JATF_CSO_ScreenDiag_AoI.pdf

10 July 2020 / FA7013-20-S-0002AOI_02

General Information

1. Screening & Diagnostics Area of Interest (AoI) Background Significantly increasing the U.S. access to COVID-19 Screening & Diagnostics testing capability will be critical to getting Americans back to work safely and respond to future outbreaks. Given the challenge of the effort at hand and its importance to the health and livelihoods of the American people, solutions from the test manufacturing community to expand the U.S. Industrial Production Capacity of existing COVID-19 Diagnostic Testing capability is critical to not only respond to pandemics but also ensure the security of the nation as it relates to test manufacturing.

The Department of Defense Joint Acquisition Task Force (JATF) and Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT) need to understand industry’s ability to expand the domestic manufacturing production capacity of Molecular, Antigen and/or Antibody Laboratory and Point-of-Care (POC) / Near POC test analyzers or assays which either have an existing U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or can submit evidence of having submitted an FDA EUA packet as well as have a high throughput test processing.

2. AoI Expansion Request This AoI solicits solution briefs to meet Health and Human Services Assistant Secretary for Preparedness and Response (HHS/ASPR) priorities for meeting Strategic National Sourcing 2.0 strategy to expand domestic production capacity of test analyzer or assay manufacturing, or related support activities and be able to deliver products from those capacity efforts to customers within the next 30-60-90-120 days, incremental to existing company capacity expansion plans.

Throughout this AOI, the term analyzer is used to refer to machines that process tests and assays are meant to refer to the test kits and components: swabs and media, pipettes, reagents, cartridges and manufacturing efforts that support production of these items.

a. For manufacturers of analyzers and assays, what would be required to expand production capacity beyond existing internal capacity expansion plans?

i. Provide descriptive information of analyzer and assay models including:

1. An estimate of the current number of analyzers deployed and active across the U.S

2. Level of technical training required to operate each analyzer including medical certifications, whether a “patient care setting” or sterile environment is required or if a non-sterile testing environment will suffice, and how many analyzers can a single technician operate simultaneously.

3. Standard frequency and duration of maintenance required for each analyzer as well as requirements on storage, transportation and handling of analyzers and assays.

4. Standard total operating life of each analyzer specifically by years and total test throughput over that period of time.

5. What is the level of high throughput test processing per analyzer?

6. Specifics related to specimen collection (type of swab, type of media, specimen of choice, etc) and requirements after sample is taken (i.e. refrigeration, storage, handling requirements, and testing environment considerations).

7. What is your self-identified test sensitivity and specificity? Have you conducted any studies or are you aware of any independent assessments revealing potentially confounding information on false positive and false negative rates?

8. What diseases can each analyzer test for using the same and/or different cartridges in addition to COVID-19

ii. Provide information on the manufacturing and plant information where the expansion efforts would occur, including:

1. Information regarding workforce availability where manufacturing capacity will occur.

2. At a high level, an estimate of the % of production of the analyzer and assay by current manufacturing location.

3. Information on the use of external suppliers / contract manufacturers to produce analyzers & assays and the components they produce.

iii. Provide a timeline for establishing the capacity expansion and ability to deliver products from those capacity efforts to customers.

iv. Provide current weekly production capacity of each analyzer and assay model currently, and % allocated to the U.S and provide weekly production capacity after capacity expansion plan is implemented

b. Additional inputs requested from manufacturers of analyzers and assays:

i. Do you have the ability to drastically ramp up to 10 times current production rate? If not, what is your maximum production increase in rough order of magnitude? What capital would be required to ramp up to this capacity? How quickly can you ramp up to the proposed rough order of magnitude?

ii. What are the constraints of expanding production capacity at supplier / contract manufacturer’s plants?

iii. For your analyzer machines and assays: If you were to significantly scale up production (e.g., multiples of annual capacity), which components would be most capacity constrained? Who are the main suppliers of these components? Who are potential alternative suppliers of these components?

iv. Would you be willing to enter additional partnerships, licensing arrangements, or other commercial agreements with additional manufacturers to reach scale quickly for both analyzers and assays? If so, what terms and conditions would be required?

v. How could the U.S. government support your company in sourcing and increasing the supply of these components?

3. SPIRAL 1 through 3– Submission Requirements

1. SPIRAL 1 through 3– Submission Requirements

a. All guidance governing the content and evaluation criteria for required submission can be found the below at the following JATF CSO link:

https://beta.sam.gov/opp/11fe0354f7bd4330aa147b64c1082f81/view?keywords=%22jatf_cso_ covid_19%20response%22&sort=-relevance&index=&is_active=true&page=1 https://beta.sam.gov/opp/11fe0354f7bd4330aa147b64c1082f81/view?keywords=%22jatf_cso_covid_19%20response%22&sort=-relevance&index=&is_active=true&page=1 https://beta.sam.gov/opp/11fe0354f7bd4330aa147b64c1082f81/view?keywords=%22jatf_cso_covid_19%20response%22&sort=-relevance&index=&is_active=true&page=1

b. Solutions briefs for this Area of Interest shall be submitted at the email below:

JATFCSO_AOI_SCREENING@afwerx.af.mil

c. Once submission is received, offerors will receive a Response Submission Number via email.Please ensure that your solution brief has your firm’s point of contact information to include Name, Title, Phone number and Email.

2. AoI Open Period

a. Solution Briefs may be submitted immediately upon reviewing this AOI. Solutions Briefs will be accepted until 12:00PM EDT; 3 Aug 2020.

b. Evaluations will begin within 48 hours of the posting of this AOI.

Questions concerning this AOI can be sent to the following email:

JATFCSO_AOI_SCREENING@afwerx.af.mil

**Companies are advised that any Prototype Other Transaction Agreement (OTA) awarded in response to this Area of Interest may result in the award of a follow-on production contract or transaction without the use of competitive procedures. The follow-on production contact or transaction will be available for use by one or more organizations in the Department of Defense and, as a result, the magnitude of the follow-on production contract or agreement could be significantly larger than that of the prototype OTA. As such, any Prototype Other Transaction Agreement will include the following statement relative to the potential for follow-on production: "In accordance with 10 U.S.C. 2371b(f), and upon a determination that the prototype project for this transaction has been successfully completed, this competitively awarded prototype OTA may result in the award of a follow-on production contract or transaction without the use of competitive procedures.