COVID-19 Rapid Test SOW - DRAFT W58P0522R0003.pdf

500M Antigen Based Test Kit Requirement

I. Contract Scope

Army Contracting Command (ACC), on behalf of the Department of Health and Human Services (HHS), intends to award multiple contracts for the procurement of approximately 500,000,000 FDA approved/authorized diagnostic tests indicated for non-prescription home use for the qualitative detection of protein antigen from the novel coronavirus SARS-CoV-2, and known variants of concern that cause COVID-19. The Over –the-Counter (OTC) test kits could be provided by either U.S. or non-U.S. based manufacturers. The awardees will make deliveries, based on United States Government (USG) direction, to locations within California, USA or other locations to be provided. These Antigen tests may also be delivered to, and used to support, other federally-funded customers, including federally-funded customers at other locations. The awarded contracts must not interfere with, or in any way disrupt, current production or delivery orders intended for any commercial or government entity located in the U.S. or its territories. The U.S. government reserves the right to make subsequent solicitations or multiple awards until the upward limit of tests are purchased. The U.S. government reserves the right to cancel any award to a manufacturer whose test kit authorization is revoked, clearance rescinded, or otherwise fails to detect the novel coronavirus SARS-CoV-2, and known variants of concern such as Omicron that causes COVID-19. The U.S. government also reserve these rights for any future variants of concern that arise during the period of performance.

II. Specifications

The manufacturers shall supply 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). Approvals and / or authorizations for the above stated indication must be obtained prior to a manufacturer submitting its proposal. 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. All potential manufacturers shall provide documentation that 1) its test kits have been authorized, cleared, and/or approved as able to detect the protein antigen of the novel coronavirus SARS-CoV-2 and, further, is able to detect the Omicron and other variants of concern; 2) for non-U.S. based manufacturers: the manufacturer shall (a) currently have the scalability to produce at least 20,000,000 home use, antigen based, test kits per month between January and March 2022, (b) be able to deliver 50% of the proposed test kits to specified locations within the U.S. or its territories, within 30 days of the award, and (c) deliver the remaining quantity within 30 days thereafter; 3) for U.S. based manufacturers: the manufacturer shall (a) currently have the scalability to produce at least 7,500,000 home use, antigen based, test kits per month between January and March 2022, (b) be able to deliver the proposed test kits to specified locations within the U.S. or its territories, within 30 days of the award, and (c) deliver the remaining quantity within 30 days thereafter ; 4) substantiates it has the requisite supply chain to produce the corresponding number of home use test kits it proposes; and 5) an explicit listing of the contents of its test kits. The following specifications apply:

CLIN 0001 Rapid Antigen Based Over the Counter (OTC) Tests

1. A quality management plan and agreement for manufacturing that conforms to the Quality System Regulation at 21 CFR Part 820 or required Subparts consistent with their Emergency Use Authorization (for example, subsections H, I, or O). Awardee will facilitate Government inspections and/or quality assurance audits – periodic, ad hoc or for cause – of Awardee’s or sub-agreement holders’ facilities included in the supply chain. Applicable vendor – supplier quality agreements shall be submitted with all proposals.

2. All delivered items shall be clearly labeled and expiration marked on all items; the expiration date must be no less than four months post-delivery to U.S. locations.

3. Test kits shall be FDA authorized, cleared, or approved for non-prescription home use, or have an emergency use authorization for non-prescription home use by the FDA no later than date of contract award, for the qualitative detection of protein antigens from the novel coronavirus SARS-CoV-2 and, further, must detect variants that causes COVID-19, such as the Omicron variant.

4. All test kits shall be configured consistent with the FDA approved/authorized labeling.

5. Each delivered test kit shall include all necessary components to run the tests from a single sample collection to end result, such as sterile swabs, test tubes, droppers, plastic envelopes, test cartridge, and / or other such components. Test kits requiring multiple sterile swabs or dilutions are considered a single test kit.

6. The Ag OTC tests shall provide rapid testing results for the novel coronavirus SARS-CoV-2, which includes the Omicron and other variants of the virus, with time to a reported result not to exceed 30 minutes.

7. Provide documentation that the tests can effectively detect the novel coronavirus SARS- CoV-2 including the Omicron and other variants of concern as defined by the Centers for Disease Control (CDC) (2021, December 1). SARS-CoV-2 Variant Classifications and Definitions. https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-classifications.html#concern.

8. The manufacturer shall ship the test kits in their standard packaging, per the corresponding EUA, either as single test kits or in a larger parcel that contains either two or four individual test kits, each of which will remain within its standard packaging.

The following deliverables are required:

Deliverable Format/Deliver to Date

Kick-off meeting Virtual meeting Within 5 days of contract award Kick-off meeting notes (should contain a detailed overview of the discussion)

Electronic copy of Kick-Off Meeting Notes – POC

Within 5 days of meeting being held

Shipping Tracking #’s Electronic to POC Within 24 hours of shipping

Notification of investigation of nonconformities relating to product, processes, and quality system

Electronic to POC Within 3 business days of occurrence

Notification of FDA correspondences or inspections, to include but not limited to 483s, consent decrees, and recalls

Electronic to POC Within 48 hours of receipt from FDA

Shipping and receipt confirmation report, inventory report capturing lot numbers and expiration dates

Electronic to POC Monthly

Final Report Summary of all manufacturing, pick-ups, and distribution of product under performance of this contract.

Within 5 business days from end of contract or final delivery date (if after contract end date)

Note: Offers from Authorized Manufacturer Distributors must include a Letter of Commitment from the Manufacturer to be considered for award.

III. Ordering Quantities TBD

IV. Delivery

1. Destinations. The Contractor shall deliver F.O.B. Destination to a designated US location.

2. Distribution Planning and Tracking.

Performer is responsible for shipping from the site of manufacturing to US distribution center(s) within California, USA or other locations to be provided. Performer must provide a logistics plan outlining how delivery requirements in Section II will be met, including delivery volumes and schedule.

3. Shipping Frequency.

Performer must provide a logistics plan outlining how delivery requirements in Section II will be met, including delivery volumes and schedule.

4. Period of Performance.

Period of Performance: Ninety Days

5. Pricing. Pricing for transportation will be separate from the unit price and intended to be bid on a per unit basis for the selected transportation method (s).

V. Evaluation of Offers TBD