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 funding opportunity is to continue the High-End Instrumentation (HEI) Grant Program administered by ORIP. The objective of the Program is to make available to institutions high-end research instruments that can only be justified on a shared-use basis and that are needed for NIH-supported projects in basic, translational, and clinical biomedical or biobehavioral research. The HEI program provides funds to purchase or upgrade a single item of expensive, leading-edge, specialized, commercially available instrument or an integrated instrumentation system. An integrated instrumentation system is one in which the components, when used in conjunction with one another, perform a function that no single component can provide. The components must be dedicated to the system and not used independently.

Types of supported instruments include, but are not limited to: MRI imagers, PET/CT imagers, cyclotrons, photoacoustic imagers, mass spectrometers, NMR spectrometers, electron microscopes, cryo-electron microscopes, X-ray diffractometers, and super-resolution microscopes. Applications for standalone computer systems (supercomputers, computer clusters and data storage systems) will only be considered if the system is solely dedicated to biomedical research.

In particular, the HEI program enables the introduction of advanced leading-edge technologies providing new capabilities to biomedical research. In such cases, a risk-return trade-off is expected and allowed. Due to the novelty of the technologies and the uniqueness of their implementation, specialized and technologically savvy groups of investigators will be needed to lead the adoption of such advanced instruments for biomedical research and to develop innovative biomedical applications. Therefore, if such a novel instrument is requested, the applicant should demonstrate special technical expertise, merging multiple fields of science and technology, such as biology, physics, and bioinformatics. For integrated systems, the applicant must provide a detailed description about how the system will be put together and about the technical expertise of the individual(s) who will be responsible for assembling the system. The applicant must also provide a detailed description of training for the investigators listed in the application about the use of the novel technology in advancing their research. Accordingly, the HEI program requires that any unique instrument or an integrated system must be developed by reliable commercial vendors and guaranteed by the manufacturer’s one-year warranty.

All instruments and integrated systems must be dedicated to biomedical research only.

In rare special circumstances when an institution cannot justify sole use of the high-end instrument for NIH-supported and other biomedical research, the institution may request a Special Use Instrument (SUI). Eligibility requirements for SUI requests are described in Section III.3.

Foreign-made instruments are allowed.

The HEI Program will not support requests for:

• An instrument with a base cost of less than $750,001.
• Multiple instruments bundled together.
• Purely instructional equipment other than under the conditions of SUI see Section III.3.
• Instruments that are not commercially available and do not have a manufacturer warranty.
• Institutional administrative management systems or clinical management systems.
• Instruments to be used for clinical (billable) care, other than under the conditions of SUI see Section III.3.
• Software, unless it is integrated in the operation of the instrument and/or necessary for the generation of high-quality output experimental data from the instrument.
• Additional stand-alone workstations for data processing, licenses, and duplicate software items.
• General purpose equipment (such as standard machine shop equipment), equipment to furnish a research facility (such as autoclaves, hoods, equipment to upgrade animal facilities), and equipment for routine sustaining infrastructure (such as standard computer networks or general-purpose data storage systems).
• Disposable devices, office furniture, and supplies.
• Alteration or renovation of space to house the instruments.

Applicants are advised to discuss with the HEI Scientific/Research Contact (See Section VII) any questions about appropriate types of equipment, eligibility, and Program requirements, prior to submitting an application for an integrated instrumentation system.

To promote cost-effectiveness, encourage optimal sharing among individual investigators, and foster a collaborative multidisciplinary environment, the instrument should be integrated in a core facility, whenever possible.

Each applicant institution must propose a Program Director/Principal Investigator (PD/PI) who can assume administrative and scientific oversight responsibility for the requested instrument. See Section III.1for qualifications for the PD/PI. The PD/PI will also be responsible for:

• Requesting no-cost extensions of the project period, if needed.
• Preparing (and working with the institution to submit) a Final Research Performance Progress Report (Final RPPR) at the end of the project period. See Section VI.4 for the content of the Final RPPR.
• Preparing and submitting Annual Usage Reports (AURs) of the instrument to the NIH for a period of four years after the project end date, see Section VI.4.

An Advisory Committee must be named to assist the PD/PI in administering the grant and overseeing the usage of the instrument. For details on the composition of the Advisory Committee, see Section IV.2 under "Administration." The PD/PI and the Advisory Committee are responsible for the development of guidelines for:

• Maximum utilization of the instrument, including time allocation.
• A detailed plan for the day-to-day management and safe operation of the instrument.
• A plan to ensure that access to the instrument is limited to users whose projects have received approval from the Institutional Review Board, the Institutional Animal Care and Use Committee or the Biosafety Committee, as applicable.
• A financial plan for the long-term operation and maintenance of the instrument during the post-award period.
• Relocation of the instrument within or outside the institution or change of ownership if such change is necessary.
• Recommending a new PD/PI, if such a need arises.

The PD/PI and the Advisory Committee should convene meetings and issue annual reports on the instrument status, including their recommendations for instrument operations.

NIGMS Area of Interest: NIGMS is interested in co-funding S10 applications that include research projects aligned with the mission of NIGMS. NIGMS-supported research may utilize specific cells or organ systems if they serve as models for understanding general systemic principles. NIGMS also supports research in specific clinical areas that affect multiple organ systems.

In parallel, NIGMS is especially interested in promoting participation of Institutional Development Award (IDeA) states and programs in the S10 Program. The IDeA program will provide co-funding for scientifically meritorious applications from IDeA states and encourage sharing and collaboration among institutions, programs, and states.

Applications Not Responsive to this NOFO

An individual application requesting more than one type of instrument (for example, a mass spectrometer and a confocal microscope) 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, and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

The PD/PI should document (in the biographical sketch) technical expertise directly related to the type of requested instrument. The PD/PI does not need to have an NIH research grant or any other research support but is expected to be an expert on the requested instrument. The PD/PI may be a core 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.

Multiple PDs/PIs are not allowed under the S10 mechanism.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

There is no restriction on the number of applications an institution (as identified by a specific Unique Entity Identifier (UEI)) can submit to the Shared Instrumentation Grant (SIG) and the HEI Programs each year, provided the applications request different types of equipment. However, only one application to the Basic Instrumentation Grant (BIG) Program is allowed per receipt date. Concurrent SIG, HEI, or BIG applications for the same instrument (or the same type of instrument with added special accessories for example, to meet the HEI budget requirement), are not allowed unless documentation from a high-level institutional official must be provided, clarifying that this is not an unintended duplication, but part of a campus-wide instrumentation plan. Applicants are advised to discuss with the HEI Scientific/Research Contact (see Section VII) about potential duplications before submitting two applications for the same type of instrument.

A single application requesting more than one type of instrument (for example, a mass spectrometer and a confocal microscope) is not responsive to this NOFO and will not be reviewed.

Major User Group

At least three Major Users who have substantial need for the instrument must be identified. Each of these Major Users must be a PD/PI on a distinct active NIH research award (i.e., a grant or a cooperative agreement) in an area of basic, translational, or clinical research. The requirement is one award per investigator, with more awards per investigator allowed. An award given to multi-PDs/PIs is counted only once towards the fulfillment of this requirement. NIH training or fellowship grants (i.e., T and F mechanisms), other non-research and SBIR/STTR grants, Other Transaction (OT) awards and contracts cannot be counted towards the fulfillment of this requirement. Once the eligibility requirement of at least three Major Users with distinct NIH-funded research projects has been met, additional users with active research awards from NIH or other sources may be added as Other Users. Investigators with funding from sources such as other Federal agencies (e.g., NSF, DoE, DoD), private foundations, or academic institutions, can be added as Major Users, provided they are engaged in basic, translational, or clinical research and can demonstrate a substantial need for the instrument. Major Users can be researchers from the same department or several departments, divisions or schools at the applicant institution, or from nearby or regional institutions. In certain circumstances, as technology dictates, Major Users may come from distant institutions, but they must demonstrate the need for the instruments and describe plans for regular access to the instrument.

To demonstrate the clear need for the requested instrument, the projects supported by NIH research awards (i.e., grants or cooperative agreements) should together use the instrument at the 75 percent level of the Accessible Usage Time (AUT) or higher; see Section Other Project Information for the definition of AUT (under "Justification of Need"). If a SUI is requested, the projects supported by NIH research awards should together use the instrument at the 75 percent level of the Biomedical Research Time (BRT) (see below for the definition of SUI and BRT).

Major Users supported by NIH research awards should collectively use the instrument at the 35 percent level of the AUT or higher (or at the 35 percent level of BRT, if a SUI is requested); see Section Other Project Information for the definition of AUT (under "Justification of Need").

The Major User group must meet the eligibility requirement at the time of submission. In addition, if/when the application is considered for funding, the HEI Program Staff will check that the Major User group eligibility requirement is also met at the time of award.

Special Use Instruments (SUI)

In rare special circumstances, to extend the outreach of the HEI Program to cases when an institution cannot justify sole use of the high-end instrument for NIH-supported and other biomedical research, the institution may contribute a portion of the cost of the requested instrument commensurate with the proposed use of the instrument for other than biomedical research. The non-biomedical research activities supported by the instrument may include research in other fields, curricular instructions, and billable clinical care. This rare request will be designated as a SUI. In such situations, the instrument’s Biomedical Research Time (BRT) must be at least 50% of the AUT or the percentage of the NIH contribution towards the purchase of the instrument, whichever is larger. In addition, the non-NIH funds must not be less than 25% of the total instrument price. Definitions of how to calculate BRT and AUT appear in Section IV in the Justification of Need section of the Instrumentation Plan. All other requirements outlined in this NOFO still apply.

The Institution must provide specific long-term plans to secure and protect access to the instrument for biomedical researchers, as detailed in Section IV.2 under "SUI Request."
If an Institution is considering a SUI request, the applicant is strongly advised to consult with Scientific/Research Contact(s) and Financial/Grants Management Contact(s) (see Section VII) before submitting an application as it is likely that special administrative procedures will have to be followed.

Quote

An itemized quote from the vendor with appropriate academic discounts and warranty terms (specified directly in the quote) is required and must be included in the application.

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.

Letter of Intent

A letter of intent is not required.

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 is no overall page limit for the entire Instrumentation Plan. However, there are specified page limits for each section of the Instrumentation 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. It is expected that the length of the Instrumentation Plan's narrative will depend on the type of the requested instrument and the number of users. To be successful, an application does not have to reach the page limits:

• Introduction to Resubmission (if applicable): 2 pages.
• Justification of Need: 6 pages in total.
• Technical Expertise: 2 pages in total.
• Research Projects section must not exceed 20 pages in total. This section can be structured in subsections Research Projects of Major Users and Research Projects of Other Users, or subsections Specific Research Topics. The limit is 2 pages per each Major User's project; however, fewer pages are strongly recommended. The Research Project of Other Users subsection is strongly limited to be succinct, describing 3 or more projects per page.
• Summary Table(s): 6 pages in total.
• Administration (Organizational / Management Plan): 6 pages in total.
• Institutional Commitment: 3 pages in total.
• Overall Impact/Benefit: 3 pages in total.

Note: Letters of Support and Bibliography & References Cited Section are not included in the page limitations.

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.

Descriptive Title: Enter the generic name of the instrument requested in the title (for example, 600MHz NMR Spectrometer or High-Throughput DNA Sequencer).

Proposed Project: CY 2025 submission: enter start date 02/01/2026 and end date 01/31/2027; CY 2026 submission: enter start date 02/01/2027 and end date 01/31/2028; CY 2027 submission: enter start date 02/01/2028 and end date 01/31/2029.

Estimated Project Funding:

Total Federal Funds Requested: Enter the total Federal funds for the requested instrument. This entry cannot exceed $2,000,000 which is the maximum award under the HEI Program. If the cost of the instrument is more than $2,000,000, enter $2,000,000 (or any lower amount of the requested Federal Funds).

Total Non-Federal Funds: If Total Federal Funds Requested (described immediately above) and Total Federal & Non-Federal Funds (described immediately below) are not the same, enter the difference in this line. Explain how the difference will be paid in the Equipment section on the SF424 (R&R) Other Project Information form (described below).

Total Federal & Non-Federal Funds: Enter the total cost of the instrument from the quote.

Program Income: Enter zero as this does not apply to the HEI Program.

NOTE: A warning will be generated during submission for any S10 with a budget in excess of $500,000. This warning can be ignored.

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 instrument and an explanation of the need for the instrument to advance research projects of the Users. The application's broad, long-term objectives should be stated, concisely describing how access to the instrument will enhance the health-related goals of the research projects. This section should be informative to other persons working in the same or related fields and understandable to a scientifically or technically literate reader.

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 instrument or are relevant to research projects, which will be supported by the instrument. References of the Research Projects Section may appear in this section or may be listed at the end of individual research subsections.

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

Equipment: Describe the requested instrument by stating its manufacturer, model number, specific features, and accessories. Provide a detailed budget breakdown of the main instrument 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 in a single attachment with the equipment description as part of this upload. As described above in 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 will be returned to applicants without review.

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

Do not describe the need for the instrument or accessories in this section; such narrative should be a part of the Justification of Need section of the Instrumentation Plan.

Other Attachments:

I) Instrumentation Plan (in lieu of Research Plan form).

The entire Instrumentation Plan (with the sections described below) must be saved as a single PDF file - named Instrumentation Plan - and attached via Other Attachments. Organize the Instrumentation Plan in the specified order as described below, starting each section with the appropriate section heading (i.e., Justification of Need, Technical Expertise, Research Projects, etc.). Do not include links to websites for further information. Do not include animations/videos.

• Introduction: Only in the case of a resubmission, include an Introduction describing the changes that have been made in response to comments in the previous review.
• Justification of Need: Name the requested instrument. Compare performance of the requested model with other similar instruments available on the market. Justify the need for specific features and special accessories of the requested instrument. Each such feature or accessory must be utilized by at least three Major Users.

If the requested instrument is under a lease agreement, demonstrate that the instrument is considered state-of-the-art at the time of the application submission (see details in Section IV.6 Funding restrictions).

Justify the need for software. All software supported by this program must be integrated in the operation of the instrument or be necessary for generation of high-quality output data from the instrument. Depending on the needs of research projects, different configurations of such software may be needed to ensure productive scientific use of the instrument. If such additional software modules are requested (e.g., software configuration for the acquisition of metabolomics data, microscope image acquisition and control modules, tools for MRS/MRI functionalities), they must be essential for the advancement of research projects of at least 3 Major Users. As noted previously, stand-alone workstation, duplicate software items, and software licenses are not allowed.

Explain why the chosen model and its manufacturer are the most suitable for your user group. Preliminary data are not required, though if feasible, can be included to justify the choice of the instrument. Especially, if access to a demo instrument is practical preliminary data are encouraged. Provide an inventory of similar instruments existing at your institution, neighboring research institutions, or otherwise accessible; describe why each similar instrument is unavailable or inappropriate for the proposed research. If similar instruments are listed as "unavailable," add a letter to the Letters of Support section from the instrument manager explaining why the instrument is not available to your user group. Include specific documentation on the current usage and downtime of each of these existing instruments in annual hours and a realistic estimate of the projected usage for the requested instrument. Tables may be used to clarify the presentation. Tables included within this section will count towards the specified page limit.

Define and justify the AUT for the requested instrument. The AUT is the number of annual hours the instrument can be practically used for biomedical research. AUT hours may be limited by the time an instrument operator is available (if an operator is required), site or building access schedules, scheduled maintenance, start-up and standardization, and any other factors that take time away from the use of the instrument for biomedical research. More importantly, AUT will be limited by the type of the technology requested; some instruments can be and are typically operated 24/7 while other technologies can be used only during regular hours. Therefore, justify the AUT based on the type of the technology requested and an individual managerial plan at your institution to make clear that the AUT corresponds to expected practical full-time use of the instrument at your institution.

If a SUI is requested, provide the BRT for the instrument. BRT is the number of annual hours that the instrument is available to conduct biomedical research. If an instrument is exclusively used for biomedical research, the BRT is equal to AUT. For a SUI to be considered for funding through the HEI program, its BRT must be at least 50% of AUT, or the percentage of the NIH contribution towards the purchase of the instrument, whichever is larger (see also Section III.3). The justification of needs for a SUI can only be based on the requirements of NIH-funded or other biomedical research of the Major and Other Users, and not on other non-biomedical-research needs. However, if such other needs require special accessories, clearly explain what they are as they are exempted from the justification by the Major Users need. Use of the Table of Accessories may help clarify a description of SUI (see Summary Tables below).

• Technical Expertise: Describe the technical expertise of individuals who will set up and run the instrument. Specify who will ensure that the instrument is safely operated and appropriately maintained. State who will train new users. If the instrument requires complex sample preparation or consultation for experimental designs, describe the expert individuals who will serve in that capacity. Address technical support for data collection, management, and analysis.
• If an innovative leading-edge instrument providing new research capabilities is requested demonstrate special technical expertise present needed for the adoption of the technology for biomedical research. Describe training for the investigators about the use of the novel technology in advancing their research.
• Research Projects: In this section, describe the benefit of the requested instrument to enhance Users research projects. First, describe the research projects of Major Users. You can organize this section into subsections Research Projects of Major Users or Specific Research Topics . The latter format may be especially useful to avoid redundancies in the presentation of research projects if several Major Users pursue research topics which follow similar protocols and scientific benefits of the new instrument for their projects are comparable. All Major Users must have substantial need for the requested instrument. Detailed eligibility requirements for Major Users are described in Section III 3.

Since the research projects have been previously peer reviewed, describe their details only as necessary to explain how the requested instrument will advance the projects research objectives. Do not copy the Specific Aims section from a funded application. Present sufficient technical details about types of samples or specific experimental protocols to be employed to allow evaluation of whether the instrument is appropriate, will be effectively utilized, and would provide advantages over other methods and other similar existing or new instruments. In particular, explain the need for special features and accessories of the requested instrument by describing the specific studies that will utilize these options as at least three Major Users must need any of these special options. Similarly, if special software modules are requested, justify how they will advance the research projects of at least 3 Major Users. Preliminary data are not required, but if available, they may be used to illustrate the benefit of the requested instrument to the research projects. Describe how generated data will be handled and analyzed so that benefits of the entire experimental set-up can be evaluated. Summarize benefits that the requested instrument will provide towards answering specific scientific questions. Be succinct and clear.

If you choose to structure this Research Projects section by including the research projects of Major Users subsections, limit the text to no more than 2 pages per each Major User's project. In the beginning of each Major User's Project narrative, list the PI’s name and grant information (number, title, project start and end dates). Specify the anticipated usage in annual hours for each project.

If you choose to group Research Projects in subsections Specific Research Topics, list Major Users, their funded grants that you describe therein, and their cumulative usage as measured annual usage hours, in the beginning of each subsection.

In cases of certain technologies (such as computer systems or X-ray detectors), a large number of users, exceeding what is necessary to make a strong case for the need of the instrument, may be expected. Keep in mind that the sole number of users is not a compelling factor to justify scientific needs for the requested instrument.

A section entitled Other Users Projects may be used to describe the need of the requested instrument to advance projects from Other Users and the user community at your institution (e.g., unfunded users who have significant need for the instrument to develop their research programs or users whose expected needs are at the level of 1% or less of the expected usage time). Include a sum of the anticipated usage in annual hours for all Other Users.

The Research Projects section should focus on detailed explanation of how the requested instrument will advance research projects. Research projects may be drawn from a broad array of topics in basic, translational, or clinical research; in particular, research projects on the advancements of technologies for the benefit of biomedical research may be included.

• Summary Tables: At the beginning of this section, please re-state the AUT (and BRT if a SUI) in annual hours, as introduced in the Justification of Need Section.
  
  Next, insert the following summary tables - a) Research Projects of Major Users, and b) Research Projects of Other Users. The tables should have the following columns: User's name, grant number (for NIH awards, list the grant numbers such as R01IC123456), brief title of the project, grant start and end dates, and estimated usage in annual hours. If there are multiple Users funded by the same grant, list a total of their estimated usage in annual hours for projects supported by that grant. If applicable, include a separate table to indicate the users' needs for any requested accessory. If a SUI is requested, these tables should clarify accessories which are not needed for the Major or Other Users. Do not list users whose annual usage is at the level of 1% or less of AUT.

Following the tables, state:

i. The total estimated usage time by all Users projects in annual hours,

ii. The percentage of the estimated usage time devoted to Major Users NIH-funded projects, and

iii. The percentage of the estimated usage time devoted to all NIH-funded projects.

Major Users with NIH research funding should use the instrument at the level of at least 35% of the AUT (or BRT); all NIH-funded users  should use the instrument at the level of at least 75% of the AUT (or BRT).

Provide an estimated usage time and AUT for the requested instrument, considering that both the AUT (related to the administration of the instrument) and the expected usage (depending on actual need for the instrument) may be significantly different for different types of instruments and at different institutions.

• Administration (Organizational/Management Plan): Describe the organizational plan to administer the grant. Describe where the instrument will be located, how it will be utilized, how requests to use the instrument will be made, how time will be allocated among Major and Other Users, how other projects and new users will be enlisted. Describe how users will be trained in experimental design, instrument operation and data analysis. Describe typical day-by-day management of the instrument. If the plans are to install the instrument in a setting other than a core or a shared resource facility, describe the procedures that will implement and assure broad access to the instrument and its use on a shared basis.

List the names and titles of the members of the local Advisory Committee. The membership of this Committee should be broad to balance interests of different users and should include members without conflicts of interest (non-users of the requested instrument) who can resolve disputes if they arise. The membership of this Committee should include at least one senior institutional official who will represent the financial commitment of the institution. It is recommended that the Advisory Committee includes at least 4 members. Major and other active Users  of the instrument may be members, but none should be the Chair. The PD/PI cannot be a voting member of the Advisory Committee.

The PD/PI and the Advisory Committee should convene meetings and prepare annual reports on the instrument status. The reports will become part of the Final Research Performance Progress Report (Final RPPR) and the Annual Usage Reports (AUR) (see Section VI.4).

Provide a plan about how the Users will be instructed and reminded about citing the S10 award in their publications and how their compliance will be verified.

Describe a plan for managing access to the instrument if users' projects involve human subjects, vertebrate animals, or biohazards such as infectious materials.

Financial Plan: Submit a specific financial plan for the long-term operation and maintenance of the instrument as such costs are not supported by the S10 Program. Explain how various operational costs will be met; specifically, costs associated with routine operation and maintenance of the instrument, and costs for support personnel. Enumerate the sources of income such as charge back fee structure, grants, or institutional support. The financial plan must include a table for years 1-5 of operation. For year 1, enter anticipated expenditures and anticipated income, showing how these estimates were derived. For years 2 - 5, approximate amounts, based on data for year 1, are sufficient. 
Typically, during year one, the maintenance costs are fully covered by a one-year manufacturer warranty. In subsequent years, costs of maintenance must be considered in the financial plan.

Include a description of projected changes of the financial plan over the subsequent four years.

Operation: Include salary support of expert personnel that will operate the instrument and oversee routine care and procedures for standardization.

Maintenance: May include a service contract, or funds for parts and local technical personnel who will maintain the instrument (if such personnel are qualified to do so).

Supplies: Include necessary supplies for operating the instrument such as chemicals, cryogenics, and other expendable items.

Software: include costs for updates/maintenance of software licenses needed for the proper operation of the instrument or additional software for data analysis.

Anticipated Income: Enumerate the sources of income, such as any charge back fee structure, grants, or institutional support.

• Institutional Commitment: Describe the institutional infrastructure available to support the instrumentation, including space to house the instrument and site for sample preparation, if applicable. Confirm the institutional support toward the maintenance and operation of the instrument. In particular, confirm the institutional commitment to the financial plan for maintenance and operations for five years from the installation date of the instrument or for its effective lifetime. Describe institutional support for personnel. The timeline of institutional support should be consistent with the expected usable lifetime of the type of requested instrument.
• Overall Impact/Benefit: Explain how the instrument will impact NIH-funded research and contribute to the institution's long-range biomedical research goals.

II) Letters of Support
All letters of support should be combined into a single file named Letters of Support and uploaded as a separate attachment via Other Attachments. This combined file should include, as applicable:

• Letters from institutional officials.
• Institutional commitment for the proposed financial plan for maintenance and operations.
• Letters about inventory of instruments at the institution which are unavailable to the PD/PI (as noted in the Justification of Need Section), as applicable.
• The institution (i.e., the entity with the same UEI number as the applicant’s institution) must also provide a table that includes information about performance of all previous S10-awarded instruments within the past five years; that is, submission in CY 2025: FYs 2020-2024; submission in CY 2026: FYs 2021-2025; submission in CY 2027: FYs 2022-2026. (If there have been no awards, please state so). The table should have the following columns:

1) S10 Grant Number.

2) Year of Award.

3) Installation Date of the Instrument.

4) PD/PI's name.

5) Generic Name of Instrument.

6) Instrument Status: Active (instrument in use), Pending (order placed, but instrument not delivered, instrument received but not installed or not calibrated for general use), Upgraded (or replaced), Not Available (sold, decommissioned, transferred); (If the instrument is currently non-functional, provide a succinct explanation of the instrument status immediately following this table).

7) Actual Usage Time: Actual total time in hours per year the instrument was used for research. If the instrument has been functioning for less than a year, the usage time can be extrapolated to reflect annual hours.

8) Maintenance Agreement: Active (Warranty in place), In-House (or Self-Insured), None (Fee for Service, Pending), Not Available (no longer supported by manufacturer).

9) Publications: Enter the number of research publications that cite the S10 award or have been linked with the S10 award in My NCBI. The number of reported publications should be verified in the NIH RePORTER. If there are no publications for any of the previously awarded S10-awarded instruments, provide an explanation immediately following this table.

• Letter from Biosafety Official. If human, animal, or infectious materials, which could create a potential biohazard, are to be analyzed, a signed letter from the institutional biosafety officer is required. The letter should state that the proposed containment plan has been reviewed and adheres to documented biosafety regulations.

SF424(R&R) Senior/Key Person Profile

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

Include the profile of the PD/PI, Major Users, Other Users, and technical personnel, as applicable.

This NOFO requires the attachment of Current & Pending Support for the PD/PI at the time of application submission. If PD/PI has no research grant or any other research support, state None in the form.

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.

PHS 398 Research Plan

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

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.

Under the S10 mechanism, funding requests are limited to the purchase cost of the instrument only. Support for technical personnel, service contracts, extended warranties, software (except as defined in Part 2, Section I), and supplies are not allowable. Cost sharing towards the purchase of the instrument is not required and any institutional funds contributed to the costs of the purchase of the instrument are voluntary. If the amount of funds requested does not cover the total cost of the instrument, the application should describe the proposed source(s) of funding to cover the balance of the cost of the instrument and document their availability in a letter signed by an appropriate institutional official. Note that any voluntarily committed cost will be noted in the Notice of the Award and the institution will be held to the commitment and reporting requirements.

This Program does not provide facilities and administrative (F&A) costs or support for construction or alterations or renovations. Matching funds are not required. However, commitment of an appropriate level of institutional support, to ensure the associated sustaining infrastructure, is expected and should be described. The appropriate Grant will be awarded for a period of one year and is not renewable.

Applicants proposing the purchase of an instrument that the institution is planning to lease prior to an award are urged to consult with their institutional sponsored projects office and the NIH Grant Management Office (see Section VII for contact information) regarding the applicable NIH policy prior to executing the leasing agreement. If the leasing agreement was executed more than one year prior to submission of the HEI application, the applicant must provide a strong justification for the requested Federal funds. This justification must demonstrate that the leased instrument is considered state-of-the-art at the time of submission - appropriate award adjustments may be necessary. Execution of a purchase order or agreement, making a down payment or other formal commitment to purchase the equipment prior to award will automatically eliminate an applicant from eligibility for an award.

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.

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

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• 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.

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.

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.

Specific to this NOFO, all S10 annual reports, including Final RPPR and four annual usage reports (AURs), must be submitted to https://s10reports.od.nih.gov/ for review and approval. A Final RPPR is required at the expiration of the grant that describes the purchased instrument, and a list of all users and description of the value of the instrument to the investigators and to the institution as a whole. The following information about the award and the instrument must be included in the HEI Final RPPR:

1) Grant Number: 1S10OD#####-01

2) Principal Investigator: (Name, Institution, Department, Address)

3) Funding Period

4) Name of Instrument (including manufacturer and model)

5) Total Purchase Cost

6) Total HEI Award Amount

7) Other Sources of Funding (if appropriate)

8) Instrument Installation Date

9) List of users, their funding and hours of use

10) List of publications, if available. This publication list should be consistent with the NIH Public Access Policy.

11) A narrative describing the impact of the instrument on the research community, specific research accomplishments, and administration and operation of the instrument.

A Final RPPR needs to be reviewed and approved by HEI Program Officer before officially submitting to the eRA Commons. The Final RPPR must be submitted electronically through the Closeout module in eRA Commons. For facilitation of Final RPPR preparation, the Scientific Research/Contact staff will contact grantees prior to the due date for report and provide specific instructions.

Annual Instrument Usage Reports

In addition, for the period of four years after the Final RPPR, on the anniversaries of the expiration of the award, Annual Instrument Usage Reports (AURs) must be provided to the NIH. These reports will include analogous information requested in S10 Final RPPR (as listed above in Final Research Performance Progress Report section) about the usage and operation of the instrument, with an attached report from the Advisory Committee, description of research which benefited from the instrument, and a summary of research outcomes as documented by publications.

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Monika Aggarwal, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0783
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Kenneth Holiness
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-6854
Email: [email protected]

Section VIII. Other Information

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

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