Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

The 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, electron and light microscopes, mass and nuclear magnetic resonance (NMR) spectrometers, protein and DNA sequencers, biosensors, cell sorters, and biomedical imagers. Applications for "stand alone" computer systems (supercomputers, computer clusters and storage systems) will only be considered if the instrument is solely dedicated to the research needs of a broad community of NIH-supported investigators.

The HEI Program will not support requests for:

• an instrument with a base cost of less than $600,000;
• multiple instruments bundled together or a series of complementary related instruments;
• software, unless it is integral to the operation of a piece of equipment;
• purely instructional equipment, institutional administrative management systems, clinical management systems;
• instruments used for clinical (billable) care;
• general purpose equipment or an assortment of instruments to furnish a research facility and equipment for routine sustaining infrastructure (such as, standard machine shop equipment, standard computer networks, autoclaves, hoods and equipment to upgrade animal facilities).

The HEI Program supports instruments for research purposes 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 equipment is allowable.

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.

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/scientific oversight responsibility for the requested instrumentation. See Section III.1 for qualifications for the PD/PI. The PD/PI will be responsible for:

• Requesting no-cost extensions of the project period, if needed.
• Preparing (and working with the Institution to submit) a Final Progress Report at the end of the project period that describes the purchased instrument, lists all users and publications resulting from use of the instrument, and outlines the value of the instrument to the investigators and to the institution as a whole. See Section VI.3.
• Submitting Annual Equipment Usage Reports to the NIH for a period of four years after the Final Progress Report. 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;
• Day-to-day management and safe operation of the instrument;
• If appropriate, a plan to ensure that access to the instrument is limited to users whose projects have received approval from institutional human subjects, animal welfare or biosafety committees;
• A financial plan for the long term operation and maintenance of the instrument during the post award period;
• The relocation of the instrument within or outside the institution or changes of ownership, if such changes are necessary;
• Naming a new PD/PI, if such a need arises due to the departure of the current PD/PI

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

Higher Education Institutions

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

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Under the general research support authority of Section 301(a) (3) of the Public Health Service Act, Shared Instrumentation Grant awards are made to public and non-profit domestic institutions only. These institutions include health professional schools, other academic institutions, hospitals, health departments, and research organizations. Federal institutions, foreign institutions, and for-profit institutions are not eligible to apply. A Federal institution is defined by the NIH as a Cabinet-level department or independent agency of the executive branch of the Federal Government or any component organization of such a department or agency.

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

Applicant Organizations

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

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

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

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

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

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 or non-tenured faculty member of the applicant organization, 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:

• 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 Shared Instrumentation Grant (SIG) and/or HEI Programs each year provided the applications request different types of equipment. Concurrent SIG and/or HEI applications for the same instrument (or the same type of instrument with added special accessories to meet the HEI budget requirement) are not allowed, in general. If two or more S10 (either SIG or HEI) 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.

A Major User group composed of three individuals who have substantial need for the instrument must be identified. Each member of this group must be a PD/PI on a distinct NIH-funded research grant or cooperative agreement 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.) PDs/PIs on NIH training or fellowship grants (e.g., T and F mechanisms) and other non-research grants are not eligible to be Major Users. Once the eligibility requirement 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 once the requirement of at least three NIH-funded Major Users has been met. 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 and 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 Other Project Information for the definition of AUT. Major Users supported by NIH grants should together require at least 35 percent of the AUT.

The Major User group must meet the eligibility requirement at the time of submission and at a later time if/when the application is considered for funding by the HEI Program Staff.

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.

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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. The sections cannot exceed the page limit including tables, graphs, figures, diagrams, and charts. Although there is no overall page limit, applicants are reminded to be informative yet 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.

• Introduction to Resubmission: 3 pages (if applicable)
• 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 or subsections Specific Research Topics. The limit is 4 pages per Research Projects of Major User subsection; however, three or fewer pages are STRONGLY recommended.
• 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.

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 02/01/2017 and end date of 01/31/2018.

Estimated Project Funding:

Total Federal Funds Requested: Enter the total Federal funds for the requested instrument.

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

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

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

Program Income: Enter zero it as 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 is meant to serve as a succinct and accurate description of the requested instrument and the need of the research projects for the instrument. State the application's broad, long-term objectives, 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 these 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, and specific features and any 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. As described above in SF424 Cover form, include an explanation of Total Non-Federal Funds in this section (if applicable).

If human 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 here; such narrative should be a part of the Justification of Need section of the Instrumentation Plan (see below).

Other Attachments:

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.

• 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. Explain why the chosen model and its manufacturer are the most suitable for your user group. Preliminary data is 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. 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) which is the number of annual hours the instrument can be used for any research purpose. AUT hours may be limited by the times an instrument operator is available (if an operator is required), site or building access schedules, estimated or scheduled maintenance, start-up and standardization, and any other factors that take time away from use of the instrument. Justify (table format is suggested) the AUT for the proposed instrument based on the individual situation at the applicant institution. AUT for the same instrument may differ among different institutions.
  
  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).
• Technical Expertise: Describe the technical expertise present at the institution to set up, run and maintain the instrument. Specify who will operate the instrument, train new users, ensure that it is operated safely and is appropriately maintained. Also, address technical support for data collection, handling, and analysis. Likewise, if the instrument requires complex sample preparation or consultation for experimental designs, describe the expert individuals who will serve in that capacity.
• Research Projects: In this section describe the benefit of the requested instrument to enhance research projects. You can divide 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. In addition, if there are Minor Users and other users include a subsection Other Users Projects (see 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 employed, 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 utilize these options as at least three Major Users must need any of these special options. Preliminary data is not required but if it is available, it may be used to illustrate the benefit of the requested instrument to the research projects. Be succinct and clear about implementation of experimental protocols and anticipated gains. Describe how data generated will be handled and analyzed so benefits of the entire experimental set-up can be judged. Present benefits that the requested instrument will provide towards answering specific scientific questions.
  
  If you choose to divide this section into Research Projects of Major Users subsections, list the PD/PI’s name and grant information (number, title, project start and end dates) in the beginning of each subsection.
  
  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 by the percentage of the AUT.
  
  Conclude this section with a subsection Other Users Projects to describe the need of the requested instrument to advance projects from Minor Users and the user community (e.g., unfunded users who have significant need for the instrument to develop their research programs or users whose expected need is at the level of 1% or less of AUT). In particular, in cases of certain technologies 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 in some detail in other subsections and devote this separate subsection 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 this section on the precise 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 advancements of technologies for the benefit biomedical research may be included. You should demonstrate that NIH-funded investigators will use the instrument at the level of at least 75% of AUT.
• Summary Table(s): Show a table summarizing Research Projects of Users. The table should have the following columns: User's name, grant number: for NIH awards list the complete grant numbers (e.g. 5R01HL123451-01A1), brief title of the project, grant start and end dates, and estimated number of AUT hours and estimated percentage of BRT - if a SUI is requested. If there are multiple Users funded by the same grant, clearly indicate their names and their estimated number of AUT hours of use of the instrument for projects supported by that grant. In addition, make a separate table to indicate the users' needs for any requested accessories. In particular, if a SUI is requested, this table 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.
• Administration (Organizational/Management Plan): Describe the organizational plan to administer the grant. In particular, describe how the instrument will be utilized, how requests to use the instrument will be made, how time will be allocated among Major 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.
  
  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. 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).
  
  Describe a plan for managing access to the instrument if users' projects involve human subjects, vertebrate animals or biohazards such as infectious materials.
  
  Submit a specific financial plan for long-term operation and maintenance of the instrument. Explain how various operational costs will be met; specifically, costs associated with routine operation of the instrument, maintenance, and support personnel. 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 amounts 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 to operate the instrument and provide its routine care and standardization.
  • Maintenance: May include a service contract, or funds for local technical personnel (and parts) who will maintain the instrument if such personnel are qualified to do so.
  • Supplies: Necessary supplies for operating the instrument such as chemicals, cryogenics, and other expendable items.
  • Anticipated Income: Enumerate the sources of income such as charge back fee structure, grants, or institutional support.
• 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 AUT, but also no less than the portion of the NIH contributions 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 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.
• Institutional Commitment: Describe the institutional infrastructure available to support the instrumentation; including space to house the instrument and site for sample preparation, if needed.
  
  Confirm the institutional support toward the maintenance and operation of the instrument. Describe institutional support for personnel. 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. The review panel will evaluate the time of institutional support of the financial plan for this instrument in terms of consistency with the expected usable lifetime for the instrument dependent upon 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.

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:

• letters from institutional officials;
• institutional back-up for the proposed financial plan;
• and letters about inventory of instruments at the institution which are unavailable to the PD/PI (mentioned in the Justification of Need Section).
• The institution must also provide a table that provides information about instrument performance of all previous S10 awards for instruments awarded within the past five years. The table should have the following columns: S10 grant number, year of award, installation date of the instrument, PD/PI's name, generic name of instrument, current instrument status (i.e., in use, traded-in, transferred, non-functional), actual AUT, status of maintenance agreement, and number of publications citing the S10 award. If the instrument is currently non-functional, the institution must provide a supplementary explanatory text.
• If human, animal, or infectious materials, which could create a potential biohazard, are to be analyzed, a signed letter from the institutional biosafety officer stating the proposed containment plan was reviewed and that the plan adheres to documented biosafety regulations. This letter is required in the application, if applicable.

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

Include profiles of the PD/PI, the Major Users, and the technical person(s) responsible for the maintenance and operation of the instrument. For the Major Users, select "Other" under Project Role. Then complete the Other Project Role Category by inserting Major User. For technical person(s), select "Technician" for Project Role field. Follow the instructions in the SF424 (R&R) Application Guide for Additional Senior/Key Person Profile(s) if there are more than 8 Major Users.

Current and Pending Support: Since Just-in-Time does not apply to the S10 mechanism, this FOA requires current and pending support for the Program Director(s)/Principal Investigator(s), each Major and Minor User and/or technician at the time of application submission.

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

Not Applicable

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, and supplies are not allowable. Cost sharing towards purchase of the instrument is not required. 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. Documentation of the availability of the remainder of funding, signed by an appropriate institutional official, should be included in the application and must be presented to NIH prior to issuance of award.

The 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 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood 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 and additional 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. For example, a project that by its nature is not innovative may be essential to advance a field.

Justification of Need

Is the need for the instrument clearly and adequately justified? Is the equipment essential and appropriate? Are all specific features and special accessories 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? Justification of selection of 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 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?

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 for the needs of their specific projects? If accessories are requested for the instrument, do at least half of the Major Users require each of the accessories for their research projects?

Administration

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?

Institutional Commitment

Did the Institution provide the required letter of commitment to back-up the submitted financial plan 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? Has the institution provided the required Letter of Support table listing previous S10 instruments awarded and installed within the past five years? Is the management of awarded S10 instruments adequate? 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.

Not Applicable

Not Applicable

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

Not Applicable

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

Not Applicable

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

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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:

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response 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:

• 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 balance among various types of instruments supported and geographical distribution of awards.

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 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 [email protected].

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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 Progress Report (FPR) 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. This report is needed by the NIH for informing the public, administrative and Congressional officials about the research resources it supports. The following information about the award and the instrument be included in the HEI FPR:

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

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

Funding Period

Name of Instrument (including manufacturer and model)

Total Purchase Cost

Total HEI Award Amount

Other Sources of Funding (if appropriate)

Instrument Installation Date

List of users, their funding and hours of use

List of publications, if available.

This publication list should be consistent with the NIH Public Access Policy.

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

A report from the Advisory Committee.

The HEI FPR must be submitted electronically through the Closeout module in eRA Commons. For facilitation of FPR 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 FPR, 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 FPR (as listed above in Final Progress Report section) about the usage and operation of the instrument, including a report from the Advisory Committee, research which benefited from the instrument, and research outcomes as documented by publications.

For facilitation of AUR preparation, the HEI Scientific Research/Contact staff will contact grantees prior to the due date for report and provide specific instructions.

Acknowledgments

Any publications and other research reports which arise from experiments conducted using the instrument must acknowledge the HEI award.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Abraham Levy, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0777
Email: [email protected]

Nuria Assa-Munt, PhD
Center for Scientific Review (CSR)
Telephone: 301-451-1323
Email: [email protected]

Long Nguyen
National Center for Advancing Translational Sciences (NCATS)
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-402-6737
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.