It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

Purpose

The NEI Center Core Grant combines three or more Resource and/or Service Cores for a group of R01 investigators to enhance their research, consolidate resources, avoid duplication of efforts, and/or contribute to cost effectiveness by providing a service with lower costs or higher quality than could be attempted for independent projects by several individual PDs/PIs. Shared resources and facilities that are accessible to a group of independently funded investigators lead to greater productivity for the separate projects, and can provide instrumentation and facilities that are too costly to be maintained by an individual investigator. The design and purpose of each Center Core may vary in how it serves its users. This program is designed to enhance an institution's environment and capability to conduct vision research and to facilitate collaborative studies of the visual system and its disorders.

A NEI Center Core Grant should increase the productivity and impact of research in eligible projects of the Core users, and should create a collaborative environment to increase scientific interactions. A strong research base of funded projects is an eligibility requirement and a major factor in obtaining an NEI Center Core Grant award. Any institution or consortium applying for a NEI Center Core Grant must have an active, established program in basic, epidemiological, biomedical or behavioral research in one or more of the NEI mission areas described at https://www.nei.nih.gov/funding/nprp.

Specific Areas

NEI-supported Center Cores should consist of discrete units or Cores, each devoted to a specific activity that would be impractical or less efficient to support on an individual research project grant. The purpose of each Core is to support a resource or service that enhances or facilitates the research efforts of a group of independent investigators, each having NEI funding. Cores may involve the purchase and maintenance of shared instruments. Sharing of NEI Center Core Grant resources and services with other NIH-funded collaborators and with investigators new to vision research is encouraged.

The Administrative Core supports the overall management of the Center Core which includes an organizational structure sufficient to coordinate and integrate the activities of the Resource and Service Cores, and to determine the distribution and utilization of funds.

Resource Cores facilitate the production of materials for research, or support the purchase, maintenance, and technical support of shared equipment. Examples may include, but are not limited to: confocal microscopy, electron microscopy, tissue and cell culture services, genotyping, microarray analysis, mass spectrometry, high throughput sequencing, database management, hybridoma production, laboratory animal resources, image analysis, and brain and eye imaging. Resource Cores may also help support computer experts, biostatisticians, and other individuals who can assist or collaborate with participating investigators in conducting vision research.

Service Cores support essential laboratory or technical services provided by one or more highly skilled persons. Examples of this type of core include, but are not limited to an electronics shop, a machine shop, and photography services.

Studies involving human subjects are not allowed. However, Core resources and services can be accessed for secondary studies that use human specimens, cell lines, or data provided that these have been stripped of identifiers and appropriate approvals have been obtained through the individual research grants that support collection of human subject material.

See Section VIII. Other Informationfor award authorities and regulations.

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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

Other

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. 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.
• 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.
• o 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from 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.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101).

The applicant institution must have 8 or more eligible grants. Eligible grants are defined as active NEI-supported R01s. Grant applications in administrative extensions, with or without additional funds, are not eligible. Administrative supplements, revisions, and sub-contracts cannot be counted toward eligibility.

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core (use for Administrative Core)	6
Core (use for Resource/Service Core)	6

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required; maximum of 1
• Resource/Service Core: required; minimum of 3

When preparing your application, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Facilities & Other Resources: Describe and give examples of institutional commitment and support of the goal of fostering vision research.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: List the outcomes that are expected to be achieved with this Center Core.

Research Strategy: The Research Strategy section should include the following subsections:

Background: Describe the overall Center Core and how it would be used to enhance the capabilities of participating NEI-funded investigators and the institution for conducting vision research. If pertinent, describe how Center Core resources and services would be used to help initiate or to continue collaborative studies, and/or to help attract scientists to research on the visual system.

Significance: Clearly show how the resources and/or services provided by the Center Core will meet the scientific needs of the research base and serve multiple investigators. Explain the likelihood that the Center Core will increase efficiency, accelerate progress, and promote new research directions and scientific collaborations among the Senior Persons and other users.

Innovation: Clearly explain how the Center Core uses innovative ways to communicate or integrate activities among the Resource/Service Cores, or across basic and clinical research. Also explain the innovative methods proposed for allocating resources or promoting new cross-departmental or multi-disciplinary collaborations.

Approach: Detail the plans to establish and maintain communication and cooperation among Senior Persons and other users. Provide an adequate management plan for the Research and Service Cores that should include including strategies for implementation, allocation, NEI-R01 grantee user prioritization, quality control, and utilization of the Cores. The management plan should address accountability, flow of authority, dispute resolution, evaluation and integration with the institution's fiscal and academic administrations.

Table: The table should only list NEI-supported R01s that will count towards eligibility. Eligible grants are defined as NEI-supported R01s. Grant applications in administrative extensions, with or without additional funds, are not eligible. Administrative supplements, revisions, and sub-contracts cannot be counted toward eligibility. The table should include the complete grant number, title, and PD/PI.

Letters of Support: Documentation confirming and describing institutional commitment and contribution should be included in the Overall Component.

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.

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. The Appendix can only include the following additional material: maps, floor plans, questionnaires and examples of sign-in sheets. Information such as publication lists, person lists or biographical sketches are not acceptable appendix material.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

Not Applicable. The NEI Center Core Grant does not allow the use of Human Subjects.

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.

When preparing your application, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Not Applicable. The NEI Center Core Grant does not allow the use of Human Subjects.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Administrative Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The PD/PI of the overall NEI Center Core Grant should be also named as the Director of the Administrative Core. This individual need not hold a qualifying R01.

• Budget forms appropriate for the specific component will be included in the application package.
• Administrative Core Director: Salary support may not exceed 0.6 person months.
• Secretarial and Administrative Staff: Salary support may be requested to the extent that it relates directly to the management of the Center Core activities.
• Costs for all secretarial and administrative activities (including support for the Core Director) may not exceed 15% of the total direct costs of a Core Grant award in any year.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: List the goals of the Administrative Core.

Research Strategy: Describe the integration, coordination and evaluation of the activities of the Service/Resource Cores. Include the establishment of priorities, allocation of resources, and the scheduling for use of a Core among participating investigators.

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.

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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. Not Applicable. The NEI Center Core Grant does not allow the use of Human Subjects.

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. Not Applicable. The NEI Center Core Grant does not allow the use of Human Subjects.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Resource/Service Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Core
• Proposed Core Start/Ending Dates

PHS 398 Cover Page Supplement (Resource/Service Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource/Service Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

The NEI Center Core Grant does not allow the use of Human Subjects.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Resource/Service Core)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Resource/Service Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are using the core.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Resource/Service Cores should be directed by a NEI-funded, independent investigator who has the expertise to supervise its use. Resource/Service Core Directors should have an active NEI R01 grant. Other arrangements may be proposed but must be well justified.

Budget (Resource/Service Core)

• Director: Salary support may not exceed 0.4 person months.
• Technical Support Personnel: Salary may be requested.
• Equipment: Requests for shared equipment are allowed.
• Supplies: Consumable supplies may be requested if they are directly related to the operation of the Cores (photographic supplies, electronic parts, machine shop stock, tissue culture media, etc.).
• Travel: Not allowed.
• Patient Care Costs: Not allowed.
• Other Expenses: Equipment maintenance, computer time, and the leasing of computer lines are examples of the many types of allowable costs.
• Human subject's reimbursement, animal care per diem charges (boarding), and costs associated with seminars, conferences, workshops, etc. are not allowed.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Resource/Service Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: List the goals of the Resource/Service Core.

Research Strategy: For the individual Resource/Service Core, describe how the Core resources or services will enhance the research activities and accomplishments of the projects using this Core. Include how the Resource/Service Core will provide increased or innovative capabilities, facilitate increased productivity or effectiveness through sharing expertise or centralizing labor-intensive tasks, foster collaborative or new research directions, bridge basic and clinical research, or attract new investigators into vision research. Methodologies already in use at the institution may be described briefly. Methodologies new to the institution need to be described in detail and strategies delineated for successful implementation.

Resource/Service Core Use and Impact: Describe how this Resource/Service Core will enhance the research capabilities of investigators using it citing some specific examples. Characterize the extent to which the Resource/Service Core will be used by each investigator, employing the terms "limited," "moderate," or "extensive". This information should be summarized in a table labeled with (Resource/Service name) Core Usage.

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.

Appendix: Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Appendix can only include the following additional material: maps, floor plans, questionnaires and examples of sign-in sheets. These must be specific for the Core otherwise they should be included in the appendix of the Overall Component. Information such as publication lists, person lists or biographical sketches are not acceptable appendix material.

PHS Human Subjects and Clinical Trials Information (Resource/Service Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
Not Applicable. The NEI Center Core Grant does not allow the use of Human Subjects.

Delayed Onset Study
Not Applicable. The NEI Center Core Grant does not allow the use of Human Subjects.

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.

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) using ASSIST or other electronic submission systems. 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.

This initiative is not subject to intergovernmental review.

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.

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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.

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 Center Core 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 Center Core proposed).

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

Does the Center Core 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 Center Core 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? Does the Center Core provide resources and/or services to meet the scientific needs of the research base? Will the Center Core be used by multiple investigators? What is the likelihood that the Center Core will increase efficiency, accelerate progress, and promote new research directions and scientific collaborations among the Senior Persons and other users?

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?

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? Does the Center Core use innovative ways to communicate or integrate activities among the Resource/Service Cores, or across basic and clinical research? Are there innovative methods for allocating resources or promoting new cross-departmental or multi-disciplinary collaborations?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center Core? Have 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 Center Core 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?

Are there plans to establish and maintain communication and cooperation among Senior Persons and other users? Are there adequate management plans for the Research and Service Cores, including implementation, allocation, NEI-R01 grantee user prioritization, quality control, and utilization of the Cores? How well does the management plan address accountability, flow of authority, dispute resolution, evaluation and integration with the institution's fiscal and academic administrations?

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?

As applicable for the Center Core 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 Center Core 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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable.

As applicable for the Center Core 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.

Applications from Foreign Organizations