Part 1. Overview Information

Key Dates

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

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

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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This Notice of Funding Opportunity (NOFO) invites eligible institutions to seek funds to transform or improve the operations of existing shared research facilities through the purchase and installation of latest equipment that enable and enhance a broad range of research-supporting activities. Any equipment supported by this NOFO must be substantially used in a laboratory research core facility, animal facility, or similar shared-use research space to ensure broad benefits for the institutional research community. Moreover, any request must be justified by research-related demands for the modernization of research-supporting functions or for the advancement of facility operations. This NOFO does not support the purchase of scientific instruments or their components, nor components of building-level infrastructure equipment that indirectly support research activities (such as HVACs or power generators).

NIGMS will co-fund applications from higher education institutions that award undergraduate (B.S. or B.A.) and/or graduate degrees in biomedical sciences and have received no more than $6 million dollars per year (total costs) from NIH Research Project Grants (RPGs) in each of the preceding two fiscal years, calculated using NIH RePORTER, at the time of the application.  Applications to be considered must support research aligned with the NIGMS mission. Applications for research capacity building in Institutional Development Award (IDeA)-eligible states will be considered.  

NIH recognizes that modern physical infrastructure that supports the scientific enterprise is indispensable for the advancement of biomedical research. Laboratory spaces or animal facilities are considered eligible if the space/facility: i) employs a wide range of advanced technical solutions to create well-controlled environments, ii) provides research spaces with equipment to facilitate and optimize research-supporting activities, and iii) provides tools that assist in facility operations and monitoring.

The objective of this NOFO is to support the acquisition of latest, technologically advanced equipment needed to advance the operational efficacy, productivity, and throughput; improve energy efficiency, enhance, or streamline operating processes and procedures in core laboratories, animal research facilities, or other shared-use research support space. Providing access to such equipment can also expand the capacity of essential support services for evolving and emerging research programs. Maintaining current functions, replacing broken equipment, and routine upgrading are not supported by this NOFO. This NOFO does not support the acquisition of scientific research instruments that acquire experimental data or any other instrument directly involved in experimental processes that lead to data collection. Some examples of such excluded instruments include, but are not limited to, spectrometers, microscopes, biomedical imagers, cell analyzers, sequencers, PCR machines, chromatography equipment, and metabolic cages. Computer and data storage systems supporting scientific data collection, storage, and analysis are also not supported by this NOFO. These instruments may be requested through ORIP’s shared instrumentation programs.

Animal research facilities are one of the targeted research areas of this NOFO. Examples of supported equipment for animal facilities include, but are not limited to:

• Multi-functional ventilated cages and/or cage racks for small animals
• Specialized caging system for large animals
• Aquatic animal systems equipped with water quality assessment sensors
• Automated feeding or watering systems to aid in consistency and accuracy of animal care
• Robotics and automations for animal facility operation
• Advanced, environmental-friendly, high performing or high-throughput cage, rack, bottle, and tunnel washer systems  
• Veterinary care devices and veterinary diagnostic systems
• Telemetry equipment to monitor cage conditions and/or animal well-being for purposes of animal husbandry (not experimental data collection)
• Environmental management devices that assist in the monitoring and customizing of environmental conditions, such as temperature, humidity, air flow, and lighting.

Core laboratories and specialized facilities are other spaces targeted by this NOFO. Without access to modern research facilities with well-controlled environments and furnished with specialized support equipment, many research functions are not feasible. Examples of supported modern laboratory research equipment include, but are not limited to:

• Modern biobanking or cryopreservation equipment
• Freezers assisted by robotic arms or other forms of automation
• Biosafety cabinets
• Fume hoods
• Incubators
• Centrifuges
• Autoclaves or other sterilizers
• Cryogenic gas recovery/recycling equipment (servicing two or more instruments)
• Environmental chambers, isolators, or other chambers designed to create specialized environments
• Bioreactors
• Lyophilizers
• Liquid dispensers or other automated sample preparation equipment (single piece of equipment)
• Cryostats or other tissue sectioning equipment
• Single piece, integrated slide staining equipment (multiple pieces for single steps in the process are not allowed)
• Nucleic acid extraction equipment
• Peptide or oligonucleotide synthesizers
• 3D Printers
• Automated cell processing equipment
• Water purification/treatment equipment (in lab, not for an entire building)

Other equipment that modernizes, streamlines, or improves the operating efficiency of the facility is also supported. Computers or other electronics that are built into the equipment with specialized software may also be a part of the equipment request if and only if they are inseparable from the requested equipment.

Equipment supported by this NOFO differs in its functionality from scientific research instruments, but such equipment is critically needed to advance and accelerate the operations of research facilities and, as a result, contributes indirectly to the overall advancement of scientific research. Any equipment acquired under this NOFO must benefit the larger biomedical research enterprise at the applicant institution and represent a technological step forward. The application narrative should demonstrate that the request for the equipment is driven by the demands of active areas of biomedical research at the institution. The facility may serve investigators whose research is supported by NIH, other Federal agencies, private foundations, institutional funds, or other sources. Current NIH research funding is not a requirement for submission of an application. Once installed, the requested equipment should enable new and advanced capabilities, offer innovative technological solutions, or enhance support operations, as well as benefit the user community and multiple research projects of many investigators. Maintaining current functions, replacing broken equipment, and routine upgrading are not supported by this NOFO. Likewise, equipment that is normally considered to be a component of building infrastructure is not supported, e.g., HVAC systems, building-level water treatment systems, or back-up power supplies of any type. Any application that proposes general outfitting, clusters of equipment, scientific instruments or their components, and/or other non-allowed expenses will be deemed unresponsive to this NOFO and subject to withdrawal from review or consideration for funding. The acquisition of a single piece of latest equipment necessary to support specialized research-supporting activities is the goal of this NOFO. Moreover, only one facility can be supported; this NOFO does not support the upgrading of multiple facilities at a single institution. Only one type of equipment may be requested. Auxiliary items required for the physical operation of the major equipment piece are also permitted, e.g., a centrifuge with a rotor. Such auxiliary items must be dedicated to the main equipment piece, required for the main equipment piece to function, and not be capable of stand-alone operation. Multiple items of the same type of equipment are also permitted, e.g., cages racks with cages, but any request must be justified by the research-related demands on the facility and the operational capacities therein. Clusters of equipment serving a single or multiple support function(s) are not permitted, e.g., incubators, biosafety hoods, and centrifuges for cell culture. General outfitting of the support space, e.g., purchasing multiple pieces of different equipment is also not permitted under this NOFO.

Moreover, it is encouraged that all requested equipment adheres to the highest level of energy efficiency available to reduce environmental impacts.

All applicants are strongly encouraged to reach out to the Scientific/Research Contact(s) before submission of an application to discuss equipment requests and eligibility criteria. In addition, there is an FAQ and (archived) webinar providing additional guidance that can be viewed at ORIP's Equipment web page.

Applications Not Responsive To This NOFO

An individual application requesting more than one type of equipment (for example, a biosafety hood and a freezer) is not responsive to this NOFO and will not be reviewed.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• 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)

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

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

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

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

The PD/PI does not need to have an NIH research grant or any other research support. The PD/PI may be a core or an animal research facility director, tenured, or non-tenured faculty member of the applicant organization. The PD/PI must be affiliated with the applicant organization and must be registered on eRA Commons. Typically, the PD/PI will be a scientist with a leadership role in overseeing or managing the shared-use facility and relevant scientific or technical expertise (documented in the biographical sketch) related to the requested technology.

Multiple PDs/PIs are not allowed under this NOFO.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

Only one application per institution (normally identified by having a unique entity identifier (UEI) or NIH IPF number) is allowed. An institution that received an award under this NOFO in the immediate past fiscal year is not eligible to apply for this NOFO unless the previous award has been fully closed out by the date of submission. Specifically, an institution that received an award under PAR-24-028 is not eligible to apply for this NOFO for the September 25, 2024 due date. In other words, only one active equipment award is permitted at a time.

Location – Shared-use Facility

The equipment must be placed in a core facility, an animal research facility, or other shared used space to ensure that it supports research-related needs of a broad institutional research community. Awards will only be made to facilities that are operational. If a facility is under renovation/construction at the time of proposal submission, a certificate of beneficial occupancy must be provided in the Just-in-time process, in order to be considered for an award.

Letter from an Institutional Official

A letter from a high-ranking institutional official (e.g., Dean, Provost, President) indicating institutional financial support for the operations of the shared facility, as well as a commitment to continued software licensing beyond the first year, if applicable, must be included.

Quotes

A valid quote (for each requested item) from the commercial vendor with a one-year warranty guaranteed by the manufacturer and appropriate academic discounts, is required and must be included in the application. The quote must specify the model number, describe the technical requirement for the installation and operation, and itemize accessories, as applicable.

Letter from the Director of Planning, Design and Construction

A letter from the Institutional Director of Planning, Design and Construction (or equivalent) is required. The letter should state (with supporting details) that the space and the utilities are appropriate for the installation and functioning of the requested equipment.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Page Limitations

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

For this NOFO, there are specified page limits for each section of the Modernization Plan as described below. All tables, graphs, figures, diagrams, and charts must be included within the page limits for these sections. The applicants should make every effort to be succinct. To be successful, an application does not have to reach the page limits described here.

Justification of Need and Research Projects: 4 pages.

Operational Innovations and Benefits: 2 pages.

Resources Management, Administration, and Institutional Commitment: 3 pages.

Overall Impact/Benefit: 1 page.

“Note: A Data Management and Sharing Plan is not applicable for this NOFO

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Project Summary/Abstract: The Project Summary/Abstract should contain a succinct and accurate description of the requested equipment and an explanation of the need for the equipment to advance research operation and innovation at the applicant institution. The application's long-term objectives should be stated, concisely describing how access to the equipment will enhance the research at the applicant institution.

NOTE: The Project Summary/Abstract must be no longer than 30 lines of text.

Project Narrative: Using no more than two or three sentences, describe the relevance of this research to public health. In this section, be succinct and use plain language that can be understood by a general, lay audience.

Bibliography & References Cited: List only publications that demonstrate the researchers' expertise in operation and usage of the requested equipment or are relevant to research projects that will be benefited from the equipment.

Facilities & Other Resources: Not Applicable. Do not include an attachment here.

Equipment: Describe the requested equipment by stating its manufacturer, model number, specific features, and accessories. Provide a detailed budget breakdown of the equipment and requested accessories, including tax and import duties, if applicable. An itemized quote from the vendor, with appropriate discounts and warranty terms, is required. The quote must be scanned and combined with the equipment description as a single document. As described above in the SF424 Cover form, include an explanation of Total Non-Federal Funds in this section (if applicable).

Applications without a quote will be deemed incomplete and returned to the applicant without review.

If human, animal, or infectious materials, which could create a potential biohazard, are to be analyzed, funds for accessory containment equipment may be requested in the budget.

Do not describe the need for the equipment in this section; such narrative should be a part of the Justification of Need and Research Projects section of the Modernization Plan.

Other Attachments:

Other Attachments (Required)

For this NOFO, other Attachments follow the page limits described below, please do not include additional text to circumvent page limits.

1) Modernization Plan: 11 pages in total.

The entire Modernization Plan (with the sections described below) must be saved as a single PDF file - named Modernization Plan - and attached via Other Attachments. Organize the Modernization Plan in the specified order as described below, starting each section with the appropriate section heading (i.e., Description of the Facility, Justification of Need and Research Projects, Operational Innovations and Benefits, Resources Management, Administration, and Institutional Commitment). Do not include links to websites for further information. Do not include animations/videos.

The Description of the Facility should describe i) the shared-used facility where the proposed equipment will be installed, ii) demonstrate novel capabilities or operational innovations that will be enabled by the equipment, iii) justify the request by research-related needs, and iv) describe long-term plans for the maintenance and usage of the equipment.

The Description of the Facility should include information about the location of the facility, areas of research supported, types of research services offered, and the research community that depends on services provided by the facility. The PD/PI should demonstrate that the facility is used on a shared basis and describe its role in supporting the institutional research enterprise. The areas of science supported by the facility should be outlined to illustrate how the equipment request is driven by research-related demands. Research supported by NIH, other Federal agencies, private foundations, or other sources should also be summarized. Deficiencies in the facility’s existing equipment infrastructure that limit the services it offers and the research-related activities it supports, should serve as the basis for the justification of the modernization needs. If the facility will house live vertebrate animals, the facility design must be compliant with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and Guide for the Care and Use of Laboratory Animals (Guide) by balancing engineering and performance standards and setting a target for optimal practices, management, and operations while encouraging flexibility and judgment. Applicant institutions are also required to comply, as applicable, with the standards described in the Animal Welfare Act, and other Federal statutes and regulations.

A floor plan indicating the proposed location of the equipment must be attached – see required Other Attachment 3) – to demonstrate that the location meets the space, utility access, and any other requirements for the operations of the equipment. Do not include such text directly on the floor plan to circumvent the page limits. A letter from the Institutional Director of Planning, Design and Construction in Other Attachments (4) should complement the text in this section and information on the floor plan. Issues related to the management of access to or operating the equipment, and the long-term equipment maintenance should be addressed to demonstrate the feasibility of the project.

The Justification of Need and Research Projects: 4 pages. Name the requested equipment. Compare performance of the requested model with other similar equipment available on the market. Justify the need for specific features and special accessories of the requested equipment.

Justification of Need should describe how the proposed equipment will remedy the infrastructure’s deficiencies, improve the facility’s operations, modernize the facility’s environment, or streamline its management. If the project is located at an animal research facility, planned improvements in animal management, maintenance, or care should be presented and connected (as applicable) to improvements in the rigor, reproducibility, and translatability of the animal-based research.

Explain why the chosen equipment model and its manufacturer are the most suitable for your setting. Preliminary data are not required, though if feasible, can be included to justify the choice of the equipment. Provide an inventory of similar equipment existing at your institution, or neighboring research institutions; describe why each similar equipment is unavailable or inappropriate for the proposed research.

Describe the equipment requested and demonstrate that the chosen model(s), when installed, will optimally address current deficiencies, and meet research-driven demands. Technical specification of the equipment together with its demands on building systems (HVAC, electrical, plumbing) should be described to demonstrate the feasibility of the project. The use of green technologies offering savings in energy, water, and other functional efficiencies should also be addressed.

If computing component or software is requested, the component or software supported by this program must be inseparable from the requested equipment and is critical in the operation of the equipment.

If applicable, the PD/PI should describe NIH-funded research awards that will benefit from the project. The PD/PI should demonstrate broader benefits for the user community. To add to the justification, the PD/PI should also demonstrate how the project will benefit institutional biomedical research programs over the long term. Explain the research projects that will benefit from the requested equipment to enhance these research investigations. Research projects may be drawn from a broad array of topics in basic, translational, or clinical research; NIH funded projects and research projects that have impact on biomedical research and health are expected to be included. If the equipment will benefit a large number of research projects, describe a few projects in this section and list up to 12 active grants in an optional table following detailed instructions below.

Especially, if multiple items of the same type of equipment are requested, the narrative should show the need for that level of capacity in the context of the facility’s operations and services. Similarly, if auxiliary items are requested, the configuration must be described in detail and how the auxiliary items are required for the functionality of the main piece of equipment. If a time-limited software license is requested, a financial commitment towards its renewal in outward years must be also documented in the support letter from a high-ranking institutional official – see required Other Attachment (2).

Operational Innovations and Benefits: 2 pages. Explain how the requested equipment will revolutionize, modernize, or advance the operations of the facility. Explain what the operational innovations are, how the operational innovations will advance the research support to a new level, and how the advancement in research support will benefit biomedical research activities to the institutional research programs and research community over the long term.

Resources Management, Administration, and Institutional Commitment: 3 pages. Explain how the installation and test of the equipment will be managed in a core or a shared resource facility setting. Further, describe how the facility and resources are managed, and operation is administrated. Describe existing expertise of prospective operators or staff in operating and maintaining the equipment and how operators will be trained in equipment operation and maintenance. Explain the organizational plan to administer the grant. Describe where the equipment will be located, how it will be utilized. When applicable, explain how requests to use the equipment will be made and how time will be allocated among the users. Describe typical day-by-day management of the equipment to assure broad access to the equipment and its use on a shared basis.

Overall Impact/Benefit: 1 page. Explain how the equipment will transform or advance research operation, contribute to the institution's long-range biomedical research goals and benefit broad research and health.

2) Letters of support: up to 3. A letter from a high-ranking institutional official (e.g., Dean, Provost, President) indicating institutional financial support for the operations of the shared facility and research activities conducted therein. If any term-limited software licenses are requested, a detailed financial commitment to support renewal of licenses in outward years must be demonstrated.

(Optional) A letter about inventory of equipment at the institution which are unavailable to the PD/PI (as noted in the Modernization Plan Section).

When applicable, a letter from Biosafety Official. If human, animal, or infectious materials, which could create a potential biohazard, are to be handled, a signed letter from the institutional biosafety officer stating the proposed containment plan was reviewed and adheres to documented biosafety regulations. If relevant, this letter is required in the application.

3) An 8.5” x 11” (letter size) image of the floor plan – see Modernization Plan section for details.

4) A letter from the Institutional Director of Planning, Design and Construction (or equivalent) stating (with supporting details) that the space and the utilities are appropriate for the installation and functioning of the requested equipment.

5) A timeline (of one year duration) reflecting activities from receipt of Notice of Award to the end of the grant period.

6) (Optional) An optional table of up to 12 active grants held by end-users of the facility may be included to demonstrate the need for the added support capacity. The table should include the following columns only: PI/PD, start date, end date, title, funding source, and annual direct costs. No more than 12 grants may be included in the table.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

Appendix materials are not allowed for this FOA.

PHS 398 Research Plan

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

Other Research Plan Section

End-user Letters of Support (LOS) are not required for this NOFO and should not be included. Reviewers will be instructed to disregard any LOS that are attached.

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

Other Plan(s): 

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

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

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

Non-allowable Costs include, but are not limited to:

• Scientific instruments such as PCR machines, chromatography equipment, microscopes, spectrometers, biomedical imagers, cell analyzers, sequencers, and metabolic cages
• Components of scientific instruments, e.g., NMR probes or detectors
• Furniture
• Disposables/consumables and supplies
• Contractual services
• Service contracts or other charges for routine maintenance/upkeep of the equipment or software licensing fees beyond the first year of the award
• Equipment used for clinical/veterinary (billable) care
• Equipment that is not commercially available and does not have a manufacturer’s warranty valid for at least one year
• Institutional administrative management/scheduling systems, LIMS systems, and clinical management systems
• Development of novel technologies
• A&R costs and any other installation-related costs not part of the vendor quote
• Removal costs of older equipment
• Personnel costs
• Travel costs
• Equipment that is part of the building infrastructure, e.g., HVACs, plumbing, cabling, data ports, water treatment (building level), power generators, and back-up power supplies of all types

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications Not Responsive To This NOFO

An individual application requesting more than one type of equipment (for example, a biosafety hood and a freezer) is not responsive to this NOFO and will not be reviewed.

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

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

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.

For this NOFO, note the following:

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

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

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

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policies and practices, 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/Benefit score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the NIH Council of Councils. 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.
• Program balances among various types of supported instruments and geographical distribution of awards.

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Applicants should ignore eRA system-generated just-in-time (JIT) requests which are typically sent soon after peer review. If an application is considered for funding, ORIP SIG Program staff will send PD/PI special instructions on how to submit a JIT update, from the e-mail address s10reports@od.nih.gov. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. Once an application is selected for funding, the grants management officer may request additional information.

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

2. Administrative and National Policy Requirements

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

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH 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 NOFO.

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

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

Not Applicable

3. Data Management and Sharing

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

Not Applicable

4. Reporting

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

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

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Xiang-Ning Li, M.D., Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0777
Email: xiang-ning.li@nih.gov    

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov 

Kenneth Holiness
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-6854
Email: holinesskd@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.

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