Part 1. Overview Information

Key Dates

Dates in bold and italics reflect changes per NOT-GM-25-020

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

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

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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

National and Regional Resources (NRRs) enable access to state-of-the-art technologies, methods and expertise essential to advancing biomedical research that may not be widely available to individual laboratories. Moreover, regional (multi-state) or national resources can achieve economies of scale by serving substantial numbers of users more efficiently and economically than activities that are maintained by individual institutions, each with its administrative, equipment, staffing and maintenance needs. 

The primary goal of this NOFO is to support NIGMS mission-related resources that can add value and achieve economies of scale by serving a demonstrated, substantial number of investigators (typically >100) at a national or regional (multi-state) level. The intent is to provide access to investigators without regard to the particular biomedical focus of their research.

This program provides support to established resources and new ones formed through consolidation of multiple existing regional or local facilities. Only those resources with technical capabilities that fall within the program areas supported by NIGMS are responsive to this NOFO. This initiative complements the Mature Synchrotron Resources and the National Centers for Cryoelectron Microscopy programs, which specifically address those technologies. Applications to support synchrotron-based resources will not be accepted under this NOFO.

Resource Characteristics

For this NOFO, a resource is defined as an activity that provides research capabilities and expertise to a large number of researchers and is available to any qualified investigator. Resources supported under this NOFO should be essential to making the most impactful, timely, rigorous, reproducible, and cost-efficient progress in a field within NIGMS-supported program areas. Priority for resource access should be given to NIH-funded researchers and other United States-based academic researchers, but should be available to other qualified scientists. Plans for sustainable financial support of the resource can include fees for service if they are well justified. User fees may be scaled to different classes of users. For more information, see FAQs for Core Facilities section B. Charges to NIH Supported Users.

A resource should:

• Benefit a large number (typically >100) of investigators
• Support NIGMS-mission related technologies 
• Provide access to technologies, services and/or assets that are not already widely and economically available to most users
• Provide state-of-the-art technical capabilities
• Support technologies that are unlikely to become obsolete in the near future
• Be properly designed for efficient use
• Be appropriately staffed to ensure resource maintenance and user support
• Have quality control measures in place
• Offer equal-opportunity access to users external to the host institution through an open application process. At least 75% of active instrument time should be dedicated to open access use.
• Maximize effective use through outreach and training

Resources can be physical or computational, or a combination of both. Examples of items that resources may provide include, but are not limited to:

• High-end instruments and equipment
• Computational hardware and software
• Research materials, such as rare or specialized reagents, and libraries
• Research tools for data generation and analysis
• Access to specialized methods and expertise
• Repositories for research organisms, cell lines, and other non-clinical biologicals

Stand-alone data resources (databases, data repositories, and knowledge bases) will not be supported by this NOFO. These can be supported through existing NIH-wide programs initiatives organized through the Office of Data Science Strategy (e.g., PAR-23-236 and PAR-23-237). Applications may include databases essential to other resource capabilities. Clinical biospecimen repositories will not be supported by this NOFO.

A National Resource may be focused on one or multiple experimental techniques or technologies that are only available at a limited number of sites in the United States.

A Regional Resource can include capabilities that are available in certain geographic areas, but not in others, or that by centralization can achieve significant economies of scale. Resources should support substantial user bases at multiple institutions in multiple states. The number of users who can access the resource's services will be considered during peer review and in funding decisions. Resources that provide access to technologies or methods that are already accessible at reasonable cost to most potential users will not be supported by this NOFO.

Non-Responsiveness Criteria

The following types of resources are non-responsive to this NOFO and will not be reviewed:

• Those with technical capabilities that are not within the program areas supported by NIGMS 
• Synchrotron-based resources 
• Stand-alone data resources (databases, data repositories, and knowledge bases) 
• Those that collect, maintain and distribute clinical samples (biospecimen repositories) 

Supported Activities 

Resources should already be developed and only require support to maintain current best practices, state-of-the-art technologies, defray operating expenses, provide user training, and publicize the services provided. The following activities are supported: 

• Maintenance of instrumentation, data collection, data reduction, and analysis 
• Replacement of existing equipment with the latest instrumentation, provided it is justified in terms of user service and cost efficiency 
• Resource implementation, including process refinement, methods improvement, and software development for optimal operations 
• Improvements that may involve limited engineering or development, particularly to increase efficiency of operations 

Resources with technologies that require major development or optimization can be supported through the Biomedical Technology Optimization and Dissemination Centers (BTOD, RM1) or NIGMS Technology Development (R21 and R01) programs. Additionally, staff at NIGMS-supported NRRs are eligible to apply for the NIGMS Technology Development (R21 and R01) program to support new technology development activities. Potential applicants are encouraged to contact the Scientific/Research Contact for this NOFO for further clarification.

In the case of research materials collections and repositories, support can be requested to maintain and extend the collections through the production or the acceptance of new material donations. Support for quality control, cataloging, propagation, and distribution of materials can also be provided.

In the case of computational facilities and software resources, support can include hardware upgrades or migration to cloud-based or other computational environments. Optimization of computer code, implementation or integration of complementary software developed with other funding, and maintenance and updating of required databases could also be included.

Program Expectations

• This program is intended to support state-of-the-art resources that have demonstrated capacity to serve a substantial user base. NIGMS anticipates that support for resources will be renewable provided that they remain in high demand by a substantial user community (i.e. a typical user base of greater than 100 per year, or, if less than 100, with strong justification) and their service(s) cannot be provided through other cost-efficient means, such as commercial vendors. Resources that are capable of transitioning to other mechanisms of support, such as fee-for-use or commercialization, should work toward achieving that goal. Technologies and other resources that become widely available in the scientific community will no longer be supported through this NOFO.
• Each resource should have a website that provides up-to-date and complete information about facilities and services, policies, and the user access and application process. 
• The PD/PI is required to devote at least 2.4 person-months (20% full-time effort) to provide overall scientific guidance and resource management. At least one additional senior scientist is required to devote a minimum of 6 person-months effort (>50% full-time effort) to managing the resource. The PD/PI and senior scientist must be distinct individuals.
• An external scientific advisory board is required, but members of the board should not be named in the application or contacted prior to completion of peer review unless they are already in place for the existing resource.
• Students, postdoctoral fellows and other trainees should only be involved in the operation of the resource under rare, extremely well-justified circumstances. In cases where trainees are to be involved in resource operations, a strong institutional letter describing how these activities are integral to the students' or trainees' overall training goals is required. 
• Users can acknowledge resource staff in their papers and must cite the facility's grant as providing support for their work.  
• Resource staff are employed to provide users with efficient and productive service and normally should not be included as authors on users' publications that result from resource use. They may have other independently supported research commitments that enable them to lead their own research projects and to collaborate on resource users' projects that require effort beyond normal resource services. Any access to the resource for resource staff projects must be obtained through the normal user application process, and in competition with all other user applications. Resources must have plans in place to avoid prioritizing projects simply because they would result in staff co-authorship. 
• NIGMS will monitor the resource utilization based on information provided in annual progress reports and publications that were enabled by the service, which should be cited accordingly.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

Non-domestic (non-U.S.) components of U.S. Organizations are 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 How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

For this NOFO, at least one of the PDs/PIs must devote at least 2.4 person-months. At least one senior scientist, an individual distinct from the PD/PI, must devote at least 6 person-months to the resource.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Page Limitations

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

For this specific NOFO, the Research Strategy section is limited to 30 pages.

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments: The attachment listed below must be included in the application. Applications that do not include this attachment will be withdrawn without review.

Publications Enabled by the Resource: 

• If the proposed resource is already established or is newly formed through consolidation of existing local or regional facilities, provide a bibliography of publications enabled by the resource or facilities during the previous five years. 
• Highlight five highly impactful publications at the top of the list and include a two sentence description of the importance of the work to the field for each of these five publications. 
• Use the standard NIH reference format. 
• For renewal applications only, all publications that have resulted from the last funding period should be included. 

This attachment should be titled “Publications Enabled by the Resource”.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

• The PD/PI is required to devote at least 2.4 person-months to provide overall scientific guidance and resource management. Additionally, at least one other senior scientist is required to devote at least 6 person-months to managing the resource. Personnel costs commensurate with the effort stipulated for the PD/PI and senior scientist may be requested in the budget. 
• In the budget justification, applicants must provide names (if available), person months effort, and the role on the project for all contributing personnel. Applicants should present a single overall budget including funding requests for all activities of the resource and provide a single budget justification that includes the justification of specific subaward items. 
• Funding may be requested for the supported activities described in Section I or other well-justified activities. This NOFO will not support research and development activities, except for limited technology optimization needed to improve user service and resource efficiency .
• In the budget justification, provide detailed information about support received or anticipated from other entities. This could include, for example, additional funding from another government agency, user fees, or institutional support.
• When transition to other means of support is feasible, the funding requested should align with a transition plan. A reduction in requested support as the project period progresses and the resource transitions to other sources of support is appropriate.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Describe the overall aims of the Resource. If more than one technology or other service is included, present each as a separate aim. Include as specific sub-aims each planned improvement intended to maintain the facility at the state-of-the-art and to achieve efficiencies or economies of scale.

Research Strategy: Use the following headings in the Research Strategy:

• Overview
• Resource Capabilities and Improvements
• Administration
• Operation and Maintenance Plan
• User Training and Outreach
• Evaluation and Reporting Plans

I. Overview

1. Describe the overall objectives of the resource and discuss the importance of this particular resource to biomedical research as well as its relationship to other similar resources within the US and world. Note that a resource is not required to be unique, although that may be an asset. 
2. Discuss how the proposed activities and components integrate to form a coherent resource, while providing a brief summary of each resource activity, including its administration.
3. Provide evidence that summarizes the impact, high demand for, and productivity of the resource over the last 3 years and for the project period:
   • The summary should include data with projections of how the resource achieves or will achieve economies of scale: (a) Existing resources should document their support of a substantial number of users (typically >100 per year) at institutions throughout a region or the nation. Applications for resources with fewer than 100 users should provide a strong justification that support for a resource with this smaller user base is warranted; (b) For new resources resulting from consolidation of multiple regional or local facilities, applicants should provide well-documented projections of a substantial user base for the consolidated resource and describe the economies of scale that would result from consolidation.
   • Existing resources should also include outcomes of advisory board evaluation, review processes, etc., specified for each of the resource's capabilities.
   • Additional evidence that should be provided but does not substitute for the actual or projected resource utilization as described above may include: (a) the number of publications enabled by the resource through collaboration or service activities, (b) service hours provided, (c) number of users, (d) summaries of instrument use time logs, (e) requests for access, and (f) white papers and editorials that demonstrate community interest.
4. Provide a timeline for implementation of the resource activities. 

Note that for this NOFO, "Innovation" is defined as a coherent plan to ensure that independently funded investigators have cost-effective access to biomedical technologies and expertise that are not widely available and will enable biomedical research within the NIGMS-mission areas.

II. Resource Capabilities and Improvements

1. Resource Capabilities: Summarize the scientific and technological capabilities of the resource, including instrumentation and facilities, collections of materials and other research tools, supporting computational and data reduction infrastructure, hardware and software, and expertise of interest to the user community.

• Describe the experimental station(s) and workspace(s) that users will directly access
• Document user interfaces, which should be straightforward, and user-friendly
• If applicable, provide details of any remote access processes, procedures, and interfaces
• Summarize planned improvements intended to maintain the facility at the state-of-the art and to achieve efficiencies
• If relevant, indicate how the proposed resource plans to utilize open-source software and/or equipment that can be commercially obtained or has been previously developed
• If applicable, provide plans for data storage and transfer to users
• Describe how the technological capabilities and services are sufficiently stable with regard to major developments so that only implementation of upgrades and minor optimization, rather than substantial new technological development, is necessary
• Delineate the role and contributions of personnel in the technological and scientific operations of the resource. Do not repeat information included in the biosketches 

2. Resource Improvements

• Summarize planned improvements intended to maintain the facility at the state-of-the art and to achieve efficiencies
• Describe any plans to implement emerging technological and methodological refinements that enhance the impact for the user community and improve the utility or efficiency of the resource 
• Provide details of any improvements that involve extensive engineering, including information about appropriate technical review boards or other expertise to be consulted to obtain adequate feedback through the development and implementation stages
• For improvements that involve software development, describe plans to ensure that industry programming standards are met, provide software portability when appropriate, and document and make software readily available to the user community. Sharing of source code is encouraged.

Applicants are encouraged to discuss planned improvements of their technologies with Scientific/Research staff prior to submission to ensure that they conform to the requirements of this NOFO.

III. Administration

1. Resource Organizational Structure

Define the roles and contributions of personnel in the technological and scientific operations of the resource. Do not repeat information included in the biosketches.
Describe how the PD(s)/PI(s), the technical operations leaders, and other key personnel are appropriately trained for their respective roles, able to devote adequate effort to the resource activities, and have a history of performing services for the scientific community at large
Outline how the PD(s)/PI(s) and the proposed resource staff will be organized with respect to its activities: technical operations, user service, maintenance or upgrade projects, administration, user training, and outreach activities
Describe how staff with appropriate skills and knowledge will be recruited and retained

2. Grantee Organization

Describe the relationship of the resource to the administrative structure of the grantee organization(s)

3. External Scientific Advisory Board

Describe in general terms how members of the required External Scientific Advisory Board would be chosen and how the board would operate, but do not include names of specific individuals unless they have already been involved with the resource in the past few years and would therefore be in conflict for review

IV. Operation and Maintenance Plan

1. Resource Operation, Maintenance and Contingency Plans

• Outline plans for how resources will be maintained for continuous operation, including routine equipment service and calibration, adding new materials to existing collections, or improving upon established procedures. This description should include plans for quality control and assurance.
• Provide plans for operations during resource downtime including, if appropriate, alternative resources that users may access
• Provide contingency plans for unexpected shutdowns or equipment failures
• Describe details of service contracts that provide emergency repair services.
• To sustain efficient management of the resource, include a contingency plan in the event that the PD/PI or the Senior Scientist or other key staff can no longer fulfill their obligations due to health, retirement, or other unforeseeable circumstances

2. User Access

• Describe procedures for handling requests for resource use, and for the adequate distribution of resource time and access
• Describe plans for ensuring broad access for institutions and regions across the country and not just for highly-resourced institutions.
• Providing resource service to as many meritorious users as possible is an important goal of this initiative and applications should clearly describe how the proposed resource will meet this goal

3. Resource Sustainability

• Applicants are strongly encouraged to develop and include additional plans to sustain resources. For example, non-prohibitive cost recovery charges ("co-pays") are encouraged and should be discussed in the application. However, if the application proposes co-pay fees, they should either be sufficiently low so as not to serve as a barrier to access for users at lower resourced institutions or a system should be proposed to provide low/no-cost access to meritorious researchers who do not have sufficient support to pay the requested fees.
• The application should include a clear plan if the resource plans to transition to other sources of support at the end of the award period. NIGMS encourages exploring the potential of future resource commercialization and the implications of such a shift for the user community. Applicants should anticipate that NIGMS funds may not continue beyond the funding period.

V. User Training and Outreach

1. User Training Procedures and Activities: A combination of one-on-one interactions with resource staff, web-based manuals and training modules or tutorials, etc., may be used for user training. User training activities that should be documented include:

• Required plans for individualized user training in the safe and proper operation of the available resource facilities
• User training to prepare biomedical researchers to effectively use and apply the resource technologies and data collected to their own research

2. Outreach Activities: Describe the planned outreach activities and how they will accomplish the following objectives:

• Informing the broader scientific community about the technical capabilities of the resource
• Promoting and enabling the broader use of the resource.
• Actively recruiting new users
• Providing user training to a broad range of individuals

A variety of approaches can be proposed to meet these goals. These approaches can include, but are not limited to publishing articles, books, newsletters, annual reports, or specialty issues of technical journals; issuing press releases; presenting research results at meetings; conducting workshops and conferences; distributing software products. All resource outreach activities must acknowledge NIGMS grant support and cite the NIGMS grant number.

Additionally, every resource is required to maintain a robust online presence, which should be described in the application. The website should minimally provide information about the following:

• The resource’s funding source(s), including the NIGMS grant number
• The resource’s capabilities
• How users can access the resource
• Contact information
• How resource users should cite the grant
• Links to online tutorials, as applicable
• The availability of software, reagents, and other resources, as applicable
• An image gallery that features data and results
• A section of plain language information for the general public about the technologies
• A section on current newsworthy items directed to the general public

VI. Evaluation and Reporting Plans

The application must include an evaluation plan with measures for both short-term and long-term goals. Examples could include tracking user numbers, home institutions, background and training, requests for services, successful use of the resource products (materials or data), publications citing use.

Quantifiable measures of intermediate results and success are critical and should be built into the resource as:

• short-term internal metrics for utilization and ongoing improvement (e.g., number of uses and number of new users per year/quarter)
• long-term objective metrics to gauge impact of usage on the scientific field (e.g. high Relative Citation Ratio (RCR) publications resulting from the resource and patents linked to publications)

Some qualities tracked in evaluation science include:

• adequacy (serving the community's needs)
• trustworthiness (operating according to specifications)
• authenticity (objects are what they should be)
• integrity (absence of unintended changes)
• availability (ease of access)
• documentation (description of the service available)
• transparency (users' view of operations)

The research community being served will have expectations about the resource that should be captured and documented.

The applicant should describe how the evaluation metrics will be used to optimize performance and efficiency of operation of the resource. Key metrics of resource use and impact should be made available on a public website and applicants should describe how this will be accomplished.

This section must include a plan for reporting data to NIGMS on an annual or more frequent basis as required under terms and conditions of the grant award.

Letters of Support: 

• Letters of support should be limited to only those who are named in the application (e.g., collaborators, senior/key personnel and other significant contributors) and are expected to contribute in a substantive way to the content and operation of the proposed resource.
• Include letters from appropriate institutional leaders confirming any specific commitments to the resource
• If students or trainees are involved in the operation of the resource, the application must include a strong institutional letter describing how these activities are integral to the students' or trainees' overall training goals.
• Do not include letters of support from individuals, groups, or consortia who are users but not contributors to the resource

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

The following modifications also apply:

In addition, if applicable, applications should include a Software Sharing Plan.

Other Plan(s): 

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

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for responsiveness, completeness and, compliance with application instructions by NIGMS. Applications that are non-responsive, incomplete or non-compliant will not be reviewed.

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

Applicants requesting $500,000 or more in direct costs in any year are not required to contact a Scientific/ Research Contact prior to submitting an application. The Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide is not applicable to this NOFO.

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

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

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

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities and NIGMS funding policies.
• Geographic distribution of resources.
• Increase in national access to important technologies and the creation of large economies of scale.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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

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

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

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

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

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

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

Successful recipients under this NOFO agree that:

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

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

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

Not Applicable

3. Data Management and Sharing

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

4. Reporting

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

Tracking the demand for and utilization of the resource is important for ongoing improvements in the short-term and for gauging impact of usage on science in the long-term. A reporting plan tailored to the resource to best evaluate the productivity, availability, efficiency, and impact of the resource is required and should be reported or uploaded in pdf under G.1 of the RPPR. Report data on an annual basis to track the demand for and utilization of the resource, as outlined in the Evaluation and Reporting Plan section of the Research Strategy. Grantees should refer to the guidelines for preparing the R24 RPPR for more information. Sample data may include the following:

• Resource usage, including the total annual hours available at the facility, and aggregate information on hours dedicated toward maintenance, general user time, and any other usage
• For each technical capability, the number of user groups accessing the resource and the number of visits by each group. A visit may be considered usage in person, by remote access, or as a mail-in sample with data collected by resource staff.
• The institutional affiliation(s) of each user
• Geographic distribution of users
• The level of demand for each of the technical capabilities in terms of number of user requests received and number granted access
• Funding source(s) for each user group project and a compiled summary table of projects associated with each technical capability. If the funding source is NIH, report the grant number that supports the project
• Publications and database or software repository depositions. Software downloads, data uploads and downloads, and website metrics should be included.
• Several (3 or 4) science highlights that the resource enabled
• Challenges to the resource, including but not limited to equipment failures, loss of key personnel, unexpected suspension of operations, etc, and solutions to these challenges
• Metrics regarding user training and dissemination activities

 If circumstances change from the plan described at the time of application to transition to other means of support, describe adjustments to the transition plan in the annual RPPR Section F Changes.

 Program Income earned and expended under the award must be reported on the annual Research Performance Progress Report (RPPR), Section G.11, and on the Federal Financial Report. 

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the National and Regional Resources program, employing the measures identified below. In assessing the effectiveness of the program in serving the needs of the research community and evaluating research capacity building investments, NIGMS may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of the grant period for updates on participants subsequent outcomes.

In evaluating the R24 National and Regional Resources Program, NIGMS expects to use the following measures:

• Resource user base
• Instruments: number of external users, number of internal users, requested instrument time, numbers of experiments or studies, total hours of experiment time, instrument time in hours by external users, instrument time in hours by internal users
• Biological samples or reagents: number of users, number of samples or reagents deposited to resource, number of samples or reagents requested, number of samples or reagents disseminated by the resource, number of samples or reagents maintained by the resource
• Data, software, and computational modeling: number of users, number of data processes/analyses by the resource, number of downloads, number of uploads, number of website visits
• Breadth of user base: from research institutions, undergraduate-focused institutions, other organizations (such as companies), user institution geographical locations

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

NIGMS R24 Mailbox
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Center for Scientific Review (CSR)
[email protected]

Dina Wilson
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Section VIII. Other Information

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

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