Find below answers to frequently asked questions for applicants to
Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional) (PAR-25-242).
Learn more about the
Mobile Health: Technology and Outcomes in Low and Middle Income Countries (mHealth) Program.
General
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The mHealth Funding Opportunity Announcement (NOFO) is an R21/R33 phased innovation award. What is meant by a phased award?
The NIH Phased Innovation Award (R21/R33) mechanism provides up to 2 years of R21 support for initial developmental activities, and up to 3 years of R33 support for expanded activities. Proposed projects should include both an R21 phase, with milestone-driven developmental activities, and an R33 phase with expanded activities that will build on the initial developmental phase to achieve the aims of the entire award.
The R21 grant mechanism is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. The R33 award is to provide a second phase for the support for innovative exploratory and development research activities initiated under the R21 mechanism. Applications proposing only R21 or R33 activities alone will not be accepted. -
How will the phased award application be reviewed and awarded?
Please see
PAR-25-242 Section V. Application Review Information for more information about scoring criteria. Please note, applicants must include information about research activities to be undertaken in both the R21 and R33 phases of the award to be deemed responsive. The R21/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R21/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will assign a single impact score for the entire application, which includes both the R21 and R33 phases.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation. -
How does a phased innovation award transition from the R21 phase to the R33 phase?
Prior to funding an R21/R33 application, program staff will contact the applicant to discuss the proposed milestones. The Program Director and the applicant will negotiate and agree on a final set of milestones. These will be incorporated into the terms and conditions of the award and will be the basis for judging the success of the R21 work.
Prior to the end of the R21 phase, awardees will submit a package that requests transition to the R33 phase. This package will include a progress report that describes progress towards each of the initial milestones, and a clear description of how research during the R33 phase will be impacted by attainment of the R21 milestones. These materials will be reviewed by the NIH IC Program staff and then, if selected, will be transitioned to an R33 award without the need to submit a new grant application. Decisions on transitioning to the R33 phase will be based on the original R21/R33 peer review recommendations, successful completion of the originally described milestones, program priorities, and availability of funds. -
How are milestones for the R21 phase of the Phased Innovation R21/R33 grant mechanism determined?
The Transition Milestone section must propose milestones for completion of the R21 part of the project, a discussion of the suitability of the proposed milestones for assessing success in the R21 phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 study. Transition Milestones should be well-defined, specific, quantifiable and scientifically justified; they should not be simply a restatement of the R21 specific aims. Milestones may be provided for the R33 phase at the discretion of the applicant. Transition Milestones should be sufficiently rigorous scientifically to be valid for assessing progress in the R21 phase. Any available preliminary data that will support or justify the proposed hypothesis, rationale or development plan may be included. However, preliminary data are not required for an R21/R33 application. -
Do applicants have to wait for a response from the NIH to their letter of intent before submitting an application?
No. Letters of intent are solely for the purpose of planning the review. They inform the NIH of who may be planning to submit and what institutions are involved. Applicants are encouraged to communicate with NIH staff prior to submitting an application to ensure they will be responsive to this PAR. Applications will be screened for responsiveness prior to initial peer review, and non-responsive applications will be withdrawn before peer review. NIH staff can provide feedback on responsiveness and scientific content prior to submission. Letters of intent are expected to provide the following information to NIH staff: - Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PDs/PIs
- Names of other key personnel
- Names of participating LMICs
- Participating institution(s) (U.S. and LMIC)
- Number and title of this funding opportunity
- Descriptive title of linked application
- Institution submitting linked application
- Name(s), address(es), and telephone number(s) of the PDs/PIs on linked application
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How many applications can my institute submit?
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time. -
Can I be a named researcher on more than one application?
Applicants may be named investigators on more than one proposal if the proposed projects are scientifically distinct and do not propose undue scientific overlap. -
Is it possible to have multiple PIs, with one of the PIs located in a U.S.-based institution?
Yes, applications with multiple PIs are not restricted. Please note that while the NOFO encourages but does not require multiple PI status when submitting the grant application, key personnel from both LMIC and U.S. institutions must be included. -
Do I need to provide current and pending support documentation for all key personnel?
The Research Support section in the bio sketch is adequate to meet the NOFO instruction. There is no need to provide separate current and pending support documentation for all key personnel with the application. -
Do all PDs/PIs need to have an eRA Commons ID?
All PDs/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. For additional information, see the
eRA Commons Registration FAQs. -
Is it required for applicants to have and maintain a System for Award Management (SAM) registration for applications in response to this NOFO?
Yes, the submitting institution and all PDs/PIs are required to register in order to submit an application using the online systems. Applicants must have a valid
12-character unique entity identifier (UEI) created in SAM.gov. number in order to begin each of the following registrations:
- System for Award Management (SAM) – Applicants must complete and maintain an active entity registration (formerly CCR registration), which requires renewal at least annually. The renewal process may require as much time as the initial registration. Use the sam.gov "Manage Entity" function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
- Grants.gov
- eRA Commons – Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Find detailed instructions about this
multiple step process.
Note that NIH requires electronic applications in response to this NOFO and it is critical that applicants complete all required registrations well in advance of the application deadline as the registration process can take several weeks or longer. Applications in response to this NOFO must be successfully submitted by the deadline. -
Does the application have a page limit?
Yes. All page limitations are described in the
SF424 Application Guide and the
Table of Page Limits must be followed. As indicated in the Table of Page Limits, the R21/R33 Research Strategy Section is limited to 12 pages. -
Are appendix materials allowed in my application?
Yes. Please note that there are specific instructions in the NOFO for material that must be included in the appendix. -
This NOFO states that clinical trials are optional. How is this determined?
Applicants proposing to conduct a clinical trial under this NOFO should review the
NIH policy on clinical trials and
case studies for reference. The
NIH Definition of a Clinical Trial must be used to determine whether or not you are conducting a clinical trial. It states a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavior outcomes.” A
decision tool is available to assist with the determination. Applicants are also encouraged to review NIH policy on clinical trials and case studies for reference. -
Where can I find additional guidelines for submitting an application?
Carefully follow the specific guidelines/requirements found in both the Application Guide and the Funding Opportunity Announcement (NOFO). Be aware that the instructions in the NOFO supersede those found in the SF424 application guide.
See the
Annotated Forms for tips on how to fill in the SF424 forms.
All applications must be submitted electronically. Applicants should follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (see
PAR-25-242, Section IV. Application and Submission Information for specific information) or in a Notice from NIH Guide for Grants and Contracts. -
What is the timeframe for submission of applications?
Applications to this PAR are received once per year. The application due date for non-AIDS and AIDS applications is currently in late March. Please refer to the NOFO for the relevant due dates for the specifc cycle you plan to submit for. Applicants and their institutions should familiarize themselves with the requirements of electronic submission through grants.gov, including registration of the applicant and the institution through NIH Commons (see above regarding registrations). It is strongly suggested that you submit your application electronically a few days BEFORE the actual deadline. Remember, you must check for error messages to your email address after submission to Grants.gov AND subsequently when the application is transferred automatically to eRA Commons (error messages go to your eRA Commons Account). You must correct any Grants.gov and eRA-identified errors BEFORE the submission deadline or your application will NOT be accepted by NIH. Verify that your application is viewable in your eRA Commons account. If you cannot view the application in eRA Commons, NIH has not yet accepted it! Do not wait until the last day. Late applications will not be accepted for review.
Check your application for common errors before you submit, or see "Avoiding Common Errors." -
When will review results be sent to applicants?
Scores can be accessed from the PI's NIH eRA Commons account 1-2 days after the review. The NIH summary statement with the critiques of the initial peer reviewers will be available in the NIH eRA Commons (in the account of the PI, linked to the application number) approximately four to six weeks after the review meeting. Reviews for March receipt dates are held in June or July. The results of the review are presented to the FIC Advisory Board in September/October, with the earliest date for funding decisions in December of that year. -
On what basis are applications selected for funding?
Applications will be selected for funding based on scientific merit, current NIH program research priorities, and availability of funds. Applicants are highly encouraged to discuss potential research aims with program officials to determine fit with programmatic research priorities.
Eligibility
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Who is eligible to apply?
Both US and LMIC institutions are eligible to apply to this funding opportunity and broad partnerships are highly encouraged. While it is not required (although encouraged) for applications submitted to this NOFO by
LMIC institutions to have US partners, all applications submitted to this NOFO by
US institutions are required to involve LMIC researchers as key personnel. Individuals from U.S. and LMIC institutions are eligible PDs/PIs. At least one individual from a proposed LMIC institution must serve as a PD/PI or other key personnel. Individuals from non-U.S. high income country institutions are not eligible as PDs/PIs, but may participate as partners or collaborators in proposed programs. -
How do I find out what countries are classified as LMIC?
For a current listing of LMIC countries, please review
World Bank Country Classifications information . The LMIC definition used in the mHealth NOFO includes "low income economies," "lower-middle income economies," and "upper-middle income economies." -
As a U.S. applicant, what kind of organizations can I partner with in an LMIC?
U.S. applicants can partner with organizations such as institutes of higher education as well as non-profit, for-profit, or government organizations in LMICs. -
Can applicant organizations partner with non-U.S. high-income country organizations?
Yes. U.S. applicants can partner with organizations in other high-income countries such as institutes of higher education as well as non-profit, for-profit, or government organizations. -
Are non-governmental organizations (NGOs) in LMICs eligible to apply to this NOFO?
Yes. An NGO is an eligible applicant organization for this NOFO as long as it is able to provide a stable administrative and research infrastructure so that research and research capacity investments would be sustained for the foreseeable future. If you have any doubts about your eligibility, contact the program officer. Please note that for-profit foreign organizations are not eligible to apply to this NOFO. -
If I’m an LMIC investigator, how do I find appropriate US partners?
While a US institution is not required, it is strongly encouraged.
NIH RePORTER and
NIH World RePORT are powerful tools for identifying researchers that align with your research interests in various regions of the world. You are also encouraged to network broadly through scientific meetings, review pertinent literature and contact appropriate researchers, etc. -
May I submit if my topic is eligible for the NOFO but does not fit any of the participating NIH institutes other than Fogarty?
If your R21/R33 application is an eligible topic for the NOFO, you do not have to find an NIH specific Institute or Center (IC) "home" other than Fogarty for the application before you submit. An assignment will be given during application submission, either remaining with Fogarty or assigned to another appropriate partner IC. Prior discussion with other interested ICs is helpful for referral purposes and for subject matter expertise, but it is not required.
Budget
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How much total support is available for mHealth R21/R33 grants?
The R21 phase may not exceed $125,000 in direct costs in any single year of the R21 phase. The R33 phase may not exceed $200,000 in direct costs in any single year of the R33 phase. The project period is limited to 2 years for the R21 phase and up to 3 years for the R33 phase. The total project period may not exceed 5 years. -
What indirect cost rates should be used in preparing the budget?
For U.S. institutions, indirect costs (also known as Facilities & Administrative [F&A] costs) are reimbursed based on institutional negotiated rate agreements.
For foreign institutions, the NIH provides limited F&A costs (8% of total direct costs less equipment) to help support the costs of compliance with NIH requirements. Since the F&A costs are intended for compliance costs only, other items normally considered an F&A cost can be requested as a direct cost, e.g. rent. -
Can an application request funding related to infrastructure, such as internet costs?
While costs associated with certain infrastructure needs, such as internet, could be requested, applicants should consider sustainability of their intervention when developing an application. Please note, though, that the R21/R33 is a phased exploratory/developmental research award and not meant to support significant infrastructure development. For instance, if a proposed intervention weren’t feasible without significant infrastructure development prior to launch of the intervention, this could be seen as a detriment during review with respect to the environment-related scored review criteria.
Research Activities
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The mHealth program recently was relaunched utilizing the R21/R33 phased award mechanism instead of the R21 mechanism used in previous years. How does the mHealth R21/R33 differ from the previous R21?
The primary difference between the previous mHealth R21 NOFO and the current R21/R33 NOFO is the addition of the R33 phase for further validating the mHealth intervention, as well as further testing its feasibility and effectiveness. The R33 phase provides an additional 3 years of support (up to $200,000/year in direct costs) after the 2-year R21 phase (up to $150,000/year direct costs). Importantly, there is a specific focus under this revised NOFO on catalyzing innovative new or emerging technologies, platforms, systems, and analytics. -
The mHealth initiative supports
FIC’s strategic plan by stimulating innovation in the development and implementation of technologies to address global health problems; how should I interpret “innovation” for the purpose of this NOFO?
Applicants should very clearly and compellingly explain how the proposed mHealth intervention or tool utilizes innovative technology, platforms, systems, or analytics that are new or emerging and describe any advantages over existing technology, platforms, systems or analytics used to address the same or similar problems. Consideration should be made regarding how the intervention or tool addresses the health problem in the LMIC context and whether the proposed research offers potential advantages related to effectiveness, affordability, usability, accessibility, or sustainability within this context. Applicants should carefully review the NOFO’s Scored Review Criteria (Section V. Application Review Information) for specific information about what constitutes “innovative” research under this NOFO.
Research Capacity Building
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Applicants are required to develop strategies for research capacity building within the research plan portion of the mHealth R21/R33 application. What types of capacity building are appropriate/acceptable?
There are many different models for research capacity building that would be considered responsive to the mHealth NOFO. You are encouraged to reach out to pertinent NIH Institute and Center program staff contacts (listed in the NOFO) to discuss your proposed research capacity building portion of your application, as necessary.
Updated December 5, 2024