National Institutes of Health (NIH)
High-End Instrumentation (HEI) Grant Program (S10 Clinical Trial Not Allowed)
S10 Biomedical Research Support Shared Instrumentation Grants
Reissue of PAR-18-598
The High-End Instrumentation (HEI) Grant Program encourages applications from groups of NIH-supported investigators to purchase or upgrade a single item of expensive, specialized, commercially available instruments or integrated systems. The minimum award is $600,001 of direct costs. The maximum award is $2,000,000 of direct costs. Types of instruments supported include, but are not limited to: X-ray diffraction systems, nuclear magnetic resonance (NMR) and mass spectrometers, DNA and protein sequencers, biosensors, electron and confocal microscopes, cell-sorters, and biomedical imagers.
January 29, 2019
April 30, 2019
May 31, 2019, by 5:00 PM local time at the applicant organization. All types of applications allowed for this funding opportunity are due on this date.
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.
February 1, 2020
June 1, 2019
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The purpose of 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 expensive research instruments that can only be justified on a shared-use basis and that are needed for NIH-supported projects in basic, translational or clinical areas of biomedical/behavioral research. The HEI Program provides funds to purchase or upgrade a single item of expensive, 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 could 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 and nuclear magnetic resonance (NMR) spectrometers, DNA and protein sequencers, biosensors, electron and light microscopes, cell sorters, and biomedical imagers. Applications for "stand alone" computer systems (supercomputers, computer clusters and data storage systems) will only be considered if the instrument is solely dedicated to the research needs of NIH-supported investigators.
To facilitate the introduction of advanced cutting-edge instrumentation 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 qualified 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 physical and biological sciences. For integrated systems, the applicant must provide a detailed description about how the system will be put together and about technical expertise of the individual(s) who will be responsible for assembling of 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 to advance their research.
All instruments, integrated systems, and computer systems must be dedicated to 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:
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, to encourage optimal sharing among individual investigators, research groups and departments, and to 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 instrumentation. See Section III.1 for qualifications for the PD/PI. The PD/PI also will be responsible for:
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:
The PD/PI and the Advisory Committee should convene meetings and issue annual reports on the instrument status, including their recommendations for the 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 encourages sharing and collaboration among institutions, programs, and states.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose clinical trials.)
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
ORIP intends to commit about $30 million in FY 2020 to fund an estimated 25 awards.
Applications will be accepted that request a single, commercially available instrument or integrated system. The minimum award is $600,001 of direct costs. There is no upper limit on the cost of the instrument, but the maximum award is $2,000,000 of direct costs. 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.
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations 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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
There is no restriction on the number of applications an institution can submit to the SIG and/or High-End Instrumentation (HEI) Programs each year, provided the applications request different types of equipment. Only one Shared Instrumentation for Animal Research (SIFAR) application per institution as identified by the DUNS number, is allowed. In general, concurrent SIG, HEI and/or (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. If two or more S10 (either SIG, HEI, or SIFAR) applications are submitted for similar equipment from the same institution, documentation from a high-level institutional official must be 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.
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 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, and OT awards cannot be counted towards the fulfillment of this requirement. Once the eligibility requirement of three Major Users with 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 from 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 grants should together require at least 75 percent of the Accessible User Time (AUT) (see Section IV.2 for the definition of AUT) or 75 percent of Biomedical Research Time (BRT) if a Special Use Instrument (SUI) is requested (see Section IV.2 for the definition of BRT and the paragraph below for the definition of SUI). Major Users supported by NIH grants should together require at least 35 percent of the AUT (or 35 percent of BRT – if a SUI is requested).
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.
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 portion of the NIH funds of the cost of the instrument, whichever is larger. Definitions of how to calculate BRT and AUT appear in Section IV in the "Justification of Need" Section of the Instrumentation Plan. If an Institution makes a request for SUI, the non-NIH funds must not be less than 25% of the total instrument price. 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.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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 for these sections. The applicants should make every effort to be succinct. It is expected that the length of the 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 described here.
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 SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 02/01/2020 and end date of 01/31/2021.
Estimated Project Funding:
Total Federal Funds Requested: 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.
All instructions in the SF424 (R&R) Application Guide must be followed.
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, with any appropriate discount, from a vendor is required. The quote must be scanned and combined in a single attachment with the equipment description as part of this upload. Applications without a quote will not be considered for funding. As described above in SF424 Cover form, include an explanation of Total Non-Federal Funds in this section (if applicable).
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.
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 (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.
Justify the need for software. Recall that all software supported by this program must be integrated in the operation of the instrument and/or be necessary for the 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 the productive scientific use of the instrument. If such additional software modules are requested (e.g., to support mas spec metabolomics, special imaging protocols for optical microscopes, special pulse sequences for MRI) they must be essential for the advancement of research projects of least 3 Major Users.
Explain why the chosen model and its manufacturer are the most suitable for your user group. Preliminary data are not required, though if feasible, you may include preliminary data to justify your choice. 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.
For the requested instrument, define and justify the Accessible User Time (AUT). 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 Biomedical Research Time (BRT) for the instrument. BRT is the number of annual hours that the instrument is available to conduct biomedical research. In the case for which the total cost of the instrument is requested from the NIH or the instrument will be exclusively used for biomedical research, the BRT is equal to AUT. BRT cannot be less than 50% of AUT (Section III.3). If a SUI is requested, its choice cannot be justified by the needs of non-biomedical researchers (that is, other researchers than Major and Minor Users). However, if such other users 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).
Since the 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, would 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 judged. Summarize benefits that the requested instrument will provide towards answering specific scientific questions. Be succinct and clear.
If you choose to structure this Research Project 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 PD/PI’s name and grant information (number, title, project start and end dates). Also, specify the anticipated usage in annual hours for each project.
If you choose to group research projects in subsections Specific Research Topics, in the beginning of each subsection list Major Users, their funded grants that you describe therein, and their cumulative usage as measured annual usage hours.
In addition, if there are Minor Users and other users, include an up to 4-page long section 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 science, translational investigation, or clinical trials; in particular, research projects on the advancements of technologies for the benefit of biomedical research may be included.
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 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 in this section a separate table to indicate the users' needs for any requested accessory. In particular, 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 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 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% of the AUT (or BRT).
Reviewers will comment whether the estimated usage time and AUT are reasonable 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.
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 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.
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.
Special Use Instrument (SUI): In a special case of a SUI, the applicant must include a section entitled “Plan to Protect Access of Major and Minor Users to the Instrument”. According to the eligibility requirement, the Major and Minor User group must have access to the instrument at least 50% of the BRT, but also no less than the portion of the NIH contribution towards the purchase of the instrument. General description of the times and days that are assigned to the user group’s biomedical research must be detailed. The applicant should also provide a description of the other uses of the instrument and demonstrate the effect (positive or negative), if any, on the Major and Minor Users. If a change of instrument configuration is required to serve the other uses, the applicant must show how such changes will be implemented and describe plans to decrease their burden on Major and Minor Users. The process of implementing potential adjustments in scheduling and of other aspects of the instrument administration must be described, for the expected lifetime of the instrument. If a SUI is requested, it is the responsibility of the Advisory Committee to safeguard the research interests of the Major and Minor Users group. It is expected that the Advisory Committee will monitor the instrument use and issue to ORIP an annual report that documents how the appropriate access of biomedical researchers to the instrument is maintained.
If a SUI is requested, the PD/PI must describe and document source(s) of funds from the institution, other Federal or State agencies, or private foundations which will be used to purchase this instrument. The PD/PI must describe special requirements, if any, associated with expenditure of how the non-NIH funds will be allocated. In particular, if the PD/PI applies for other grants where the costs will be allocated for this instrument at the same time frame as this application is being submitted these efforts must be detailed.
II) Letters of Support: All letters of support should be combined in a single file named Letters of Support and uploaded as a separate attachment via Other Attachments. This combined file should include, as applicable:
1) S10 Grant Number;
2) Year of Award; Installation Date of the Instrument;
3) PD/PI's name;
4) Generic Name of Instrument;
5) 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));
6) Actual Usage Time (actual total time in hours per year the instrument was used for research; if the instrument has been installed less than a year ago, the hours can be extrapolated for an estimate of hours per full year);
7) Maintenance Agreement (Active (Warranty in place), In-House (or Self-Insured), None (Fee for Service, Pending), Not Available (no longer supported by manufacturer); and
8) Number of Publications Citing the S10 Award. Please verify that the reported publications cite the award (or have been linked to the S10 grant and are listed in the NIH RePORTER). If the instrument is currently non-functional, the institution must provide a supplementary explanatory text. An explanation must also be provided if there are no publications for any of the previously awarded S10 grants.
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.
Current and Pending Support: 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.)
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
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 is 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.
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 Grants 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.
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.
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.
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.
Only the review criteria described below will be considered in the review process.
Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall benefit score to reflect their assessment of the likelihood that the requested instrument will exert a sustained, powerful influence on the conduct of research projects and their scientific outcomes, in consideration of the following 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 by 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? If a SUI is requested, is BRT well defined and reasonable? Justification of selection of the proposed instrument may include, but is not limited, to comparison with other commercially available instruments of similar function.
Does the institution have the technical expertise to make effective use of the requested equipment? How well-qualified 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? How will new users be trained? How will biosafety procedures be implemented?
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 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?
Is the plan for the management and maintenance of the requested instrument appropriate? 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? How will research time be allocated among the projects? Are the sharing arrangements equitable? If needed, are the policies to manage projects which have human subjects, animals or biohazards adequate? 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 there 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?
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?
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.
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.
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.
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 comment whether applicants employed the best economical approaches, including securing academic discounts, to formulate the cost-effective budget while meeting users' scientific needs.
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 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:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted to this FOA. 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:
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.
Applicants should ignore the 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 firstname.lastname@example.org.
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.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
Cooperative Agreement Terms and Conditions of Award
A Final Research Performance Progress Report (RPPR) 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 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 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.
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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred
method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information
(Questions regarding application instructions, application processes, and NIH
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Malgorzata Klosek, PhD
Office of Research Infrastructure Programs (ORIP)
Nuria Assa-Munt, PhD
Center for Scientific Review (CSR)
Gavin Wilkom, M.I.M.
Office of Research Infrastructure Programs (ORIP)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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