Part 1. Overview Information

Key Dates

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

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

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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Health equity research is a strategic priority for many NIH institutes, including the National Eye Institute (NEI, Strategic Plan) and the National Institute on Minority Health and Health Disparities (NIMHD, Strategic Plan).  In 2023, the NEI and the NIMHD co-hosted a workshop that identified the need for innovative approaches for advancing vision health equity.  Despite advances in the prevention, treatment, and management of eye conditions such as refractive error, cataract, glaucoma, and diabetic retinopathy, some communities (i.e., NIH-designated Populations that Experience Health Disparities, defined below) continue to experience a disproportionately higher visual impairment and poorer health outcomes. For example, the higher incidence of glaucoma among African Americans and diabetic retinopathy in Hispanic and Latino communities in the United States underscores the need for early access to vision health services.  Furthermore, individuals from lower socioeconomic backgrounds or those living in rural and underserved urban areas often experience barriers to receiving essential eye care, such as refractive correction, cataract surgery, or vision rehabilitation.  Additionally, individuals who are visually impaired or blind frequently experience inadequate healthcare access and utilization of quality healthcare services. These health disparities can result in delayed diagnoses and treatment, which can exacerbate the severity of conditions, cause preventable vision loss, and diminish quality of life.

Research on the causes of these vision health disparities has been emerging in recent years. The populations are more susceptible to risk factors that are shaped by multi-level, multi-domain influences (e.g., discrimination, economic status, immigration status, education, public safety, language, cultural barriers). Collectively known as social determinants of health (SDOH), these are multi-level social factors with an impact on human health that help to explain population-based differences in healthcare (i.e., screening, surveillance, and treatment) access, utilization, and literacy underlying health disparities.

In the vision field, factors causing health disparities (see the NIMHD Research Framework) may interact with one another to affect vision health disparities.  As examples, individual-level factors may include occupation, immigrant status, experiences with discrimination or ableism, or vision health literacy/awareness; interpersonal-level factors may include family beliefs about eye care, household instability, or working non-traditional hours that limit time for regular eye exams; community-level factors may include exposure to environmental hazards (e.g., pollution or poor lighting), access to healthy food or neighborhood violence that deters people from accessing care; and societal-level factors may include inadequate public transportation or healthcare policies that limit affordable eye care access. These factors may affect individuals' ability to maintain healthy vision and contribute to vision health disparities.

Communities experiencing health disparities may also lack access to evidence-based treatments for eye conditions, such as refractive error, cataract, glaucoma, and diabetic retinopathy. While interventions directly addressing vision health disparities are currently limited, successful examples such as targeted community outreach programs for diabetic retinopathy screening demonstrate the potential of multi-level approaches to overcome barriers such as awareness, access, and mistrust of the healthcare system.  Interventions addressing access, including expanding vision services in rural and underserved communities through telemedicine, also offer promising avenues for improving vision health outcomes.

Therefore, NEI and NIMHD recognize that innovative approaches to addressing vision health disparities include community-engaged research and multi-level interventions.  Community-engaged research (defined below) involves partnering with communities throughout the research process to refine and scale-up interventions that better reflect the community’s needs, values, practices, and priorities.  Multi-level interventions (defined below) include interventions that target more than one level of influence (such as individual and interpersonal or individual and community) across multiple domains (i.e., behavioral, physical/built environment, health care system).  In the context of vision health, community-engaged research on interventions could simultaneously address eye conditions and the root causes of health disparities by focusing on the social determinants of health (defined below), which include the conditions and environments in which people are born, live, learn, work, play, worship, and age.  Additionally, addressing factors such as sex/gender and the unique health needs of women’s health is critical for reducing disparities in vision health outcomes.

Key Definitions for this NOFO

• Community: A social group connected by geographic proximity, special interest, or similar situations (e.g., specific locality, shared government, common cultural/historical heritage).  A community may be self-defined or defined by the catchment area of local government or service providers (e.g., residents served by a county school district or community clinic).  Examples of communities include but are not limited to neighborhoods, towns, cities, counties, school districts, reservations or tribal communities, military bases, or college campuses.
• Community-engaged research: Research that requires working collaboratively with and through those who share similar situations, concerns, or challenges in the research process.  Approaches to community engagement include participatory action research, community-based participatory research, team science, empowerment evaluation approaches, community asset mapping, and citizen science.  Key elements include trust-building, co-learning and capacity building, shared decision-making, and using culturally aware and sensitive research methods, questions, and materials that reflect linguistic and cultural nuances, such as tailored outreach, recruitment, retention, and informed consent processes.
• Community organization:  An organization that provides goods, services, support, resources, or advocacy to members of a defined community.  Examples include community or faith-based organizations, local businesses, neighborhood authorities and associations, labor unions, patient or consumer advocacy groups, regional/ local and public healthcare systems, school districts, law enforcement or criminal/juvenile justice agencies, or social service agencies.  For the purposes of this NOFO, academic research centers, academic healthcare organizations, and private healthcare organizations do not fall within the definition of a community organization.
• Health Equity: Health equity is when everyone has the opportunity to attain full health potential (i.e., to be as healthy as possible), and it involves removing or mitigating barriers or disparities so that no one is disadvantaged from achieving this potential because of their social position or other socially determined circumstances. 
• Multi-level Intervention:  An intervention at two or more levels of influence, including community (a group of people living in a defined geographic area or having particular characteristics in common, structural, and/or environmental determinants of health), organizational (large healthcare systems, community health clinics, public health organizations, community-based organizations, social services, schools, workplaces, other service providers, etc.), interpersonal (e.g., social groups communication, social supports, relationships with others), and individual (e.g., community residents, employees, caregivers, family members, providers;).  See the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants at different levels of influence).
• NIH-designated Populations that Experience Health Disparities: Racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, sexual and gender minorities (SGM), people with disabilities, and any subpopulations that can be characterized by two or more of these descriptions (Minority Health and Health Disparities: Definitions and Parameters | NIMHD).  
• Social Determinants of Health (SDOH): Social determinants of health (SDOH) encompass both structural and individual factors that affect a wide range of health, functioning, and quality-of-life outcomes and risks.  Healthy People 2030 classifies SDOH into five domains: economic stability; education access and quality; health care access and quality; neighborhood and built environment; and social and community context (Healthy People 2030).    

Research Objectives

This funding opportunity supports research that aims to promote health equity by preventing, reducing, or eliminating disparities in eye and vision health.  The objective is to promote interventions that improve vision health via community engagement across more than one levels and domains.  Specifically:

• Research must involve interventions that simultaneously address vision health conditions and social determinants of health at more than one level of influence (i.e., individual, interpersonal, community, societal) and across multiple domains (i.e., behavioral, physical/built environment, health care system) as appropriate.
• Research must include a focus on improving vision health in one or more NIH-designated Populations with Health Disparities (defined above).  
• Research must demonstrate meaningful community engagement in different stages of the project.  Evidence of community engagement includes but is not limited to community organizations holding key personnel roles (e.g., as Co-Investigator or co-leading multiple principal investigators) on research projects.  

Additionally, applicants should note the following:

Team science involving the convergence across multiple areas of expertise are strongly encouraged in this initiative. These areas may include but are not limited to health services, health disparities, education, health economics, behavioral science, implementation science, and social science research.

Systems level and structural interventions (e.g., access to resources) to improve and integrate eye care and/or promote access to eye care at the clinical and community levels are encouraged. Interventions should be based on conceptual models that propose mechanisms of action and pathways explaining vision health or vision health disparities and SDOH, as applicable.

Developing interventions that target the complex causes or consequences of disparities and address risk factors and promote protective factors of vision health are encouraged. Interventions should extend beyond modifying individual-level health behavior (i.e., should include interpersonal, community, or societal levels). The proposed projects are encouraged to measure the multi-level and/or multi-domain SDOH addressed and affected by the intervention, as applicable.

Applicants are encouraged to conduct tailored interventions in a variety of settings (e.g., clinics, schools, community centers, pharmacies, workplaces, churches, justice settings, fitness centers), disaggregated subpopulations, and include unique considerations of persons belonging to multiple populations experiencing health disparities through an intersectional approach, as appropriate.

Investigators proposing to evaluate the effect of an intervention on a health-related biomedical, behavioral, or clinical outcome are strongly encouraged to use appropriate intervention study designs. These designs include but are not limited to: a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a rigorous quasi-experimental design such as a group- or cluster-level regression discontinuity design or an interrupted time-series design, or a rigorous alternative. Whenever participants are assigned to study arms in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states) and observations taken on individual participants are analyzed for intervention effects, special methods are required for analysis and sample size. Methods consistent with plans for assignment of participants and delivery of interventions should be documented in the application (additional information available at https://researchmethodsresources.nih.gov/). Applicants are strongly encouraged to assess SDOH using measures available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org), as appropriate. Interventions may also include health information technology applications (e.g., behavior monitoring tools, decision aids, health information portals) and/or social media elements to reduce disparities and improve health.

Projects should be community-engaged and culturally grounded. For this NOFO, we encourage approaches that include greater participation and collaboration with the community of interest, including shared leadership of community members in the research design and implementation of the project. Collaborations with relevant community and organizational entities may include researchers with relevant lived experience, community organizations, healthcare providers, public health organizations, consumer advocacy groups, and places of worship or religious institutions. Specifically, projects are expected to recognize the diversity of disproportionately affected populations and value of lived experiences to address the unique needs of a target community with cultural sensitivity and awareness of what may limit or facilitate the availability of resources. As appropriate for the research questions posed, inclusion of key community members in the conceptualization, planning and implementation of the research is encouraged.

Specific Areas of Research Interests include but are not limited to the following:

• Develop strategies (e.g. mobile eye care or telemedicine) to reach underserved urban and/or rural areas to improve access to vision health services.
• Adapt and refine existing health equity interventions to address vision-related health disparities.
• Collaborate with faith-based organizations, community centers, transit authorities, businesses, or other organizations to deliver vision health interventions.
• Implement approaches to changing community norms, reducing structural barriers, and/or improving community attitudes (e.g., reducing prejudice, stigma, or discrimination) towards people with visual impairments.
• Employ multi-level (e.g., patient, caregiver, provider, system) culturally and linguistically diverse communication strategies to address multiple risk and protective factors to improve vision health.
• Identify culturally informed health communication strategies and programs to promote vision health literacy and best practices among immigrant communities.
• Conduct interventions addressing screening, disease management, and adherence to treatment for improving vision health in rural underserved communities.
• Tailor interventions to address diagnostic (screening) and management pathways for persons with visual impairments belonging to one or more populations experiencing health disparities.
• Assess the effectiveness of school-based vision screening programs and their impact on academic performance for children in low resource settings.
• Investigate interventions targeting social and community-level influences (e.g., cultural beliefs, community and family norms) as they contribute to vision health in NIH-defined health disparities populations.
• Develop approaches that incorporate environmental and social determinants of health to address vision health disparities, such as interventions addressing the home, work, or neighborhood built environment.
• Address health care team or organizational-level factors (systems) that facilitate the treatment delivery and follow-up care for vision health.
• Address systematic barriers to vision care and accommodate cultural and individual diversity for multiple subpopulations.
• Adapt evidence-based interventions to ensure cultural relevance for those with limited-English proficiency and low health literacy in low resource settings to improve quality of care and vision health outcomes.
• Develop and sustain community-level culturally informed health promotion strategies and programs (e.g., access to healthy foods, along with screening programs) to promote vision health.
• Address the digital divide (e.g., augmented digital interventions with non-digital components) as it relates to vision health and vulnerable populations, including low-income communities, older adults, as well as their caregivers, who cannot easily use or access many digital health interventions.
• Utilize digital health software, devices, and systems that are interoperable with existing infrastructure in the community such that resulting data is interoperable with relevant health information systems where applicable.

Note: The 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.  For additional information on NEI Clinical Trial policies, see NOT-EY-23-001.  Applicants are strongly advised to reach out to the NEI Scientific Contact before submitting applications for guidance about NEI’s interests and more information regarding clinical trial designations.

Standardized Ocular Imaging Expectations

Applicants are strongly encouraged to use common formats for files and metadata standards when incorporating ocular imaging in their research proposals (see NOT-EY-24-006).  It is anticipated that the widespread adoption of standardized imaging formats will significantly advance the field by 1) simplifying streamlined digital workflows; 2) enhancing interoperability of large datasets; and 3) developing extensive and comprehensive training sets for artificial intelligence driven research.  By promoting these standards, the goal is to create an environment where data can be seamlessly integrated and analyzed across different studies, thereby, amplifying the overall impact of vision research. 

Applications Not Responsive to the NOFO

• Applications that do not address vision health and/or a vision disorder.
• Applications without a focus on an NIH-designated population experiencing health disparities in the US (see definition above).
• Applications that do not propose more than one level interventions (see definition above).
• Applications that do not involve one or more community partners, as indicated by inclusion of representatives of community organizations in all stages of the project.
• Applications from foreign organizations.
• Applications that include a clinical trial that involves more than minimal risk to participants.

Non-responsive applications will be withdrawn without review. Applicants are strongly encouraged to reach out to the relevant scientific contact(s) to discuss whether their applications are responsive.

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

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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.

2. Cost Sharing

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

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Brian Hoshaw, PhD 
Telephone: 301-520-6806  
Email:[email protected] 

Page Limitations

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

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

SF424(R&R) Cover

All instructions in the 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.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

Other Attachments:

The application must include the following attachments A) Plan to Engage the Community, B) Milestone Plan, and C) Letters of Support.

A) Plan to Engage the Community (required)

In an "Other Attachment" entitled "Plan to Engage the Community", applicants must include a 1-page summary of strategies to enhance the proposed project through the involvement and engagement of community partners, including plans to involve people with lived experiences.  The Plan will be considered as part of the scientific and technical peer review evaluation, as well as at the programmatic level with respect to funding decisions.

B) Milestone Plan (required)

In an "Other In an attachment" entitled "Milestones", applicants must provide detailed project performance and timeline objectives. The proposed milestones must include achievable goals for the project as follows:

• Completion of start-up activities as applicable (finalization of protocol, completion of any final regulatory approvals, contracting of sites, registration in ClinicalTrials.gov, etc.)
• Enrollment of 25%, 50%, 75% and 100% of the projected recruitment
• Completion of data collection
• Completion of primary and major secondary analyses
• Publication of primary and major secondary outcome manuscript(s)
• Time-frame for when data will be shared in a public repository
• If applicable, reporting of results in ClinicalTrials.gov

C) Letters of support (required): Provide one or more letters from community partners and/or community leaders indicating endorsement of the community intervention(s) proposed, as well as any arrangements regarding involvement of personnel, or use of data, resources, or facilities of community-based organizations; as well as letters of support from institutions with a key role in the study. 

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Specific Aims:  This section must include an overview of the study design; a description of the communities of focus, including the populations experiencing health disparities that will be included; and a summary of social determinants of health that will be addressed.

Research Strategy:  This section must include the following, incorporated within the page limits of the Research Strategy:

• Provide an overview of the state of the science, a discussion of the health disparity or clinical problem(s) being studied, and the potential impact of the results.
• Describe the focus on population (s) experiencing health disparities in the proposed intervention.
• Identify and describe how the intervention constitutes a multi-level intervention.  Specify the potential for the intervention to be sustainable in the community after the project is over and scalable to other communities.
• Identify and describe the roles of community partners.  Indicate how the project will engage communities and various partners.in the proposed study.
• Provide a conceptual model or framework that describes hypothesized causal pathways between the multi-level intervention, social determinants of health, and vision/health outcomes. 
• Describe how the composition of the research team represents a convergence of expertise and disciplines.
• Discussion of any anticipated impediments that could require a revision in the timeline, accompanied by a discussion of alternative approaches.

Other specific requirements and considerations:

• Describe the scientific, clinical, and administrative experience and qualifications of the PD(s)/PI(s) and other key study personnel.
• Discuss consideration of ethical issues involving the population or the disease/condition under study.
• Demonstrate that budget allocation has adequately considered funds for community partners according to their proposed roles.

Data and Safety Monitoring Plan:  If applicable, applicants proposing a project involving a clinical trial must describe the risks involved in the trial, protections that will be in place, and expertise necessary on the Data and Safety Monitoring Committee (DSMC) as appropriate. Do not name any potential DSMC members.  

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s): 

All instructions in the How to Apply-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 How to Apply- 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

Applications must be submitted electronically following the instructions described in the How to Apply Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply 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.

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Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

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.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

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

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 National Eye Institute, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

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

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

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

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

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

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]

Jimmy Le, ScD
National Eye Institute (NEI)
Telephone: 301-435-8160
Email: [email protected]

Houmam Araj, PhD
National Eye Institute (NEI) 
Phone: (301) 435-8166
E-mail: [email protected]

Cheri Wiggs, PhD
National Eye Institute (NEI) 
Phone: (301) 402-0276
E-mail: [email protected]

Carolina Vanessa Solissanabria, M.D., MPH, FACS
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-402-1366
E-mail: [email protected]

Brian Hoshaw, PhD
National Eye Institute (NEI)
Telephone: 301-520-6806  
Email: [email protected]

Karen Robinson Smith
National Eye Institute (NEI)
Telephone 301-435-8178
Email: [email protected]

Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: [email protected]

Section VIII. Other Information

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

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