RFI for Test Manufacturing Capacity Preservation and Expansion - FINAL.docx

Solicitation Number ASPR Testing and Diagnostics Working Group Request for Information Preservation and Expansion of Current Domestic Capacities for Laboratory-Based Testing and Manufacturing of Over-The-Counter (OTC) Rapid Antigen and Point-Of-Care (POC) Nucleic Acid Amplification Tests (NAATs)

CONTRACTING OFFICE ADDRESS

Charles Strickland 200 Independence Avenue, SW Washington, DC Charles.Strickland@hhs.gov

ADDITIONAL GENERAL INFORMATION

This is a Request for Information (RFI) only as defined in FAR 15.201(e) to obtain information about U.S. national health security industrial base sustainment , risks, and opportunities which may be addressed by investments made under provisions in Title III of the Defense Production Act (DPA) that have been delegated to the Department of Health and Human Services (HHS). Of particular interest are the technical, manufacturing, and market barriers to establishing and sustaining a viable business for the manufacturing capacities of interest and the solutions to addressing those barriers. This RFI is not a request for competitive proposals: therefore, responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. Companies that respond will not be paid for the information submitted except as an allowable cost under other contracts as provided in FAR 31.205-18, “Bid and Proposal Costs.” Utilizing information gathered from this RFI, under separate Request for Proposal (RFP), the Government has contracted non-government personnel to function as technical advisors to the Government reviewers. All non-government personnel shall have Non-Disclosure Agreements (NDAs) on file with the Government. The Government reviewers function as the final decision makers.

NOTE: Responses to this RFI are due no later than thirty (30) calendar days after posting. If late information is received, it may be considered by the Government reviewers, depending on the agency time constraints. Parties contemplating responding to this RFI are requested to e-mail the Contracting Point of Contact: Charles.Strickland@HHS.gov, stating their intention to do so within 5 business days of the RFI release (excluding the release date).

GENERAL INTENT

DESCRIPTION

HHS provides this RFI inviting industry to provide information on the technology and manufacturing capacities of interest. Industry responses to the RFI will be assessed and may assist in potential future actions.

Note: There is no guarantee that Market Research conducted under this RFI will become a project, and responders to this RFI will have no competitive advantage in receiving awards related to the submitted topic area. The information submitted in all responses may be utilized to help the Government further define its requirements. If the Government develops a project that addresses any submitted or similar topic, the resulting procurement will address technology and business specific requirements as defined by the Government to achieve program objectives.

BACKGROUND

Within the Federal government, the Office of the Assistant Secretary for Preparedness and Response (ASPR) at HHS is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from intentional and unintentional exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents and infectious diseases (inclusive of the pandemic threats). HHS has been delegated authorities for utilizing the DPA. Title III of the Defense Production Act of 1950 (50 U.S.C. App. § 4501 et seq.) grants the President of the United States the authority to provide appropriate incentives to create, maintain, restore, modernize, and expand the production capacities of domestic sources for critical components, critical technology items, and industrial resources essential for the execution of the national security strategy of the United States and securing the defense industrial base.

There are several incentive structures available under Title III of the DPA. These include:

• Purchases (Grants) - §303a.

· Provide direct funds as working capital to assist in establishing production capacity.

• Purchase Commitments (P.C) - §303a.

· Guaranteed incentive to establish and maintain production capacity.

• Loans / Loan Guarantees – §301, §302.

· Direct loan and guarantee programs with market commensurate terms to support production supply.

• Subsidy Payments - §303c.

· Direct payments to ensure the continuation of production supply.

These authorities enable HHS to make purchases to create or expand (scale-up) production capacity; improve quality and yield; purchase sample batches for process validation and qualification testing; develop and implement business and marketing plans, purchase and install production equipment, and provide guaranteed market to incentivize companies to establish production capability.

The DPA itself contains three criteria that every Title III project must meet before any funds may be obligated on a Title III activity. The DPA stipulates that the President must certify to Congress that the activity satisfies the criteria. The statutory criteria state that:

(1) The industrial resource, material, or critical technology item is essential to the national defense;

(2) Without Presidential action under the DPA Title III, United States industry cannot reasonably be expected to provide the capability for the needed industrial resource, material, or critical technology item in a timely manner; and

(3) Actions under Title III are the most cost-effective, expedient, and practical alternative for meeting the need.

One additional screening criteria is also considered in determining the applicability of the use of Title III authorities; the combination of U.S. national defense (military) demand and foreseeable non-defense (commercial) demand should be greater than the total domestic industrial capability resulting at the conclusion of the Title III activity. Title III activities must consider the impact of potentially creating excess capacity. While the health security demand for a technology or component is the key consideration from an HHS perspective, the projected commercial demand for use in the civilian market can be included to address this issue. Considering whether demand will exceed supply addresses the likelihood that an economically viable industry will result from the Title III activity and those additional financial incentives will not be necessary to maintain the business.

Please note that DPA Title III is concerned with only domestic sources. Foreign capabilities will not be considered. Title III cannot be used to create or expand a foreign source, regardless of the essentiality of the technology to U.S. defense requirements. The DPA defines domestic source to be a business concern that performs in the United States or Canada substantially all the research and development, engineering, manufacturing, and production activities required of such business concern under a contract with the United States relating to a critical component or a critical technology item and that procures from such concerns substantially all of any components and assemblies required under a contract with the United States relating to a critical component or critical technology item. Territories and possessions of the United States, and the District of Columbia are considered part of the domestic United States.

Within HHS, DPA Title III is recognized as a set of statutory authorities for addressing industrial base/technology transition issues, not a source of funds. Funding for Title III initiatives may be provided in the President’s budget, or by Program Offices of Record, or by Agencies or other Federal Agencies as funding offsets for specific Title III efforts. HHS ASPR periodically publishes Title III RFIs that provide industry the opportunity to offer insight to the technology transition/industrial base needs of the specified critical technologies of interest to the Government.

REQUEST DETAILS

The COVID-19 pandemic has demonstrated how important a robust and resilient public health industrial base is in ensuring the health and security of the United States. It also highlighted the need for critical public health industrial investments at a scale never seen before in the United States. The HHS is conducting market research from manufacturers on their expertise, capacities, challenges, and innovative best practices with various components of the supply chain.

HHS is interested in industry feedback aimed at both 1) sustaining current testing and manufacturing capacities that have been established domestically over the last 12 months prevent capacity loss due to market volatility and 2)expanding current domestic testing and manufacturing capacities. Specifically, HHS is interested in feedback on what it would take to sustain manufacturing capacities and industry to expand domestic laboratory test capacity and supply and domestic manufacturing capacities for Over-the-Counter (OTC) Rapid Antigen tests and Point of Care (POC) Nucleic Acid Amplification Tests (NAATs). This is inclusive of preserving and expanding end-to-end, current peak manufacturing, throughput, workforce, quality management, packaging and labelling and distribution capacities. HHS ASPR is also interested in any vertical integration of supply chains that would be leveraged to gain efficiencies in the preservation and expansion of manufacturing capacities. In addition, HHS ASPR is interested in any expansion activities that would be leveraged to enhance capacity to produce diagnostics or conduct diagnostic tests to detect pathogens beyond SARS-CoV-2 (COVID-19), for existing or emerging infectious diseases and future public health emergencies. Such diagnostics could be for individual pathogens or designed to detect multiple pathogens within a single test.

HHS ASPR is seeking information from manufacturers for:

· Any supply chain considerations and feedback on implementation of vertical integration efforts to gain efficiencies for preserving current peak throughput, manufacturing capacities and expanding domestic manufacturing capacities.

· What is needed for preservation of current peak throughput, manufacturing capacities and expanding of current capacities for lab-based tests, OTC Rapid Antigen and POC NAATs. This is inclusive of supply chain needs (reagents, media, swabs, membranes, cases, and other ancillary components), options for vertical integration of identified supply chain needs, and any workforce, quality management, equipment, facility, packaging and labeling and distribution needs.

Interested companies are encouraged to determine if they have information pertaining to this topic. HHS is investigating the need to expand existing domestic, economically viable, merchant supplier production capabilities to achieve the goals above for use in health security applications. Emphasis is placed on rapidly establishing projects that support preserving and expanding current peak manufacturing capacities.

Typical tasks may include procurement, installation, and qualification of testing and production equipment; manufacturing line prove-out; workforce preservation, quality management, production of samples for customer and/or Government evaluations; and the implementation of business and marketing plans. Additionally, HHS ASPR is interested in any information pertaining to pricing of raw materials/feed stock, the commercial demand for this product, vertical integration of supply chains, or the potential dual use of any production equipment for health security and commercial applications.

In addition, HHS ASPR is interested in any expansion activities that would be leveraged to enhance capacity to produce diagnostics or conduct lab-based testing to detect pathogens beyond SARS-CoV-2 (COVID-19), for existing or emerging infectious diseases and future public health emergencies or emerging infectious diseases. Such diagnostics could be for individual pathogens or designed to detect multiple pathogens within a single test.

REQUIRED RESPONSES

Limit RFI responses to 30 single-sided, single-spaced pages in no less than 11-point font.

*** Responses must be UNCLASSIFIED *** ***Proprietary information provided must be marked appropriately*** To protect such data, each line or paragraph on the pages containing such data must be specifically identified and marked with a legend similar to the following:

“The following contains proprietary information that (name of Responder) requests not be released to persons outside the Government, except for the purposes of review and evaluation.”

Responses must be submitted in the following format:

TITLE: Preservation and Expansion of Current Domestic Capacities for Laboratory-Based Testing and Manufacturing of Over-The-Counter (OTC) Rapid Antigen and Point-Of-Care (POC) Nucleic Acid Amplification Tests (NAATs)

PART I: Business Information Please provide the following business information for your company/institution and for any teaming, joint venture partners, or subcontractors:

· Phone Number:

· E-mail Address:

· Web Page URL:

Government Proposed North American Industry Classification System (NAICS) Codes:

· 325413 - In-Vitro Diagnostic Substance Manufacturing

· 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

· 334516 - Analytical Laboratory Instrument Manufacturing

· 423450 - Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers

· 424210 - Drugs and Druggists’ Sundries Merchant Wholesalers

· 541380 – Testing Laboratories

· 621511 - Medical Laboratories

Based on the Government proposed NAICS Code, state whether your company is:

· A statement as to whether your company is domestically or foreign owned (if foreign, please indicate the country of ownership).

PART II: Capability Survey General Capability Questions

1. Provide an insight into the nature of potential problems in your industry (e.g., lack of production-scale capability, market demand for lower cost item), and how addressing those problems would help sustain or expand domestic capacity for laboratory-based testing or manufacturing capacities for OTC or POC NAAT tests.

2. How can the U.S. Government mitigate or solve the problem?

3. Describe your company's experience on previous projects similar in complexity to this requirement. Include contract numbers, a brief description of the work performed, period of performance, agency/organization supported, and an individual point of contact (Contracting Officer or Program Manager).

4. What quality assurance processes and test qualification practices does your company employ? Provide a description of your quality program (ISO 9001, AS9100, etc.).

a. Provide a detailed quality plan implementing AS9100 (or equivalent).

b. Provide a Quality System Regulation/Medical Device Good Manufacturing Practices (CGMP) as described in 21 CFR 820.

5. Summarize the technical expertise at the Senior levels (i.e., Leadership and Key Personnel).

6. Delineate supply chain expertise, qualifications, and certifications to ensure supply chain resilience (in house or third party).

7. Provide experience of key personnel in manufacturing and supply chain management. If none then state NONE.

8. Provide the regulatory qualifications, experience, and certifications of the key personnel.

9. Please describe your experience or understanding of the regulatory approval process?

10. What security measures do you have in place to mitigate technological threats to production?

PART III: Specific Topics Technical Questions

1. Provide a clear description of the proposed product, throughput, technology needs, and supply chain constraints.

2. What is your company’s current maximum capacity per month for this requirement? Provide information on any facility reserves you may possess.

3. Describe the advantages of the proposed technology, process, manufacturing and distribution methods over existing technologies and substitutes in terms of cost, performance, public health benefits gained, and other factors.

4. Provide clear and definitive details of the equipment and instrumentation already in place. In your testing or manufacturing process, do you use newer technologies such as automated digital monitoring to help detect and correct problems in real time, avoid waste, and improve efficiency? If yes, please describe. Your answer will not bear on your qualification on future proposals.

5. In describing the supply chain constraints, potential for vertical integration, throughput, manufacturing, workforce, quality management, packaging, labeling and distribution needs, please detail the required raw materials, workflows, and other contributing facets to manufacturing, scaling and distribution.

6. Please provide information on the key barriers and constraints that your company faces in the conducting lab-based testing or manufacturing OTC rapid antigen and/or POC NAATs (i.e. regulatory, legal, legislative, policy, staff constraints, budget limits, decreased business due to higher production costs, etc.). Your answer will not bear on your qualification on future proposals.

7. Please provide a clear and definitive description of any supply chain needs, proposals for vertical integration to gain manufacturing efficiencies, as well as manufacturing, throughput, workforce, quality management, packaging, labeling and distribution needs, along with any additional supporting documentation that would validate your company’s position.

8. Please also clearly provide specifics for what is required to preserve current peak manufacturing capacities and to expand production capacities in the next 12-24 months, along with any additional supporting documentation that would validate your company’s position.

9. Please include an assessment of the accessibility of your company’s testing capacities, OTC rapid antigen test and/or POC NAATs—including self-administration and result interpretation—for people who are blind or visually-impaired; individuals with physical, cognitive, or other disabilities; and individuals who need non-English language or literacy support. If your company’s product is largely inaccessible for these individuals, please provide a clear and definitive description of how you can improve accessibility.

Market Dynamics Questions

1. Explain how competition and other market factors have affected domestic industrial capabilities within your industry.

2. Provide details and insight on similar and competing products or technologies for both Government and commercial applications, and the strengths and weaknesses of your technology, testing capability and/or manufacturing process. Cite market shares and trends, if possible.

Competitiveness and Risks Questions

1. Are there new technologies or approaches you feel may have great potential for improving the production quality, speed, and/or volume of testing or manufacturing?

2. Include an assessment of the time and cost to bring the new capacity on-line and competitiveness with other sources (domestic or foreign) or with alternative technologies. Address all factors, including the company’s current financial position and long-term financial stability.

3. How might a disaster (global pandemic, local natural disaster, cybersecurity attack etc.) disrupt your production or your ability to service or supply your customers?

4. What risks are you incurring with increased reliance of domestic sources? What combinations of foreign, near shore or onshoring would you recommend for your industry?

Regulatory Questions

1. Please provide information compliance-based regulatory/quality issues including but not limited to the provision of a timeline and supporting information that you have met.

2. Provide describe your methodology, testing strategy, and results to ensure your products meet public health oversight/compliance requirements around safety and/or efficacy; and share objective statistical data.

Manufacturing and Supply Chain Resilience Questions

1. Please provide details about your appropriate FDA certifications and validation.

2. Please provide national scalability potential and capacity (e.g. Memorandums of Understanding (MOUs)/ Letters of Intent (LOIs)/evidence of partnership networks, purchase orders, and sales) to ascertain your firm’s viability.

3. Briefly describe your Supply Chain Strategy and how it integrates and adds value to your business model/plan.

4. Describe how your Supply Chain Strategy increases resilience in the following two ways.

a. Your strategy anticipates or resists emerging/unforeseen disruptions.

b. Your strategy’s design to recover from disruption if/when it has occurred.

5. Describe partnerships, licensing arrangements, or other commercial agreements that might help to reach scale more quickly and what terms and conditions would be required.

6. What level of foreign suppliers sourcing do you use within your supply chain? What would it take to increase domestic sourcing in your supply chain?

7. What would be other strategies to maintain domestic capability throughout the supply chain?

REQUESTS FOR CLARIFICATION POINTS OF CONTACT:

A responder may request clarification in writing from the Contracting Office for any requirement that is unclear by sending an e-mail to the Contracting Point of Contact: Charles.Strickland@hhs.gov.

Any requests for clarification must be received no later than seven (7) business days prior to the close of this RFI in order to receive a timely response. Clarifications may be posted on the RFI announcement website to benefit all interested responders. Interested responders are encouraged to periodically check the website during the response period for clarifications.

FORMAT & PAGE LIMITATION

Your submittal should be provided on standard letter size 8-1/2 by 11inch paper, limited to a maximum of 30 single-sided, single-spaced pages. The font for text should be Times New Roman 11-point or larger. The Responder may use oversize pages (including “foldouts”) where appropriate to contain graphic presentations. Oversize pages do not count as extra pages within the page limitations. Submitted responses should be in Microsoft Word or Adobe Acrobat format. Existing commercial documentation and product literature can also be submitted and is not subject to a page limitation. Note: Responses must be unclassified. Reponses may contain proprietary information but must be appropriately marked.

SUBMISSION OF DOCUMENTATION

Documentation shall be delivered to the Contracting Office at the following address:

Charles Strickland 200 Independence Avenue, SW Washington, DC Charles.Strickland@hhs.gov

INFORMATION APPROACH

HHS-ASPR may or may not select any of the listed technology areas for use as a project. Projects developed from these topics, as with all projects, may be competed in a full and open competition. HHS ASPR is not required to provide feedback to responders. HHS ASPR may respond directly to obtain additional or clarifying information.

DISCLAIMER

This is a RFI only as defined in FAR 15.201(e) to obtain information about Technology Readiness Levels (TRLs), Manufacturing Readiness Levels (MRLs), capabilities and market information related to the technology of interest for planning purposes. Of particular interest are the technical, manufacturing and market barriers to establishing a viable business for the technology of interest. This RFI is not a request for competitive proposals; therefore, responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. Companies that respond will not be paid for the information submitted. No telephone calls will be accepted requesting a bid package or solicitation.

OPERATIONS SECURITY (OPSEC) REQUIREMENTS:

All responses to this document shall follow appropriate OPSEC measures. This is required to reduce program vulnerability from successful adversary collection of possible sensitive unclassified and/or proprietary information, and violations of export control requirements. Guidance can be provided by HHS ASPR Security as needed. Please note, any potential critical program information (CPI) generated as part of this response will be reviewed to determine the need for a Program Protection Plan (PPP) or to be included as part of an existing PPP.

ADDITIONAL INFORMATION

Additional information about HHS ASPR is available on the following website: www.phe.gov.

All responsible sources may submit information in response to this RFI.

Responses to this RFI are due no later than 16 March 2022 If late information is received, it may be considered by the Government reviewers, depending on agency time constraints. Please note, the Government is not required to provide feedback to RFI responders. Direct all inquiries to the Contracting Points of Contact listed in the Requests for Clarification Points of Contact paragraph.