DLAPDF of REDACTEDSigned COVID Test Kits c-3 JA final counselredactions ajg_Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPEITION

Estimated Requirement of 180M tests.

Contract Dollar Values:

Estimated Dollar Value:

Estimated Maximum Dollar Value:

The estimated dollar value is based on current demand from HHS. The estimated number of tests required was derived from a survey of domestic manufacturers in the U.S. and outlying areas and their production capacities. The estimated number of tests is based on market research that revealed levels needed by manufacturers to continue production in order to meet projected demand for the fall and winter of 2022. The estimate considers the need to quickly respond to unanticipated demands resulting from the uncertain trajectory of the current COVID-19 pandemic, the continued national emergency and the potential increase in COVID-19 cases across the United States due to the development and unpredictability of the COVID-19 variants.

Market research for this acquisition was conducted on August 2, 2022 to determine the domestic sources approved by the FDA to supply at-home test kits that require no separate readers or use of a smartphone. The FDA’s list of authorized at-home OTC COVID-19 diagnostics tests contain twenty-one (21) unique manufacturer names: Abbott Diagnostics, Access Bio, Acon Laboratories, Beckton Dickinson (BD), Celltrion USA, Cue Health, Detect, Ellume Limited, Genabio Diagnostics, iHealth Labs, Inbios International, Lucira Health, Maxim Biomedical, Orasure Technologies, Osang LLC, PHASE Scientific, Quidel Corporation, SD Biosensor, Siemens Healthineer, Xiamen Boson Biotech and Watmind USA. Individual outreach was conducted with each of the manufacturers of over-the-counter tests to determine country of origin (COO) for the domestically manufactured OTC COVID-19 test requirement. Outreach in combination with a labeling review of the manufacturer’s instructions for use (IFU) provided by FDA revealed that Acon’s Flowflex COVID-19 Antigen Home Test, iHealth’s COVID-19 Antigen Rapid Test, Genabio’s COVID-19 Rapid Self-Test Kit, Siemen’s Healthineer’s CLINITEST Rapid COVID-19 Antigen Self-Test, Watmind’s Speedy Swab Rapid COVID-19 Antigen Self-Test and Xiamen Boson’s Rapid SARS-Cov-2 Antigen Tests are made in China.

Although Trade Agreements Act (TAA) compliant, data from HHS and the FDA’s links to the IFUs revealed that the authorized at-home OTC COVID-19 diagnostics tests manufactured by Celltrion, Detect, Ellume, Osang LLC, PHASE Scientific, and SD Biosensor are currently made overseas. COVID-19 OTC diagnostic tests manufactured by BD are manufactured in Canada and China.

The only known domestic manufacturers of authorized at-home OTC COVID-19 diagnostics tests in accordance with FAR 6.302-3(b)(iv)(A) are Abbott Diagnostics, Access Bio, Cue Health, Inbios International, Maxim Biomedical, Orasure Technologies, and Quidel Corporation. Cue

Health’s COVID-19 Test for Home and OTC requires the use of an ancillary reader and a smartphone in order to obtain and view a diagnostic result. In addition, Cue Health currently has an Electronic Catalog (ECAT) laboratory contract where ECAT customers’ use of Cue products, including the Cue Health app, is subject to terms of use and a license agreement.

Market research indicates that there are currently six (6) domestic manufacturers on the list of FDA-authorized OTC COVID-19 tests that meet the Government’s requirement. The manufacturer names and products are listed in the table below:

Manufacturer Name

Manufacturer Part Number Product Name Unit of

Issue

Qty per Unit of Issue

Result Time

ABBOTT 195-140 BinaxNOW COVID-19 Antigen Self Test KT 1 15 min

ABBOTT 195-160 BinaxNOW COVID-19 Antigen Self Test KT 2 15 min

ACCESS BIO RCPM-00171 CareStart COVID-19 Antigen Home Test KT 1 10 min

ACCESS BIO RCPM-00271 CareStart COVID-19 Antigen Home Test KT 2 10 min

ACCESS BIO RCPM-00471 CareStart COVID-19 Antigen Home Test KT 4 10 min

INBIOS CAGS-1 SCoV-2 Ag Detect Rapid Self-Test KT 1 20 min

INBIOS CAGS-2 SCoV-2 Ag Detect Rapid Self-Test KT 2 20 min

MAXIM 94311

MaximBio ClearDetect COVID-19 Antigen Home Test

KT

1 15 min

MAXIM 95677

MaximBio ClearDetect COVID-19 Antigen Home Test

KT

2 15 min

MAXIM 97382

MaximBio ClearDetect COVID-19 Antigen Home Test

KT

4 15 min

ORASURE 1001-0616 InteliSwab COVID-19 Rapid Test KT 2 30 min

QUIDEL 20402 QuickVue At-Home OTC COVID-19 Test KT 1 10 min

QUIDEL 20431 QuickVue At-Home OTC COVID-19 Test KT 2 10 min

4. The applicable statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(3), FAR Part 6.302-3(a)(2)(i) (“To maintain a facility, producer, manufacturer, or other supplier available for furnishing supplies or services in case of a national emergency or to achieve industrial mobilization.")

5. The use of this authority is necessary for the preservation of the United States Government’s (USG) domestic industrial base for the manufacture of COVID-19 OTC tests. HHS previously obtained OTC COVID-19 Home Tests through contract number SPE2DE-21-D-0048 with final deliveries scheduled for September 2022. Although there will be some coverage provided by the existing contracts through September, due to the current unpredictable trajectory of COVID-19 cases, the current contracts (SPE2DE-21-D-0048 (Abbott), SPE2DE-21-D-0049 (Orasure), and SPE2DE-21-D-0051 (Quidel)) are unable to meet the Assistant Secretary for Preparedness and Response (ASPR) and HHS’ increased requirement for supply to the Strategic National Stockpile (SNS). There are no other contract vehicles to support the scope of the future HHS requirement for the OTC COVID-19 Home Tests.

The ASPR received an allotment to procure additional OTC test kits. ASPR needs the procurement of additional test kits due to the anticipated surge in the spread of the COVID-19 variants, specifically, the OMICRON subvariants. The OTC test is a self-contained, visually read, lateral flow immunoassay for the qualitative detection of nucleocapsid protein antigen from COVID-19 and does not require a telehealth visit/prescription, nor require mobile or internet connection. The test shall be authorized by the FDA under an EUA or otherwise FDA approved.

The uncertain nature of the trajectory of the pandemic and shelf- life limitations make it necessary to maintain an adequate production base whose planned capacity is sufficient to cover pandemic surge requirements. Test kits must be manufactured within the month of delivery and have a minimum of eight (8) months (75% remaining upon delivery) of remaining shelf-life upon delivery to USG designated locations. The estimated requirement for this procurement is up to 180 million tests.

The USG intends to limit competition to domestic manufacturers of the OTC antigen Covid test kits. Those contractors are currently: Abbott, Access Bio, Inbios International, Maxim, Orasure and Quidel. The USG intends to award contracts to a minimum of four (4) vendors to maintain balanced sources of supply and provide for a sufficient industrial base. This acquisition seeks to award multiple contracts to the responsible offerors who can comply with the requirements of the solicitation and offer the solicited products at fair and reasonable prices. Minimum and economic production quantities were ascertained through market research with the sources currently on the FDA approved list for this Test Kit and indicate that at least four awards can be made to meet ongoing demand and maintain production at those facilities. Based on the monthly economic production quantity (EPQ), there are at least two vendors who can meet the estimated 40% quantity of 72M tests over the performance period with monthly EPQs ranging from 6M – 100M. The monthly EPQs for the remaining vendors indicate there are at least two vendors who can meet the estimated 10% quantity of 18M tests over the performance period. The USG will decide on the maximum number of awards to lowest-priced technically acceptable (LPTA) offerors based on weekly capacity until the estimated requirement for up to 180M tests is met.

No one vendor will be awarded a contract with an estimated value more than 40% of the total estimated requirements (72 million tests).

There is a critical need to continue domestic production of these COVID-19 Test Kits due to the continuing National Emergency. These test kits will contain rapid Antigen (Ag)-based diagnostic tests indicated for non-prescription home use that are Food and Drug Administration (FDA) approved, 510(K)-cleared (which allows a vendor to market the test after the COVID-19 public health emergency is over), or have Emergency Use Authorization (EUA) to detect the SARS-CoV-2 virus, which causes COVID-19. The COVID-19 Testing and Diagnostic Working Group (TDWG) worked with all domestic manufacturers to analyze impacts if tests are not purchased while there is such low demand. A brief survey of domestic manufacturers that represent the bulk of the market for OTC COVID-19 tests revealed that the majority of capacity and thousands of manufacturing jobs would be lost without direct procurement efforts from the USG, increasing the time required to reach maximum capacity. This will cause the lead time for manufacturing ramp up to increase from two (2) to four (4) months to reach maximum capacity