Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Eye Institute (NEI)

Funding Opportunity Title
A Community Research Resource: Characterization of the Resident Ocular Microbiome. (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-EY-22-001
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.867
Funding Opportunity Purpose

The overall purpose of this funding opportunity announcement (FOA) is to invite applicants from multidisciplinary research teams to develop a community-based resource of microbial data associated with the resident ocular microbiome of healthy individuals. The data include factors microbial communities elaborate that impact human physiology. This announcement will support research projects designed to: delineate and characterize core ocular microbial constituents in the front of the eye; understand their immune and neuro interactions and contributions to the maintenance of homeostasis; and integrate microbiome, omics, and clinical data to determine profiles that promote health of the ocular surface. The front of the eye or anterior segment includes the ocular surface, cornea, iris, ciliary body, conjunctiva, lens, eyelids, and periocular skin.

Key Dates

Posted Date
April 06, 2022
Open Date (Earliest Submission Date)
June 05, 2022
Letter of Intent Due Date(s)

June 6th, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 06, 2022 Not Applicable Not Applicable November 2022 January 2023 April 2023

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.

Expiration Date
July 07, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

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.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The National Eye Institute (NEI) Anterior Segment Initiative (ASI) was launched in 2019 to address challenges in understanding and treating disorders of the anterior segment of the eye. The ASI is developing workshops and events to explore the role of the immune system in the anterior segment, and how the immune system interacts with ocular nerves in disease and in healthy aging. The ocular microbiome is one component of this initiative. An executive summary of a recent NEI-sponsored workshop addressing challenges in studying the ocular surface microbiome can be found here: NEI Microbiome Report.

The National Institutes of Health (NIH) Human Microbiome Project (HMP) characterized several ecological niches of the human body, most notably in the nasal passages, oral cavity, skin, gastrointestinal tract, and the urogenital tract. Results from this project showed that the diversity and abundance of each habitat's signature microbes vary widely among healthy subjects. Metabolic reconstruction of metagenomic data demonstrated that the core biochemical and metabolic pathways are relatively stable among individuals despite variation in community structure and ethnic/racial background. The HMP has also generated resources and leveraged technologies that facilitate characterization of the human microbiota and further our understanding of how the microbiome impacts human health and disease. These include DNA sequencing such as 16S rRNA gene-based amplicon sequencing and metagenomic approaches, software programs such as Decontam R statistical methods that are used to identify and visualize contaminating DNA features, as well as the use of bioinformatics to integrate large microbial, omics and clinical datasets.

Recent data suggest the existence of a resident ocular microbiome—one that may play a protective role in corneal infections. Studies are being undertaken to explore the gut, oral and ocular microbiome’s role in various eye conditions including dry eye, meibomian gland dysfunction, endophthalmitis, uveitis, blepharitis, diabetic retinopathy, age related macular degeneration and contact lens wear. But explorations of ocular microbiome dysbiosis have been stymied by the lack of robust data on the phylogenetic and taxonomic composition including diversity and abundance of the microbiota that exist in a healthy eye. Likewise, the molecular underpinnings of noted associations between the microbiome and ocular immune modulation and homeostasis remain largely unexplored.

Delineating the range of structural and functional configurations of a healthy population’s resident microbial community will pave the way for broader studies of the epidemiology, ecology, and translational applications of the human ocular microbiome. Knowledge of the diversity and abundance of resident microbiota is critical to advancing the development of microbiome-based interventions for prevention and treatment of eye diseases.

This announcement invites applications proposing to develop a community-based resource of microbial communities and factors they elaborate that are associated with the resident ocular surface microbiome of healthy individuals. As a result, discovery-based projects that are not hypothesis driven may be appropriate.

Characterization of the anterior segment’s microbiome and microbial strains and interactions that modulate host physiology will require the coordinated efforts of investigators with diverse sets of expertise including clinical vision research, microbiology, high-throughput genetic sequencing, generation of multi-omics data, bioinformatics, and systems for culturing cells and validating microbes. This FOA accordingly uses the U24 mechanism to invite applications from multidisciplinary teams of investigators to create a community research resource.

Specific Areas of Research Interest

This FOA invites applications proposing research to identify core constituents of the ocular surface microbiome, describe factors that promote colonization and assess the ocular microbiome’s role in the health of the anterior segment. This announcement will support research projects that utilize 16S rRNA sequencing, metagenomic approaches, culture, and other microbe validation methods to identify phylogenetic and taxonomic markers. The use of genome sequencing data to identify members, quantify the abundance of and characterize the complexity and biogeography of microbial communities on the ocular surface of healthy individuals is also encouraged. Our interests includes identifying factors elaborated by these microbial communities that will enhance our understanding of the ocular microbiome’s contribution to immune modulation and maintaining homeostasis by integrating microbiome, multi-omics, and clinical data to determine profiles that promote health of the ocular surface. Studies focusing on the front of the human eye (the anterior segment), which includes the cornea, iris, ciliary body, lens, conjunctiva, eyelids, and periocular skin, will be responsive to this announcement. Studies proposing to determine how the resident microbiota change to promote eye disease/conditions or that focus on the back of the eye or the gut microbiome’s contributions to conferring ocular disease risk and maintaining wellness will not be considered responsive to this FOA. Clinical trials will not be supported under this FOA.

Areas of interest under this FOA include, but are not limited to:

  • collection of biological samples and associated clinical data (e.g. demographic, residence, medications, allergies)
  • processing of samples to extract analytes (e.g., DNA, RNA, protein, metabolites)
  • generation of microbial genetic sequencing data (e.g., utilizing 16S rRNA, next generation shotgun sequencing, amplicon sequencing technology, metagenome-wide association studies (MWAS) or other metagenomic sequencing methods)
  • cultures of microbes
  • quantification of microbial load
  • identification of metabolically active microbes
  • analysis of biofilms and other factors that promote microbial colonization
  • identification of chemical structures of compounds elaborated by microbial strains
  • generation and integration of other types of high-dimensional human and microbial multi-omics data focused on immune modulation and homeostasis (e.g., metagenomics, metatranscriptomics, metabolomics, metaproteomics)
  • analysis of data to define microbiome profiles/signatures of a healthy resident ocular microbiome
  • reconstruction of metabolic pathways and networks and evaluation of interactions among the microbial community and host including supplement and medication use
  • studies to identify human genetic variants associated with microbial phenotypes as well as interactions among genotype, microbiome and ocular constituents in order to predict ocular homeostasis
  • validation (demonstration of causal role) of microbial strains and molecules in immune modulation and prevention of colonization of potential pathogens. The assays for validation must focus on components from human samples but may make use of primary cultured cells or tissues, engineered reporter cell lines, cultured organoids, gnotobiotic animals, or other experimental systems

The resources generated from these investigations must include:

  • research protocols including detailed methods for sample collection and processing; DNA extraction; reagents used; sequencing methods and data analytic techniques
  • annotated genome sequences of microbiota from healthy individuals
  • datasets used to identify key microbes and compounds
  • structured data dictionary
  • software and analytic methods used during the project.

The resources may also include additional elements including but not limited to:

  • functional data from biospecimens obtained from healthy individuals
  • chemical structures of key compounds and the metabolic pathways they elaborate that have a role in modulating host immune response
  • samples of purified compounds demonstrated to modulate host physiology
  • all -omic datasets used to evaluate microbial strains and compounds
  • annotation of host genomic sequences with genetic pathways whose functions are impacted by the microbes and compounds modulating host immune response and homeostasis
  • cultures of t microbes
  • cell lines or reagents for other assays used to validate roles of microbes and compounds in modulating host physiology.

Applications Not Responsive to this FOA

The following types of applications will be considered non-responsive to this FOA and will not be reviewed:

  • applications proposing to study the relationship between the microbiome and ocular diseases may apply for a R01 award under the Parent R01 Program Announcement, PA-20-185, https://grants.nih.gov/grants/guide/pa-files/PA-20-185.html
  • applications proposing studies of the gut microbiome’s influence on ocular health and disease
  • applications proposing studies of the ocular microbiome of the posterior segment of the eye
  • applications proposing a clinical trial
  • applications proposing to focus on studies of animal microbiota composition or activity versus human. However, applications using animal models to validate human strains and molecules will be considered responsive,

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. All applicants responding to this FOA are encouraged to utilize well-established specimen collection and microbial community characterization methods; existing population resources; well-validated and well-established data collection instruments; reference reagents established for microbiome analyses as applicable; cutting-edge tools and technologies for computational and comparative analyses; reference databases and established database storage systems (see NLM Data Sharing Resources); and, common data elements (see NIH CDE Repository https://cde.nlm.nih.gov/home) as applicable to advance their research goals.

These projects will be milestone driven. Milestones and timelines will be submitted by the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) in the initial application. These milestones may be refined and evaluated on an ongoing basis. Adjustment of project aims and budgets by the NEI may be required based on the progress of the project toward meeting its milestones.

Applications are expected to use common data elements (CDE), data harmonization and integrating principles across projects supported by this FOA as well as early sharing of information, preliminary results, raw data, resources, and technologies (see the Resource Sharing Plan - Section IV and the Primary responsibilities of the PD(s)/PI(s) - Cooperative Agreement Terms and Conditions of Award - Section VI).

Investigative Teams

This FOA strongly encourages the establishment of investigative teams that are multidisciplinary, bringing together complementary microbiome science, omics, bioinformatics, and vision research expertise. Proposed teams should demonstrate technical and intellectual synergy and bring to bear the resources needed to make major inroads in the field.

To achieve reproducibility, collaborative program teams are expected to develop stringent quality assurance protocols for each step of the sample collection, processing, and analysis pipeline, including rigorous use of both positive and negative controls.

The NEI will establish a consortium consisting of the investigative teams funded under this FOA who will work collaboratively and with the NEI to develop cross-cutting integrating principles and standards that will facilitate comparison of study results and to achieve the overall goal of developing a community-based resource of microbial communities that are associated with the resident ocular surface microbiome of healthy individuals and the factors they elaborate. PD(s)/PI(s) funded through this RFA will be required to attend annual in-person investigator meetings and quarterly videoconferences to share information and ideas, foster collaborations and facilitate project goals. Sharing data and technology among the members of the consortium will be required at the earliest stages of the research and with the broader scientific community after the completion of the project.

Scientific Oversight Committee

The projects will be milestone driven. NIH staff including Program Directors will closely monitor progress in meeting the milestones and data sharing requirements of all projects funded by cooperative agreements under this FOA and will provide recommendations to the PD(s)/PI(s). As needed, the SOC will provide an extra level of scrutiny for programmatic relevance and progress in cases where adjustments in funding may be required. Experts from the scientific community chosen by the NEI in consultation with the PD(s)/PI(s) may be asked to join the Scientific Oversight Committee (SOC) as needed to assist in the monitoring of progress, fostering of collaborations and to provide advice to the NEI and PD(s)/PI(s) that is aimed at characterizing the resident ocular microbiome. PIs should not include potential names for the SOC in their application.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

RFA:

The NEI intends to commit up to $5 million in total costs in FY 2023 to fund up to 6-8 awards.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project. Costs for data sharing and travel expenses to attend in-person annual meetings must be included in the budget request.

Award Project Period

 The scope of the proposed project should determine the project period. The maximum project period is 3 years

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

Eligible Organizations

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)
Foreign Institutions

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

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

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

Required Registrations

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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

Dr. Brian Hoshaw
National Eye Institute (NEI)
Telephone: 301-402-0566
Email: brian.hoshaw@nih.gov

Page Limitations

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

Instructions for Application Submission

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.

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 Budget

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

Research participant costs will be considered in the context of other existing institutional clinical resources. Attempts should be made by the applicant institution to utilize existing clinical facilities such as CTAs and population resources including leveraging of ongoing population studies (e.g., All of Us Study). Costs relating to the clinical research efforts of the investigators may be funded through this award, provided there is no overlap of funding. Only those participant costs directly related to these research activities may be charged to the grant.

Domestic and foreign travel of project personnel directly related to the collaborative team activities of the award as well as travel of collaborative team members for attendance at annual investigators meetings is allowable.

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:

Specific Aims: This section should focus on addressing scientific needs for developing a community-based resource of microbial communities and factors they elaborate that are associated with the resident ocular surface microbiome of healthy individuals.

Research Strategy: This section should clearly describe the set of resources which will be developed and how each step in the resource development pipeline will be accomplished. Discuss how proposed studies will lay the groundwork for a research resource which characterizes the anterior segment microbiome and informs our understanding of its role in ocular immune modulation and homeostasis. Provide justification for the proposed study sample size and target population. Potential research pitfalls and alternate strategies should be addressed.

The following elements are required in the research strategy:

Milestone Plan - Applicants are required to provide detailed project performance milestones and timelines along with criteria for evaluation. The proposed milestones must include but are not limited to:

• Completion of start-up and validation activities as applicable

• Sample collection from 25%, 50%, 75% and 100% of the projected recruitment

• Processing of samples to extract analytes

• Completion of genetic sequencing

• Preparation of annotated datasets for broad sharing

Team Science - Applicants are required to provide specific information on how the research team will bring together complementary scientific expertise to make major inroads in the field. The following points should be addressed in this attachment and are an important part of the application:

1) A description of the collaborative team aspect of the work. Since the overall goal of the FOA is to create resources by bringing together investigators from varied disciplines to attack a complex problem in a coherent fashion, the advantages of bringing together the set of proposed investigators should be well delineated. How the team synergies will facilitate answering the complex problem should be clearly articulated. Collaboration- and technical readiness should be addressed. Describe how team activities will significantly enhance the investigators' existing capabilities and introduce new approaches to accomplish research aims. How will effective collaborations more rapidly advance science?

2) A clear administrative structure and plan of operation for proposed interactions among the participating project investigators and institutions. The plan must address: collaborative arrangements, duties, and responsibilities; lines of communication among study components; strategies for coordinating and integrating members' work; the timely receipt, inventory, routing, processing, analysis, storage, retrieval and archiving of biological samples; protocols for the timely production, inventory, storage, security and transfer of project data; plans and preliminary schedule for study reports; and, the process for locking the final dataset and sharing.

Leveraging Resources - Applicants are required to provide specific information on how the research strategy will leverage existing resources to accomplish research goals. Describe plans for utilization of: existing resources that increase the efficiency of the entire team and facilitate the use of state-of-the-art technologies; well-established specimen collection, microbial community characterization, and bioinformatics methods; existing population resources; well-validated and well-established clinical data collection instruments; cutting-edge tools and technologies for computational and comparative analyses; reference reagents, databases and established database storage systems (see NLM Data Sharing Resources) and common data elements (see NIH CDE Repository https://cde.nlm.nih.gov/home) as applicable to advance their research goals.

Quality Assurance - Applicants are required to provide specific information on the quality control methods (QC) to be employed in each step of the sample collection, processing, and bioinformatics pipeline. Describe plans to reduce the risk of contaminants entering the experimental system, minimize false positive reads and maximize yield. As applicable, discuss plans for: validating sample collection and recovery methods; mock communities for system testing and validation; spike-in positive and negative microbe- and DNA controls; dedicated equipment; methods to minimize extraction kit and reagent contamination and controls for batch effects; extraction methods that will maximize yield; microbial enrichment methods; and analytic tools to discriminate contamination from true signal (e.g., denoising).

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

The following modifications also apply:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. All applicants should provide specific detailed plans and timelines for resource sharing including raw data, preliminary data, and multi-omics data, methodologies (e.g., software, reagents, and sequencing techniques), protocols for sample collections and analysis, and the development of reference standards as applicable. Resources, technology, and preliminary data must be shared with the NEI, SOC, and other research teams receiving funding from this FOA at the earliest stages. Detailed plans for sharing with the broader research community and continued availability of project data and resources after the end of the project period should also be included. The final negotiated version of the resource sharing plan will become a term and condition of the award of the cooperative agreement.

The following modifications also apply:

Data Sharing Plan: Applicants to this FOA must address the Data Management and Sharing Plan and provide a timeline that includes specific milestones and metrics for their evaluation for scientific progress, and data sharing. The plan must include use of Common Data Elements (CDEs). Please refer to the implementation guidance (NIH Data Sharing Policy and Implementation Guidance) on how to develop a data sharing plan. Applicants are strongly encouraged to follow the recommendation in the new NIH Policy for Data Management and Sharing (Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan), which will be in effect on January 25, 2023.

NEI program staff will conduct an administrative review of the data management and sharing plan and may negotiate modifications of the plan with the prospective awardee prior to award. The final negotiated version of the data management and sharing plan will become a term and condition of the award of the cooperative agreement.

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions.

Foreign Institutions

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

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 fieldof 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 (DUNS number or UEI as required) provided on the application is the same number 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 NEI Referral Office by email at ellen.liberman@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

 

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.

For this particular announcement, note the following:

Consistent with the FOA's call for developing a community-based resource of microbial communities and factors they elaborate that are associated with the resident ocular microbiome of healthy individuals, discovery-based projects that are not hypothesis driven may be appropriate.

Overall Impact

Overall Impact

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).

Scored Review Criteria

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.

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA:

Will this project substantially move the field closer to achieving the goal of developing a research resource of microbial communities and factors they elaborate that are associated with the resident ocular microbiome of healthy individuals? Is the plan for sharing the data and resources likely to be effective in making them broadly accessible both while the project is ongoing and afterwards?

To what extent will the data and resources described in the application be useful to the broader research community in delineating the range of structural or functional configurations of a healthy population’s resident microbial community and paving the way for broader studies of the epidemiology, ecology and translational applications of the human ocular microbiome including the development of microbiome-based interventions for prevention and treatment of eye diseases?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific for this FOA:

Is the research team appropriate? Will the collaboration bring together new combinations of investigators and approaches?

Does the research team demonstrate a synergy in technical and intellectual abilities and bring to bear the resources needed to make major inroads in the field? Has collaboration and technical readiness been addressed. Is the team’s administrative structure and plan of operation conducive to project success?

 

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific for this FOA:

Does the applicant propose appropriate milestones, timelines, and metrics for evaluation?

Are the Quality Assurance plans outlined in sufficient detail and will they reduce the risk of contamination, minimize false positive reads, maximize yield, discriminate contamination from true signal and generate reproducible results?

Does the scientific approach appropriately leverage: shared resources that increase the efficiency of the entire team and facilitate the use of new technologies; established specimen collection and microbial community characterization methods; existing population resources; well-validated and well-established clinical data collection instruments; cutting-edge tools and technologies for computational and comparative analyses; reference databases and established database storage systems; and, common data elements as applicable to advance research goals?

Is the proposed sample size and inclusion/exclusion criteria justified in terms of the scientific goals and research strategy proposed?

Is the plan for sharing the data and resources likely to be effective in making them broadly accessible both while the project is ongoing and afterwards, in a manner which will advance the understanding of physiological or pathophysiological mechanisms, or the development of microbiome-based interventions for prevention or treatment of disease?

 

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

 
Additional Review Criteria

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.

   

For research that involves human subjects but does not involve one of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

 

Not Applicable

 

Not Applicable

 

Not Applicable

Additional Review Considerations

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.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

 

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

 

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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 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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Eye Council. 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:

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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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.

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the recipients for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Determining experimental approaches, designing protocols, conducting experiments, analyzing interpreting and publishing research data
  • Attending meetings with investigators, NEI staff, and members of the SOC to foster collaborations and exchange information and ideas to accelerate progress towards achieving research goals
  • Developing milestones with specific timelines and criteria for evaluation, and making appropriate revisions based on the feedback from the Principal Investigator meetings and recommendations from the SOC and NEI
  • Discussing and sharing information, preliminary results, raw data, resources, and technology with the NEI, the SOC, and the other investigative teams (i.e., recipients of awards issued under this FOA) as appropriate and consistent with achieving the goals of the program.
  • Sharing data, final results, and technology with the broader research community as appropriate.
  • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • The NEI Program Official will be responsible for each award's normal scientific and programmatic stewardship and will be named in the award notice. Normal Program Official stewardship includes:
  • Enforcement of general statutory, regulatory, or policy requirements.
  • Approval of recipient plans prior to award and review of performance after completion.
  • Evaluation of progress by reviews of technical or fiscal reports, site visits, or external consultants, to determine that performance is consistent with the terms and conditions of the award.
  • Technical assistance requested by recipients, or unanticipated procedures to correct programmatic or financial deficiencies in recipients' performance.
  • Scientific/technical discussions with recipients, or actions to facilitate or expedite interactions between recipients.

The NEI Project Coordinator is not involved with normal program stewardship but will provide technical assistance, advice, coordination, and other program actions supporting the recipients of these cooperative agreements during the conduct of an activity, above and beyond the levels required normally for program stewardship of grants. Program Coordination includes:

  • Establishing a SOC with input from the PD(s)/PI(s);
  • Attending and participating in the Principal Investigator and SOC meetings;
  • Assisting in the development of the meeting agendas and logistics;
  • Assist the SOC in evaluating achievement of milestones;
  • Assist with the establishment of a consortium for the purpose of sharing information and coordination of research activities among the recipients of these cooperative agreements.

Areas of Joint Responsibility include:

None; all responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. 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.

Application Submission Contacts

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: http://grants.nih.gov/support/ (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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Lisa Neuhold, Ph.D.
National Eye Institute (NEI)
Telephone: 301-443-5401
Email: lneuhold@nei.nih.gov

Peer Review Contact(s)

Brian Hoshaw, Ph.D.
National Eye Institute (NEI)
Telephone: 301-402-0566
Email: brian.hoshaw@nih.gov

Financial/Grants Management Contact(s)

Karen Robinson Smith
National Eye Institute (NEI)
Telephone: 301-435-8178
Email: karen.robinson.smith@nei.nih.gov

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.

Authority and Regulations

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.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.