Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional) is sponsored by National Institutes of Health (NIH).

This Notice of Funding Opportunity encourages exploratory/developmental research applications for the development, validation, feasibility, and effectiveness of innovative mobile health (mHealth) interventions or tools specifically suited for low- and middle-income countries (LMICs). It focuses on utilizing new or emerging technology, platforms, systems, or analytics to improve clinical and public health outcomes.

Applicants are required to propose partnerships between at least one U.S. institution and one LMIC institution.

PAR-25-242: Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Fogarty International Center ( FIC ) National Eye Institute ( NEI ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Mental Health ( NIMH ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Dietary Supplements ( ODS ) Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional) R21 / R33 Phased Innovation Award Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) 93. 989, 93.

242, 93. 313, 93. 865, 93.

399, 93. 173, 93. 853, 93.

286, 93.

867 Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to encourage exploratory/developmental research applications that propose to study the development, validation, feasibility, and effectiveness of innovative mobile health (mHealth) interventions or tools specifically suited for low- and middle-income countries (LMICs) that utilize new or emerging technology, platforms, systems, and/or analytics.

The overall goal of the program is to catalyze innovation through multidisciplinary research that addresses global health problems, develop an evidence base for the use of mHealth technology to improve clinical and public health outcomes, and strengthen mHealth research capacity in LMICs.

This NOFO provides support for up to two years (R21 phase) for technology development and feasibility studies, followed by a possible transition to expanded research support (R33 phase) for validation, larger-scale feasibility, and effectiveness studies. Transition to the R33 depends on the completion of applicant-defined milestones, as well as program priorities and the availability of funds.

All applicants must address both the R21 and R33 phases. Funding Opportunity Goal(s) The John E. Fogarty International Center (FIC) supports research and research training to reduce disparities in global health and to foster partnerships between U.S. scientists and their counterparts abroad.

FIC supports basic biological, behavioral, and social science research, as well as related research training and career development. The research portfolio is divided into several programs that support a wide variety of funding mechanisms to meet programmatic objectives.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions 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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information 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 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.

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/ ). 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.

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).

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; 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 applicants to engage in outreach and recruitment activities consistent with existing NIH practices and applicable law: (1) Funded programs may not use the race, ethnicity, or sex of a researcher, trainee, faculty candidate or other program participant as an eligibility or selection criteria, and (2) NIH does not use the race, ethnicity, or sex of researchers, trainees, faculty, or other program participants in the application review process or funding decisions.

Specific Research Interests of the Participating NIH Institutes, Centers, and Offices 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 women in LMICs.

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 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 various 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.

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.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. 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. 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 Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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 must complete and maintain the following registrations as described in the How to Apply- 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 the 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.

Eligible Individuals (Program Director/Principal Investigator) 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.

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 How to Apply-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. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission 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.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- 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 various 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. All instructions in the How to Apply- 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. All instructions in the