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

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

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The primary goal of this FOA is to support resources that can add value and achieve economies of scale by serving a demonstrated, substantial base of investigators at a national or regional (multi-state) level. A secondary goal is to enable the separation of support for the resources themselves from support for the research that leads to the development of resources. This separation is desirable because the goals of a resource e.g., user service, utility, efficiency of operation are not the same as those of a research project, so evaluating proposed resources using a research grant framework may lead to perverse incentives and may not promote the desired outcomes.

This program will establish a means for supporting established resources and new ones formed through consolidation of multiple regional or local facilities. Only resources previously supported by NIGMS will be funded through this program. Major technology research and development efforts will not be supported by this FOA. This initiative complements the Mature Synchrotron Resources FOA (PAR-19-232), which specifically addresses that particular class of resources.

Background

Research resources enable access to state-of-the-art technologies, methods and expertise essential to advancing biomedical research that may not generally be 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 when these activities are funded separately through grants to 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 seek to create economies of scale by supporting shared regional and national resources.

Historically NIGMS has supported the development of unique technical capabilities and research tools using a variety of mechanisms. These have included the P41 Biomedical Technology Research Resources, P01 Program Project and P50 Center Grants, U54 and other cooperative agreements associated with previous NIGMS large scale program initiatives, in addition to individual research project grants. Support for resources in IDeA states has been provided through the COBRE and INBRE programs.

Support will be limited to established or newly consolidated resources that have been developed with NIGMS support and that do not require further major research and development efforts. Technology development will be limited to that needed to maintain state-of-the-art capabilities or to improve efficiency of operation. Eligible resources can include equipment, facilities, services, research tools, materials and organism repositories, computational facilities and software. Support will not be provided for stand-alone databases and data resources since it is expected that NIH-wide initiatives organized through the Office of Data Science Strategy will provide mechanisms for support for these resources. The breadth of impact and user base of proposed resources should be on the same scale as synchrotron beam lines and the national and regional cryo-electron microscopy centers. It will be up to the applicant to demonstrate that the resource they are proposing is sufficiently developed and serves, or could serve, the needs of a substantial user community at a national or regional scale. Resources proposed for this program are not intended to replace resources specific to the mission of other NIH Institutes and Centers.

Resources should already be developed and only require support to maintain current best practices, state-of-art technologies, defray operating expenses, provide user training, and publicize the services provided. They must be accessible to all U.S.-based biomedical researchers whose projects are vetted through a transparent peer review process and comply with relevant NIH expectations and requirements as described in this FOA.

National resources may be focused on single or multiple experimental techniques 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. Institutions in IDeA states supported by COBRE and INBRE awards are encouraged to participate in collaboration with institutions in other IDeA and/or non-IDeA states to form regional partnerships. The boundaries of these regions are to be defined by the applicants. NIGMS has no pre-set regional definitions for this FOA, although the number of users who could receive access to the resource's services will be considered during peer review and in making funding decisions.

For this FOA, a resource is defined as an activity that provides research capabilities and expertise to a large number of investigators and is available to any qualified investigator as a service. Resources supported under this FOA should be essential to making the most impactful, timely, rigorous, reproducible, and cost-efficient progress in a field. In addition, the resources must have large and active user communities. 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. See: https://grants.nih.gov/grants/policy/core_facilities_faqs.htm#3618

A resource should:

• 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
• 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. Example resources include, but are not limited to:

• Instruments, equipment, and facilities
• Computational hardware and software
• Research materials, such as rare reagents, and libraries
• Research tools for data generation and analysis
• Access to specialized methods and expertise
• Repositories for research organisms, cell lines and other biologicals
• Biospecimen banks (limited to areas of direct NIGMS mission responsibility)

Stand-alone data resources (databases, data repositories, and knowledgebases) will not be supported by this FOA. Databases essential to other capabilities of the resource can be included. Tissue banks with no immediate and specific user demand, and those serving primarily the mission of other NIH Institutes and Centers will not be supported.

Supported Activities

Supported activities can include maintenance of instrumentation, data collection, data reduction, and analysis. Replacement of existing equipment with the latest instrumentation will also be supported, provided 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 improve efficiency of operations. While the distinction between new development and upgrades that maintain current best practices may not always be clear, this FOA does not encourage or intend to support significant new technology development. For example, support could be provided to an NMR facility to acquire a probe from a commercial vendor. Support would not be provided for the development of a new prototype requiring extensive effort by resource personnel. Other funding opportunities should be sought for such endeavors. Resources requiring major technology development can be supported through the P41 Biomedical Technology Research Resources program. Potential applicants are encouraged to contact Scientific/Research staff about this or any other issue.

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 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.

Funding through this FOA will support resource administration, technology maintenance, required technology upgrades, user access, user training, and outreach to the community about the capabilities and services offered by the resource as well as the science it enables. The PD/PI will be required to devote 20% full-time effort (2.4 person-months) to provide overall guidance, and at least one senior scientist will be required to devote greater than 50% full-time effort (>6 person-months) 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. Details pertaining to the support available through this FOA can be found in the Budget instructions in Section IV.2.

NIGMS recognizes that diversity at all levels contributes to excellence in research training environments and strengthens the research enterprise. Accordingly, resources are expected to be inclusive of all qualified users and to provide user training and outreach to individuals from diverse backgrounds, including individuals from groups underrepresented in the biomedical sciences (see NIH's Interest in Diversity).

There are narrowly defined eligibility criteria for this pilot program. The proposed activity must fit the definition of a resource given above and must have been developed with previous NIGMS support. Eligible mechanisms were determined by an NIGMS analysis of its portfolio identifying how resources have previously been funded. The eligibility requirements are detailed in Section III.3. Resources that have received funding from multiple sources, including NIGMS, will be considered, but the NIGMS supported component must have been clearly identifiable and acknowledged.

No budget limit or sunset is pre-specified. This program is intended to support state-of-the-art resources of sufficient scope to serve a substantial user base. NIGMS anticipates that resources will be renewable as long as they remain in high demand by a substantial user community and their service cannot be provided through other cost-efficient means, such as through 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 will no longer be supported through this FOA.

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. The users can acknowledge resource staff in their papers and must cite the facility's grant as providing support for their work. Authorship would only be appropriate if resource personnel contributed substantially to the intellectual development of the research and manuscript preparation, which would be expected to occur only rarely. 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 time they use at 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 co-authorship for staff. NIGMS will monitor the distribution of resource utilization and expects that most activity will be normal user service rather than collaborations with staff that result in co-authored publications.

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

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

Higher Education Institutions

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

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

• 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)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

For this FOA, at least one of the Program Director(s)/Principal Investigators must devote at least 2.4 person-months to the resource.

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

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. 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)
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Eligibility is restricted to resources that have been developed with previous NIGMS support or that will be created by consolidation of multiple resources that have received previous NIGMS support. Support can have been NIGMS center or research project grant funding and can include NIH Common Fund efforts that were administered by NIGMS. Resources supported under COBRE awards or INBRE awards are eligible to apply, although the areas of science supported must fall within the research mission of NIGMS. Resources funded under SBIR and STTR awards are not eligible. The resource should have been supported by a currently active NIGMS grant award (including those in No Cost Extension) within at least the past two years prior to the application due date. Only those resources whose technical capabilities fall 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. Contacting the Scientific/Research staff in advance is strongly recommended. Applications that do not adhere to the eligibility criteria will not be reviewed.

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.

It is critical that applicants follow 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.

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:

NIGMS R24 Mailbox address
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exception:

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

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.

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

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

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:

User Research Project: Provide details for five representative user research projects. These should make clear the role of the resource in advancing the user's research and the engagement of the user with resource facilities and personnel. Limit to one page per project.

Publications Enabled by the Resource: Provide a bibliography of publications that have been enabled by the resource over the previous five years. Use the standard NIH reference format.

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

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

PD/PIs are required to devote 20% full-time effort (2.4 person-months) to provide overall scientific guidance and resource management. At least one senior scientist is required to devote greater than 50% full-time of his/her effort (>6 person-months) to managing the resource.

A single overall budget is to be presented including funding requests for all activities of the resource and providing a single budget justification that includes the justification of specific subaward items. Funding may be requested for upgrading equipment, operation and maintenance, outreach and user training, but not for research and development activities.

In the budget justification, provide detailed information about support received or anticipated from other entities. This could include co-funding by 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.

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

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

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: For this FOA, a resource should meet a demonstrable and timely need of a substantial national or regional scientific community that is not easily or cost-effectively satisfied in other ways. Evidence of the depth and breadth of impact on a scientific community should be provided, as should evidence that economies of scale would be created by supporting the resource. A summary of publications, white papers, and editorials (as provided in Other Attachments "Publications Enabled by the Resource") that demonstrate community interest may be included, but do not substitute for hard data on resource utilization (e.g., numbers of users, summaries of instrument time logs, requests for access, outcomes of review processes).

USE THE FOLLOWING HEADINGS IN THE RESEARCH STRATEGY SECTION

• 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 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 activity of the resource including its administration. Indicate how the resource will achieve economies of scale by supporting a substantial number of users at institutions throughout a region or the nation.

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, service hours, number of users, etc., specified for each of the resource's capabilities. Provide evidence of past success of the resource in providing needed expertise to the users. 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.

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 that are 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 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 Biosketch.

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 and maintenance or upgrade projects, and 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 that are supported by an institutional support letter as indicated 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

A plan for the operation and maintenance of the resource must be described. Maintenance activities may include daily service and calibration of equipment, adding new materials to existing collections, or improving upon established procedures. Appropriate plans must be described for assurance of quality control. Discuss required maintenance activities. Provide contingency plans for unexpected shut-downs or equipment failures. Describe operations during resource downtime. Describe how resources are and will be maintained for continuous operation. Provide details of service contracts that provide emergency repair services, especially any components designed to minimize downtime.

Describe procedures for handling requests for use of the resource, 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 co-pay fees are proposed, they should either be low enough so as not to produce a bar 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 how the proposed resource would meet this goal should be described clearly.

If the resource is of a nature that could conceivably be transitioned to other sources of support at the end of the award period, then a transition plan should be included. Exploring the potential of future commercialization of the resource and the implications of such a shift for the user community are also encouraged. Awardees should anticipate that NIGMS funds may not continue beyond the funding period. If an award is made, the transition plan should be adjusted annually if circumstances change from the initial plan described at the time of application.

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 seminars and lectures, workshops and short courses, or symposia offered independently or in conjunction with society meetings attended by the user community is optional but 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 web 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).

Evaluation and Reporting Plans

The application must include an evaluation plan with measures for both short-term and long-term purposes. Examples could include tracking the number 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)
• long-term objective metrics (to gauge impact of usage on the scientific field)

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, and these 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. How this will be done should be described.

This section must include a plan for reporting data to NIGMS on an annual or more frequent basis as required during negotiation 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 in the resource. Include letters from appropriate institutional leaders confirming any specific commitments to the resource.

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 In addition, applications are expected to include a Software Sharing Plan, if applicable, and a Data Sharing Plan.

Software Sharing Plan: If applicable, a software dissemination plan with appropriate timelines is expected to be included. There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the dissemination plan based on its likely impact. A dissemination plan guided by the following principles is thought to promote the largest impact:

• The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
• The terms of software availability should include the ability of outside researchers to modify the source code and to share modifications with other colleagues as well as with the investigators. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Applicants are expected to propose a plan to manage and disseminate the resource improvements or customizations of their tools and resources that are contributed by others. The application may include a plan to incorporate the enhancements into the "official" core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or 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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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.

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.

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

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the resource 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 resource that by its nature is not innovative may be essential to advance a field.

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: Does the proposed resource address an important scientific need that is well justified? Could the need have been easily satisfied in other ways? Will the resource support progress in the field? Will the resource produce significant economies of scale?

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

Will the resource serve a substantial national or regional (multi-state) user base?

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 the PD(s)/PI(s) well qualified to effectively administer the resource? Are the PD(s)/PI(s), the technical operations leaders, and other key personnel appropriately trained for their respective roles? Are they able to devote adequate effort to the resource activities? Do they have a history of performing services for the scientific community at large? Is a sound plan in place for recruiting and retaining staff with the appropriate skills and knowledge?

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 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 the plans for the operation and maintenance of the resource adequately developed? Are appropriate plans in place for assurance of quality control? Are appropriate procedures in place for handling requests for the resource, and for the adequate 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 presented? Are any plans for the formation and operation of an external scientific advisory committee likely to promote success of the resource?

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? Is there an adequate institutional commitment to the resource?

As applicable for the resource 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.

Metrics for Evaluation

The committee will evaluate the feasibility and adequacy of the plan for evaluation of the resource activity's impact, including measures for both short-term and long-term purposes, as well as quantifiable measures of intermediate results and success.

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

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

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

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

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

Not Applicable

Not Applicable

Not Applicable

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.

Not Applicable

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

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

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

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. If the application proposes charging user fees, the reviewers will also comment on the reasonableness and justification for these fees.

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:

• 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.
• Will receive a written critique.

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.
• 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.

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.

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 grantee’s business official.

Awardees 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

When multiple years are involved, awardees 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:

• Resource usage, including the total annual hours of 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 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. Downloads of software, data and website metrics should be included.
• Several (3 or 4) science highlights that were enabled by data collected at the resource that demonstrate the value and impact of the resource.
• Metrics regarding user training and dissemination activities.
• Report on activities to provide training to individuals from underrepresented groups. See: https://www.nigms.nih.gov/Training/Diversity/Pages/Approaches.aspx for more information on how NIH defines underrepresented groups.

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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.

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: 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: [email protected] (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: [email protected]

Michael Bender, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Jennifer Billington
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

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 45 CFR Part 75.