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 SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) 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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This FOA uses the R03 grant mechanism to advance research in high-priority mission areas of the NIH Institutes, Centers, and Offices (ICOs) through analysis of currently available data within the All of Us Research Program’s Researcher Workbench using well accepted analytical tools and methods.

There is a companion FOA (R21; link) for applications to advance research in high-priority mission areas of the NIH ICOs by developing new methods, models, and tools and using them to analyze data in the Researcher Workbench. The new tools will be made broadly available to the scientific community.

Background

The All of Us Research Program is building a database to help transform the future of health research by equipping researchers nationwide with expansive health data from various populations, including those populations understudied in biomedical research. The All of Us Research Program characterizes populations that are underrepresented in biomedical research (UBR) as groups that historically have low participation rates in biomedical research studies (including clinical trials). These groups include (1) racial and ethnic minority groups and/or (2) sexual and gender minority groups; (3) children and older adults; and people with (4) disabilities, (5) barriers to accessing health care, (6) lower incomes, or (7) limited educational attainment; and/or (8) residents of rural areas. Data are refreshed once or twice a year. Data available to registered researchers include:

[Note: these numbers reflect the data available in the June 14/16 (v6) data release. They may need to be updated prior to posting in the NIH Guide.]

• data from 372,000+ participants [, 80% from communities underrepresented in biomedical research overall (including racial and ethnic minorities, sexual and gender minorities, people living in rural areas, and other groups)].
• whole genome sequence data from nearly 100,000 participants (nearly 50% of whom self-identify as a member of a racial or ethnic minority group)
  • 593,000,000+ unique variants, which Include 100M+ variants with = 3 occurrences not seen in gnomAD 3.0 (n = 71,702)
• electronic health record data from 258,000+ participants (including demographics, visits, diagnoses, COVID diagnoses and medications)
• survey data from 372,400 participants from nine different questionnaires capturing participant data on lifestyle, health care utilization and access, and COVID-19 participant experience.
• Fitbit data from more than 12,800+ participants who linked their personal data to their All of Us account
• physical measurements from 306,000+ participants (including blood pressure, heart rate, BMI, and more)

The All of Us dataset, available to scientists across the United States, provides unprecedented opportunities for a wide range of studies to understand how biological, behavioral, and environmental factors influence health and a broad range of diseases and conditions. The All of Us data are housed on the Researcher Workbench, which also includes tools, along with personalized support resources, such as an integrated help desk, regular office hours, sample datasets and more.

Researchers must register for access to the All of Us Researcher Workbench to analyze data (https://www.researchallofus.org/register). Once registered, researchers can create research projects using collaborative workspaces, cohort-building tools, interactive notebooks, and more. Currently, researchers must complete the All of Us Research Program data access process to access the Researcher Workbench and Registered Tier data. Additional training is required to access the Controlled Tier, which includes more granular data on participants, as well as whole genome sequences and genotyping data, as described above. The All of Us Research Hub (https://www.researchallofus.org/) is a good place to start to learn more about data access and use, and explore research underway. The Researcher Workbench (link at the beginning of this paragraph) also provides information on computing costs (this RFA will not be using STRIDES; https://cloud.nih.gov/about-strides/).

Research Objectives and Scope

Studies are encouraged that can help advance research in high priority mission areas of the NIH ICOs. The R03 award supports projects that use widely accepted approaches and methods.

Applications that develop new analytical tools and methods and apply them to investigations using the data in the All of Us Researcher Workbench should be directed to the companion R21 FOA (need to provide FOA number and link).

Applications must make direct use of All of Us data that are available through the Researcher Workbench. Applicants may analyze the All of Us data in combination with other existing datasets, but for the purpose of this competing small grant program, they should not propose ancillary studies that would require the collection of additional data beyond what is already available in the Researcher Workbench or studies that would require a linkage of All of Us data to other datasets at the level of the individual.

Because information regarding the user experience could help NIH improve its data resources, it is expected that NIH will receive feedback from awardees on usability and utility of datasets and public data portals, which the awardees can provide in their progress reports to ICO Program Officers.

Applicants will be expected to make their workspace, and any tools they develop, available to other registered users of the All of Us Researcher Workbench.

Applicants may request funds, in addition to research costs, to present their work using All of Us data at a national meeting and/or All of Us Researchers Convention.

ICO-Specific Considerations

NCI

The National Cancer Institute is interested in research across the cancer continuum including: assessment of cancer risk and related risk factors, early detection and prevention, diagnosis and treatment; and cancer control and epidemiology including: assessing cancer incidence, prevalence, prognosis, survival, health outcomes, and health disparities across the lifespan.

NCCIH

The mission of NCCIH is to determine, through rigorous scientific investigation, the fundamental science, usefulness, and safety of complementary and integrative health approaches and their roles in improving health and health care. NCCIH seeks to expand the knowledge base about how multifaceted complementary health approaches exert their effects, and describe how these approaches improve resilience, restore health, and manage symptoms in a whole person health framework. Examples of complementary approaches include therapies or interventions with nutritional (e.g., special diets, dietary supplements, herbs, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, devices related to these approaches), and/or a combination of psychological and physical (e.g., yoga, tai chi, music or dance therapies, other forms of art-based therapies) input. In the context of this RFA, NCCIH is particularly interested in encouraging investigators who desire to analyze data in the All of Us Research Workbench to describe the utilization and integration of complementary and conventional care, associations of complementary health approaches with health outcomes, and when possible, use analytic methods that could attempt to account for bias in the data.

NHGRI

NHGRI supports the development of resources, approaches, and technologies that accelerate and support studies focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; genomic data science and bioinformatics; training and developing researchers, and enhancing the diversity of the genomics workforce; and ethical, legal, and social issues related to genomic advances. The NHGRI encourages applications that will develop new analytical approaches and their use to analyze All of Us data that fall within NHGRI’s mission.

The 2020 NHGRI Strategic Vision and NHGRI Action Agenda emphasize that the promise of genomics can t be fully realized without a diverse genomics workforce. To enhance inclusivity of the research environment, NHGRI encourages applicants to strive to compose teams richly diverse in perspectives, backgrounds, and academic disciplines, and provide full opportunity and participation to all individuals, including those from groups underrepresented in the genomics workforce.

NHGRI is interested in utilizing this funding opportunity to encourage the use of the All of Us database by all investigators, including those from groups underrepresented in the genomic research community. NHGRI encourages Minority Serving Institutions (institutions with a historical commitment to training students from underrepresented racial or ethnic groups) and/or IDEA-state institutions that have not received substantive funding from NHGRI (>$1M/year in at least one of the last three fiscal years) to apply in order to promote the use of the All of Us workbench at institutions that are not already involved in All of Us.

NHLBI

The National Heart, Lung, and Blood Institute (NHLBI) is interested in research that supports analysis of data in the AoU Researcher Workbench with focus on Heart, Lung, Blood, and Sleep (HLBS) Health and Disease. Areas of interest include, but are not limited to: 1) Validate known algorithms for outcomes measures of HLBS Conditions (such as lung, blood, and heart manifestations of acute COVID-19 infection and Post-Acute Sequelae of COVID-19, COPD, and heart failure), established by use of patient measurements and or electronic health records. Apply algorithms to detect unique differences across health care institutions, urban vs. rural areas, and across diverse geographic regions. 2) Use established software algorithms, including those based on artificial intelligence and machine learning, to analyze sensor-collected data wearable devices data to determine reference ranges. 3) Develop prognostic models for HLBS disease conditions leveraging deep clinical phenotypes, WGS data, TOPMed or other datasets outside AoU. 4) Use models of proven ecological validity to delineate the complex network of environmental factors (daily activities, exposures, built environment, economics, etc.) influencing risks for chronic HLBS diseases, trajectory, severity, treatment response, and outcomes. 5) Combine AoU geographic, environmental, and clinical data to assess how different health determinants converge to influence HLBS conditions. 6) Use AoU data to study the exposure-response relationship for respiratory and cardiovascular outcomes to inform planning in the health sector. 7) Take advantage of widely used bioinformatics-based tools for big data analytics to predict and identify early signs of HLBS diseases through changes in longitudinal EHR data, clinical events, wearables and/or from patient-provided information (e.g., surveys). 8) Use AoU data in demonstration projects to generate and/or validate phenotypes previously developed in large trans-omics racially diverse cohorts, such as TOPMed.

NIAAA

NIAAA is particularly interested in applications making use of the All of Us dataset’s unique variables: electronic health records (EHR), whole genome sequences, surveys, including the AUDIT-C, and physical activity tracker data. Specific topics of interest include but are not limited to: comorbidities between alcohol use disorder (AUD) and other health diagnoses; EHR and alcohol health services; pharmacoepidemiological approaches relevant for AUD and drinking outcomes; relationships between alcohol consumption and health; and alcohol use and AUD across the lifespan. Given the racial and ethnic diversity of the data in the Researcher Workbench, applications should include a consideration of how they will incorporate NIH-defined minority health populations in their research analysis.

NIAID

NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. NIAID’s Division of AIDS is working to better understand HIV and how it causes disease, find new tools to prevent HIV infection, develop new and more effective treatments for HIV-infected people, and find a cure. NIAID’s Division of Microbiology and Infectious Diseases conducts and supports research on nearly 300 infectious agents and investigates the biological properties of these pathogens and the immune system’s responses to them. Findings from this research are vital to NIAID efforts to create vaccines, drugs, and diagnostic tools to better diagnose, prevent, and treat infectious diseases. NIAID’s Division of Allergy, Immunology and Transplant supports basic and clinical research to increase our understanding of the causes and mechanisms that lead to the development of allergic and immunologic diseases and to expand knowledge that can be applied to improving techniques of diagnosis, treatment, and prevention.

NICHD

NICHD supports research in areas relevant to normal and abnormal human development, including contraception, reproductive health, fertilization, pregnancy, childbirth, prenatal and postnatal development; childhood development through adolescence; intellectual and developmental disabilities; and rehabilitation medicine.

Grant applications and project proposals must fall within the missions of the scientific branches of NICHD's Division of Extramural Research or its National Center for Medical Rehabilitation Research. Potential applicants are strongly encouraged to visit these pages for recent scientific advances and emerging public health topics. https://www.nichd.nih.gov/grants-contracts/research-areas/priorities

NIDA

NIDA is interested in research that leverages All of Us data to better understand causal and risk factors for substance use disorders (SUD); the relationship between SUD, pain, and other common comorbidities; and the clinical consequences of substance use and misuse. This research includes but is not limited to:

Understanding how SUD affects long-term health and risk of chronic conditions over the lifespan, including their onset and evolution over time, and the interplay with other factors, including social determinants of health.

Genetic studies of SUD, including studies that use genetic variants linked to SUD as a proxy to establish causality between SUD and other conditions and diseases (Mendelian Randomization), and studies evaluating how genetic variants affect SUD treatment response.

Understanding chronic pain as a comorbidity of SUD, treatment-seeking for pain as a risk factor, and demographic and personal medical history variables that may increase this risk.

Application of data science, including state-of the-art machine learning, computational, and modeling approaches toward predicting trajectories of SUD risk, understanding SUD trajectories from development of addiction through recovery, demonstrating associations between outcomes and treatment services, and uncovering systemic or individual-level barriers to selection and implementation of evidence-based interventions.

Potential clustering of genetics, comorbidities, psychosocial factors, personal medical history, environmental exposures, and other factors to identify common and replicable subtypes of SUD towards mechanistic investigation and targeted intervention.

NIDCD

NIDCD is interested in those applications that address mission specific sensory and communication disorders. The application must be related to NIDCD’s specific programs of hearing, balance, taste, smell, voice, speech and language.

NIDCR

NIDCR supports research and research training to advance fundamental knowledge about dental, oral, and craniofacial (DOC) health and disease, and translate these findings into prevention, early detection, and treatment strategies that improve overall health for all individuals and communities across the lifespan. Strategic Priorities are laid out in NIDCR Strategic Plan 2021-2026. Of particular interests are:

Characterizing individual variability in genetic makeup, environmental exposures, and lifestyle choices to derive more precise and individualized treatments for the management and prevention of DOC diseases.

Establishing the interconnectedness of oral health with overall health through innovative methodologies to ascertain study populations and evaluate population variance in genetic architecture and environmental influences.

Applying Artificial Intelligence/Machine Learning (AI/ML) approaches to leverage electronic health record (EHR) and other types of data (e.g., genomics, imaging, social determinants of health) to redress oral health disparities and advance health equity.

NIDDK

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in applications that use the data within the All of Us Research Program’s Researcher Workbench (e.g., from whole genome sequence, electronic health records, surveys) that are related to the development, progression and/or management of diseases and conditions within its mission which include diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life (https://www.niddk.nih.gov/about-niddk/research-areas). Applications should align with NIDDK’s Strategic Plan for Research (https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/niddk-strategic-plan-for-research), including proposals that focus on advancing our understanding of biological pathways and environmental contributors of health and disease. NIDDK is particularly interested in applications advancing methods related to health equity research, as well as methods that would help to advance research on sex/gender differences, sexual and gender minority-related research and racial/ethnic diversity (see NOT-DK-22-003). Applicants are strongly encouraged to contact NIDDK staff listed below prior to applying.

NIMH

The NIMH mission is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. Applications considered for funding by the NIMH must fall within the areas of research priority detailed in the NIMH Strategic Plan (https://www.nimh.nih.gov/about/strategic-planning-reports). Applicants are strongly encouraged to contact Scientific/Research Contact(s) prior to submission

NINDS

NINDS welcomes applications that utilize the data available through the All of Us Researcher Workbench to support the NINDS mission to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people. Applications that relate to issues of health equity, which the All of Us sample may be well positioned to address, are of particular interest. NINDS urges investigators to follow the NIH guidance for rigor and transparency in grant applications (https://grants.nih.gov/policy/reproducibility/guidance.htm) and additionally recommends the research practices described athttps://www.ninds.nih.gov/Funding/grant_policy

OBSSR

OBSSR does not administer or manage grants, but can provide funding support to the ICO that manages the grant. Applicants responding to OBSSR interests are encouraged to contact their ICO Program Officer to be sure their proposal also meets the priorities of the ICO. OBSSR is particularly interested in supporting research that leverages the multiple levels of influence available within the All of Us dataset to help advance understanding of the interplay between genetic factors, behaviors and other individual factors, interpersonal and relationship factors, and social determinants of health.

Topics of interest to OBSSR include, but are not limited to:

The relationship among genomics, health behaviors (e.g., physical activity, sleep, substance use), and social and built environment variables (e.g., neighborhood characteristics, health care access) and their impact on health and wellbeing across the lifespan.

Identification of behavioral phenotypes based upon integration of biological, genomics, EHR, passively-collected data (e.g., Fitbit), and survey data.

Analyses of data from various sources (genomics, electronic health records, survey) and levels (individual, interpersonal, contextual) to better understand impacts on overall health and wellbeing among people to address the Inclusion of Women and Minorities policy and the Inclusion Across the Lifespan policy. .

ODSS

ODSS is interested in stimulating researchers including early-stage investigators into biomedical research with innovative data science approaches to enhance broad domain knowledge, to ensure meaningful, interpretable, and scalable data utility for individual, community, and population-level health and/or biomedical discovery.

ODSS does NOT award grants. Please contact the relevant NIH ICO program contact listed for questions related to NIH ICO research priorities and funding.

OSC

OSC manages the NIH Common Fund programs which address emerging scientific opportunities, pressing challenges, and innovative endeavors across biomedical research. Common Fund programs are short-term, goal-driven, strategic investments, with deliverables intended to catalyze research across multiple biomedical research disciplines. Many CF programs generate high value data sets that may be useful in combination with All of Us data. OSC is interested in applications from any awardee that combine All of Us data with Common Fund data resources (such as 4D Nucleome, Acute to Chronic Pain Signatures, Bridge to Artificial Intelligence, Cellular Senescence Network, Extracellular RNA Communication, Gabriella Miller Kids First, Genotype-Tissue Expression, Glycosciences, Harnessing Data Science for Health Discovery and Innovation in Africa, Human BioMolecular Atlas Program, Illuminating the Druggable Genome, Integrated Human Microbiome Project, Knockout Mouse Phenotyping Program, Library of Integrated Network-based Cellular Signatures, Metabolomics Workbench, Molecular Transducers of Physical Activity in Humans, Nutrition for Precision Health, Somatic Cell Gene-Editing, Stimulating Peripheral Activity to Relieve Conditions, or the Undiagnosed Diseases Network).

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

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 FOA.

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 Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 his/her 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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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 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 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 FOA. 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 SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement 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:

Katherine M. Malinda PhD
Telephone: 301-435-0912
Fax: 301-480-2644
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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.

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.

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.

R&R or Modular Budget

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

R&R Subaward Budget

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

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:

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.

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.

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

See Part 1. 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. Overview Information 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 Policy on Late Application Submission.

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 SF424 (R&R) 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.

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 FOA 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the {IC} Referral Office by email at {[email protected]} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

Any instructions provided here are in addition to the instructions 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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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.

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 submitted in response to this FOA. 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.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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 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 FOA 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

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: General and 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 Research Terms and Conditions
• 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that 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 FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 45 CFR Part 75.205 and 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

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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 FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 45 CFR Part 75 and 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]

Sheri Schully, Ph.D.

All of Us Research Program
Telephone: 240-827-1691
Email: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Winifred K. Rossi
National Institute on Aging (NIA)
Telephone: 301-496-3836
Email: [email protected]

Bracie Watson
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: 301.402.3458
E-mail: [email protected]

Rebecca Eve Hommer, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-827-2257
E-mail: [email protected]

Dana Wolff-Hughes, PhD
National Cancer Institute (NCI)
Telephone: 240-620-0673
Email: [email protected]

Josh Fessel, MD/Ph.D.

National Center for Advancing Translational Research (NCATS)

Phone: 301-402-7734

Email: [email protected]

Jean M Lawrence, ScD, MPH, MSSA, FACE
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 594-8804
E-mail: [email protected]

Ellen’s Liberman
National Eye Institute (NEI)
Phone: (301) 435-8174
E-mail: [email protected]

Lillian Shum, PhD
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-0618
E-mail: [email protected]

Susan Nicole Wright
National Institute on Drug Abuse (NIDA)
Phone: 301-402-6683
E-mail: [email protected]

National Institute of Mental Health (NIMH)
Jenni Pacheco, Ph.D.
Telephone: 301-443-3645
Email: [email protected]

Jamie Marshell White
Office of Research on Women's Health (ORWH)
Phone: (301) 496-9200
E-mail: [email protected]

Christian Rene Gomez
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0222
E-mail: [email protected]

Beth Jaworski, Ph.D.

Phone: 301-496-0979

Email: [email protected]

Steve Tsang

Office of Data Science Strategy

Phone: 240-627-3330

Email: [email protected]

Brett Miller, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9849
Email: [email protected]

George J. Papanicolaou, Ph.D.
Office of Strategic Coordination (OSC)
Telephone: 301-480-6722
Email: [email protected]

Carolyn Williams, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-2305
Email: [email protected]

J. Rafael Gorospe M.D. Ph.D.

NIH Office of AIDS Research (NIH OAR)

Email: [email protected]

Phone: 240-292-4824

Laura Elizabeth Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-451-8507
E-mail: [email protected]

Sekai Chideya-Chihota, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 240-552-2994
Email: [email protected]

Stephanie M George, PhD, MPH, MA
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-4974
E-mail: [email protected]

Rongling Li
National Human Genome Research Institute (NHGRI)
Phone: 301.480.2487
E-mail: [email protected]

Katherine M. Malinda, PhD,

Phone: 301-435-0912

Fax: 301-480-2644

[email protected]

Replace this text with Staff Contact Name

Philip Smith
National Institute on Aging (NIA)
Phone: 301-555-1212
E-mail: [email protected]

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: (301) 435-0713
E-mail: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Natasha Loveless
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-594-8853
E-mail: [email protected]

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: [email protected]

Gabriel Hidalgo, MBA
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-827-4630
E-mail: [email protected]

Diana Rutberg, MBA
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: [email protected]

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: [email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]

Kimberly Stanton
National Heart, Lung, and Blood Institute (NHLBI)
Phone: (301)827-8054
E-mail: [email protected]

George Coy

Office of Data Science Strategy

Phone: 667-231-9522

Email: [email protected]

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

Gabriel Hidalgo
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4630
Email: [email protected]

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Sahar Rais-Danai
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-5032
E-mail: [email protected]

Deanna L Ingersoll
National Human Genome Research Institute (NHGRI)
Phone: 301-435-7858
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 45 CFR Part 75 and 2 CFR Part 200.