�鶹��

What is the RADx Program? Why was it created?

Congress provided supplemental appropriations of no less than $1,000,000,000 to the NIH Office of the Director as part of the Paycheck Protection Program and Health Care Enhancement Act on April 24, 2020. The Congressional intent of these funds is “to develop, validate, improve, and implement testing and associated technologies; to accelerate research, development, and implementation of point of care and other rapid testing; and for partnerships with governmental and non-governmental entities to research, develop, and implement the activities outlined in this proviso.” With the supplemental appropriations, NIH created the Rapid Acceleration of Diagnostics (RADx) Program to develop, validate, improve, and implement testing and to accelerate research and develop technologies for rapid testing at the point of care.

How is RADx Underserved Populations (RADx-UP) different from the other RADx initiatives?

Whereas other RADx initiatives are focused on the development of better diagnostic tools, RADx-UP is focused on understanding and addressing COVID-19 morbidity and mortality disparities among underserved and vulnerable populations across the United States by implementing testing programs that will overcome barriers to and increase uptake of testing in these populations. To read more about the other RADx projects please go to this site.

What is the governance structure for RADx-UP?

Please go to the RADx Program website located here to learn about the governance of the various RADx Initiatives, including RADx-UP.

Does each FOA have different eligibility criteria?

Yes.

For  (SEBI) and  (individual research awards) - Existing grants that can be revised in response to this NOSI are limited to eligible non-fellowship, non-career, active research and resource grants, cooperative agreements, and small business grants (SBIR and STTR) (i.e. “F” and “K” awards are not eligible). Currently funded grantees may apply for work that is related to their funded project, whether within the scope or outside of the scope of the current project. You may apply regardless of the time remaining on the current project, even if your parent award is in a no-cost extension.

For  (large-scale networks, consortia, and centers) – There is a limited pool of eligible grants for supplementation described in detail in the  of the NOSI. This limited pool of applicants contains large-scale networks, consortia, centers and other current programs that have adequate capacity, infrastructure, and established community-engaged relationships to support large-scale testing. Again, you may apply even if your parent award is in no-cost extension.

For  (U24, Coordination and Data Collection Center) – Unlike the NOSIs, this is for a new award rather than a revision to an existing award. Eligibility is described in the text of the FOA. Foreign entities and foreign components are not allowed to apply for or be part of this funding announcement.

How many administrative supplements or competitive revisions is a grant permitted to have (for example, if we already have 1 diversity supplement and another administrative supplement, are we eligible to apply)?

There is no limit on the number of administrative supplements or competitive revisions that a parent award can have.

As a current grantee, can I apply for a competitive revision award that proposes work that continues past the end-date of my currently funded project?

Yes. If your grant is currently active or even in a no-cost extension, you can be awarded funding that extends past the end date of your current project. The project period of the parent award will be extended to accommodate the competitive revision.

In the NOSIs and the FOA, there is a statement at the top by the lists of participating ICs that says, “All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.” Does this mean that my competitive revision application needs to address the mission of the IC that issued the parent award?

No. This statement simply means that your application needs to fall within the mission of NIH. This should not be a hurdle for any applicants.

If I am submitting an application in response to the Coordination and Data Collection Center FOA (RFA-OD-20-013), am I precluded from also submitting a competitive revision application through one of the other NOSIs?

No, you are not precluded. You may submit applications to any of the funding opportunities for which you are eligible.

Regarding the three competitive revision NOSIs, can there only be one competitive revision application per institution, or can we submit multiple applications from different mechanisms?

Competitive revision applications can be submitted for any current and eligible NIH parent award. If an institution has multiple NIH awards that are current and eligible, they may submit competitive revision applications through multiple parent awards. However, the same parent award may not be used to apply to both the NOT-OD-20-120 and NOT-OD-20-121 NOSI.

Can an investigator apply to more than one COVID-19 NOSI using a single parent grant? For example, a COVID-19 NOSI issued by an IC and a RADx-UP NOSI.

Yes, in general, you may apply to multiple supplement or competitive revision NOSIs using a single parent award unless other specific NOSI(s) have limitations. However, the same parent grant may not be used to apply to both the testing site NOSIs: NOT-OD-20-120 and NOT-OD-20-121. Also, an applicant may not submit the same supplement or competitive revision application to multiple NOSIs – the applications must be scientifically distinct (and have no budgetary overlap).

Can multiple applications be submitted to a NOSI which include the same study sites, but which focus on different populations at these sites, e.g., children, adolescents, elders?

It is possible to submit multiple competing revision applications to the same NOSI from the same parent award, though applications must be scientifically distinct. However, we recommend that a parent award submit only one application to a given NOSI for this purpose. That one application can include the different populations on which you would like to focus.

Can multiple proposals come from the same network as long as they have different approaches or aims?

If each competitive revision application is referencing a different parent award, then a network/consortium may submit multiple applications to the same NOSI. The applications must be scientifically distinct. Also, please note that the same parent grant may not be used to submit competitive revision applications to both the NOT-OD-20-120 and NOT-OD-20-121 NOSIs.

Is eligibility limited by the amount of current carryover on a grant?

Eligibility is not limited by the amount of carryover funds on the parent award.

Can a foreign component be included in an application to these NOSIs? What about comparison studies using a U.S. population and a low-and-middle-income country?

Competitive revision applications to these NOSIs may not propose new foreign components and may not request additional funding for existing foreign components. This includes comparison studies with foreign populations. Also, a foreign parent awardee cannot submit applications to these funding announcements.

Are Small Business Innovation Research (SBIR) recipients eligible to apply for these competitive revisions?

Yes. As stated in the Notice of Correction (NOT-OD-20-157) to the Eligibility sections of NOT-OD-20-119 and NOT-20-OD-120, SBIR grants are eligible. Eligibility for NOT-OD-20-121 is limited to parent awards of specific FOAs as outlined in NOT-OD-20-121.

Is a G08 grant eligible for this supplement?

Yes. As stated in the Eligibility section of NOT-OD-20-119 and NOT-20-OD-120, active resource grants are eligible. G08 grants are resource grants and are eligible. Eligibility for NOT-OD-20-121 is limited to parent awards of specific FOAs as outlined in NOT-OD-20-121.

Are tribal organizations eligible to receive funding directly? Also, how did the tribal leadership consultation of May 28 inform the development and/or revision of this funding opportunity? What changes were made if any?

The three NOSIs are all competitive revisions, and if the tribal organization has an active, eligible NIH award, then they may apply for a competitive revision. If the tribal organization is not a current recipient, they can still form a partnership with an applicant and receive funding through a consortium agreement. Information regarding the May 28^th tribal consultation can be found .

If the parent grant has an international focus (non-US target population), is it still eligible to apply for this COVID supplement grant, for which the eligible target population is only US residents?

The RADx NOSIs are focused on the US population. An award with existing foreign subaward or foreign component is eligible to apply for a competitive revision. However, as stated in NOT-OD-20-138, competitive revision applications to these NOSIs may not propose new foreign components or subawards and may not request additional funding for existing foreign components or subawards. If your competitive revision meets that criteria, then you may be eligible.

As a community provider working during COVID19 with high risk populations, are there any opportunities here that could be a fit as a non-NIH recipient?

The RFA (RFA OD-20-013) allows all eligible entities, as outlined in the RFA, to submit a new application. You can also be included as a research partner for any of the applicants applying to the NOSIs.

What are the key differences between NOT-OD-20-121 and NOT-OD-20-120?

One key difference between these NOSIs is that NOT-OD-20-121 is a limited competition and NOT-OD-20-120 is not.= NOT-OD-121 is eligible to specific large-scale networks, consortia, and centers that are listed in the . NOT-OD-20-120, however, is intended to solicit applications from individual NIH research awards that may not necessarily be part of an existing large-scale network, consortium, or center.

The other key difference between these two NOSIs is the size of the budget. For NOT-OD-20-120, the budget can be no more than $1,300,000 in direct costs for the entire 2-year project period. For NOT-OD-20-121, the budget can be no more than $3,500,000 in direct costs for the entire 2-year project period (up to $5,000,000 Total Costs).

I am a project lead of a U54 NIH-funded Center of Excellence that will be submitting a competitive revision application to the Limited Competition Community-Engaged Research NOSI (NOT-OD-20-121). Am I precluded from also submitting a competitive revision application for a separate R01 through the other Community-Engaged Research NOSI (NOT-OD-20-120)?

No, you as individual researcher are not precluded from submitting more than one application. You may submit applications to any of the funding opportunities for which you are eligible. Note that the same parent grant may not be used to apply to both the NOT-OD-20-120 and NOT-OD-20-121 NOSIs. Also, please ensure you are not submitting the same application to multiple funding opportunities; applications should be scientifically distinct.

Can we apply to NOT-OD-20-120 under our NCI cancer grant (P30) or a HRSA grant? I realize the NOT-OD-20-120 NOSI is intended for individual NIH research awards rather than large-scale networks; however, it is unclear if we must apply under an R01.

NOT-OD-20-120 is not restricted to R01 or equivalent mechanisms. Active research and resource grants, cooperative agreements, and small business grants (SBIR and STTRs) are eligible to apply through NOT-OD-20-120. NRSA training and fellowship grants, and career development awards are not eligible to apply for funding. Note, applicants that are part of the eligible large-scale networks, consortia or centers listed on NOT-OD-20-121 are encouraged to apply through that NOSI. Also, a parent grant cannot apply to both NOT-OD-20-120 and NOT-OD-20-121.

Grants from another federal agency or funding organization may not apply to these NIH competitive revisions NOSIs.

Regarding investigator/institutional eligibility within a network: Can one or a subset of member institutions apply to the relevant NOSI, or is the expectation that all members of the designated network apply jointly?

A competitive revision is a revision to a parent NIH award. Therefore, the contact PI indicated on your competitive revision application will be the contact PI indicated on the parent award. The remainder of the research team and/or multiple PIs on the competitive revision can be different from the parent.

If a group of awardees (e.g., network, consortium, center) is intending to apply “together” for competitive revisions, then there are a couple options.

1. Each interested awardee in the eligible network could apply for a separate competitive revision for their specific parent award.
2. A single parent award could submit a competitive revision on behalf of the network (or subset) and then subcontract to the other awardees in the network. Note, this approach gives that parent awardee more control over the other awardees in the network.

The NIH does not have a strong preference on the approach. The awardees may want to consult with their NIH Program Officer for recommendations specific to their situation.

If one site in a network would like to apply, but not the whole group, should they apply to  or ?

Assuming your award meets the limited competition eligibility for NOT-OD-121, you may apply to one or the other.

For NOT-OD-20-121, some ICs have listed coordinating centers as an eligible grantee, others do not. Was that intentional, or are coordinating centers for listed programs that are not specifically called out also eligible?

The  includes a list of FOAs whose awards are eligible to apply for a competitive revision through NOT-OD-20-121. If your parent award is not associated to one of those FOAs, then you are not eligible to apply to NOT-OD-20-121.

I am writing with a question about the notice NOT-OD-119. I understand that projects which are explicitly qualitative will not be funded. Would a project that makes use of qualitative methods as well as normative analysis and direct stakeholder engagement be considered for funding?

The application would technically be considered as it is mixed methods. However, applications relying heavily on qualitative methods should strongly justify how their approach will meet the goals of the NOSI and consider whether a quantitative component would complement their goals.

It appears that the questions to be addressed in NOT-OD-20-119 are basically the same as those in NOT-OD-20-120 and NOT-OD-20-121; it just doesn't involve testing?

NOT-OD-20-119 looks at social, ethical and behavioral issues that interfere with testing uptake and work towards pragmatic ways to address them. NOT-OD-20-119 will inform the other testing projects. Please look at the NOSI for a broader list of considerations.

Are center grants eligible for NOT-OD-20-119 or only R grants?

Yes. As stated in the Eligibility section of NOT-OD-20-119, active research or resource grants and cooperative agreements are eligible. Center grants may apply.

For NOT-OD-20-121, can investigators be included in the application who are not part of the eligible networks? Can community partners only come from those already established by the eligible networks?

A competitive revision application can be submitted by the recipient of a parent award that is already funded under one of the eligible large-scale networks, consortia, or centers. While the contact PI must be the same as the parent, the contact PI can propose a different research team for the competitive revision, and the members of that research team do not already need to be part of the parent award or the network, consortium, or center. The contact PI can also propose new collaborators or community partners in the competitive revision application, and those partners don’t already need to be part of the parent award or the network.

Does the network site PI have to be a multiple PI to qualify as part of the network proposal, or can anyone listed on the grant from that site say they are the competitive revision PI?

A competitive revision application can be submitted for an active NIH parent award. The contact PI on the parent award will also be the contact PI for the competitive revision.

Does NIH expect multiple-PIs for network proposals across multiple sites?

The contact PI on the competitive revision application may assemble a research team that is appropriate for their proposal. This team may include multiple PIs.

Can my project collaborate with a PI from Puerto Rico?

Yes. If you have a parent NIH grant, you may collaborate with PIs from U.S. Territories for any of these funding announcements.

Can an institution submit a CDCC application (RFA-OD-20-013) as the lead institution, while also serving as a subcontractor on another CDCC application led by another institution?

Yes.

What are the submission dates for the RADx-UP FOAs?

How do I apply to a NOSI?

In order to submit a competitive revision application through one of the three NOSIs, you must first have an existing NIH award that meets the eligibility requirements for the respective NOSI. Competitive revision applications in response to the NOSIs must be submitted using the following targeted funding opportunity or its subsequent reissued equivalents:

•  Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional) is intended to provide funds for NIH grantees applying to expand the scope of their active grant.
• The funding instrument, or activity code, for the competitive revision application will be the same as the parent award.

For funding consideration, all applicants must designate the appropriate NOSI Number (i.e., "NOT-OD-20-119", "NOT-OD-20-120", "NOT-OD-20-121") (without quotation marks) in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R) Form. Applications without this information in Box 4b will not be considered for this initiative.

When applying, do I also need to specify the IC? Is there any advantage to applying to one IC over another?

When you apply to a competitive revision NOSI, you are doing this through a parent award that is already associated to a specific IC. The four RADx-UP funding opportunities are being funded by OD and are part of a trans-NIH effort. ICs will not make individual decisions as to who should be funded. There will be a trans-NIH review and recommendation process, and only the OD will be funding awards.

What are the page limits for the research strategy?

NOT-OD-20-119 (Social/Ethical Behavioral): 12 pages

NOT-OD-20-120 (Testing-Open Competition): 6 pages

NOT-OD-20-121 (Testing-Limited Competition): 12 pages

RFA-OD-20-013 (Coordinating Center): 12 pages, as described in the SF424 Application Guide and the .

If I submit my application early, will it increase my chances of being funded?

NOT-OD-20-119 and NOT-OD-20-120 each have two application receipt dates: August 7 and September 8. The applications received on August 7 will be reviewed first and funding decisions will be made so that awards can be issued in September. The applications received on September 8 will be reviewed next so that awards can be issued in November. If you submit early and you are selected, you may start the project early.

If my application is rejected and there are two receipt dates, can I resubmit?

No. There is only one opportunity to apply for the RADx-UP FOAs. However, some meritorious applications submitted August 7, 2020, but not immediately funded are still eligible for consideration along with applications submitted September 8, 2020.

A group of universities maintains a nationwide consortium of Satellite Centers which is central to our outreach and dissemination efforts. Can they be mobilized to support proposed research in our competitive revision application if they weren’t featured in the parent grant?

Yes, it is allowable to feature new partnerships in your competitive revision applications.

Will I need to obtain additional IRB approval as a result of my competitive revision application?

Yes, the applicant should start now and work closely with their IRB (including Tribal IRBs) to expedite this process so that awards are not delayed.

Do the funding announcements require applicants to receive FDA approval prior to submission? Or can the FDA approval be completed within the award period?

Applicants should demonstrate in their application that they have the capacity to acquire, disseminate, and utilize diagnostic tests that have already been FDA-authorized/approved. Because the specific tests that have been FDA-authorized/approved may change over time, applicants are encouraged to check with the FDA for updates.

For NOT-OD-20-120 and 121, are applicants expected to propose a randomized controlled trial or other experimental design to determine best testing practices?

Randomized clinical designs are not required. Other study designs are also acceptable, as long as rigorous research is emphasized.

For NOSI NOT-OD-20-121, is it expected/required that an applicant describe (and budget subawards for) specific collaborations with other centers that are members of their consortium (e.g., CTSA hubs)? Or might collaborations across such consortia evolve informally post-award?

Collaborations and partnerships may continue to grow post award; however, your application will be evaluated partially on the strength of your current/proposed collaborations.

Is it expected that NOT-OD-20-120 and 121 applications will propose studies of specific currently approved tests OR should they reserve final decisions about specific tests, depending on new technologies likely to come along by the time of RADx funding?

Applications should propose studies with current FDA approved/authorized technologies. As more technologies are approved/authorized, then the study may evolve based on this newly approved/authorized technology.

Do applicants to the NOSIs need to include in their application how they plan to de-identify any patient identifying data as part of their data sharing plan? Will there be any generalized guidance for applicants released later for this aspect?

The CDCC awardee should include a plan on how to de-identify patient data. For applicants to the NOSIs, they are not required to include a plan.

It seems that it would be challenging for groups writing proposals for the other RADx-UP NOSIs to address data storage and security BEFORE a CDCC has been identified that can provide them with this type of info. Am I misunderstanding the proposed structure?

Individual projects will have to arrange for data collection, storage and cleaning within the project and before transfer to the CDCC. The CDCC is responsible for data collection and alignment both before collection, through shared tools and use of common data elements, as well as throughout the research process.

Is the budget limited to $13M direct including the $2M for Rapid Pilot Studies and $750k for Community Engagement projects? Or should the budget reflect $13M plus funds for Rapid Pilot and community engagement projects?

The costs for the Rapid Pilot Studies and the Community Collaboration Grants programs should be included within (not in addition to) the $13 Million per year direct costs of the CDCC application.

How should the funds for each of the additional programs (Rapid Pilot and Community Engagement) be spread across the years? Should we assume $2M and $750k per year, respectively?

Correct.

Regarding the Rapid pilot program mentioned in the CDCC FOA (RFA-OD-20-013), are they limited to supporting pilot projects just within the RADx-UP funded sites?

Though we anticipate many of these funds will go toward the existing RADx-UP network, the CDCC may support Rapid pilot studies outside of the RADx-UP network. For the CDCC application, the applicant will need to describe the process for setting up the pilot projects program rather than define specific pilots for us to consider.

For the CDCC, can you please clarify if the Community Engagement core includes community and health system engagement (as indicated in only one place in the RFA). It seems that most health system engagement activities fall under the Data integration, coordinating, and sharing core.

Yes, as stated in the RFA, the Community Engagement core includes health system engagement.

For the CDCC, do you prefer the applications include or exclude specific names of potential Data Safety Monitoring Board (DSMB) members? In past coordinating center applications, we were instructed not to name them because they could no longer be reviewers.

It is not necessary to include specific names of potential DSMB members.

In addition to a focus on COVID-19 testing outcomes, can I study the impact of COVID-19 on other health outcomes?

No. Funds provided by this initiative must focus on COVID-19 testing. While focusing on other health outcomes may be a worthy research proposal, that is outside the scope of RADx-UP.

Can grantees propose to study co-morbidity factors (e.g., HIV/AIDS and alcohol/drug misuse) that may affect COVID-19 outcomes?

Yes. It is allowable for co-morbidity factors as well as social factors to be included in testing research projects to understand the reasons for testing (or lack of testing) among underserved and/or vulnerable populations and to understand ways that we can have a bigger impact in these populations.

Can serologic testing be proposed?

Yes, it is permitted to propose antibody testing in your application. Both diagnostic and serologic testing are targeted in these NOSIs and the project application can include both forms of testing.

Can antibody testing be done on banked specimens?

Testing of banked specimens would be based on the consent agreement that is established with the research participants to allow their specimens to be used in future research.

The three competitive revision NOSIs allow for proposed work that expands the scope (outside of scope) of the parent award. Please confirm that this means that it is permissible to change research locations, populations, new aims, etc., as long as the applicant can make a case that they have community partnerships/ties, testing capacity, etc.

Yes, competitive revision applications can propose additional (domestic) locations, populations, and aims. The competitive revision is not intended to change the aims of the parent award, but to add new, additional aims to the scope of the parent award.

Do applications need to focus on the same populations as those which are the focus of the parent grants?

No. The competitive revision can propose new populations. However, the applicant must be able to explain their relationships and partnerships for reaching these new populations.

Is the focus meant to be broad screening of asymptomatic persons, or focused on symptomatic individuals and targeted contacts?

Either approach is fine. You should use the approach that makes the most sense for your research project, community, and targeted populations.

Is the vision that one project will focus on a single specific population or have multiple targets and perhaps sub-programs within it?

Either approach is fine. You should use the approach that makes the most sense for your research project, community, and targeted populations.

Can a study design be proposed that would include populations that are not underserved/COVID-19 vulnerable for comparison purposes?

Yes, such a design can be proposed.

Does not including a clinical trial lowers your chances for application approval?

No. Study design should be commensurate with the goals of the new application.

How large must my project be? In people? sites? Is City-wide in a large city large enough?

There is no required project size; however, the purpose of the NOSIs is “to understand factors that have led to disproportionate burden of the pandemic on these underserved populations so that interventions can be implemented to decrease these disparities”. Projects will be evaluated for scope and potential breadth of impact.

Is access to emerging vaccines included in the scope of the FOAs?

This is not a primary goal of this initiative but could be considered a long-term goal.

Would a project that focused on the association between air pollution and SARS-CoV-2 infection in an underserved population fit within the scope of these NOSIs?

No, the effects of air pollution and the associated risk of COVID-19 are not included in the scope of this initiative. However, certain populations with disproportionate burden of environmental exposure are considered vulnerable populations and should be considered for testing under the scope of RADx-UP.

Can a subpopulation (e.g., cancer patients) be used for NOT-OD-20-120 or 121?

There is no prohibition on the analysis of sub-populations if it is justified based on power calculations and impact.

Can you use a non-FDA authorized test as a comparison?

You must use FDA authorized test for the primary purpose of the testing research. However, if a researcher wants to use another test as a comparison (that may not be FDA authorized) this would be permitted.

Please talk more about common metrics. Should our proposal include these in our design? How do we access them?

As stated in the NOSIs: To maximize consortium research and rapidly implement approaches to address the COVID-19 pandemic, comparisons across datasets or studies and data integration are essential to collaboration. Projects funded through this NOSI are strongly encouraged to use the following resources:

• Data Harmonization for Social Determinants of Health via the PhenX Toolkit: Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on social determinants of health (SDOH) across studies. In particular, studies with human participants should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the .
• A trans-NIH working group is making existing COVID-19 survey items and investigator contact information publicly available through two NIH-supported platforms: the NIH Public Health Emergency and  and the . Researchers addressing COVID-19 questions, whether population-based or for clinical research, are strongly encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded.

Is it expected that there will be national partners for community engagement to reach the intended populations?

There is not an expectation for a national partner. Each applicant should be engaged within their defined community.

Regarding NOT-OD-20-119, 120, and 121: Many of the goals of 119 seem to be critical for those working in community engagement and testing with underserved populations. Can we ask similar questions in 120/121 as in 119?

You may ask SEBI-related research questions in applications to NOT-OD-20-120 and NOT-OD-20-121, but the focus of applications to those NOSIs should be testing, as outlined in the NOSI.

Regarding SEBI, NOT-OD-20-119, the NOSI notes a research interest related to acceptability of vaccine trials (in addition to testing). Is a proposal at an advantage if it adds SEBI of vaccine trials?

The focus of the RADx-UP initiative is COVID-19 testing; every application should focus significantly on testing. Applications that can additionally look ahead to examine barriers to and acceptability of vaccine trials and vaccination will address another, secondary aspect of interest. Applicants are encouraged to read all four RADx-UP NOSIs to get a clearer picture of how vaccination work is being thought of.

For NOT-OD-20-119 - we live in a state with huge and shocking ethnic disparities in COVID-19 prevalence between ethnic groups. Would assessing SEBI factors related to this prevalence disparity be responsive to the NOSI or does the project have to focus only on testing uptake?

As outlined in the NOSI, applications to NOT-OD-20-119 should have a strong emphasis on understanding how SEBI has an impact on testing.

With the limited number of SEBI awards anticipated, would a project with a more local (say statewide) focus be competitive?

The geographic reach of the SEBI projects will be considered, as outlined in the NOSI. The population(s) studied, and the generalizability of study findings to other populations and geographic areas is likely to be important as well.

Is follow-up of participants to observe infection expected?

Follow up requirements will depend on the study design. If necessary, to achieve the goals of the proposed study, follow up will be expected.

Is the vision that one project will focus on a single specific population or have multiple targets and perhaps sub-programs within it? Would you recommend that expertise with different populations/Community Based Organizations be rolled into a single project?

Whether or not to study multiple populations and programs will depend on study design and capability. For the larger networks and multisite programs (NOT-OD-20-121), it is quite likely that multiple targets and subprograms might be successfully studied, although responding to the FOA does not require such an approach. For the individual projects (NOT-OD-20-120), it may be more difficult to study multiple targets and populations. One of the reasons for requiring data coordination and collaboration is to allow for comparisons of populations across sites (as well as within sites where feasible).

Is the expectation that research projects should be doing their own testing or linking to other available testing in the area?

Where feasible to link to local resources for testing, certain cost-efficiencies may be found and longer-term sustainability may be seen. But for areas where such testing is not available, incorporating testing into the research study is acceptable.

Would a study seeking to understand population level factors associated with testing in underserved populations but not directly conducting diagnostic tests be within the scope?

It is not likely that such a study would be eligible for NOT-OD-20-120 or NOT-OD-20-121. If the topic relates to social, ethical or behavioral implications, NOT-OD-20-119 may be appropriate.

If the original/parent grant does not have a community outreach focus, can we still submit to the NOSI with an added community outreach/partners focus?

Yes. You may add an outreach focus through a competitive revision, which expands the scope of the parent award.

Is there a problem with collaborating with the top three labs who are already collecting and testing for the COVID-19 antigen? Do we seek out alternative labs with the capacity for collections or collections and testing?

You should use the approach that makes the most sense for your research project, community, and targeted populations.

For the SEBI NOSI, can testing be done as part of the approach to, for instance, test hypothesis related to mechanisms and mediators of testing dissemination/implementation?

As stated in the “Areas of Research Interest” for NOT-OD-20-119, development and pre-testing of potential interventions to increase testing access, acceptability, feasibility, and uptake would be of interest. However, they should not be the primary aim of the application. Potential applicants considering applications focused on interventions to increase access and uptake of COVID-19 diagnostics should consider our other NOSIs.

Is the expectation that the coordinating center's role is to manage only research data related to RADx-UP funded programs (i.e. the data they are collecting), or is the coordinating center’s role to manage and enable downstream (secondary) sharing of data from RADx-UP funded projects, to create more widely accessible resources?

The Coordination and Data Collection Center is involved in both activities.

For applications to NOT-OD-20-120, are multisite studies allowed?

Yes, you may propose multiple sites in your application.

Would populations that are "digitally disconnected" be considered as "underserved and/or vulnerable" populations?

The NOSIs define underserved as “NIH-designated health disparity populations and/or other groups known to experience barriers to accessing needed health care services or have inadequate health care coverage. A full description can be found at .” The applicant should explain why they are choosing the population that they are and show how they are underserved, in accordance with the definition.

Are healthcare workers for a vulnerable population considered a relevant subpopulation to be included in the study for NOT-OD-20-120?

NOT-OD-20-120 states:

COVID-19 medically and/or socially vulnerable populations: Residents of nursing homes and assisted living facilities; community-dwelling older adults; individuals with intellectual, developmental, sensory, or physical disabilities, cognitive impairment or dementia, or communication disorders; homeless populations; individuals involved with the criminal or juvenile justice systems (incarcerated or under community supervision); individuals with medical comorbidities known to increase risk of severe COVID-19, including heart failure and related cardiovascular conditions, diabetes mellitus, chronic lung disease, obesity, HIV/AIDS; pregnant and post-partum women; children and adolescents; individuals living in congregate housing such as shelters or residential treatment facilities; individuals in overcrowded housing; individuals with substance use disorders or serious mental illness; migrant and immigrant populations; residents of tribal lands or reservations; communities exposed to high rates of air pollution or other toxic exposures; and rural and remote communities.

The applicant should explain why they are choosing the population and show how they are underserved, in accordance with the definition.

Since the CDCC will be coordinating efforts across the nation, are you expecting to see established national underserved population community partners already in place in applications? Or will established local/regional partners be acceptable?

There is not an expectation for the CDCC to have a national network in place.

The scope of CDCC as a coordinating hub is unclear. How large is the scope of this coordination? Is this between the centers or large studies? If so how many? Will smaller individual research projects also be included? If so, how many?

The CDCC will support the entire RADx-UP initiative with 60+ awardees expected. Some of the awards under the other NOSIs may include multiple partners.

To clarify - in the CDCC managed pilots, researchers may propose development of new testing technologies - right? But not in the NOSIs

As stated in RFA-OD-20-013, the CDCC pilot studies will assess the feasibility of integrating newly developed technologies (e.g., by RADx-tech or RADx-ATP awardees). The pilot studies should not be used to develop new technologies.

How can emerging but not yet FDA-authorized testing modalities (e.g., novel saliva-based LAMP or antigen testing) be integrated into RADx-UP, as RADx-UP allows only authorized tests?

It is conceivable that the current list of FDA approved/authorized tests will change and then may be integrated into your study.

Is it responsive to integrate a social determinants research aspect into the smaller testing (NOT-OD-20-120) proposal?

It is responsive to include such an aspect in your proposal. As stated in the background section of NOT-OD-20-120 and 121, “projects are also expected to specify strategies to: a) address individual and structural social determinants of health (SDOH) that present barriers to participating in testing, follow-up, and retesting...”

What are the budget limitations for applications to each FOA/NOSI?

NOT-OD-20-119 (Social/Ethical Behavioral): No more than $400,000 per year in direct costs for the 2-year budget.

NOT-OD-20-120 (Testing-Open Competition): No more than $1,300,000 in direct costs for the entire 2-year budget and 75% of the funds must be allocated to expenses in the first year.

NOT-OD-20-121 (Testing-Limited Competition): No more than $3,500,000 in direct costs for the entire 2-year budget (up to $5,000,000 Total Costs) and 75% of the funds must be allocated to expenses in the first year.

RFA-OD-20-013 (Coordinating Center): No more than $13 Million in annual direct costs per year for up to 4 years.

For NOT-OD-20-121, if the overall supplemental project period is less than two years, are we still permitted to budget up to $3.5 million in direct costs ($5 million in total costs) and must we still allocate 75% of total costs in the first year?

You are permitted to request the full budget amount. You should request a budget that is appropriate for the scale and length of your proposed project. Our expectation would still be that at least 75% of the funds are allocated to expenses in the first year to reflect the rapid ramp up and outreach during the first part of the study.

Reflecting the unique federal-nation status, data sharing issues, and complexities of obtaining tests, is there a subset of funds directed toward a Tribal-specific CDCC?

There is no subset of funds for a Tribal-specific Coordination and Data Collection Center.

Are pre-award costs allowable?

Yes. Pre-award costs may be incurred from January 20, 2020, through the public health emergency period and prior to the date of the federal award.

Do these funding opportunities provide resources to purchase testing supplies and process assays in settings where that type of processing is not available on site?

Yes, these are acceptable costs to include in your budgets for competitive revision applications under NOT-OD-20-120 and NOT-OD-20-121. Note that any tests must be FDA approved/authorized.

Are there resources available through this funding for reporting back to community members their test results?

The budget you request should support the return of COVID-19 test results.

Can we include costs in our budget to support participants travel to the testing sites (if needed)?

Yes. This is an allowable cost.

Can the funding be used to address the potential implications of a positive test (e.g., support for housing, food support during quarantine)?

The purpose of RADx-UP is to identify COVID-19 disparities in underserved and/or vulnerable populations, with a focus on testing. The inclusion of supports to address housing, food, etc. may be allowable if they are significant components of the study design.

To the extent that a project needs to procure tests for a population/setting that does not have them readily available, how should applicants budget for those? Is there a recommended dollar amount? Can NIH help negotiate pricing?

For NOT-OD-20-120 and NOT-OD-20-121, the applicant is responsible for determining which tests will be needed for their specific research design and accounting for the costs appropriately in the budget. The NIH will not be involved in negotiating testing or other supplies on behalf of the applicant.

The language for NOT-OD-20-121 makes reference to both Total Cost and Direct Cost budget limitations for applications. Which do I need to abide by in my application?

A deviation from standard processes was approved so that budgets in applications to NOT-OD-20-121 should be within the Total Cost limitation.

For NOT-OD-20-121, how much of the budget is expected to go to the community partners?

No proportion is specified because study designs and costs unrelated to investigators and partner teams (e.g. supplies, travel, etc.) may vary. In addition, the ability of community partners to accept federal funds may vary. However, documentation of robust and meaningful participation by community partners in all study aspects is expected.

Are incentive costs to study participants allowable?

The purpose of RADx-UP is to identify COVID-19 disparities in underserved and/or vulnerable populations, with a focus on testing. Incentive payments to volunteers or patients participating in a RADx study are an allowable cost and may include quarantine and services to participants that test positive for COVID-19. Incentive payments to individuals to motivate them to take advantage of grant-supported health care or other services are allowable if within the scope and integral to the approved project.

Can the funding be used to address the potential implications of a positive test (e.g. quarantine and services)?

The purpose of RADx-UP is to identify COVID-19 disparities in underserved and/or vulnerable populations, with a focus on testing. Incentive payments may include quarantine services to participants that test positive for COVID-19, when those services are integral to the success of the project.

For NOT-OD-20-120 and 121, can funds be used to renovate space? One site needs more space to distance patients and would like to modify a room and some space.

If charges for minor alterations and renovations are allowable on the parent award, then they are allowable charges on the supplement as long as it is scientifically justified and supports the scope of the competitive revision. Consideration should be given to the emergency timeline of this program and the adequacy of funds remaining to achieve the purpose of the program.

For NOT-OD-20-120 and 121, can funds be used for equipment to increase testing capacity?

The application will be reviewed partially on the applicant’s ability to demonstrate their capacity for testing. As stated in NOT-OD-20-120 and 121, under the “instructions” for completing an application, the application should include:

• A Testing Capacity section to demonstrate access to FDA-authorized/approved test kits, personal protective equipment (PPE), and access to certified laboratories (e.g., hospital, institutional, public health, or private commercial) to process tests with the ability to store, transport and return of test results in an appropriate manner and as quickly as possible.

Costs for special purpose equipment are allowable if it is scientifically justified and supports the scope of the competitive revision. Please contact your NIH Grants Management Officer for more specific information on your situation.

For NOT-OD-20-120 and 121, can funds be used for staff to monitor tracking and results (e.g. an IT staffer to set up system and track)?

Staff to monitor tracking and results would be allowable. As stated in NOT-OD-20-120 and 121, under the “instructions” for completing an application, the application should include:

• A Consortium Data Reporting Unit to demonstrate the capability and infrastructure of the applicant to report on the number of COVID-19 tests conducted, their results, and subsequent actions and referrals, for the overall study population and relevant subpopulations. The Unit must also disseminate effective implementation strategies for rapid uptake across consortia as relevant through the CDCC.

How should we be budgeting for testing kits given the likelihood of new diagnostics becoming available and the noted role of the CDCC as a broker for tests with vendors?

The applicant should budget for the likelihood that newer diagnostic technologies will become available that the applicant may want to deploy. Regarding the role of the CDCC, as stated in RFA-OD-20-013 under “Specific Research Objectives,” the CDCC is not intended to be responsible for procuring supplies for the testing sites, but rather to be of assistance to specific sites (e.g., coordination/negotiation with vendors) as needed.

Just to confirm, unlike NOT-OD-20-120 and 121, there is no requirement to spend 75% of the funds in year 1 under NOT-OD-20-119?

Correct.

For the CDCC, regarding Steering Committee meetings: For budgeting purposes, could you give us an idea of how many people might be expected to be included on the Steering Committee?

As stated in “Section VI. Award Administration Information” of RFA-OD-20-013, “Steering Committee voting membership shall consist of the Principal Investigator(s), NIMHD Program staff [ Project Scientist(s)]. Quarterly meetings of the Steering Committee will be held in the first year of the award. One of these meetings must be an in-person meeting, travel conditions permitting, in Bethesda, MD. Frequency of meetings in succeeding years will be decided by the Steering Committee at the beginning of each budget period.” As stated elsewhere in the FOA, the RADx-UP consortium will consist of approximately 60 awardees.

With the significant increase in funding, should the CDCC include funding for community organizations and health care systems to be part of the consortium’s community of practice? (Research Objective 3: Community Engagement, first bullet: Create and support a strong, vibrant community of practice among health care systems and settings, community partners, community-based organizations, and other stakeholders to provide support and facilitate research activities).

It is acceptable to include funding for community partners as part of your application as they are significant components of the program design. Funding for inclusion of previously unengaged community partners can be provided through the community collaboration grants program that the CDCC is tasked with establishing and running. This is specifically to create a community of practice with key stakeholder at all levels and to assist with costs such as preparation of information on testing in linguistically and culturally appropriate form to engage community members among other uses.

For the CDCC (RFA-OD-20-013) pilot programs, are the budget caps inclusive or exclusive of CDCC pilot program administrative expenses such as salaries for administrators of the pilot program, reviewer expenses, web/database costs, etc.?

The total cost caps for the Rapid Pilot Studies is $2,000,000 and for the Community Collaboration Grants is $750,000.

May we request funds in our CDCC application budget (RFA-OD-20-013) to administer/manage the pilot program?

Yes. Additional funds for the CDCC to manage the program may be requested in the application and should be categorized as direct or indirect costs/F&A in accordance with negotiated indirect cost rate agreements and Chapter 7 of the NIH Grants Policy Statement, available at .

Will this follow the traditional peer review process?

Using the authorities provided to the NIH under this public health emergency, NIH will be utilizing an expedited review process.

For competitive revision applications in response to the three NOSIs: The reviews will be centralized into trans-NIH review groups after IC-specific confirmation of basic eligibility and feasibility. Applications will be evaluated for scientific and technical merit by internal NIH staff review panels, in accordance with the review criteria specified in , as well as the additional review criteria provided in each corresponding NOSI. All applications in response to a specific NOSI will be reviewed together, regardless of the parent award mechanism (e.g., U54, UM1, U24, R01, etc.).

For U24 applications in response to the CDCC solicitation (RFA-OD-20-013): Applications will be evaluated for scientific and technical merit by an appropriate NIH review group, using the review criteria stated in .

Will I receive a summary statement?

Competitive Revision applications to the three NOSIs and U24 applications to the CDCC solicitation () will not receive a summary statement (written critique) following the review.

Who selects and pays for these awards?

Following the review process, the RADx-UP governance committee will make funding recommendations to the NIH Director based on review results as well as consideration of program balance and program priorities.

Though all awards will be issued by the NIH Institutes and Centers (ICs), decisions on which applications to fund will be made centrally, and only the NIH Office of the Director will be funding these awards. ICs may not fund the applications received through the three NOSIs or the CDCC FOA with other appropriated funds.

Will applications submitted on August 7th and September 8th be reviewed together?

NOT-OD-20-119 and NOT-OD-20-120 each have two application receipt dates: August 7 and September 8. The applications received on August 7 will be reviewed first and funding decisions will be made so that awards can be issued in September. The applications received on September 8 will be reviewed next so that awards can be issued in November. If you submit early and you are selected, you may start the project early. If you apply early and are not selected for funding immediately your application can still be considered for funding along with those submitted later.

Does consideration of future directions from a proposal (e.g. generation of patient cohorts for follow-up) affect scoring/funding decisions?

The applicant will be evaluated based on the eligibility requirements listed in the current RADx-UP funding opportunities. As noted in the “Review Process” section of NOT-OD-20-119, 120, and 121, an additional review criterion is, “Sustainability: How feasible and appropriate are the plans for sustainability of project infrastructure and partnerships that may be leveraged for future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts?”

Especially given the COVID-19 pandemic, most tribal communities have been totally shut down, meaning that we have not been able to determine our data-sharing approach. Will the reviewers be properly prepared to understand tribal data sovereignty-related issues?

Yes, multiple participants on the review panels are familiar with working with Tribal Nations and the considerations that need to be given to this community.

Will applicants be required to have an infection control protocol?

Applicants will not be required to follow a specifically defined infection control protocol. Infection control is very important, and applicants are expected to follow infection control requirements and procedures at their institution.

Am I expected to collaborate or share data with other awardees, even if my parent award is not a cooperative agreement?

NIH expects that all competitive revisions funded under this NOSI will actively coordinate, collaborate, and share data with other Testing Research Projects, the Coordination and Data Collection Center (CDCC), and other research supported by the SEBI program, as allowed, considering Tribal IRB processes and Tribal data sovereignty where appropriate.

What are the expectations of reporting test results to local Tribal and/or community partners?

Grantees are expected to demonstrate knowledge of and to comply with federal, state, local, and/or Tribal requirements on testing, reporting and surveillance policies in study protocols.

Can the testing technology Core of the CDCC bulk order PPE for the testing sites?

When needed, the CDCC may coordinate and assist with vendor purchase discussions of FDA-authorized tests and supplies and provide technical support and coordination/negotiation for testing equipment to the RADx-UP Consortium for local procurements for the Testing Research Projects. The intent is not for the CDCC to be responsible for procuring supplies for the testing sites, but rather to be of assistance to specific sites if they were are encountering problems obtaining supplies.

Who is doing what in relation to cleaning data, aggregating it, linking it, etc.?

The research site should have members of their team who are familiar with data management, cleaning, storing, and transferring for analytical purposes. The CDCC data component will provide overarching guidance and guidelines that they would like all the research sites to follow and then the specific detail of how to clean and transfer data. This will all be further delineated in the data management policies that the RADx-UP consortium will work on, once established.

For awards made under the NOSIs, in addition to posting data with the CDCC, would we also need to post our data in the IC Data Archive of our parent award?

That would depend on the policies regarding the parent award. If a parent award has a requirement for depositing all data into an IC data archive, then those policies would still apply.

We understand the need to use shared questionnaires / data collection instruments for individual projects and sharing the data with the coordinating center, but for projects under NOT-OD-20-121, will a grant recipient be responsible for the data management, analysis and publication of their study, or will we need approval by the consortium for all these activities?

As stated in the NOSIs, projects are expected to collect and share their data with the CDCC. Analysis and publications will occur at the local level within each of the teams supported, as well as overarching hypotheses that the consortium will explore as shared publications. The CDCC will establish a Steering Committee to develop policies governing matters such as authorship and will cooperate with other awardees in the publication and dissemination of program results.

Is the mini-grant program open to consortium members only, or to any current NIH grantee, or to anyone in the research community?

As described under “Research Strategy” of RFA-OD-20-013, the CDCC applicant will “elucidate plans for establishing, implementing, and evaluating these pilot programs, including the types of projects that will be supported and how the CDCC will attract applicants…”

After the first 4 years for the CDCC, what will be the next step? Does NIH have a plan to continuously fund this Data Center?

The plan after the first four years of the CDCC has not yet been determined.

What is the role of the CDCC in the DSMB meetings?

As stated in the “Specific Research Objectives” of RFA-OD-20-013, the CDCC will establish and manage a Data Safety Monitoring Board (DSMB) for the RADx-UP consortium. The CDCC will support collaboration and communication among the DSMB and other parts of the RADx-UP program, including logistics and management support, such as organizing meetings and maintaining documentation.

Can you describe how the CDCC might be involved in traditional data coordinating center roles such as providing methodological and statistical expertise. Will the CDCC be expected to do data analysis and participate in preparing scientific publications?

As described in the “Specific Research Objectives,” the CDCC is expected to provide methodological and statistical consultation on cross consortium research design and analytics. They will also establish a Steering Committee to develop policies governing matters such as authorship and will cooperate with other awardees in the publication and dissemination of program results.

For the CDCC, Test Technology component, is there interest in formal systematic reviews to compile evidence from the emerging diagnostic tests?

As described in the “Specific Research Objectives,” the CDCC should “maintain up-to-date knowledge and expertise on new COVID-19 related diagnostics and provide frequent communication to the RADx-UP consortium about new testing approaches, FDA-authorization or approval status, testing supply availability, and considerations for the implementation of emerging testing protocols.” It is up to the applicant to propose how they will do this.

What is role of the CDCC as it relates to the Community-Scientific Advisory Board(s)?

As stated in the “Specific Research Objectives” of RFA-OD-20-013, the CDCC will support collaboration and communication among the Advisory Board and other parts of the RADx-UP program, including logistics and management support, such as organizing meetings and maintaining documentation.

Will novel testing techniques previously submitted to RADx-tech or RADx-ATP be available to RADx-UP to address the applicability to underserved populations and how it could benefit them?

As described in NOT-OD-20-120 and 121, the applicant may include plans to integrate new technologies and techniques into the testing model over time. New technologies developed by RADx-tech or RADx-ATP, and have received FDA-authorization, may be utilized in the research for RADx-UP. As described in RFA-OD-20-013 under “Specific Research Objectives,” the CDCC will be tracking these technologies and providing information to RADx-UP awardees for their consideration.

How can I get more information about these opportunities?

Website: Please visit the RADx Program website here for a general overview of the different program initiatives.

Webinars: NIH will hold two pre-application webinars to discuss the RADx-UP funding opportunities.

The first webinar, to be held on Friday, June 26, 2020, from 2:00pm - 4:00pm EDT, will include an overview of the RADx-UP initiative, followed by presentations on each funding opportunity with question and answer sessions for each. The webinar will conclude with a final, open question and answer session.

The second webinar, to be held on Wednesday, July 1, 2020, from 3:00pm - 5:00pm EDT, will focus on questions for applications for the Coordinating and Data Collection Center in response to RFA-OD-20-013. Questions related to the other three FOAs will also be addressed.

You can pre-submit questions for the webinars via RADxInfo@nih.gov and ask questions in the chat box during the session. The webinar will be recorded and added to the RADx Program website. Registration is required to participate.

Program Contacts: You may also reach out to the relevant points of contact (POC) located at the bottom of each NOSI/FOA or, for competitive revisions, the program official (PO) in the IC that supports your current grant.

Email: You may email your questions about the program to RADxInfo@nih.gov and we will respond as soon as possible.

What additional resources are available online?

The �鶹�� Library of Medicine (NLM) has a number of unique resources including access to research literature and . Also, there is a network of 8,000 libraries and community-based organizations across the US -- including a dissemination of COVID-19 information ().

Also, the  provides access to COVID-19 related data collection tools (CRFs, DCFs, instruments, surveys, questionnaires) that are currently in use.

Another important resource is the  which provides access to many of the COVID-19 instruments contained in the DR2 collection, but broken down into specific topic areas for improved ease of use. The PhenX Toolkit also provides recommended standard data collection protocols for conducting biomedical research.