Attachment 04 Questions and Answers Batch 2.pdf

Question # Question Response

Would we have the flexibility to work with partners (subcontractors) if necessary? Yes

Will the Prime contractor be responsible for compensating the laboratory vendor? Yes

3 Is this expected to be a multiple award IDIQ contract?

No, not anticipated to be a Multiple Award Indefinite Delivery / Indefinite Quantity (MA IDIQ) contract. The Government intends awarding up to four Other Transaction Authority (OTA) agreements.

4 What is the anticipated value of the Coordination Hub contract? The Government is not able to answer at this time.

What compensation methodology is anticipate; eg per test unit fixed fee, FFP or T&M for logistics support? The Government intends to award up to four Firm Fixed Price (FFP) agreements.

6 What are the criteria to be selected? Any and all evaluation criteria will be detailed in the Other Transaction Authority (OTA) Announcement.

Can a contractor be awarded more than one hub or Coordinating Center? RFI ‐ all award criteria will be detailed in the Other Transaction Authority (OTA) Announcement

How is reimbursement for services provided contemplated in this model? The Govt intends to award up to four Firm Fixed Price (FFP) agreements.

Will HHS circulate any presentations or materials from the virtual engagement following the event? General information will be posted to beta.SAM. Industry Event specific information will be shared with invited parties.

10 Expected Volumes (Will this be awarded by state?) The Government intends to award up to four Firm Fixed Price (FFP) agreements.

11 Will this be released as an RFP? The Govt will release an Other Transaction Authority (OTA) Announcement on beta.SAM.

6. Billing

a. Will program management services be billable?

b. Will we be required to bill any services to insurance or other third parties? Or will all services be billed to Coordinating Centers and Coordinating centers then bill to HHS directly? The Govt intends to award up to four Firm Fixed Price (FFP) agreements. Please refer to the Other Transaction Authority

(OTA) Announcement.

7. Process/Other

a. When will a final RFP be issued? How long will vendors have to respond?

b. What is the envisioned overall timeline for the program to begin and end?

c. Are all 4 coordinating centers expected to be equal in size (i.e., 25 million tests per month each, or ~6.25 million tests / month?)

d. Are there any considerations for a scenario where vendors make large investments to support the program but testing volumes do not materialize?

e. Could there be a commitment to purchase minimum volume thresholds?

f. What key elements of the proposal will guide your decision process?

g. What coordination will there be with state programs that overlap this effort? How does this differ from state programs?

Please refer to the Other Transaction Authority (OTA) Announcement and Statement of Objectives (SOO).

14 How will billing be addressed? Please refer to the Other Transaction Authority (OTA) Announcement

What is the expected reimbursement for acting as a Coordinating Center beyond the reimbursement for COVID‐19 testing? Please refer to the Other Transaction Authority (OTA) Announcement.

16 Is this throughout 2021? Please refer to the Other Transaction Authority (OTA) Announcement.

In addition to all of the support for the coordination hub functions, what amount, if any, of financial or other resource support to you expect to offer the Testing Laboratories themselves in order to expand their capacity and customized tests and their accessioning protocols to better suit Educational and other under‐served community support

Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement. Offeror's are required to build all applicable pricing elements into the Contract Line Item Pricing Template provided with the OT.

Is it expected the government will make 4 awards, one for each coordination center, and each coordination center is responsible for establishing its own laboratory network as a part of its proposal? Or will the government issue separate awards to Coordination Centers and laboratories?

The Government intends to award up to four Firm Fixed Price (FFP) agreements. Each coordination center will be responsible for establishing its own laboratory network as part of its proposal.

Section 3, line 106 states the government will deliver “one‐time startup equipment to the laboratories.”

a. Will the government provide equipment/cover costs necessary for each hub/lab to scale for surge testing as described in section 5.1? If additional capital equipment is needed for a hub to scale from 1.5m to 3m tests to surge, should that be identified in a proposal?

b. Will the government procure lab equipment directly through a separate contracting initiative or will the equipment be procured through the Coordination Center Primes?

c. If the government does not perform procurement directly, will Coordination Centers or labs be authorized to procure products and services under GSA schedules via a FAR51 letter?

Section 3, line 105/106/107 states "First, USG contracted coordination centers will deliver materials and one‐time startup equipment to the laboratories with an emphasis on expansion of fully operationalized testing platforms."

Offeror's are required to build all applicable pricing elements into the Contract Line Item Pricing Template provided with the OT.

If the offeror has a SURGE threshold in which additional laboratory equipment would be required, that shall be specified in its proposal.

If an offeror requires a GSA Schedule for the procurement of products, that shall be identified in its proposal.

What will be the past performance requirements for Coordination Centers and labs? Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

What will be the evaluation criteria overall? (i.e. LPTA, best value) Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

Will a potential RFP be “full and open” or will there be any small or disadvantaged requirements at either the Prime or Sub/lab level? The Other Transaction Authority (OTA) Announcement will not be restricted.

Will RADx awardees with excess capacity given any special consideration or be paired with Coordination Centers or labs to maximize the government’s previous investments?

This is a stand alone requirement. Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

How will funds be distributed across the Coordination and partner labs? The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements.

What is the timeline for the pilot? Why is this being run as a pilot? How long does HHS envision running this program? 6 month and max a year per document?

Please refer to the Other Transaction Authority (OTA) Announcement for timeline. This is not a pilot, but a prototype seeking innovative solutions to demonstrate the ability to establish regional coordination hub(s) for expanding COVID testing capacity.

Please give an example of Organizational Conflict of Interests (OCI) and speak to how this will be addressed.

An Organizational conflict of interest means that because of other activities or relationships with other persons, a person is unable or potentially unable to render impartial assistance or advice to the Government, or the person’s objectivity in performing the contract work is or might be otherwise impaired, or a person has an unfair competitive advantage. It is the offeror's responsibility to identify OCIs, if any, and mitigate them.

If a company has established relationships with school districts, and that company is not selected to participate in this program, will these school district not be allowed to utilize the company as their lab partner?

The US Government is not restricting any arrangements as a part of this effort. It is the responsibility of the coordination center to establish agreements as necessary to conduct testing.

3. Permissible Award Uses:

a. Are the coordinating centers responsible for billing for testing performed at the testing laboratories (academic, commercial, etc.) within the hub?

b. Is third party reimbursement required for testing or is that included as part of this award?

c. How much of the award maybe used for direct vs. indirect costs?

All expenses related to execution of the SOO are to be included in the offeror’s proposal. All billing will be through the prime contractor for each OTA Agreement. No third parties, such as insurance, shall be billed. Additional billing instructions and timelines will be included as part of the agreement between the selected offeror(s) and the USG.

Would it be beneficial to offer insurance billing for lab testing and/or specimen collection?

All expenses related to execution of the SOO are to be included in the offeror’s proposal. All billing will be through the prime contractor for each OTA Agreement. No third parties, such as insurance, shall be billed. Additional billing instructions and timelines will be included as part of the agreement between the selected offeror(s) and the USG.

Thank you for offering government contracted support to the coordinating centers. We’d like to advocate for these resources to be assigned at the time of contracting. Building this strong collaboration early is helpful to the success of the team and regional hub. Can you give us insight on when these resources will likely be available?

The additional support is anticipated to be available at the same time as award of the agreement for the coordination center, or shortly thereafter.

Understanding on how the model will be funded and how government funds will be allocated. Will there be future funding allocated to this program? Is the current funding for the 6 month period only or beyond? This will be critical for the coordinating centers to review the regional budget and establish partnerships accordingly. Please refer to the Other Transaction Authority (OTA) Announcement and Statement of Objectives, for the requirement.

32 How will the coordination center’s services be reimbursed? Please refer to the Other Transaction Authority (OTA) Announcement and Statement of Objectives, for the requirement

The Statement of Objectives, Section 5.2., lines 189‐191 states, “The contractor (serving as the coordination center) shall identify and enter into appropriate contractual relationships with as many laboratories as necessary (e.g., ten) to complete the testing requirement identified in Objective 5.1. Does this mean that the contractor will be responsible for payment to the laboratories? Is there any recourse with the federal government if the contractor does not pay the laboratories?

Yes, the coordinating center is responsible for all agreements with the laboratories. Any late payment or non‐payment recourse by the laboratories providing testing services in support of the awardees to this OTA would be limited to action(s) against the same.

If an entity has partnerships with other labs throughout a region that can assist with this requirement, when should those partnerships be identified? Please refer to the Other Transaction Authority (OTA) Announcement and Statement of Objectives, for the requirement

Will participating organizations (e.g. school system) pay for the testing? Or will testing be provided free of charge to the entity?

Testing is free of charge to the entity. Offeror's are required to build all applicable pricing elements into the Contract Line Item Pricing Template provided with the OT.

Sample collection will not be conducted by the Coordinating Center and will be the responsibility of the state, local or school authorities. The Coordinating Center can provide guidance and assistance in implementing a collection protocol that local agencies and schools will perform in order to achieve the desired testing objective.

Outreach and social marketing. Targeting "[s]chools, shelters, and organizations in underserved communities" entails substantial social marketing capabilities ‐ can these be subcontracted or must these be organic capabilities of the offeror?

These will be the responsibility of the coordination center but may be subcontracted as necessary to obtain the objectives of the SOO

Test procurement. On page 8, the statement says the Feds "will maintain a list of preferred EUA test suppliers with known areas of excess capacity, which may be amended as needed from time to time." How compulsory would use of these suppliers be? This requirement has been revised. Please refer to the most recent version of the SOO.

Will the regional coordinating centers be based on the existing FEMA/USG federal response regions? Regional coordination centers are as established in the SOO and are based on consolidation of existing HHS regions.

What is the coordination center's role in reimbursement of laboratories for tests performed? Does the coordination center have responsibility for disbursing funds to laboratory partners?

What pricing model to you anticipate coordinating centers use to reimburse participating labs?

The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements.

Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

Can you clarify how you anticipate asking vendors to price this contract? Will it be one of the following models: per test, Fixed Price, Cost Plus, T&M, etc.? Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

Would it be beneficial to offer insurance billing for lab testing and/or specimen collection?

No third parties, such as insurance, are anticipated at this time to be billed. Additional billing instructions and timelines will be included as part of the agreement between the selected offeror(s) and the Government.

Does excess capacity to reach >150,000 tests per week mean a lab which can otherwise be helpful and the meet the requirement, but which has excess capacity of less than that amount will be excluded from participation?

Individual labs do not need to meet any requirement. The coordination center as a whole has an objective as established in the SOO.

What are the mechanisms for payment of tests? Are there centralized funds to support school testing? Are schools going to pay labs directly or through the coordinating center

All expenses related to execution of the SOO are to be included in the offeror’s proposal. All billing will be through the prime contractor for each OTA Agreement. No third parties, such as insurance, shall be billed. Additional billing instructions and timelines will be included as part of the agreement between the selected offeror(s) and the Government.

We are building out an expansion laboratory for this purpose that will be functional in early May. Current excess capacity is approximately 25K tests per week. Do you expect there will be any flexibility in the timeline as ramp‐up occurs?

Individual labs do not need to meet any requirement. The coordination center as a whole has a requirement as established in the SOO.

45 When will the list of preferred vendors be published? This requirement has been revised. Please refer to the most recent version of the SOO.

What is the guidance for test manufacturers who apply as a coordinating center and want to also supply tests? The test manufacturer must meet the objectives in the SOO

47 Will testing be free for K‐8 schools (funded entirely by HHS)?

Testing is free of charge to the entity. Offeror's are required to build all applicable pricing elements into the Contract Line Item Pricing Template provided with the OT.

Would you please describe how the list of preferred diagnostic tests will be developed and modified to ensure manufacturers have clarity and predictability necessary to ensure effective partnership? This requirement has been revised. Please refer to the most recent version of the SOO.

How will you address surge and sample variability under a FFP contract?

Actual testing will be reimbursed on a per test basis. Please refer to the Other Transaction Authority (OTA) Announcement for more information

You mention no insurance, 3rd party billing, does that mean insurance information will not be collected or utilized for downstream billing? Yes.

Coordination Requirements: What’s the timeframe in which this program should be available? Please refer to the Statement of Objectives (SOO).

Please clarify whether a detailed plan is acceptable or if bidders must have subcontracts with all labs in place at the time of submission. Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

53 Will the RFP require a test protocol as part of the response? Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

How will the government assure coordinating labs don't unfairly exclude smaller local competing labs from participating in the program? The coordination center is responsible for meeting the objectives of the SOO.

Will the hardware and service cost need to be included in the price of the test?

Offerors are required to build all applicable pricing elements into the Contract Line Item Pricing Template provided with the

OT.

How does a test Lab ensure their EUA approved testing and capacity availability are listed on the preferred government list? This requirement has been revised. Please refer to the most recent version of the SOO.

Should labs respond to OTA or wait to work with selected Coordination Centers?

The OTA responses are expected from coordination centers only. The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements. Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

If we are a lab, how does a lab get paid? Through the coordination center or direct from USG?

The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements.

Please refer to the Statement of Objectives (SOO) for additional information.

59 Will it be a fair process to provide bids to the coordinating sites?

The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements.

Please refer to the Statement of Objectives (SOO) for additional information.

Will Coordinating Centers be identified prior to RFP submitting date and do we, commercial labs, partner with Coordinating Centers directly or do we submit an RFP to beta.sams?

The OTA responses are expected from coordination centers only. The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements. Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

61 Is any part of this solicitation for set‐aside companies?

The US Government is not restricting any arrangements as a part of this effort. It is the responsibility of the coordination center to establish agreements as necessary to conduct testing.

62 Should entities apply for a specific region? Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

63 How are the proposals going to be evaluated? Please refer to the Other Transaction Authority (OTA) Announcement, for the evaluation criteria.

Is the upcoming RFP focused on contracting with coordination centers or with assay developers?

The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements.

Please refer to the Statement of Objectives (SOO) for additional information.

Will there be a separate RFP process specifically for laboratories?

No. The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements. Please refer to the Statement of Objectives (SOO) for additional information.

Can multiple entities apply as a partnership? For example a manufacturer and service provider.

The US Government is not restricting any arrangements as a part of this effort. It is the responsibility of the coordination center to establish agreements as necessary to conduct testing.

Will RFPs be required to include purchase agreements or contracts with test kit manufacturers? Please refer to the Other Transaction Authority (OTA) Announcement, for the requirement.

Will there be separate contracting for collection kits and other supplies or is that expected to be incorporated into the lab cost?

Offerors are required to build all applicable pricing elements into the Contract Line Item Pricing Template provided with the

OT.

Who is bidding on this RFP ‐ Coordination Centers or Labs? Or both?

Coordination Centers only. The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements. Please refer to the Statement of Objectives (SOO) for additional information.

70 Can you define "white papers"? Please refer to the Other Transaction Authority (OTA) Announcement.

Will the white papers allow for links with references including videos?

The white paper submission must adhere to the page and other limitations outlined in the Other Transaction Authority (OTA) Announcement. The USG will not review or evaluate White Paper reference links.

Can a single organization serve as multiple region’s Coordination Centers?

Yes. If an entity is interested in more than one (1) region, they may submit one (1) White Paper addressing the region(s) they are interested in. If an entity proposes on more than one (1) region, a separate proposal for each region shall be submitted.

Will the reimbursement to the laboratory per test be the same as CMS guidelines? Please refer back to the Other Transaction Authority (OTA) Announcement.

Does the government anticipate that schools or school systems will incur costs for the testing? If so, does the government anticipate subsidizing these costs?

Testing is free of charge to the entity. Offeror's are required to build all applicable pricing elements into the Contract Line Item Pricing Template provided with the OT.

Sample collection will not be conducted by the Coordinating Center and will be the responsibility of the state, local or school authorities. The Coordinating Center can provide guidance and assistance in implementing a collection protocol that local agencies and schools will perform in order to achieve the desired testing objective.

Will the coordinating centers work with partners in terms of services payments (e.g. if there are unique vendors for collection, logistics and laboratory processing, would they facilitate payment between those entities or would this follow a traditional billing model)?

The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements.

Also, please refer back to the Other Transaction Authority (OTA) Announcement.

How will the Lab contracting aspect work ‐ you mentioned that the contract will be awarded to the Coord Centers ‐ will labs need to sub contract or will lab capacity be identified centrally and then distributed to maximize the capacity available and ensure regional distribution.

The coordination center is responsible for establishing agreements with the partner labs to include funding arrangements.

Please refer to the Statement of Objectives (SOO) and the Other Transaction Authority (OTA) Announcement for additional information.

77 Is CMS pricing going to be used for the labs? Please refer back to the Other Transaction Authority (OTA) Announcement.

Will faster turnaround time (< 1 day or same day) be considered as a differentiator during the contracting process? Please refer back to the Other Transaction Authority (OTA) Announcement.

What expenses are expected to be covered through these contracts (e.g., lab operating expenses, lab capital buildout, related infrastructure) and through what funding mechanisms (e.g., per‐test, cost‐based)?

All labor and material expenses required to execute the Statement of Objectives (SOO). Also as outlined in the Other Transaction (OT) Announcement.

80 What is the duration of this contract?

The anticipated duration of the contract is stated in the Statement of Objectives (SOO). Also as outlined in the Other Transaction (OT) Announcement.

Will you consider a single technology platform to power all coordination centers and labs so standardized data collection and thus analysis on a local, state, regional and National level is possible?

Entities will be asked to submit their plans for testing, which may include using EUA, LDT and/or RUO. Molecular methods are not required. Assays and work flows that meet throughput and time requirements will be considered. The U.S.

Government seeks to ensure that proposals which meet this requirement will not redirect capacity away from another constrained sector of the U.S. diagnostic market. Proposal of EUA tests is acceptable with proper justification that it won't create impacts elsewhere.

Can we implement validated Laboratory developed pooling methodologies?

Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

i. How are you thinking about tiered testing (ex. Antigen to PCR, Pooled to PCR, Pooled to Antigen to PCR)? Is pod‐based school testing being considers?

Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

Will pooling be a part of the testing strategy for this expansion plan?

Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

It seems that recurring pool testing with reflex testing for those positive pools would be the most cost effective use of the funding. Why would pooling not be the preferred approach rather than testing everyone?

Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

86 How will pooling strategies be used for surveillance, if at all?

Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

87 Topic where questions will be centered: pooling of samples

Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

88 Are you including pooled testing in your scope?

Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

89 c. Are there specimen pooling expectations?

Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

Will use of High Ratio PCR Pooling strategies (either alone or in combination with other testing methodologies) be considered to significantly reduce cost of testing and extending the reach of appropriated funds while maintaining high levels of sensitivity and minimizing number of false negatives or positives?

Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

If High Ratio PCR Pooling is included will reflex testing be required at the lab without the need to return to the classroom for re‐testing of students in the positive pool?

Pooling is a strategy that can be implemented as part of this testing expansion effort, but is not required. Technical proposals should highlight the strengths/weaknesses, risks/mitigations of the pooling approach. Offerors should make special note of FDA and CDC guidance related to the topic, especially around requirements for reportable results for pooled methods.

How does genome sequencing of positive test results fit in this program?

Sequencing strategies can be proposed as part of this effort, but are not required. Proposals including sequencing should detail technical approaches that will enhance the testing program while maintaining the coordinating center’s ability to meet the U.S. Government's primary requirements.

93 Will NGS testing options be considered?

Sequencing strategies can be proposed as part of this effort, but are not required. Proposals including sequencing should detail technical approaches that will enhance the testing program while maintaining the coordinating center’s ability to meet the U.S. Government's primary requirements.

Will addition of rapid genomic sequencing by coordination centers and some participating labs be considered as part of the testing ecosystem to reduce community spread and increase safety of school systems and underserved populations?

Sequencing strategies can be proposed as part of this effort, but are not required. Proposals including sequencing should detail technical approaches that will enhance the testing program while maintaining the coordinating center’s ability to meet the U.S. Government's primary requirements.

Will addition of rapid genomic sequencing by coordination centers and some participating labs be considered as part of the testing ecosystem to reduce community spread and increase safety of school systems and underserved populations?

Sequencing strategies can be proposed as part of this effort, but are not required. Proposals including sequencing should detail technical approaches that will enhance the testing program while maintaining the coordinating center’s ability to meet the U.S. Government's primary requirements.

Will there be a requirement for SARS‐CoV‐2 gene targets and/or inclusion of additional respiratory pathogens such as influenza?

Sequencing strategies can be proposed as part of this effort, but are not required. Proposals including sequencing should detail technical approaches that will enhance the testing program while maintaining the coordinating center’s ability to meet the U.S. Government's primary requirements.

Will manufacturers with EUAs pending (not yet approved) be considered for award? Are EUA’s allowed?

Testing paradigms utilizing RUO/LDT tests can be proposed as long as they meet all federal, state and local regulations. It is envisioned in this scenario that reflex testing with an FDA authorized EUA test will be required for all positive specimens prior to reporting results.

98 Do all methods require an EUA?

Testing paradigms utilizing RUO/LDT tests can be proposed as long as they meet all federal, state and local regulations. It is envisioned in this scenario that reflex testing with an FDA authorized EUA test will be required for all positive specimens prior to reporting results.

Will HHS consider LDTs under CLIA high‐complexity license, as the cost for LDT is generally lower than EUA.

Testing paradigms utilizing RUO/LDT tests can be proposed as long as they meet all federal, state and local regulations. It is envisioned in this scenario that reflex testing with an FDA authorized EUA test will be required for all positive specimens prior to reporting results.

What is the expectation for the balance of clinical vs non‐clinical surveillance tests?

Testing paradigms utilizing RUO/LDT tests can be proposed as long as they meet all federal, state and local regulations. It is envisioned in this scenario that reflex testing with an FDA authorized EUA test will be required for all positive specimens prior to reporting results.

101 Will all positives be confirmed by an alternative EUA'd method

Testing paradigms utilizing RUO/LDT tests can be proposed as long as they meet all federal, state and local regulations. It is envisioned in this scenario that reflex testing with an FDA authorized EUA test will be required for all positive specimens prior to reporting results.

b. Will this program be for screening or surveillance?

i. Screening allows for individual results.

ii. Surveillance provides pooled results for a cohort (multiple testing subjects in one group).

iii. Surveillance with follow on individual test subject level results for positive cohorts.

Testing paradigms utilizing RUO/LDT tests can be proposed as long as they meet all federal, state and local regulations. It is envisioned in this scenario that reflex testing with an FDA authorized EUA test will be required for all positive specimens prior to reporting results.

If proposing an RUO solution, must there be a path to EUA/510k?

Testing paradigms utilizing RUO/LDT tests can be proposed as long as they meet all federal, state and local regulations. It is envisioned in this scenario that reflex testing with an FDA authorized EUA test will be required for all positive specimens prior to reporting results.

Are you expecting only COVID‐19 test results or also tracking Variants for this?

The expectation is that testing will correctly identify clinical samples containing SARS‐CoV‐2 virus as positive, including samples containing variant strains. There is not currently a U.S. Government requirement to specifically identify which variant strain is in the samples.

105 Is there interest in a self‐administered test kit?

The intention of this effort is to expand laboratory‐based testing for K‐8 schools and underserved populations. As such, it is envisioned that laboratory‐based molecular tests will be a major component of this effort. However, alternative testing paradigms that involve the use of other testing modalities, including rapid antigen tests, will be considered if they can meet the U.S. Government's requirements.

What percentage of testing types do you envision utilizing?

Antigen, PCR, Antibody

The intention of this effort is to expand laboratory‐based testing for K‐8 schools and underserved populations. As such, it is envisioned that laboratory‐based molecular tests will be a major component of this effort. However, alternative testing paradigms that involve the use of other testing modalities, including rapid antigen tests, will be considered if they can meet the U.S. Government's requirements.

Why rapid POC aren’t tests a bigger focus in order to curb infections? A 72 hour turn around could miss many cases.

The intention of this effort is to expand laboratory‐based testing for K‐8 schools and underserved populations. As such, it is envisioned that laboratory‐based molecular tests will be a major component of this effort. However, alternative testing paradigms that involve the use of other testing modalities, including rapid antigen tests, will be considered if they can meet the U.S. Government's requirements.

Given that most kids have been presumed to be Asymptomatic positive, have you set analytical and clinical performance goals of test types?

The intention of this effort is to expand laboratory‐based testing for K‐8 schools and underserved populations. As such, it is envisioned that laboratory‐based molecular tests will be a major component of this effort. However, alternative testing paradigms that involve the use of other testing modalities, including rapid antigen tests, will be considered if they can meet the U.S. Government's requirements.

Is testing accuracy and sensitivity considered as part of this objective?

The intention of this effort is to expand laboratory‐based testing for K‐8 schools and underserved populations. As such, it is envisioned that laboratory‐based molecular tests will be a major component of this effort. However, alternative testing paradigms that involve the use of other testing modalities, including rapid antigen tests, will be considered if they can meet the U.S. Government's requirements.

Testing

a. Is this expected to be only NAAT (PCR/TMA) or are other testing methodologies such as serology or antigen under consideration?

The intention of this effort is to expand laboratory‐based testing for K‐8 schools and underserved populations. As such, it is envisioned that laboratory‐based molecular tests will be a major component of this effort. However, alternative testing paradigms that involve the use of other testing modalities, including rapid antigen tests, will be considered if they can meet the U.S. Government's requirements.

111 Topic where questions will be centered: Sample type

There are no specifically preferred sample types; however, all proposed sample types should take into consideration compatibility with the approved FDA labeling for the EUA test(s) and/or requirements necessary to carry out other tests (LDT or RUO) that will be utilized. Coordinating centers will be responsible for communicating with the state, local or school authorities on acceptable sample types for testing.

112 Source of specimen: (Ex: Nasopharyngeal Swab / Saliva)

There are no specifically preferred sample types; however, all proposed sample types should take into consideration compatibility with the approved FDA labeling for the EUA test(s) and/or requirements necessary to carry out other tests (LDT or RUO) that will be utilized. Coordinating centers will be responsible for communicating with the state, local or school authorities on acceptable sample types for testing.

Is there a preferred collection method? (i.e. throat, nasopharyngeal, saliva, etc.)

There is no specific process required for sampling, furthermore, sample collection will not be conducted by the Coordinating Center and will be the responsibility of the state, local or school authorities. The Coordinating Center can provide guidance and assistance in implementing a collection protocol that local agencies and schools will perform in order to achieve the desired testing objective.

114 What will be the preferred method(s) for collecting samples?

There is no specific process required for sampling, furthermore, sample collection will not be conducted by the Coordinating Center and will be the responsibility of the state, local or school authorities. The Coordinating Center can provide guidance and assistance in implementing a collection protocol that local agencies and schools will perform in order to achieve the desired testing objective.

can testing be done in the school setting if EUA and protocol support that?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

116 How frequently will students at schools be tested?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

117 Will K‐8 schools be required to participate?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

What is the role of the coordinating centers to get schools to participate?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

Will the intended 25 million tests per month be allocated pro‐ rata by K‐8 population as a goal such that interested parties can reasonably estimate how many tests per month are needed to serve each state?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

How is sample volume forecasted, distributed, and assigned to the partner labs.

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

What are the goals for testing in schools? Is the expectation that testing will be available in every school/every student at an appropriate cadence?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

What will be the frequency of testing at the various sites for K‐ 8?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

Will testing teams be allowed to use centralized testing sites or will they be required to set up at individual school locations for K‐8 schools?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

If at the school locations, will they need to be on‐site at all times or only at appointed times?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

Who is responsible for the logistics, meaning the movement of materials from the labs to the collection sites and collection sites to the labs?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

How does HHS envision the interface between the Coordinating Centers with state and local public health as well as the testing laboratories and state and local public health?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

Are additional state resources available for rapid and robust collection site coverage?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

What activities do you envision the four coordination hubs to conduct?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e. population, volume, frequency, specimen collection and flow, and other pre‐analytical and post‐analytic aspects) and data reporting structures in consultation with the USG’s Testing and Diagnostics Program Management Team, laboratories, state/county/local school districts, and technical assistance groups.

The Testing and Diagnostic Program Management team will set overall testing targets for the region.

Is a testing mandate being considered for schools or will this be an opt‐in option for schools?

What incentives to opt‐in are being considered?

Coordination centers will conduct outreach to schools and other facilities interested in participating in the testing program, develop detailed testing implementation plans (i.e.