ASPR COVID-19 Testing Industry Day Response for Information Request

8July21 - This Special Notice is updated to reflect a change to the Industry Day Date to Tuesday, July 27, 2021.

ASPR COVID-19 Testing Industry Day Response for Information Request

I. Background

The purpose of this request for information (RFI) is two-fold

• Solicit inputs on lessons learned from diagnostic test makers, related consumables manufacturers, upstream suppliers, and commercial laboratories during the COVID-19 pandemic to better prepare for the next phase of the pandemic (including but not limited to lessons related to nucleic acid amplification tests, antigen tests, and next generation sequencing tests)
• Understand potential strategies for maintaining pandemic preparedness in the next 12-18 months or after the COVID-19 public health emergency is over. Potential options include warm base manufacturing, flexible contracting, stockpiling, and industrial base expansion.

This RFI is targeted towards private sector diagnostic testing manufacturers, related upstream suppliers, and commercial laboratories who might partner with the United States Government (USG) in executing on this vision.

This is not a solicitation for proposals, proposal abstracts, or quotations. Information provided in response to this request will not be shared or released publicly.

Please specify whether these responses are for United States Government (USG) access only or if the USG can share your responses with other industry participants during Industry Day by writing [Industry Day Access] at end of response.

Please submit your final responses to Section 1 & 2 of this RFI no later than Thursday, July 15th by 5 PM ET. Submit responses electronically, with subject Testing Industry Day [Company Name] RFI Response to TDWGInfo@hhs.gov.

The Industry Day will be on Tuesday, July 27nd. Submit general questions relating to the RFI or Industry Day via email to TDWGInfo@hhs.gov.

This is a request for information only and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned.

All information received in response to the RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract.

Instructions

Please submit a white paper not to exceed three (3) pages that provides perspectives on the questions in Section 1 and 2. Responses should be single-spaced in Times New Roman 12-point font.

Responses are encouraged in writing prior to Industry Day to allow the USG time to synthesize early insights and incorporate them into discussions with industry participants on Industry Day.

Section 1: Lessons Learned from COVID-19 Pandemic

The Office of the Assistant Secretary for Preparedness and Response (ASPR), in coordination with other Department of Health and Human Services (HHS) agencies, is responsible for meeting the United States' pandemic testing needs through the end of the COVID-19 public health emergency and in future pandemics.

As part of that responsibility, ASPR is beginning to synthesize lessons learned from the COVID-19 pandemic, to prepare for the remainder of this pandemic and inform longer-term planning.

Questions

Please describe key challenges and opportunities you experienced as a manufacturer or commercial laboratory over the course of the pandemic in the following areas. For each, please describe the challenges and opportunities, as well as any recommendations for how the USG can mitigate or resolve any challenges you experienced in the following areas

1. Engaging with the USG on potential funding and procurement opportunities
2. Discussing, providing projections, and problem solving with the USG in the following areas
   a. Supply chain constraints
   b. Research and Development (R&D) developments
   c. Manufacturing capacity
   d. Testing capacity
3. Communicating with the USG about other questions and concerns
4. Engaging with the USG across multiple efforts or agencies related to the pandemic response
5. In general, please describe challenges you have experienced in scaling up your manufacturing and supply chain in the COVID-19 pandemic thus far

Section 2: Potential Strategies for Future Preparedness

Beyond soliciting industry perspectives on lessons learned from the COVID-19 pandemic, the USG is interested in perspectives on strategies to ensure preparedness for potential future pandemics. Please answer all questions that are relevant to your organization's operations.

Specifically, this RFI seeks information / insights related to the following strategies

1. Warm base manufacturing
2. Flexible contracting
3. Stockpiling
4. Industrial base expansion

Below are definitions of the strategies listed above.

1. Warm base manufacturing
   • Government purchases rights to future capacity through support of facilities that enable rapid scale-up of production
     
2. Flexible contracting
   • Government reserves right to purchase existing inventory
     
3. Stockpiling
   • Building reserves of critical supplies for future use, including both raw materials (e.g.. resin, plastics, reagents) and finished goods (e.g., media, swabs, pipette tips, tests, instruments)
     
4. Industrial base expansion
   • Government-funded investments to expand manufacturing capacity, reduce bottlenecks and reduce offshore manufacturing for supply chain components (e.g., pipette tips), testing supplies (e.g., swabs), and tests (e.g., lab-based, point of care and home-based)

Questions

Warm Base Manufacturing

1. What are you doing to assess production capacity of diagnostics and diagnostic-related supplies for the next 12-18 months? Beyond the next 18 months?
   a. How often are you assessing demand? What are your future plans for existing capacity? When will you make decisions on how to use capacity?
   
2. From your perspective, is maintaining a warm base of manufacturing capacity an effective option to prepare for future pandemics? If, so, are there specific strategies you would recommend?
   
3. What challenges do you foresee with maintaining scaled up manufacturing and supply chains over the next 12-18 months? Beyond the next 18 months?
   a. Do you have any recommendations for how the USG can mitigate or resolve any challenges you experienced moving forward?
   
4. If you believe maintaining a warm base of manufacturing capacity is needed, what support would you expect from the USG?
   a. For which products or components do you consider warm base manufacturing important for improving preparedness for future pandemics?

Flexible Contracting

1. If applicable, what challenges or opportunities have you experienced in using government contracting? (e.g., especially effective or ineffective contracting mechanisms)
   a. Do you have any recommendations for how the USG can mitigate or resolve any challenges you experienced moving forward?
   
2. From your perspective, is flexible contracting with the USG an effective lever to prepare for future pandemics? (e.g., USG has right to buy at a to be determined future date)
   a. What types of flexible contracts would be most attractive to you?
   
3. If you believe flexible contracting is needed, what types of contracting mechanisms would you find most useful over the next 12-18 months? Beyond 18 months?

Stockpiling

1. What products and components related to diagnostic testing should be considered for stockpile in the next 12-18 months? Beyond 18 months? Why?
   a. If you suggest more than one product or component, please list them from highest to lowest priority and provide a rationale
   b. If there are upstream materials related to the products or components listed above that need to be stockpiled, please list them from highest to lowest priority and provide a rationale
   c. Are there other markets that would be impacted by stockpiling efforts in the production of the products or components?
   
2. Without stockpiling, what would be your steady state production level for the products and components listed above in the next 12-18 months and after the public health emergency is over?
   
3. How long will it take you to ramp up production of the products and components mentioned above to full capacity from steady state?
   
4. What are the main concerns or challenges related to stockpiling the components and upstream materials you mentioned above?
   a. What do you think is needed to mitigate those concerns or challenges?
   
5. If stockpiling is needed, what support would you expect from the USG?

Industrial Base Expansion

1. For products related to COVID-19 diagnostics testing, do you see industrial base expansion as a useful mechanism for pandemic preparedness for the next 12-18 months? Beyond 18 months? Why?
   
2. If you think industrial base expansion is needed, which products and components will need expansion of production capacity? Why?
   a. If you list more than one, please rank them from the highest to lowest priority
   b. What is your current production capacity for each product?
   
3. What timeframe of industrial base expansion do you think is reasonable for future pandemic preparedness?
   
4. What are the main concerns related to industrial base expansion as a potential mechanism for future preparedness?
   1. What do you think is needed to mitigate those concerns?
      
5. If industrial base expansion is needed, what support would you expect from the USG?