Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title
NIGMS National and Regional Resources (R24 - Clinical Trial Not Allowed)
Activity Code

R24 Resource-Related Research Projects

Announcement Type
Reissue of PAR-19-301
Related Notices

  • October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.
  • September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.
  • August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169
  • August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
  • April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109

Funding Opportunity Announcement (FOA) Number
PAR-22-065
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.859
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications for support of resources that will provide access to state-of-the-art equipment, technologies, research tools, materials, organisms, software, and/or services to a substantial regional (multi-state) or national user base. Only those resources with technical capabilities that fall within the NIGMS-supported program areas are eligible for awards. The resources should already be established or may be formed through consolidation of existing local or regional facilities. The intent is to provide resource access to investigators without regard to the specific biomedical focus of their research, while not duplicating or replacing resources supported by sources such as other NIH Institutes and Centers (ICs) or host institutions. The resource is expected to be maintained or upgraded to current best practices, make its capabilities and availability known to the biomedical research community through outreach activities, and provide user training and support.

The FOA does not support major new research and development efforts and stand-alone data resources and databases are not eligible.

Key Dates

Posted Date
November 29, 2021
Open Date (Earliest Submission Date)
May 14, 2022
Letter of Intent Due Date(s)

30 days before application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
June 14, 2022 June 14, 2022 Not Applicable November 2022 January 2023 April 2023
June 14, 2023 June 14, 2023 Not Applicable November 2023 January 2024 April 2024
June 14, 2024 June 14, 2024 Not Applicable November 2024 January 2025 April 2025

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

Expiration Date
June 15, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Research resources 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. This view is consistent with the NIGMS Strategic Plan (Objective 3-1) to “Support access to essential research resources…and to expand the national availability and accessibility of research resources from all types of academic institutions and organizations.”

The primary goal of this Funding Opportunity Announcement (FOA) is to support resources within the scope of NIGMS-supported program areas 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 eligible. This initiative complements the Mature Synchrotron Resources FOA (PAR-19-232 and its reissuance), which specifically addresses that particular class of resources. Therefore, applications to support synchrotron-based resources will not be accepted under this FOA.

Characteristics of a Resource

For this FOA, 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 FOA 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 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 overall financial support of the resource can include fees for service if they are well justified and different amounts may be charged for 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 conducting studies within the NIGMS mission
  • Support technologies required for research within the NIGMS mission
  • Provide the highest quality technical capabilities
  • Use appropriate technology that will not rapidly become obsolete
  • Be appropriately designed to achieve efficient and efficacious 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
  • Partner with other organizations as appropriate to achieve economies of scale

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

  • State-of-Art or 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 knowledgebases) will not be supported by this FOA. These can be supported through existing NIH-wide programs initiatives organized through the Office of Data Science Strategy (e.g., PAR-20-097 and PAR-20-089). Databases essential to other capabilities of the resource can be included. Clinical biospecimen repositories will not be supported by this FOA.

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

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

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. Supported activities may include maintenance of instrumentation, data collection, data reduction, and analysis. Replacement of existing equipment with the latest instrumentation will be supported, provided that it can be justified in terms of user service and cost efficiency. Resource implementation can include process refinement, methods improvement, and software development for optimal operations. Some engineering or development may be involved in the improvements, particularly if they will increase efficiency of operations. Resources requiring major technology development and optimization can be supported through the Biomedical Technology Development and Dissemination Centers (BTDD, RM1) program or NIGMS Technology Development (R21 and R01) programs. Potential applicants are encouraged to contact the Scientific/Research Contact for this FOA 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 upgrades of hardware 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.

NIGMS recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from, research and enhancing public trust. To support the best science, NIGMS encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

  • Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Individual applications and partnerships that enhance geographic and regional engagement.
  • Investigators and teams composed of researchers at different career stages.
  • Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantage backgrounds, and women.
  • Project-based opportunities to benefit early- and mid-career investigators.

Program Expectations

This program is intended to support state-of-the-art resources of sufficient scope to serve a substantial user base. NIGMS anticipates that the 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, or, if less than 100, with strong justification) and their service cannot be provided through other cost-efficient means, such as commercial vendors. Resources that are capable of being transitioned 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 FOA.

The PD/PI will be required to devote at least 2.4 person months (20% full-time effort) to provide overall guidance, and at least one senior scientist will be required to devote greater than >6 person-months (>50% full-time effort) of his/her effort to managing the resource. An external scientific advisory board will be required but should not be named in the application or contacted prior to completion of peer review.

Resource staff are employed to provide the community with efficient and productive service to users and normally should not be included as authors on users' publications that result from use of the 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. The users can acknowledge resource staff in their papers and must cite the facility's grant as providing support for their work. Resource personnel may have other independently supported research commitments that enable them to lead their own research projects and to collaborate on problems that require effort beyond normal resource services. Any access to the resource for their own research projects must be obtained through the normal application process, and in competition with all other applications. Resources must have plans in place to avoid prioritizing projects simply because they would result in staff co-authorship. NIGMS will monitor the distribution of 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

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Renewal

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

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIGMS anticipates supporting up to 5 awards for fiscal year 2023. Future year amounts will depend on annual appropriations and Institute priorities.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

A project period of up to five years may be requested.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

  • 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
Foreign Institutions

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. 

Required Registrations

Applicant organizations

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

  • 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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

For this FOA, at least one of the Program Director(s)/Principal Investigator(s) must devote at least 2.4 person-months and at least one senior scientist must devote greater than >6 person-months to the resource.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Special Requirements

Only those resources with technical capabilities that enable research activities within the program areas supported by NIGMS will be supported. Resources that support clinically-oriented research must be within one of the Institute's areas of clinical research focus. Resources that collect, maintain and distribute clinical samples (biobanks) or stand-alone data resources and databases will not be supported by this FOA. Contacting the Scientific/Research staff in advance of application submission is strongly recommended. Applications that do not adhere to the eligibility criteria will not be reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Email: R24Mailbox@nigms.nih.gov

Page Limitations

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

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments: The following attachments must be included in the application:

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 these five publications. Use the standard NIH reference format. For renewal applications only, publications that have resulted from the last funding period should be included. This attachment should be titled “Publications Enabled by the Resource”.

Plan for Enhancing Diverse Perspectives (PEDP) (1 page maximum): The application must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the Research Strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

  • Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Description of any planned partnerships that may enhance geographic and regional diversity.
  • Plan to enhance recruiting of women and individuals for groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce.
  • Proposed monitoring activities to identify and measure PEDP progress benchmarks.
  • Plan to utilize the project infrastructure to support diverse junior, early- and mid-career researchers.
  • Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
  • Publication plan that enumerates planned manuscripts and proposed lead authorship.
  • Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

This attachment should be titled “Plan for Enhancing Diverse Perspectives”.

Applications that do not include these two attachments will be withdrawn without review.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

PD/PIs are required to devote 2.4 person-months to provide overall scientific guidance and resource management. At least one senior scientist is required to devote =6 person-months to managing the resource. Personnel costs commensurate with these effort requirements 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.

Stipend costs for trainees are allowed only under highly unusual circumstances. An institutional official must provide a letter explaining how the trainee's role in the center is integral to their overall training goals (see Letters of Support below).

PEDP implementation costs: Budget request may include allowable costs (as outlined in the Grants Policy Statement) associated with PEDP implementation.

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 FOA will not support research and development activities.

In the budget justification, provide detailed information about support received or anticipated from other entities. This could include additional funding from another government agency, user fees, or institutional support, for example.

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 SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: 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 Plans

Overview

Describe the overall objectives of the resource and discuss the importance of this particular resource to biomedical research within NIGMS-supported program areas 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. 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. Provide data with projections of how the resource will achieve economies of scale by supporting a substantial number of users (typically >100) at institutions throughout a region or the nation. Applications for resources with fewer than 100 users should include a strong justification that support for a resource with this smaller user base is warranted.

For existing resources, summarize evidence of the impact, high demand for, and productivity of the resource over the last 3 years, e.g., numbers of database submissions and publications enabled by the resource through collaboration or service activities (do not repeat information already provided in Other Attachments "Publications Enabled by the Resource"), service hours, number of users, summaries of instrument time logs, requests for access, outcomes of evaluation review processes etc., specified for each of the resource's capabilities. A summary of publications, white papers, and editorials that demonstrate community interest may be included, but do not substitute for actual or projected resource utilization. For new resources resulting from consolidation of multiple regional or local facilities, applicants should provide evidence of past productivity of these facilities and well-documented projections of a substantial user base for the consolidatd resource and economies of scale that would be produced by consolidation. For this FOA, "Innovation" is defined as a coherent plan to ensure that independently funded investigators have access to biomedical technologies and expertise that are not widely available and will enable biomedical research within the NIGMS mission areas.

Include a timeline for implementation of the activities of the resource.

Resource Capabilities and Improvements

Describe 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 access directly. Describe user interfaces, which should be straightforward, and user friendly. If applicable, describe any remote access processes, procedures, and interfaces. Include planned improvements intended to maintain the facility at the state-of-the art and to achieve efficiencies or economies of scale. Technological capabilities and services should be sufficiently stable with regard to major developments so that only implementation of upgrades, rather than substantial new technological development, is necessary. Discuss the role and contributions of personnel in the technological and scientific operations of the resource. Do not repeat information that is included in the Biosketches.

While significant new technology development cannot be a goal of these resources, implementation of emerging technological and methodological refinements that enhance the impact for the user community and improve the utility or efficiency of the resource can be supported. Whenever possible, plans should be made to utilize open-source software and/or equipment that either can be obtained commercially or has been previously developed. Applicants are encouraged to discuss planned improvements with Scientific/Research staff prior to submission to ensure they conform to the requirements of this FOA. For any improvements that involve extensive engineering, provide details of 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 industry programming standards are met, to provide software portability when appropriate, to document, and to make software readily available to the user community. Sharing of source code is encouraged.

Administration

Describe the organizational structure of the resource. Indicate the relationship of the resource to the administrative structure of the grantee institution(s). The PD(s)/PI(s), the technical operations leaders, and other key personnel should be 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. Describe 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. Describe institutional commitments to the resource, which must be supported by an institutional letter, as outlined in the instructions for the Letters of Support below. An external scientific advisory board is required. Describe in general terms how members 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.

Operation and Maintenance Plan

Describe the plan for operation and maintenance of the resource, with maintenance activities that may include routine equipment service and calibration, adding new materials to existing collections, or improving upon established procedures. The description should include plans for quality control and assurance, discuss required maintenance activities, and provide contingency plans for unexpected shutdowns or equipment failures. Describe plans for staff recruitment and retention and contingency plans in the event of unexpected loss of key resource staff. Include plans for operations during resource downtime including, if appropriate, alternative resources for users and outline plans for how resources will be maintained for continuous operation. Describe details of service contracts that provide emergency repair services, especially for any components designed to minimize downtime. To sustain efficient management of the resource, include a contingency plan in the event the PD/PI can no longer fulfill the obligation due to health, retirement, or other unforeseeable circumstances.

Describe procedures for handling requests for resource use, and for the adequate distribution of resource time and access. This program encourages exploration of additional options to sustain resources. For example, non-prohibitive cost recovery charges ("co-pays") are encouraged and should be discussed in the application. If the application proposes co-pay fees, they should either be sufficiently low so as not to produce a barrier to access for users at under-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. 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.

If the resource could conceivably transition to other sources of support at the end of the award period, then the application should include a clear transition plan. 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.

User Training and Outreach

Describe, in separate sections, the:

  • User Training Procedures and Activities, and
  • Outreach Activities.

User training should prepare biomedical researchers to effectively use and apply the resource technologies and data collected to their own research. Plans for individualized user training in the safe and effective operation of the available resource facilities are required. A combination of one-on-one interactions with resource staff, web-based manuals and training modules or tutorials, etc., may be used. Broader training open to the greater research community through, for example, seminars, lectures or workshops is encouraged.

Outreach activities should have three objectives: informing the scientific community about the technical capabilities of the resource, promoting and enabling the broader use of those technologies, and actively recruiting new users. A variety of approaches can be proposed to meet these goals. All resource outreach activities must acknowledge NIGMS grant support and cite the NIGMS grant number. A robust online presence is required.

Outreach activities should include plans to advance the goal of providing user training to individuals from diverse backgrounds, including individuals from groups underrepresented in the biomedical sciences (see NIH's Interest in Diversity and Enhancing Diversity in Training Programs).

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 the number of users, the home institutions of users, background/training of the users, requests for services, successful use of the resource products (materials or data), publications citing uses, etc. 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 (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), and transparency (users' view of operations), etc. 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. Do not include letters of support from individuals, groups, or consortia who are users but not contributors to the 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.

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

The following modifications also apply:

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

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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. See Section III of this FOA for information on registration requirements.

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. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIGMS. Applications that are 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 (excluding consortium F&A) must contact a Scientific/Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

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.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed resource address the needs of the research community that it will serve? Is the scope of activities proposed for the resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the user community?

For this FOA: Will the resource support progress in the field? Will the resource produce appreciable economies of scale?

If applicable, will the software sharing plan likely have a considerable effect on progress in the community the resource serves?

Will the resource serve a substantial national or regional (multi-state) user base (typically greater than 100 users)? For resource applications with fewer than 100 users, is there a strong justification for the scientific need and impact of the facilty with the current user base size? Is there a sound plan for expanding the userbase and is it likely to markedly increase the use and/or impact of the resource?

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well-suited to their roles in the resource? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing facilities? If the resource is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the resource? If needed, does the applicant have experience overseeing selection and management of subawards?

For this FOA: Are they able to devote adequate effort to the resource activities? Is a sound plan in place for recruiting and retaining staff with the appropriate skills and knowledge? Is a sound plan in place for rapidly replacing staff who leave the resource to minimize service disruptions?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Innovation

Does the application propose innovative management, training and outreach strategies in coordinating the research resource? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of existing technologies proposed?

For this FOA: Are innovative plans presented to ensure that a large number of investigators nationally or regionally have access to biomedical technologies and expertise that are not widely available and will enable biomedical research? Are innovative approaches to increasing the utility or efficiency of operations of the resource proposed? Are there plans for innovative ways to create economies of scale?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

 

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

For this FOA: Are appropriate plans in place for quality control and assurance? Are appropriate procedures in place for reviewing requests for use of the resource, and for the equitable distribution of the resource's services among investigators and institutions regionally or nationally? Are the plans for user training and outreach likely to be efficient and effective? As applicable, is an adequate and feasible plan to transition to other sources of support provided? Are any plans for the formation and operation of an external scientific advisory committee likely to promote success of the resource? Are the contingency plans to manage unexpected shutdowns of operations and/or loss of personnel well-reasoned and sufficient? If students or trainees are involved in resource operations, are these activities strongly justified and, as described in institutional letters, integral to the student's or trainee's overall training goals? Is the plan for evaluation of the resource activity's impact feasible and adequate? Does it include both short-term and long-term measures of utility and efficiency of opetrations, quantifiable measures of intermediate results and success, as well as plans to utilize evaluation results to improve operations?

Are there proposals in the Plan for Enhancing Diverse Perspectives that are likely to increase the diversity of the user-base of the resource in terms of individuals, institutions, geographic regions, etc. or that will contribute in other ways to improving the utility, efficiency or impact of the resource? Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

Will the institutional environment in which the resource will operate contribute to the probability of success in facilitating the research projects it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the resource proposed? Will the resource benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

For this FOA: Are the user interfaces, experimental station(s) and respective workspace(s) adequate and conducive to effective user access?

To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity) contribute to the success of the project?

Additional Review Criteria

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

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; (3) Genomic Data Sharing Plan (GDS); and (4) Software Sharing Plan.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of General Medical Sciences, 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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Science Council. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities
  • Institute portfolio balance including the types of services provided and geographic distribution
  • Convincing evidence that the resource will serve a substantial national or regional user base
  • Evidence that the resource will produce economies of scale and significantly increase access to technologies or methodologies that are not widely available
  • Compliance with resource sharing policies.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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. 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. Sample data may include the following and grantees should refer to the guidelines for preparing the R24 RPPR.

  • 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.
  • Report on activities related to the Plan to Enhance Diverse Perspectives. For example, list efforts to provide training to individuals from underrepresented groups and outcomes from those efforts.

Adjust the transition plan as soon as possible or in the annual RPPR if circumstances change from the plan described at the time of application.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

4. Evaluation

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 ofthe 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 userbase

  • 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 dataprocesses/analyses by the resource, number of downloads, number of uploads, number of website visits

  • User diversity: from research institutions, undergraduate-focused institutions, other organizations (such as companies), user institution geographical locations.

  • Trainee diversity: on-site trainees (or consultations), virtual trainees (or consultations), from research institutions, undergraduate-focused institutions, minority serving institutions (MSIs), other organizations (such as companies), list of state/countries of trainee institutions.

Section VII. Agency Contacts

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

Application Submission Contacts

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

Christina Liu, Ph.D., PE
National Institute of General Medical Sciences (NIGMS)
Email: christina.liu@nih.gov

Peer Review Contact(s)

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email:stephanie.constant@nih.gov

Financial/Grants Management Contact(s)

Jennifer Billington
National Institute of General Medical Sciences (NIGMS)
Email: billingj@nigms.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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