Rapid COVID-19 Antigen Test Kits

Title: Request for Information (RFI) for COVID-19 Antigen Tests -- Over the Counter (OTC)

Synopsis: NOTE: THIS IS A REQUEST FOR INFORMATION (RFI)  The information requested in this announcement is being sought for informational planning purposes only and does not constitute a request for proposal, an announcement of a forthcoming solicitation or a commitment by the Government in any way. Also, it is not a request seeking contractors interested in being placed on a solicitation mailing list. All information is to be furnished at no cost or obligation to the Government, and is subject to change at any time. Response to this Request for Information is voluntary and no reimbursement will be made for any costs associated with providing information in response to this RFI. Data submitted in response to this Request for Information will not be returned. There is no solicitation available at this time.

Description

The United States Department of Defense (DoD) on behalf of the Department of Health and Human Services (HHS) is seeking information to assess market availability and sourcing of Federal Drug Administration (FDA) Emergency Use Authorization (EUA) or 510(k) cleared COVID-19 Antigen OTC test kits for personnel use.

Questions:

Respondents are requested to provide the following information:

1. Company Name, mailing address, CAGE/SAM Code, website, point of contact, phone number, and email address.
    
2. Business size under NAICS Code 325413 In-Vitro Diagnostic Substance Manufacturing
    
3. Does your company currently have an approved Emergency Use Authorization (EUA) or 510(k) for the products? 

• If not, has your company submitted a request to the FDA?  When were the materials submitted? 
   
• If the submission is an EUA, does the company have the ability to scale up manufacturing capacity to 500,000 or more tests per week within 3 months of authorization per FDA’s policy for prioritized review of EUA requests (https://www.fda.gov/media/135659/download)?

4. Does your company have manufacturing located within the United States to meet any requirements or would manufacturing outside the US be required?

• If outside the US, does your company currently export to the United States?
   
• Does your company ship directly or through a distributor?
   
• For a delivery location in California, USA, does your company anticipate utilizing air freight, ocean freight, or a combination? If a combination, please explain.
   

5. Does your company currently have fully manufactured, unallocated stock on hand that are available to ship within 2 weeks of a contract award?
 

• If so, how many tests are available?  What is the approximate remaining shelf-life of the product?
   

6. What pack counts does your company currently offer in standard approved packaging? (ie. 1 test per pack, 2 tests per pack, ect.)
 

• What is the standard shipment count (ie. Pallet or shipper count(s))?

7. How much product, on a monthly basis, could the company produce for the months of January through April?

8. Provide any comments or questions on the associated draft Statement of Work.

9. If your company has previously provided similar items to the USG, please provide the name of the requiring activity and the contract number(s).

Responses Due: Responses are due by 24 December 2021

Response Format: Responses are requested electronically by email to the following POCs:

Brendon.m.courtade.civ@army.mil

antoine.c.denson.civ@army.mil

laurel.d.miller2.civ@army.mil

Contracting Office Address:

Army Contracting Command – Joint COVID-19 Response Division

6472 Integrity Court, Building 4401, ATTN: CCAP-CR

Aberdeen Proving Ground, MD 21005-3013