed 20 May 2021; and at the request of the Executive Office of the President by memorandum dated 21 December 2021. 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).

3. Description of Supplies/Services: This requirement is to purchase approximately 60 Million rapid Antigen (Ag)-based diagnostic tests indicated for non-prescription home use that are FDA approved, 510(K)-cleared, or have EUA. Further, because the dominant SARS-CoV-2 variant in the U.S. is currently the omicron variant, the tests for this requirement must be able to detect all variants including omicron. One test kit is defined as all materials needed to take a sample and obtain a diagnostic result; kits requiring multiple sterile swabs or reagents are considered to be one (1) test kit. Kits will need to be packed in sets of one, two, or four test kits per package. Deliveries of product are required to start no later than seven (7) days after contract award and conclude no later than fourteen (14) days after contract award.

4. Authority Cited: 10 U.S.C. 2304(c)(2), as implemented by FAR 6.302-2, “Unusual and Compelling Urgency”

5. Reason for Authority Cited: 41 U.S.C. § 1903, Special Emergency Procurement Authority, is authorized because the President of the United States made an emergency determination under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. § 5121- 5207 (the "Stafford Act"), and the American Rescue Plan Act of 2021, in response to the COVID-19 pandemic on 13 March 2020. COVID-19 and variants thereof continue to rapidly spread throughout the United States leading to hospitalization and death of individuals across the country. FAR 6.302-2 allows for other than full and open competition based on unusual and compelling urgency. This action satisfies the requirements of FAR 6.302-2 because of (a) the urgent threat COVID-19 poses to both national security and the public health and (b) early detection and identification of COVID-19 infection increases the probability of survival through timely medical intervention and reduces the spread of the virus through early preventative measures to slow and reduce community spread.

The USG cannot adopt standard procurement times to an acquisition of this urgent public health nature. Even under the best of circumstances, a short timeline of 60 days to award competitive contracts is unacceptable. Such a delay could result in many more individuals unknowingly spreading COVID-19 and an increase in deaths due to delayed infection identification and care. Further, in order to combat the spread of COVID-19, additional supply of tests is urgently needed to meet the demand, thereby ensuring the United States sustains the capability to detect the virus while the demand for testing drastically exceeds the available capacity. Even an extremely aggressive sixty date procurement timeline to award the contracts, while extremely aggressive, would place contract award beyond the final date of product delivery contemplated by the US requirements. These tests are further critical to build up a starting supply within the Government supply chain to begin fielding tests to individual as soon as possible.

6. Efforts to Obtain Competition: As stated above, the US cannot adopt standard procurement timelines to this acquisition due to the extreme urgency of getting supplies in a timely manner. This acquisition aims to rapidly procure as many kits as possible, estimated at 60 Million, in order to rapidly meet current testing shortfalls while other procurement efforts are ongoing.

b. Subcontracting Competition: No potential subcontracting opportunities exist under this requirement at this time due to the rapid nature of the requirement beyond subcontracting to a supply manufacturer.

7. Actions to Increase Competition: Based upon market research there are currently multiple companies available that can either manufacturer or source the required test kits, however only three companies identified have significant quantities on hand that can meet the immediate delivery requirement of the subject acquisition. The US is working a multiple award competitive action simultaneous to this action to increase competition to the maximum extent practicable

8. Market Research: The DoD, in partnership with the FDA and HHS, has multiple methods to stay connected with industry. HHS conducts in-depth market research through Tech Watches, Industry Days, and interviews with individuals knowledgeable of industry trends and requirements, and through in-depth market research of companies or product-specific research. Further, a Request for Information was posted to SAM.gov on 22 December 2021 to identify interested sources that may be capable of providing the required supplies with 63 responses received.

To date 18 companies have been identified that could potentially meet the USG requirement with some stock on hand; however, after attempting to inquire directly with these companies, only three have communicated that they have tests on hand that are FDA authorized and which the NIH has confirmed detect the omicron variant of the SARS-CoV-2 virus, which is currently the dominant variant in the U.S. Multiple other companies have been identified as potential suppliers, however, the test kits these companies have in stock are either not yet allowed to be marketed by the FDA or have not undergone confirmatory testing with the omicron variant and/or their delivery timelines do not meet this urgent requirement.

The three identified companies are Medea Inc, 351 Saint Mary Street, Pleasanton, CA, Atlantic Trading LLC, 5900 Balcones Drive STE 4031, Austin, TX, and Revival Health, Manhattan, CA. These companies have been identified to have stock on hand in the United States that can meet these urgent requirements identified above.

9. Interested Sources: A Request for Information was posted on 22 December 2021 with 63 responses received. The FDA, HHS, and DoD reviewed the RFI 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 the requirements at this time.

10. Other Facts:

a. Procurement History: Multiple contracts exist across the Government for these types of items, however none with the volume or expedited timelines set forth in the instant requirement. These other procurement contracts are also for supplies allocated to other entities and use of these procurements would likely exacerbate the current deficiency of supply.

b. Other facts. Medea Inc is a Small Business; Atlantic Trading LLC is a Women Owned Small Business; Revival Health is a Small Business.

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Joseph Hamel Date: 06 Jan 2022

Title: Director, ASPR Testing and Diagnostics Working Group

12. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Nikki Batcher-Bowman Date: 06 Jan 2022

Title: Principal Deputy Assistant Secretary -Chief Operating Officer

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis IAW FAR 15.404-1(b). In accordance with FAR 15.403-1(b)(3), certified cost and pricing data will not be required as this is a commercial item.

Typed Name: William Coolbaugh Date: 06 January 2022

Title: Contracting Officer

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: William Coolbaugh Date: 06 January 2022

Title: Contracting Officer