AoI-0003_FA811921SC001-Supply Chain COVID-19 Diagnostic Testing_Final.docx

_AoI-0003 FA811921SC001

SUPPLY CHAIN COVID-19 DIAGNOSTIC TESTING

General Information

Supply Chain COVID-19 Diagnostic Testing Area of Interest (AoI) Background Significantly increasing the U.S. access to accurate and rapid COVID-19 diagnostic tests will be critical to getting Americans back to work and in school safely. These technologies, development capacity, and production capacity could potentially also serve as platforms for responding to future pandemics and managing ongoing medical challenges (e.g., influenza).

Given the technological, regulatory, and execution challenges at hand, we have established a collaboration between the Department of Health and Human Services (HHS) (Office of the Assistant Secretary (OASH), Biomedical Advanced Research and Development Authority (BARDA), National Institute of Health (NIH) Rapid Acquisition of Diagnostics (RADx)), and the United States Air Force (USAF) to understand the industry’s ability to rapidly mature and scale specific manufacturing capabilities within the diagnostic testing supply chain, including (but not limited to) the raw materials, resources, components, equipment, and enablers utilized in the production of analyzers, reagents, test kits and other pre-analytical, analytical and post-analytical diagnostic materials for COVID-19 testing.

Submissions should provide line of site from their manufactured items to the COVID-19 diagnostic activity they support or are integrated with. Submissions need not be from a United States (U.S.) based company/entity, but all expansion of manufacturing efforts must be done within the U.S. and/or its territories. Offer’s manufacturing efforts need to support the production or execution of in-vitro diagnostics (IVD) with a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or imminently expecting to receive authorization no later than March 31, 2021.

AoI expansion request This AoI solicits solution briefs from all vendors who believe they can meet Health and Human Services priorities for expanding United States based manufacturing and diversification of supply chain critical materials and equipment relevant to COVID-19 diagnostics, including:

· Sample collection and testing consumables:

· Foam tip swabs validated, or en route to validation, for existing EUA point of care tests and on existing EUA IVD products

· Injection molded plastics

· Manufacturing efforts and raw material manufacturing related to or operating in support of the above activities

· Manufacturing of materials, components, and processes that support the assemblage and performance of lab based, point-of-care and/or at-home over the counter tests, test kits/cartridges:

· Nitrocellulose manufacturing

· Injection molded and film-based plastics

· Electronics, microchips and optical interfaces

· Chemicals, adhesives, and specialty coatings

· Antibodies

· Manufacturing of molecular diagnostic reagents:

· Examples include, but are not limited to, guanidine thiocyanate, diagnostic-grade reverse-transcriptase, oligos, fluorescent tags, and other reagents utilized in extraction and amplification kits

· Create additional manufacturing diversity of qualified supply, especially in cases where components or materials are currently single-sourced

· Manufacturing of test processing consumables:

· Pipette tips for both automated and manual laboratory procedures and the manufacturing of diagnostics

· Infection control barrier resins for pipette tips

· Equipment capable of supporting the re-utilization of diagnostic consumables for diagnostics

· Equipment capable of reducing resource requirements for diagnostic testing

· Manufacturing of equipment that enables expansion/integration of capacity for test manufacturing and/or increased throughput of testing:

· Robotics and automation

· Liquid handling robots

· Sterilization

· Manufacturing of cold chain consumables and equipment necessary to expand the manufacturing, distribution, and storage of temperature sensitive diagnostic tests, components, and reagents:

· Shipping materials and packaging solutions

· Dry ice production

· Freezers

· Temperature indicators and data loggers

The desired respondents are those vendors that have developed or are developing products relevant to COVID-19 diagnostic tests, but have potential for future use in diagnostics related to other pathogens and testing requirements such as blood product testing. This AoI is not contemplated for vendor resale or distribution.

Throughout this AoI, the term “test” is used to refer to any machine, kit, assay, analyzer, device, and including supporting components that can be used to either screen for or detect SARS-CoV-2. The term “components” can include but is not limited to swabs, media, pipettes, reagents, cartridges, and manufacturing efforts that support production of these items.

Respondents must address each of the following questions and requests in their *15/20 page response:

Please provide descriptive information about the product and the diagnostic activity it supports:

List any diagnostic effort related to your product Explain whether or not your product is specific to COVID-19 or has established inclusion in other diagnostic activities If applicable, define the nature of the product changes that would be needed to make your product applicable to COVID-19 diagnostics

Please provide current status of your technology in its go-to-market journey:

Number of FDA approved/cleared IVD products on the market that your product supports and annual revenues per product US install base (# of product placements) for platform-based products Status of any regulatory or manufacturing limitations Status of participation in any other Federal testing programs or procurements (e.g. NIH RADx) Status of participation in any programs or trials outside of the federal government Aspects of the relevant components that could be considered a hurdle or barrier to maintaining/increasing production (e.g. hazardous materials, availability of materials, foreign source, etc.)

Please provide operational information about ability to scale volume:

A brief overview of your current manufacturing process Production and quality system certifications (ISO13485, cGMP, 21 CFR part 820) Current production volumes What the potential ramp-up of manufacturing could be once funding is available (include 30-60-90-120 day estimates for monthly manufacturing output potential) Maximum production rate and time to achieve Location of operations relevant to production and distribution Detail planned expansion efforts to include, but not limited to, equipment required for increases in manufacturing production and lead times, facility build-out and modifications, hiring plan, and potential areas of risk Identify limiting factors or areas of risk in your ability to scale and what can be done to address them (e.g. labor, facilities, space, access to capital, equipment availability, raw material availability, etc.)

Please include a breakout of the total proposal cost/price:

Include total requested Government investment for the expansion of U.S.-based manufacturing capabilities to include renovation projections, equipment procurement and shipping costs, etc.

Provide per item cost with quantity break points

Please provide descriptive information about your critical supply chain:

Provide bill of materials - identify technologies or suppliers required to develop and build/manufacture your item and/or any of its sub-components (amend and list documents to the above *15/20 pages if appropriate) Define the nation of origin for your supplies and suppliers For foreign suppliers or components, discuss the potential to utilize or partner with U.S.-based suppliers Identify potential bottlenecks or constraints anticipated in your supply chain and potential mitigation strategies (limited quantities equipment/material available, protracted backorders, foreign sourced equipment/material, etc.)

Discuss how expanded supply of the product(s) described would resolve a known or expected diagnostic supply-chain bottleneck Describe the integration of critical supplies, components, and sub-assemblies in your final product and how you plan to mitigate the impact of potential supply chain issues and constraints in the final deliverable If applicable, discuss any experience or plans to utilize artificial intelligence as a predictive and adaptive planning tool to monitor market supply and demand in order to inform allocation strategies and optimize the forecasting, procurement, and logistics associated with critical supplies and resource requirements

Please provide additional information about commercial considerations:

Your willingness to enter additional partnerships, licensing agreements, or other commercial agreements with alternative manufacturers in order to reach scale as fast as possible What the nature of those terms would need to be How the US government can best support your company in sourcing and increasing supplies, components, facilities, manufacturing equipment and anything else required to increase scale of manufacturing your product

SPIRAL 1 through 3– Submission Requirements

2.

3.

3.1. This AoI provides for instructions to the offeror, however, all additional guidance governing the content and evaluation criteria for required submission, can be found at the following CSO COVID 19 Response link: cso.dafact.covid@afwerx.af.mil. Offerors shall ensure instructions for content and formatting from the CSO primarily (but not limited to) located under para 1.6.2-1.6.3 are adhered to.

3.2. Solution Briefs for this Area of Interest shall be submitted to the following workflow email: supplychain.cso.dafact@afwerx.af.mil.

3.3. Once submission is received, every offeror 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. Any additional prompts for information will be sent as needed.

3.4. This AoI will accept that submissions are limited to 15/20* single-sided pages in length (not including a one (1) page, single-sided title page) via Microsoft Word (15 pages) or Microsoft PowerPoint (20 pages), respectively [Ref*]. This allowance is different than the provision of a five/fifteen (5/15) page limitation within the CSO for Word/PowerPoint submissions. In this instance the AoI requirement takes precedence.

Per the above paragraph, all proposals will be processed and reviewed, but only the first 15 pages (including any/all attachments) of the proposal will be reviewed and evaluated against the criteria. ALL Material provided later in the proposal, therefore, outside the first 15/20* pages, will not be considered/evaluated and may result in the proposal not satisfying the intent of the solicitation to identify manufacturing capability expansion in support of COVID-19 diagnostics. These submissions may be eliminated from the competition at the discretion of the Contracting Officer.

3.5. Offerors are required to allow for a Solution Brief validity of 90 days minimum from the date submitted.

4. AoI Fluid Execution

In line with the CSO and relevant to paragraphs at 1.3, detailing the CSO procedures, the Government reserves the right to forgo Spiral 2 and go directly to Spiral 3 with any number of/or all offerors at any time throughout the process. This means, the Government may pursue immediate invitation to Spiral 3 to facilitate Contract Awards with responsive Solution Briefs prior to the solicitation date closing.

5. AoI Open Period

5.1. Solution Briefs may be submitted immediately upon posting this AoI. Solutions Briefs will be accepted until 4:00PM CT, 07 March 2021 unless the government amends this AoI otherwise, or in the event there is a cancellation of the Commercial Solution Opening.

5.2. Evaluations are expected to begin within 48 hours of the posting of this AoI.

The primary Contracting Officers for this AoI are Ms. Tisha McLelland and 1st Lt Montana Pellegrini. All questions concerning this AoI must be sent to the following email: supplychain.cso.dafact@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.