Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Definition of mHealth

In the context of this NOFO, mHealth is defined as the use of mobile and wireless devices (cell phones, tablets, etc.) to improve health outcomes, health care services, and health research. The mHealth technology studied in proposed projects may include external hardware and/or software components for mobile or wireless devices. New or emerging technology, platforms, systems, and/or analytics should be incorporated. For the purposes of this NOFO, research that proposes solely SMS-based text messaging interventions will not be considered responsive.

Background

The enormous potential for mobile technology to transform health care, personal health management, and basic health research has led to the rapid development of new health-related phone applications, sensors, and devices. The potential of mHealth is especially relevant to LMICs, where cell phone ownership is rising rapidly, but access to health care and providers is often limited. While this promise of mHealth is leading to a large increase in interventions that use mobile technology, research on these interventions is often lacking.

FIC created the first iteration of this program in 2013 (funded grants can be found on the FIC mHealth program website) based on the need for a larger mHealth evidence-base in LMICs, as cited, for example, in a 2011 report by the World Health Organization (WHO; mHealth: New Horizons for Health through Mobile Technologies, Global Observatory for eHealth Series Volume 3). This need for further research regarding effectiveness has again been emphasized in the 2019 WHO Guideline:? Recommendations on Digital Interventions for Health System Strengthening. Additionally, advances in cell phone and tablet computing have increased the potential for artificial intelligence (AI) to improve healthcare delivery and health in LMICs. As a developing field, significant research is still needed to understand how AI can be best utilized and whether it can be effectively incorporated into health systems in the LMIC context, as discussed in the recent USAID report Artificial Intelligence in Global Health: Defining a Collective Path Forward, as well as USAID’s Principles for Digital Development (https://www.usaid.gov/usaid-digital-strategy/06-annex-iv and https://digitalprinciples.org/).

Partnerships

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. All applications should propose the development of mHealth or mHealth-related research capacity in the research teams and/or at LMIC institutions. The individual and institutional research capabilities and international research networks that are developed should enable future mHealth research, beyond the time period of the grant. Additional partners may be included in applications as relevant, such as non-governmental organizations (NGOs), hospitals, for-profit organizations, and government entities.

Research Objectives

This NOFO encourages research projects that study the development, feasibility, validation, and effectiveness of mHealth tools and/or interventions for the prevention, diagnosis, management, and treatment of specific health conditions or for disease agnostic/cross-cutting applications. Applicants are encouraged to propose research projects that have the potential to provide an understanding of principles underlying effective mHealth interventions or tools that are generalizable to the field. Research projects may include some mHealth technology development along with feasibility, acceptability, usability, validation, and effectiveness studies. User-centered and iterative design are highly encouraged, as is taking a systems science approach, during development stages. Applications should include as rigorous study designs as possible.

The proposed research should be divided into the R21 and R33 phases as appropriate, with the milestone-driven R21 demonstrating initial feasibility of the mHealth intervention or tool followed by further validation, feasibility, and/or effectiveness studies in the R33 phase.

This initiative aims to support projects that adapt or develop technologies that are appropriate for LMIC settings. A plethora of mHealth applications and devices have been developed in high-income countries. However, these technologies are not necessarily suitable for the needs of LMICs. Research that focuses on the problems and constraints in LMIC environments should produce more effective interventions and tools and may result in more sustainable mHealth use, especially if there is involvement from LMIC collaborators, such as businesses, hospitals, or governments.

Important Points for Consideration:

• If the mHealth intervention or tool aims to produce a specific clinical outcome, applicants should incorporate appropriate biological variables (such as sex) and endpoints and/or observational behavioral data to measure this outcome.
• Interventions that aim to produce behavior change should be based on existing social and behavioral science theories.
• The interventions or tools studied should take advantage of the unique functionality of mobile and wireless devices. Utilization of real-time data collection and feedback is encouraged where appropriate.
• New software, devices, and systems should be interoperable with existing infrastructure and resulting data should integrate with relevant health information systems where applicable.
• The reliability, safety, simplicity, affordability, durability, and power requirements of new technology being studied should be considered in the LMIC context where it will be used. Devices, interventions, and tools should be developed with a deep understanding of the LMIC context and populations, including their differential effects on women and men or on particular groups of women and men (such as pregnant women or sexual and gender minorities). Additionally, appropriate privacy and security considerations should be made.

Transition from R21 to R33 phase

Each administrating NIH Institute or Center (IC) may follow IC-specific procedures and timelines. Generally, after administrative review of an R33 transition package (see below for further information about R33 transition package contents) by NIH staff, R21 projects will be prioritized and may be approved for transition to R33 funding. Grants receiving a positive R33 funding decision will be transitioned to an R33 award without the need to submit a new competing application. Criteria used to determine which R21 projects will be continued into the R33 phase include the following:

• Successful completion of transition milestones (original or modified with prior approval) for the R21 period of the project;
• Potential of the plan for successful conduct of the R33 phase, including established partnerships;
• Availability of funds;
• NIH IC program priorities.

For grants funded through this program, awardees may submit an R33 transition package no less than two months before the completion of the R21 phase. This R33 transition package should include: 1) an R21 research performance progress report (RPPR) describing in detail the R21 period activities and accomplishments; 2) progress toward addressing the R21/R33 transition milestones, including quantifiable metrics, go/no go criteria required for successful transition, and a description of how the activities of each milestone have been sufficiently completed; and 3) a description of how research proposed for the R33 phase will be advanced through R21 research period outcomes. These materials will be evaluated by NIH Program staff, per the above criteria. It is anticipated that not all R21 awardees will be transitioned into the R33 phase. Applicants must be aware that use of a no-cost extension at the end of the R21 period (including delayed completion of the R33 transition packet) could impact the potential award of the R33.

The mHealth program strongly encourages principal investigators/program directors (PIs/PDs) to include women and individuals from groups underrepresented in clinical, biomedical, and sociobehavioral research in the country (including individuals from racial, ethnic, and socially disadvantaged backgrounds and those living with disabilities) as faculty, scientific collaborators, and trainees.

Specific Research Interests of the Participating NIH Institutes, Centers, and Offices

The Fogarty International Center (FIC) is dedicated to advancing the mission of the NIH by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs. Therefore, FIC is interested in a diversity of global health research topics that address the priority health needs of LMICs and fit the above research objectives. This initiative supports FIC's strategic plan by stimulating innovation in the development and implementation of technologies to address global health problems and by building capacity through individuals, institutions and networks to meet future and evolving global health challenges.

Applicants proposing projects related to HIV/AIDS should ensure that the research aligns with NIH HIV/AIDS high priority research topics by reviewing the NIH HIV/AIDS Research Priorities and Trans-NIH Plan for HIV-Related Research before submitting an application.

The National Cancer Institute (NCI) recognizes the potential for mobile communication technologies to: (a) contribute to prevention of avoidable cancers by promoting healthy lifestyles and behaviors; (b) support early detection, when the opportunities for curing or controlling the cancer are optimal; (c) facilitate accurate diagnosis and effective treatment planning; (d) support reliable communications between all members of the care team, including the patient, during treatment; and (e) offer an unbroken system of support during survivorship and at end-of-life. Specific examples of relevant research objectives include, but are not limited to, the following:

• Development and evaluation of mobile applications to promote smoking cessation, regular physical activity, and healthy diet
• Extending mHealth platforms to include point of care technologies
• Integrating personal surveillance data from mobile and wireless devices into e-Health records
• mHealth adaptations including games to improve patient education, primary and secondary prevention of cancer, stigma, and treatment adherence
• Improving clinical trial recruitment and addressing issues related to patient abandonment through mobile communication strategies
• Utilizing the digital photography and geo-positioning capabilities of mobile technologies to aid in the early detection of cancers especially in underserved or remote areas
• Developing capacity-building projects internationally that will offer synchronous and asynchronous management, and monitoring, of treatment plans in low resource environments
• Creating a communication safety net for cancer survivors that will support them after treatment, while adhering to the evolving guidance of a proactive survivorship care plan
• Developing support tools for hospice workers, home care specialists, caregivers, and patients to improve palliation and end-of-life decision making

The National Eye Institute (NEI) encourages innovative applications with the goal of identifying mobile health tools or technologies that aid in the screening, early detection, prevention, diagnosis, assessment, treatment or management of eye diseases and vision disorders. Additional interests include mobile health technologies that improve vision health care delivery to underserved or remote populations or increase patient adherence to treatments. NEI will not support clinical trials that are greater than minimal risk on this funding opportunity (Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests).

The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies. NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest (https://www.nibib.nih.gov/research-funding) to determine if their research fits within the NIBIB mission.

NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is seeking innovative approaches to achieving its mission. NICHD’s mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. NICHD is especially interested in applications focused on HIV/AIDS research priorities, including: Use of mHealth technologies to improve screening, assessment, prevention, treatment or management of HIV and associated complications in infant, children, adolescent, and pregnant people in LMICs.

The National Institute on Deafness and Other Communication Disorders (NIDCD) conducts and supports research in 7 scientific program areas: hearing, balance/vestibular, voice, speech, language, taste and smell. The mission of the NIDCD is to reduce the burden of communicative disorders and improve public health. NIDCD is especially interested in applications focused on newborn screening of hearing ability and early identification and treatment of voice, speech, and language delay or disorders. Mobile Health applications in augmentative and alternative communication for non-speaking individuals, and applications that promote improved access to and/or affordability of hearing healthcare are also of interest to NIDCD. Applications from institutions within a geographic region which shares the same spoken language e.g. Spanish in Latin America, Arabic in the Middle East and North Africa could offer special opportunities for regional collaboration and better health outcomes. Prospective applicants are encouraged to review the current NIDCD Strategic Plan on the NIDCD website.

The National Institute of Mental Health (NIMH) is interested in supporting research on the development and/or innovative application of cost-effective, sustainable, and scalable digital technologies to improve the accessibility, delivery, quality or effectiveness of mental health care and/or HIV prevention or care in LMICs to address the global mental health burden. Applicants are encouraged to review NOT-MH-18-031 and the NIMH Advisory Council Report Opportunities and Challenges of Developing Information Technologies on Behavioral and Social Science Clinical Research which elaborate NIMH research priorities on digital health technology for mental health conditions. NIMH encourages applications that test generalizable principles or approaches in the use of technology and encourages research attention to known challenges with the uptake and sustained use of technology-based approaches and to privacy and other safety or ethical considerations associated with use of technology for research and clinical purposes. Of lower priority for NIMH funding are applications that propose the transfer of face-to-face interventions onto digital technologies or the replication of proven/existing technologies with additional mental disorders or target populations.

Research topics considered relevant to NIMH priorities under this NOFO include, but are not limited to applications which:

• Advance digital technologies to deliver mental health care to populations in LMICs with unmet mental health needs and limited access to mental health care
• Develop innovative measurement approaches that can capture how digital technologies are used across population groups and impact mental health outcomes
• Harness passive sensing, social media, or other digital technologies to understand, manage, prevent, and predict adverse mental health or HIV outcomes in LMICs
• Leverage emerging platforms, such as social media platforms, for intervening in mental health or HIV in LMICs
• Leverage AI and/or other novel computational and statistical approaches to improve the accuracy, early detection, enhance decision making, and the speed of mental health diagnosis
• Deliver and support multi-level approaches to improve mental health or HIV-related outcomes including individual, family/caregivers, peers, providers, facilities, and health care systems
• Develop, test and validate approaches to expand access and improve engagement with digital technologies for mental health or HIV prevention and care,
• Deploy digital methods to assess psychiatric needs at the population level and identify high risk populations with greater psychiatric need
• Demonstrate cost, cost-effectiveness and affordability of digital interventions in mental health or HIV prevention and care

NIMH encourages applicants to use existing hardware/software and data from existing commercial and open-source digital health applications and online platforms, where appropriate. We also encourage harmonization across diverse methods by considering use of the following (where applicable): the NIMH Clinical Research Toolbox Webpage (NIMH Clinical Research Toolbox ); the PhenX Tool Kit (PhenX Toolkit); or RDoC, or RDoC-like constructs when defining intervention targets and outcomes, as feasible to the specific context or setting (see the RDoC webpage for more details). Inclusion of key stakeholders (patients, consumers, diverse end users, etc.,) as part of the conceptualization, planning, development, and implementation of the digital health technology across the life course of the intervention is strongly encouraged. AI models should have a life-long learning framework and include considerations to mitigate data bias and ensure inclusiveness in data sets in training, testing, and deployment phases.

The NIH Office of Dietary Supplements (ODS) is part of the Office of the Director (OD), NIH, and is interested in research on development, validation, feasibility, and evaluation of mobile technologies for nutrient status assessment, dietary intake assessment, and compliance with recommendations for food and dietary supplement intake during special life stages. Such tools or interventions should harness existing and emerging innovative technologies to enable precision nutrition approaches and rapid methods for biochemical assays. The use of artificial intelligence and machine learning to create algorithms and tools for nutritional biomarker discovery and validation is encouraged.

The ODS does not award grants, therefore, applications must be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed in this announcement. Please contact the relevant IC program contacts listed for questions related to funding.

The NIH Office of Research on Women's Health (ORWH) is part of OD/NIH, and works with the 27 NIH Institutes and Centers (ICs) to advance rigorous research addressing women's health issues. ORWH serves as the focal point for coordinating women's health research at NIH and implements the NIH Strategic Plan for Women's Health Research in partnership with NIH institutes, centers, and offices (ICOs) and co-funds research on the role of sex and gender on health.

ORWH is interested in co-funding research projects with the goal of developing innovative, sustainable, and cost-effective mobile health technologies to improve accessibility, monitoring and delivery of health care services to women across the lifespan and address maternal and infant morbidity and mortality in LMICs. ORWH invites applications to supplement active NIH awards from any of the NIH ICOs listed in this NOFO.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Non-domestic applicant organizations are restricted to organizations in LMICs, which are defined by The World Bank as low-, lower-middle-, or upper-middle-income economies - http://data.worldbank.org/about/country-classifications/country-and-lending-groups. While it is not required (although encouraged) for applications submitted to this NOFO by LMIC institutions to have U.S. partners, all applications submitted to this NOFO by U.S. institutions are required to involve LMIC researchers as key personnel.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. 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.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Brad Newsome, PhD

Telephone: 1-301-480-8389

Email: [email protected]

Page Limitations

All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

Applicants should include all institutions where research will occur as performance sites, including relevant U.S. and foreign institutions.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

All applications must have at least one LMIC researcher as key personnel. Since the mHealth field is multidisciplinary and cross-sector in nature, applicants should consider appropriate collaborations with researchers from diverse disciplines such as behavioral science, engineering, computer science, business, medicine, public health, and/or other relevant fields. In addition, applicants should consider partnering with individuals in public or private organizations, including health system entities, which could enable future research or implementation efforts within the relevant LMIC.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Applicants should budget funds for travel to the annual 2-day program network meeting in Bethesda, MD. PDs/PIs are expected to attend the network meetings and may also budget for other key personnel to attend.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Where feasible, applicants are encouraged to budget funding to their partner institution through the formation of a subaward.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Applicants must provide a single attachment of Specific Aims that includes separate aims for the R21 and R33 phases.

Research Strategy:

In preparing the R21/R33 application, investigators should consider that the application will be assigned a single overall impact score. Thus, clarity and completeness of the application with regard to specific goals and the feasibility of each phase and the milestones are critical. Applications should include the subsections described below.

1) Significance - in addition to the SF424 (R&R) Application Guide, include the following:

• Justify the relevance of the proposed research to the health of the LMIC research population(s).
• Justify the suitability of the proposed technology usage in LMICs. Part of this justification should include a description of the existing mobile infrastructure at the LMIC research location(s).
• If relevant, describe how the proposed mHealth research addresses high priority HIV research interests of NIH and is relevant to the needs of the LMIC.

2) Innovation - in addition to the SF424 (R&R) Application Guide, include the following:

• 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.

3) Approach - divided into two parts corresponding to the R21 and R33 phases. In addition to instructions in the SF424 (R&R) Application Guide, include the following:

• For the R21 phase, transition milestones and a timeline are required and should be described at the end of the approach section. The milestone subsection should include 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.
• For the R33 phase, include a timeline at the end of the approach section. Also, describe strategies that may enhance the likelihood for the mHealth intervention or tool to be implemented, sustained, and/or scaled, if the results of the proposed research are positive.
• Any available preliminary data that will support or justify the proposed research may be included. However, preliminary data are not required for an R21/R33 application.

4) Collaboration Management and Research Capacity Strengthening, include the following:

• Delineate the roles of each key personnel and provide plans for the coordination of research activities. LMIC key personnel should contribute intellectually to the development of the research proposal and planned research activities for the R21 and R33 phases.
• If working with non-academic organizations (such as hospitals, government entities, for-profit organizations, Non-Governmental Organizations (NGOs), community organizations, etc.) describe how collaborations have been or will be established and coordinated.
• Highlight factors in the investigators' background and/or institutional circumstances that will facilitate successful collaboration across partner institutions.
• Describe how the proposed research will integrate strategies for research capacity strengthening in the research team and/or LMIC institutions for both the R21 and R33 phases. The individual and institutional research capabilities and international research partnerships that are developed should enable future mHealth research, beyond the time period of the grant. Specific strategies that are proposed should be tailored to the research project and team and may include capacity building around technology development/integration/validation, data science and analytics, intellectual property, implementation science related to mHealth, or other scientific areas relevant to the proposed mHealth research.

Letters of Support: All collaborating institutions and key personnel should provide letters of support for the proposed research program. Letters of support from collaborating institutions should be supplied by institutional leaders.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Section 3 - Protection and Monitoring Plans

3.1 Protection of Human Subjects

If electronic data is being collected or transmitted, include strategies to minimize risks related to privacy and security. Potential data security needs, privacy issues, ethical issues, language and literacy barriers, etc. associated with the proposed research should be addressed in detail along with mechanisms to overcome potential barriers, effectively protect data, and ensure stakeholder and study participant safety.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by participating NIH Institutes and Centers. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular NOFO, note the following:

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.

For this particular announcement, note the following:

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Specific to this NOFO:

Transition Milestones

Given the critical nature of the milestones for the potential R21 to R33 transition, are the proposed transition milestones well-defined with quantifiable measures that are appropriate for assessing the success of the R21 phase of the application? Do the milestones have specific quantifiable criteria that will enable clear decisions about their attainment? Is it clear how the R33 phase of the study will develop and expand once the R21 milestones are achieved? Given the potential benefits of the proposed research, do the milestones support the transition and will the overall project advance the intervention or tool?

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications.

Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Appropriateness of the proposed milestones (which may be negotiated with NIH program staff).
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Relevance of proposed project to priorities of co-funding components.
• Geographic balance of programs.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Brad Newsome, Ph.D
Fogarty International Center (FIC)
Telephone: 301-480-8389
E-mail: [email protected]

Sujata Bardhan, MS, PhD
Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD)
Telephone: 301-435-0471
Email: [email protected]

Tiffani Bailey Lash
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: 301-451-4778
E-mail: [email protected]

Paul C Pearlman, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5354
Email: [email protected]

Kelly Anne King, Ph.D.
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301-402-3458
E-mail: [email protected]

Regine Douthard, M.D., M.P.H.
ORWH - Office of Research on Women's Health
Phone: 301.451.2729
E-mail: [email protected]

Michael J. Stirratt, Ph.D. (for HIV/AIDS applications)
National Institute of Mental Health (NIMH)
Telephone: 240-627-3875
Email: [email protected]

Mesfin A. Bekalu, Ph.D. (for mental health applications)
National Institute of Mental Health (NIMH)
Telephone: 240-380-0341
Email: [email protected]

Donald F Everett
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8181
E-mail: [email protected]

Patricia Haggerty, PhD
Office of Dietary Supplements
Tel. 301-529-4884
Email: [email protected]

Center for Scientific Review (CSR)
Email: FOA [email protected]

Satabdi Raychowdhury
Fogarty International Center
Telephone: 301-496-9750
E-mail: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]

Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-1404
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.