Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The purpose of this funding opportunity is to continue the Shared Instrumentation Grant (SIG) 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 biomedical and bio-behavioral research. The SIG Program provides funds to purchase or upgrade a single item of expensive, state-of-the-art, 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 spectrometers, 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 system is solely dedicated to biomedical research.

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

Foreign-made instruments are allowed.

The SIG Program will not support requests for:

• An instrument with a base cost of less than $50,000;
• Multiple instruments bundled together;
• Purely instructional equipment;
• Instruments used for clinical (billable) care;
• Institutional administrative management systems, clinical management systems;
• Software, unless it is integrated in the operation of the instrument and/or necessary for the generation of high-quality output experimental data from the instrument;
• 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).

Applicants are advised to discuss with the SIG 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:

• Requesting no-cost extensions of the project period, if needed;
• At the end of the project period, preparing (and working with the institution to submit) a Final Research Performance Progress Report (Final RPPR) 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 Usage Reports (AURs) of the instrument to the NIH for a period of four years after the project end date, see Section VI.3.

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

• Maximum utilization of the instrument, including time allocation;
• A detailed plan for the day-to-day management and safe operation of the instrument;
• A plan to ensure that access to the instrument is limited to users whose projects have received approval from institutional human subjects, animal welfare or biosafety committees, as applicable;
• A financial plan for the long-term operation and maintenance of the instrument during the post-award period;
• A relocation of the instrument within or outside the institution or changes of ownership, if such changes are necessary;
• Recommending a new PD/PI, if such a need arises.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Non-domestic (non-U.S.) Entities (Foreign 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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 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 per a receipt date. 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 SIG Scientific/Research Contact (see Section VII) potential duplicates before submitting two applications for the same type of instrument.

A single application requesting more than one type of instrument (for example, a mass spectrometer and a confocal microscope) is not appropriate for this FOA.

Major User Group

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application 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. 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. 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.

• Introduction to Resubmission (if applicable): 3 pages
• Justification of Need: 9 pages in total
• Technical Expertise: 3 pages in total
• Research Projects section must not exceed 30 pages in total. This section can be structured in subsections Research Projects of Major Users and Research Projects of Minor Users or subsections Specific Research Topics. The limit is 4 pages per each Major User's project; however, three or fewer pages are strongly recommended. The Research Projects of Minor Users subsection is limited to 4 pages.
• 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 02/01/2020 and end date of 01/31/2021.

Estimated Project Funding:

Total Federal Funds Requested: Enter the total Federal funds for the requested instrument. This entry cannot exceed $600,000 which is the maximum award under the SIG Program. If the cost of the instrument is more than $600,000 enter $600,000 (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 SIG 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.

Other Attachments:

I) Instrumentation Plan (in lieu of Research Plan section). The entire Instrumentation Plan (with the sections described below) must be saved as a single PDF file - named Instrumentation Plan - and attached via Other Attachments. Organize the Instrumentation Plan in the specified order (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.

• In troduction: 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.

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.

• Technical Expertise: Describe the technical expertise of individuals who will set up and run the instrument. Specify who will ensure that the instrument is safely operated and appropriately maintained. State who will train new users. If the instrument requires complex sample preparation or consultation for experimental designs, describe the expert individuals who will serve in that capacity. Address technical support for data collection, management, and analysis.

• Research Projects: In this section, describe the benefit of the requested instrument to enhance Users research projects. First, describe the research projects of Major Users. You can organize this section into subsections Research Projects of Major Users or Specific Research Topics . The latter format may be especially useful to avoid redundancies in the presentation of research projects if several Major Users pursue research topics which follow similar protocols and scientific benefits of the new instrument for their projects are comparable. All Major Users must have substantial need for the requested instrument. Detailed eligibility requirements for Major Users are described in Section III 3.

Since the 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 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.

• Summary Table(s): At the beginning of this section, please re-state the Accessible Usage Time (AUT) in annual hours, as introduced in the Justification of Need Section.

Next, insert the following summary tables - a) Research Projects of Major Users and b) Research Projects of Minor Users. The tables should have the following columns: User's name, grant number (for NIH awards list the grant numbers 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. 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; NIH-funded users (Major and Minor) should use the instrument at the level of 75% of the AUT.

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.

• Administration (Organizational/Management Plan): Describe the organizational plan to administer the grant. Describe how the instrument will be utilized, how requests to use the instrument will be made, how time will be allocated among Major and Minor Users, how other projects and new users will be enlisted. Describe how users will be trained in experimental design, instrument operation and data analysis. Describe typical day-by-day management of the instrument.

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.

• Financial plan: Submit a specific financial plan for the long-term operation and maintenance of the instrument. Explain how various operational costs will be met; specifically, costs associated with routine operation and maintenance of the instrument, and costs for 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 amount are required; for years 2 - 5 approximate amounts are recommended.

Typically, during year one, the maintenance costs are fully covered by one-year manufacturer's warranty. In subsequent years, costs of maintenance must be considered in the financial plan.

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

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

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

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

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

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

• Institutional Commitment: Describe the institutional infrastructure available to support the instrumentation, including space to house the instrument and site for sample preparation, if applicable. Confirm the institutional support toward the maintenance and operation of the instrument. In particular, confirm that the institution will commit to provide backup of the financial plan for five years from installation of the instrument or for its effective lifetime. Describe institutional support for personnel. The 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.

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:

• Letters from institutional officials;
• Institutional back-up for the proposed financial plan;
• Letters about inventory of instruments at the institution which are unavailable to the PD/PI (as noted in the Justification of Need Section).
• The institution (i.e., the entity with the same DUNS number as the applicant’s institution) must also provide a table that includes information about performance of all previous S10-awarded instruments within the past five years; that is, FY 2014 - 2018. The table should have the following columns:
  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.
• Letter from Biosafety Official. If human, animal, or infectious materials, which could create a potential biohazard, are to be analyzed, a signed letter from the institutional biosafety officer stating the proposed containment plan was reviewed and adheres to documented biosafety regulations. If relevant, this letter is required in the application.

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

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

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

Appendix materials are not allowed for this FOA.

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

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

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 SIG application, the applicant must provide a strong justification for the requested Federal funds. This justification must demonstrate that the leased instrument is considered state-of-the-art at the time of submission - appropriate award adjustments may be necessary. Execution of a purchase order or agreement, making a down payment or other formal commitment to purchase the equipment prior to award will automatically eliminate an applicant from eligibility for an award.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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.

Section V. Application Review Information

1. Criteria

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

Overall Impact/Benefit

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.

Scored Review Criteria

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

Justification of Need

Is the need for the instrument clearly and adequately justified? Is the equipment essential and appropriate? Are all specific features, special accessories, and the software configuration of the requested instrument well justified, in particular, by their need 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? Justification of selection of the proposed instrument may include, but is not limited, to comparison with other commercially available instruments of similar function.

Technical Expertise
Does the institution have the technical expertise to make effective use of the requested equipment? How well-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 three 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? 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?

Institutional Commitment

Does the institutional commitment letter provide support in the event of a shortfall of income? Is the institutional commitment to back-up the financial plan provided for a time period consistent with the expected effective lifetime of the requested instrument? Is the management of awarded S10 instruments adequate[1] (based on the data in the table of Previously Awarded S10 Instruments in the institutional Letter of Support)? Does the Institution provide adequate infrastructure support for the requested instrument including space to house the instrument and site for sample preparation, if needed?

Additional Review Criteria

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

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

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.

Applications from Foreign Organizations

Not applicable.

Select Agent Research

Not applicable

Resource Sharing Plans

Not applicable.

Authentication of Key Biological and/or Chemical Resources:

Not applicable

Budget and Period of Support

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications 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 balances among various types of supported instruments and geographical distribution of awards

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

Applicants should ignore eRA Commons system-generated just-in-time (JIT) requests which are typically sent soon after peer review. If an application is considered for funding, ORIP SIG Program staff will send PD/PI special instructions on how to submit a JIT update, from the e-mail address [email protected]. 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.

2. Administrative and National Policy Requirements

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

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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.

Not Applicable

3. Reporting

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

At the expiration of the grant, a Final Research Performance Progress Report (Final RPPR) is required that describes the purchased instrument, and a list of all users and description of the value of the instrument to the investigators and to the institution as a whole. The following information about the award and the instrument must be included in the SIG Final RPPR:

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

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

3) Funding Period

4) Name of Instrument (including manufacturer and model)

5) Total Purchase Cost

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

Annual Instrument Usage Report

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

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

Section VII. Agency Contacts

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

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 grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Alena Horska, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0772
Email: [email protected]

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

Gavin Wilkom, M.I.M.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0964
Email: [email protected]

Section VIII. Other Information

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

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