Pre-Application Information Webinar for the HEAL Data2Action Program

This page provides answers to Frequently Asked Questions (FAQs) about RFAs for the HEAL Data2Action Program.  The HD2A Program has 4 interrelated components:  

• HEAL D2A Innovation Grants (R61/R33, March 10 due date) (RFA-DA-22-051)
• HEAL D2A Data Infrastructure Support Center (U24, March 10 due date) (RFA-DA-22-052)
• HEAL D2A Modeling and Economic Resource Center (U24, March 10 due date) (RFA-DA-22-049)
• HEAL D2A Research Adoption Support Center (U2C, March 25 due date) (RFA-DA-22-050)

Prospective applicants to any of these RFAs are strongly encouraged to read ALL of these RFAs to understand the full context of the HD2A Program.

Responses to FAQs are provided for the HD2A program overall, and then for each component RFA.  If your question is not addressed here or in the RFA, please contact us at HEALdata2action@nih.gov.

This document will be updated as more questions are received.

FAQs:  Overall HD2A Program

Q:  May the same applicants submit multiple applications?
A:  Yes. Applicants may submit multiple applications to the same RFA, as long as those applications are scientifically distinct.  Applicants may also apply to multiple HD2A RFAs (e.g., to multiple resource/support centers).

Q:  If the project has multiple PI’s, co-PI’s, or Core Leads, how many should we budget to attend the PI meetings?
A:  The RFAs refer to two different types of meetings. The HEAL Initiative holds an annual PI meeting for all of its grant awards. Due to space limitations, projects should budget only 1 PI to attend this annual meeting (assume these meetings are 2 days in the Washington DC area).  There are also 2 in-person meetings anticipated specific to the HD2A Program (4^th quarter of Year 1, and 1^st quarter of Year 3). The RFAs indicate that projects should budget to travel up to 3 project staff to each of these meetings (assume 3 days in the Washington DC area). Specific attendees can be determined post-award.

FAQs:  HD2A Innovation Grants

Q:  For the innovation centers, must the targeted system be a hospital system or can it be a community served by public health department, or a region, city, neighborhoods, etc.?
A:  The targeted setting or system does not need to involve a hospital system. Applicants are encouraged to propose any project that will improve the utility of local data for identifying and addressing the overdose crisis through enhanced use of primary prevention, harm reduction, recovery support, or evidence-based treatment. Projects involving non-hospital settings, such as public health departments, addiction treatment programs, community health clinics, etc. are welcome. While the primary focus should be on reducing overdose rates, projects may also integrate data from systems or settings that are not directly focused on healthcare but have implications for high-risk individuals – e.g., justice settings, social services, schools, shelters, syringe programs, etc.

Q:  Could applicants propose machine-learning approaches that could help drive decisions to improve care?
A:  Yes. Applicants may propose any well-justified approach that could integrate and improve the utility of data to drive decision making to improve overdose-related outcomes.

Q:  Could you please explain how long each Phase may be?
A:  Applicants may propose an R61 phase of either 1 or 2 years, and an R33 phase of 3 or 4 years, with the entire project period (both phases combined) not to exceed 5 years. Activities in the R33 phase should build logically on the work in the R61 phase. When planning the R61 phase, applicants should carefully consider the amount of preliminary work needing to be done and how much time is reasonably needed to achieve the milestones of that phase.  

Q:  Is the entire R61/R33 application limited to 12 pages, or is it 12 pages for each phase?
A:  Applicants must describe both phases of this project within a single 12-page application. The Research Strategy includes two sections (Section A and Section B, described in the RFA) – both are to be addressed within the 12-page limit. However, please note that the application allows a separate (additional) 2-page attachment for your description of the project timeline and the proposed milestones.  (See instructions under “Other Project Information – Timeline & Milestone Plan.”)

Q:  Will all projects transition to Phase 2?  What determines whether the transition is approved?
A:  Transitions from Phase 1 to Phase 2 are neither automatic nor guaranteed. Projects will be selected for transition based on performance against the original milestones, program priorities, and available funds.

Q:  For the Innovation Projects, can you speak to walking the line between having the expertise to do the projects vs needing to leverage the support centers?  Are Innovation Projects required to utilize all 3 of the resource and support centers?
A:  Innovation Projects are expected to propose the leadership and expertise necessary to obtain, prepare, analyze, and act upon the data systems to be used. It is not expected that applicants will have access to local expertise in advanced data science, simulation modeling, economic analysis, or implementation science. NIDA expects that the Innovation Project grantees will vary in their needs for support, and also that unanticipated challenges may emerge over the course of these projects. The HD2A resource and support centers will be available to provide consultation on state-of-the-art approaches to data integration and analysis, visualization, modeling, cost estimation, and implementation of evidence-based practices. While utilizing the expertise of all three of the HD2A resource and support centers is not required, grantees are strongly encouraged to leverage this opportunity. The HD2A Program provides a unique opportunity for Innovation Project grantees to build local capacity for data-driven decision making that will lead to sustained improvements in service delivery. In Section B of the Research Strategy, applicants are asked to describe how they envision using these resource and support centers to extend the work they have proposed at their study sites. This is both to demonstrate an understanding of the HD2A Program structure, and to help NIDA anticipate potential needs.

Q:  What is the nature and extent of support we can receive from the Resource and Support Centers?
A:  The HD2A resource and support centers (the DISC, MERC, and RASC) will provide advice, technical assistance, informational resources, and some custom-built tools that may be developed based on the needs of the funded Innovation Projects. Consult the companion RFAs for detail on the activities expected of the DISC (RFA-DA-22-052), MERC (RFA-DA-22-049) and RASC (RFA-DA-22-050). These centers will provide consultation and advice, but the actual work of implementation, system change, or other selected activities is to be carried out by the Innovation Project recipients locally. 

Q:  For the Innovation Projects in the cross-sector track, how do you envision funding/project leadership be shared across the two organizations?
A:  Applicants may propose any leadership structure that makes sense for the specific project. Applications may have a single Principal Investigator with co-investigators at each site; utilize a Multiple PI structure with designated MPIs at some or all sites; or any other structure that reflects the roles and responsibilities needed to ensure appropriate access to and utilization of each site’s data, and collaborative input into the selected strategies to improve services. Budgets and subawards should be structured to reflect the efforts of the component parts.

FAQs:  HD2A Data Infrastructure Support Center

Q: The RFA indicates that DISC application budgets are limited to $1M direct and that NIH has allocated $1.5M total costs/year for this award.  Does this mean indirect costs are limited to $500K/year?
A:  No limit is imposed on indirect costs.  Applicants may budget up to $1M direct costs per year, and utilize their approved F&A rate.  The NIH set-aside of $1.5M for this award in FY22 is an estimate; it does not represent a hard cap for applicants. 

Q:  How should applicants describe or justify the $200K funds being set aside for Rapid DIMS activities?
A:  Because the Innovation Project awardees are unknown, NIDA and the HD2A Resource and Support Centers cannot anticipate the full range of support that may be needed for these projects. The RFA requires the DISC applicants to budget at least $200K direct costs per year to address unanticipated needs or emergent opportunities to assist with rapid modernization of Innovation Projects’ data systems. Given these unknowns, applicants do not need to describe exactly how these funds will be spent, but they should describe a structure for administering the Rapid DIMS program as outlined in the RFA.

FAQs:  HD2A Modeling and Economic Resource Center

Q: The RFA indicates that MERC application budgets are limited to $1M direct and that NIH has allocated $1.5M total costs/year for this award.  Does this mean indirect costs are limited to $500K/year?
A:  No limit is imposed on indirect costs.  Applicants may budget up to $1M direct costs per year, and utilize their approved F&A rate.  The NIH set-aside of $1.5M for this award in FY22 is an estimate; it does not represent a hard cap for applicants.

FAQs:  HD2A Research Adoption Support Center

Q:  The RFA is designated “clinical trial optional,” but says that applicants may not propose clinical trials to test interventions.  Isn’t this contradictory?
A:  The RASC is charged, in part, with developing a curated catalog of evidence-based practices for addressing OUD and pain. Applicants may not propose to conduct clinical trials to establish an evidence base where none exists (e.g., to develop novel clinical interventions) nor to test the efficacy or effectiveness of a newly adapted clinical intervention. As part of the Research and Evaluation Core, applicants may propose or conduct activities that might qualify as NIH-defined clinical trials, for example, a pilot test of a specific strategy to promote adoption of an evidence-based prevention program. This activity would meet the NIH definition of a clinical trial, but would not include an efficacy/effectiveness trial of that prevention program.

Q:  The RASC RFA requires a research project be specified.  Does this require a separate application or should it be described within the Research and Evaluation Core?
A:  Plans for the required rapid-turnaround research project (on the role of financing/reimbursement on the uptake of medications for OUD) should be described within the research strategy section for the Research and Evaluation Core. 

Q: Can you explain the goal of the required research project on financing of MOUD?  Is the RASC expected to conduct an implementation trial (e.g., of alternate financing structures)?
A:  The goal of this rapid-turnaround project is to better understand persistent barriers to the widespread adoption of MOUD related to financing, reimbursement, insurance, and related factors. The RASC should design a rapid-turnaround project that could support a set of recommendations for next steps – either for research or implementation – that could address these barriers and improve broader adoption. The deliverable would be the set of recommendations. The RASC is not expected to conduct an implementation trial.

Q: The RFA indicates that RASC application budgets are limited to $2M direct and that NIH has allocated $3M total costs/year for this award.  Does this mean indirect costs are limited to $1M/year?
A:  No limit is imposed on indirect costs. Applicants may budget up to $2M direct costs per year, and utilize their approved F&A rate. The NIH set-aside of $3M for this award in FY22 is an estimate; it does not represent a hard cap for applicants.