Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title
High-End Instrumentation (HEI) Grant Program (S10 Clinical Trial Not Allowed)
Activity Code
S10 Biomedical Research Support Shared Instrumentation Grants
Announcement Type

Reissue of PAR-19-177

Related Notices

NOT-OD-19-128 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research

NOT-OD-19-137 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research

Funding Opportunity Announcement (FOA) Number
PAR-20-114
Companion Funding Opportunity

PAR-20-113 Shared instrumentation Grant (SIG) Program (Clinical Trial Not Allowed)

PAR-20-112 Shared Instrumentation for Animal Research (SIFAR) Grant Program (Clinical Trial Not Allowed)
Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.351, 93.859

Funding Opportunity Purpose

The High-End Instrumentation (HEI) Grant program encourages applications from groups of NIH-supported investigators to purchase or upgrade a single item of high-end, specialized, commercially available instruments or integrated systems. The minimum award is $600,001. There is no maximum price limit for the instrument; however, the maximum award is $2,000,000. Types of instruments supported include, but are not limited to: X-ray diffractometers, mass spectrometers, nuclear magnetic resonance (NMR) spectrometers, DNA and protein sequencers, biosensors, electron and light microscopes, cell sorters, high throughput robotic screening systems, and biomedical imagers.

Key Dates

Posted Date

February 18, 2020

Open Date (Earliest Submission Date)
May 01, 2020
Letter of Intent Due Date(s)

Not applicable.

Application Due Date(s)

June 1, 2020

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

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

AIDS Application Due Date(s)

Not applicable.

Scientific Merit Review

September - November, 2020

Advisory Council Review

January 2021

Earliest Start Date

February 1, 2021

Expiration Date
June 02, 2020
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

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

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

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

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

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


  4. Table of Contents

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    The purpose of this funding opportunity is to continue the High-End Instrumentation (HEI) Grant Program administered by the Office of Research Infrastructure Programs (ORIP). The objective of the Program is to make available to institutions high-end cutting-edge 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 bio-behavioral 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: X-ray diffractometers, mass spectrometers, nuclear magnetic resonance (NMR) spectrometers, DNA and protein sequencers, biosensors, electron and light microscopes, cell sorters, high throughput robotic screening systems, and biomedical imagers. 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.

    To facilitate the introduction of advanced cutting-edge technologies providing new research capabilities to the biomedical field, a risk-return trade-off is allowed when certain classes of instruments or integrated systems are requested. Accordingly, the HEI program supports the acquisition of unique instruments or integrated systems developed by reliable commercial vendors, provided the instruments or all components of integrated systems are guaranteed by the manufacturer’s one-year warranty. Due to the novelty of the technologies and the uniqueness of their implementation, specialized and technologically savvy groups of investigators will be required to lead the adoption of such instruments for biomedical research and the development of innovative biomedical applications. Therefore, if such 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 the 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.

    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 $600,001;
    • Multiple instruments bundled together;
    • Purely instructional equipment;
    • Institutional administrative management systems, clinical management systems, or instruments to be used purely for clinical (billable) care;
    • 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;
    • Stand-alone workstations for data processing, licenses, and duplicate software items;
    • General purpose equipment (such as standard machine shop equipment), instruments 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 data storage systems);
    • Disposable devices, office furniture, and supplies;
    • Alteration or renovation of space to house the instrument.

    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.

    In order to promote cost effectiveness, encourage optimal sharing, 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.1 for 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 submitting a Final Research Performance Progress Report (Final RPPR) in collaboration with relevant institutional officials at the end of the project period. The Final RPPR will describe the purchased instrument; list all users; and report outcomes such as publications, new grant awards, and patent in which the instrument is used; and outline the value of the instrument to the investigators and to the whole institution. See Section VI.3.
    • 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.3.

    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 institutional human subjects, animal welfare, and biosafety committees, 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 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.

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

    Section II. Award Information

    Funding Instrument

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

    Application Types Allowed
    New
    Resubmission

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

    Clinical Trial?
    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    ORIP intends to commit about $30 million in FY 2021 to fund an estimated 25 HEI awards

    Award Budget

    Applications will be accepted that request a single, commercially available instrument or integrated system. The minimum award is $600,001. There is no upper limit on the cost of the instrument, but the maximum award is $2,000,000. Since the cost of the various instruments will vary, it is anticipated that the size of the award will also vary. S10 awards do not allow indirect costs.

    It is expected that applicants will employ the most economical approaches, including securing academic discounts, to formulate a cost-effective budget while meeting users' scientific needs. See Section IV. 6. Funding Restrictions for additional details

    Award Project Period

    Awards are made for one year only.

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

    Section III. Eligibility Information

    1. Eligible Applicants

    Eligible Organizations

    Higher Education Institutions

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

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

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
    Nonprofits Other Than Institutions of Higher Education
  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Foreign Institutions

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

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

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

Required Registrations

Applicant organizations

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

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

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

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

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

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

The PD/PI chosen for this application should have documented (in the biographical sketch) technical expertise directly related to the type of the chosen 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 FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

 

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) 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 NOT-OD-11-101)

There is no restriction on the number of applications an institution can submit to the HEI Program the Shared and/or the Instrumentation Program (SIG) each year, provided the applications request different types of equipment. Concurrent SIG, HEI and/or Shared Instrumentation for Animal Research (SIFAR) applications for the same instrument (or the same type of instrument with added special accessories to meet the HEI budget requirement or the same instrument in a cluster of instruments to meet the SIFAR program requirements), are not allowed unless documentation from a high-level institutional official is provided, stating 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) potential duplicates 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 appropriate for this FOA.

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 Major or Minor 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 User Time (AUT) or higher. If a Special Use Instrument (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 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. This rare request will be designated as a Special Use Instrument (SUI). In such situations, the instrument’s Biomedical Research Time (BRT) must be at least 50% of the Accessible User Time (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 FOA still apply.

The non-biomedical research activities supported by the instrument may include research in other fields, curricular instructions, and billable clinical care. 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
A valid itemized quote from the vendor with appropriate academic discounts and warranty terms 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guideexcept where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For this FOA, 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. 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): 3 pages.
  • Justification of Need: 9 pages in total.
  • Technical Expertise: 3 pages in total.
  • Research Projects section must not exceed 30 pages in total. This section can be structured in subsections Research Projects of Major Users and Research Projects of Minor Users or subsections Specific Research Topics. The limit is 4 pages per each Major User's project; however, three or fewer pages are strongly recommended. The Research Projects of Minor Users subsection is limited to 4 pages in total.
  • Summary Table(s): 6 pages in total.
  • Administration (Organizational / Management Plan): 6 pages in total.
  • Institutional Commitment: 3 pages in total.
  • Overall Benefit: 3 pages in total.

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

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

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: Enter start date of 02/01/2021 and end date of 01/31/2022.

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 SIG Program. If the cost of the instrument is more than $2,000,000, enter $2,000,000 (or less).

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

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 section).

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 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 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 scanner functionalities), they must be essential for the advancement of research projects of 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. You may use tables to clarify the presentation. Tables included within this section will count towards the specified page limit.

Define and justify the Accessible User Time (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 times 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 Minor 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 cutting-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 simply 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 4 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.

Then, if there are Minor Users and other users, include an up to 4-page long section entitled Minor Users’ Projects. Describe the need of the requested instrument to advance projects from Minor 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 Minor/Other Users.

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. In such cases, you may select a representative smaller group of Major Users and describe their research projects’ needs in detail in other subsections research projects of Major Users and devote this separate subsection (up to 4 pages) to describe research and instrumentation needs of your large user community, including Minor Users. Keep in mind that the sole number of users is not a compelling factor to justify scientific needs for the requested instrument.

You must focus the Research Projects section 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 Minor 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 Minor Users. Do not list users whose annual usage is at the level of 1% or less of AUT.

Following the tables, state

(i) a 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); NIH-funded users (Major and Minor) should use the instrument at the level of 75% or more 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 Minor 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 (e.g., Provost for Research, Dean of School, Department Chair) 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 may Chair the Advisory Committee. The PD/PI cannot be a voting member of the Advisory Committee.


The Advisory Committee should meet on a regular basis and should prepare an annual report, which will become part of the Final Progress Report and the Annual Usage Reports (see Section VI.3).

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 year one of operation with approximate dollars for anticipated expenditures and anticipated income, showing how these estimates were derived. For year one specific dollar amount are required; for years 2 - 5 approximate amounts are recommended.

Typically, during year one, the maintenance costs are fully covered by one-year manufacturer's 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 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 that the institution will commit to provide backup of the financial plan for five years from installation 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 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 back-up for the proposed financial plan.
  • 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 DUNS 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, FY 2015 - 2019. 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: List the number of research publications citing the S10 award or linked with the S10 grant in My NCBI. Do not count publications that do not cite the S10 grant or have not been associated with the S10 grant in My NCBI. 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 is required from the institutional biosafety officer stating that the proposed containment plan has been reviewed and adheres to documented biosafety regulations. If relevant, this letter is required in the application.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.

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

This FOA requires the attachment 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.

PHS 398 Cover Page Supplement

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

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

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 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 for 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. If a SUI is requested, the institutional contribution towards the purchase of the instrument will not be viewed as cost-sharing.

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. Appropriate Grant will be awarded for a period of one year and are not renewable.

Applicants proposing purchase of an instrument that the institution is planning to lease prior to award are urged to consult with their institutional sponsored projects office and the NIH Grant Management Office regarding 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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

No animations/videos are allowed.

Section V. Application Review Information

1. Criteria

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

Overall Impact
Scored Review Criteria
Additional Review Criteria

Overall Benefit

Reviewers will provide an overall benefit score to reflect their assessment of the likelihood that the requested instrument will exert a sustained, powerful, positive influence on the conduct of research projects and their scientific outcomes, in consideration of the following review criteria.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact/benefit.

Justification of Need

Is the need for the instrument clearly and adequately justified? Is the equipment essential and appropriate? Are all specific features, special accessories, and the software configuration of the requested instrument well justified, in particular, by their need of Major Users? Is Accessible User Time (AUT) well defined and explained? Is AUT reasonable for the requested technology/instrument type? Is AUT reasonable in the context of the managerial plan? Justification of selection of the proposed instrument may include, but is not limited to, comparison with other commercially available instruments of similar function.

Technical Expertise

Does the institution have the technical expertise to make effective use of the requested equipment? How well-qualifies are the participating investigators or other assigned personnel to operate and maintain the instrument, conduct the projects, and evaluate the research results, including analysis and interpretation of data? Are the plans for new users’ training well developed? Are the proposed biosafety procedures well described and appropriate? If the application requests cutting-edge innovative technology that would introduce novel capabilities to a field of biomedical research, how qualified are the assembled experts in supporting the operations and leading the adoption of such a commercially available instrument ?

Research Projects

Will research with the requested instrument advance the knowledge and understanding of the proposed projects? How will the research projects of individual Users be enhanced? Do Users adequately justify the requested instrument, and accessories for the needs of their specific projects? If accessories are requested for the instrument, do at least three Major Users require each of the accessories for their research projects? If the application requests cutting-edge innovative technology, how will the adoption of these novel capabilities benefit research projects?

Administration

Is the plan for the management and maintenance of the requested instrument appropriate? Are the plans for the use of the instrument on a shared basis well-documented? ? Are the plans for time allocation of the instrument to different projects well developed? Are the sharing arrangements equitable? If needed, are the policies to manage projects which have human subjects, animals, or biohazards adequate? Is the membership of the Advisory Committee broadly based to oversee the use of the instrument for the appropriate range of biomedical investigators, to balance interests of different users, and to resolve disputes, if they arise? Is the financial plan for the instrument for five years or the expected lifetime of the instrument reasonable and secured, balancing anticipated expenditures and anticipated income? Is the expected usable lifetime of the instrument reasonable? Are adequate plans in place to document the use and scientific benefits of the instrument by citations and acknowledgments of the S10 grant in the scientific publications?

Institutional Commitment

Does the institutional commitment letter provide support in the event of a shortfall of income? Is the institutional commitment to back up the financial plan provided for a time period consistent with the expected effective lifetime of the requested instrument? Is the management of awarded S10 instruments adequate (based on the data in the table of Previously Awarded S10 Instruments in the institutional Letter of Support)? Does the Institution provide adequate infrastructure support for the requested instrument including space to house the instrument and site for sample preparation, if needed?

Additional Review Criteria

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

 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

 

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

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

Not applicable

 

Not applicable

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

 

Not applicable

 

Not applicable

 

Not applicable

 

Not applicable

 

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Reviewers will consider whether applicants employed the best economical approaches, including securing academic discounts, to formulate the cost-effective budget while meeting users' scientific needs.

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 of Scientific Review}, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:
  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Applications will be assigned 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 . 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

Applicants should ignore eRA Commons system-generated just-in-time (JIT) requests which are typically sent soon after peer review. If an application is considered for funding, ORIP HEI Program staff will send PD/PI special instructions on how to submit a JIT update, from the e-mail address s10reports@od.nih.gov. Once an application is selected for funding, the grants management officer may request additional information.

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award
Not Applicable

3. 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.

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

At the expiration of the grant, a Final Research Performance Progress Report (Final RPPR) is required 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 SIG 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.

12) A report from the Advisory Committee.

The HEI Final RPPR must be submitted electronically through the Closeout module in eRA Commons. For facilitation of Final RPPR preparation, the HEI Scientific Research/Contact staff will contact grantees prior to the due date for report and provide specific instructions.

Annual Instrument Usage Report

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.

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threatensubmission by the due date, and post-submission issues)

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

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

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

Scientific/Research Contact(s)

Guanghu Wang, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0772
Email: HEI@mail.nih.gov

Peer Review Contact(s)

Nuria Assa-Munt, PhD
Center for Scientific Review (CSR)
Telephone: 301-451-1323
Email: assamunu@csr.nih.gov

Financial/Grants Management Contact(s)

Karen Brummett
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-827-8024
Email: karen.brummett@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Authority and Regulations
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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