Biomedical Data Translator Performance Phase — Questions and Answers

May multiple principal investigators (MPIs) be included on our award?

Yes. Given the highly collaborative nature of the program, MPIs are encouraged. If an applicant uses MPIs, an MPI leadership plan is required. Any given investigator may be named as the contact PI on only a single application.

May investigators from foreign institutions apply for this funding opportunity?

Foreign institutions and nondomestic components of United States (U.S.) organizations are not eligible to apply for this funding opportunity; however, a foreign organization may be included as a foreign component of an eligible organization’s application. Foreign components are defined as institutions or organizations that perform any significant element or segment of the project outside of the U.S., either by the recipient or an individual employed by a foreign institution, whether or not award funds are expended.

The Research Opportunity Announcement (ROA) states that there will be no written feedback from the review. How may I get feedback about my application?

Because this is a unique, one-time Other Transactions solicitation and there will not be an opportunity to resubmit, no feedback (written or verbal) will be provided.

Who will review my application?

Responsive applications will be reviewed by an evaluation group convened by NCATS. The evaluation group will consist of NIH and other federal government staff who are subject-matter experts. The evaluation group will focus its review on the “Objective Review Considerations” included in the ROA.

Who will decide whether my application is funded?

NIH will use the objective review outcomes to select a subset of applications and/or subsections of applications to negotiate potential award terms. Final funding decisions will be based on the outcome of the objective review and negotiations between the selected recipients and NIH.

I have never used the eRA Application Submission System & Interface for Submission Tracking (ASSIST) site before. May I submit my application via email instead?

No. Only applications submitted through the ASSIST site will be considered for funding. Details on how to submit applications through that site may be found in the ASSIST User Guide. Learn more about the application process from these video tutorials.
Note: Only an authorized organizational representative may submit the application.

The ROA states that an optional Letter of Intent (LOI) is due two weeks before the application. Will it hurt my chances of being funded if I do not submit an LOI?

No. If you can provide an optional LOI, we encourage you to do so as it helps with planning the objective review. If you are unable to submit a LOI by the deadline, your application will be considered for review under the same responsiveness and objective review considerations as all other applications.

I am proposing user studies on the utility of my software as part of the application. Am I required to indicate that human subjects are involved?

That strongly depends upon what users are being asked to do and how the data generated by the study will be used. The determination of whether a study constitutes human subjects research should be made by the applicant organization and may require approval by the applicant organization’s Institutional Review Board (IRB). The NIH Human Subjects Research website provides resources, including a helpful decision tool, for determining whether activity is considered human subjects research.

Does the PI need to submit the Abstract and Specific Aims in the Core tab in ASSIST? Should this information also be included in the combined PDF document that will be uploaded to the Attachments?

The applicant must submit the abstract and specific aims in the fields designated for those purposes in ASSIST. Please see sections 9 and 10 of the current Instruction Guide for NIH Other Transactions (OT) Applications in eRA’s ASSIST (Word - 56KB) for more details.

In the ROA, the budget is requested for “up to 5 years.” Does NCATS expect applicants to propose exactly 5 years of budget, or should applicants propose a budget for a single year, followed by additional budget proposals during milestone reports for subsequent years?

As referenced on page 18 of the ROA, up to five years of support may be requested in accordance with the needs of the proposed activities. Milestones usually are negotiated annually with funding typically awarded for one year at a time; however, a detailed budget request should be provided for each year of the entire proposed work period.

The NOFO states "engagement of users outside of the applicants’ home organization(s) is required." Is the "home organization(s)" defined as the primary institution(s) of the PI(s), or does it also include the subrecipient organizations?

One focus of the Translator Performance phase noted several times through the ROA is "collaboration." Please refer to the Nonresponsive section that states "the user engagement plan does not include proposed engagement of potential users of Translator outside of the team’s home organization(s)." The "team" is defined as all MPI home organizations. Please note that NCATS will be issuing a clarification to the text of the ROA as soon as possible to make this more explicit.

Based on NOT-OD-20-174, my understanding is that no hyperlinks or URLs are allowed in NIH grant applications unless specifically noted. Does this restriction apply to applications in response to this ROA?

This ROA is soliciting applications for an Other Transactions Authority award; therefore, the notice restricting the use of hyperlinks does not apply. However, while including hyperlinks to existing software packages and other online resources may seem appropriate due to the nature of the Translator program, reviewers are not obligated to view or consider any content provided in a hyperlink. All material to be considered for review must be encompassed within the application. Please refer to the Objective Review Process section of the ROA for more details on what reviewers are being asked to consider when reviewing applications.

Are applicants to this ROA expected to develop software or should they be researchers who will test the existing platform to gauge its performance and/or effectiveness in yielding proper hypotheses?

The solicitation is meant to support developers for the system, to improve it in speed and scale through software improvements and features. Additionally, it seeks to improve the results returned by the system through user testing and enhancements to the underlying data that is ingested into the knowledge graphs. We expect the award recipients to conduct user testing with groups of biomedical researchers, our primary user base. A diverse and collaborative group is likely to be most competitive for this funding.

The ROA states that a curriculum vitae (CV) or NIH biosketch for each key personnel must be included, with a list of other support as part of each one. Does this mean that both a biosketch AND a signed Other Support document are needed for all key personnel and that each cannot exceed five pages?

As stated in the ROA, a list of other support should be included as part of the CV or NIH biosketch for each of the key personnel. The list should not exceed five pages and does not need to follow any particular format. Please note that signed other support documentation submission is required during pre-award negotiation but not as part of the application.

Can one or more of the PIs on an application be part of a foreign component? Also, what are the steps that need to be taken to get prior approval for a foreign component?

As stated in the ROA, foreign components are allowed. Foreign components are defined as the performance of any significant element or segment of the project outside of the U.S. either by the recipient or an individual employed by a foreign institution, whether or not award funds are expended. One or more of the PIs may be at a foreign institution as part of a foreign component, as long as the primary applicant organization is a U.S.-based organization. For more information on foreign other support and disclosure requirements, please see the NIH Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest and NOT-OD-19-114: Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components.

If you are a non-U.S. citizen working at a U.S. institution, you will need to remain there long enough to finish your project.

• If you do not have a permanent visa, state in your application that your visa will allow you to remain in the U.S. long enough for you to be productive on the project.
• Your institution needs to ensure that you have an appropriate work visa.

Note: Although Translator is not a grant, OTA is covered under R&D as prescribed by the Guidance for Implementing National Security Presidential Memorandum 33 from which implementation of the above policies are derived.

The “Foreign Institutions” section of the ROA states that “Prior approval is required for all foreign components.” To whom should prior approvals be directed and what information is needed?

All prior approval requests will be submitted to the assigned Other Transaction program officer and Other Transaction agreement specialist by the recipient organization’s authorized representative. A request for a new foreign component would include:

1. Description of the planned activity to be conducted in a foreign country, detailed budget (if any funds will be provided) and timeline of planned activities. (Note: Funds for grant awards are paid in U.S dollars; NIH will not adjust/compensate for currency exchange fluctuations after awarding the funds.) 
2. Identification of countries with which international cooperative activities are planned.
3. Description of special resources or characteristics of the research project (e.g., human subjects, animals, disease, equipment, techniques), including the reasons the facilities or other aspects of the proposed project are more appropriate than a domestic setting.
4. Description of how the scientific environment in which the research will be conducted contributes to the probability of success (e.g., institutional support, physical resources, intellectual rapport).
5. Discussion of ways the proposed studies will benefit from unique features of the scientific environment or from unique subject populations, or how studies will employ useful collaborative arrangements.
6. Specific explanation of why this activity cannot be completed in the U.S. If multiple sites are involved, a description of the resources available at each site should be included.

Note: Prior approval for foreign components does not need to be obtained pre-application.

Does the estimated $8.5 million budget include indirect costs for the awards?

The total budget NCATS expects to award for FY 2025 is $8.5 million, including indirect costs associated with the awards.

Is it permissible for two different proposals to include the same software tool (e.g., a reasoning agent or knowledge provider) with complementary (non-overlapping) proposed work and milestones for that software on the separate proposals?

If there is no overlap in the proposed milestones, this would be permissible. Note that during negotiations, NCATS reserves the right to request milestone adjustments to ensure complementarity between awards and remove any potential overlap. 

Are there any restrictions on having multiple PIs at a subaward institution? Can these be separate subawards or should they be a single subaward?

The ROA does not list any restrictions on multiple PIs at the same organization, as long as there is no overlap in the aims/responsibilities of those PIs or their staff. In general, a single subaward should suffice for multiple personnel from one organization participating in proposed activities to be conducted in a single application.

Note: NCATS reserves the right to request milestone adjustments during pre-award negotiation to eliminate potential overlap and ensure complementarity between awards.