Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title
Modern Equipment for Shared-use Biomedical Research Facilities: Advancing Research-Related Operations (R24 Clinical Trials Not Allowed)
Activity Code

R24 Resource-Related Research Projects

Announcement Type
New
Related Notices

Funding Opportunity Announcement (FOA) Number
PAR-21-326
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.351
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites qualified academic or research institutions to apply for support to purchase and install advanced equipment to enhance and modernize research-supporting operations of biomedical research facilities. Targeted are core facilities, animal research facilities, and other research spaces that are used on a shared basis. The goal of this FOA is to strengthen research-auxiliary activities of biomedical research facilities and to enhance the efficacy of their operation. To ensure proper installation and functioning of the equipment, minor alteration and renovation (A&R) efforts can be included as a small component of the budget.

Key Dates

Posted Date
September 24, 2021
Open Date (Earliest Submission Date)
November 01, 2021
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
December 01, 2021 Not Applicable Not Applicable March 2022 May 2022 June 2022

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

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

Expiration Date
December 02, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) invites qualified institutions to seek funds to modernize the functions and operations of existing research facilities through the purchase and installation of advanced equipment that will enable a broad range of research-supporting and auxiliary activities. Any equipment supported by this FOA must be placed in a core facility, animal research facility, or similar shared-use space to ensure broad benefits for the institutional research community. Moreover, any request must be justified by research-related demands for the modernization of research-supporting functions or for the advancement of operations of the facility.

NIH recognizes that modern physical infrastructure is indispensable for the advancement of biomedical research. Laboratory spaces or animal facilities i) employ a wide range of technical solutions to create well-controlled environments, ii) furnish research spaces with equipment to facilitate and optimize research-supporting activities, iii) and provide tools that assist in facility operations.

The objective of this FOA is to support the acquisition of modern equipment needed to improve or streamline operating processes and procedures in biomedical research laboratories and in animal research facilities. Providing access to such equipment can also expand the capacity of essential support services for evolving and emerging research programs. This FOA does not support the acquisition of scientific research instruments that acquire experimental data. Examples of scientific instruments include spectrometers, microscopes, biomedical imagers, cell analyzers, sequencers, and metabolic cages. Computer and data storage systems supporting scientific data collection, storage, and analysis are also not supported by this FOA. Such instruments can be requested through ORIP’s shared instrumentation programs. The text below gives examples of equipment supported by this FOA.

Animal research facilities are one of the targeted research spaces of this FOA. Examples of supported equipment include ventilated cages for rodents, aquatic animal systems equipped with water quality assessment tools, and automated feeding systems to aid in consistency and accuracy of animal care. Telemetry equipment to monitor animal well-being is another relevant example. Also, environmental management devices that can assist in the monitoring and customizing of environmental conditions, such as temperature, humidity, air flow, and lighting are appropriate for this FOA. Overall, an animal facility furnished with modern equipment and assisted by IT management tools can help to ensure robust and reproducible experiments, an area of particular concern in animal research.

Core laboratories and specialized facilities are other spaces targeted by this FOA. Without access to modern research facilities with well-controlled environments and furnished with specialized support equipment, many research functions are not feasible. Modern biobanking and cryopreservation systems, assisted with robotic arms and other high-throughput tools, are examples of such equipment. Equipment that, when connected to building systems, modernizes, streamlines, or improves the operating efficiency of the facility are also supported. This includes specialized autoclaves/sterilizers, glass washers, fume hoods, and biosafety cabinets. Also, isolators, bioreactors, anoxic and other environmental chambers are appropriate for this FOA. Computers or other electronics with specialized software can also be a part of the equipment request if they are required for operating or monitoring the performance of the equipment. Tools for collecting and managing environmental data are supported.

As illustrated above, equipment supported by this FOA differs in its functionality from scientific research instruments, but such equipment is critically needed to advance and accelerate the operations of research facilities and, as a result, contributes indirectly to the overall advancement of scientific research. Any equipment acquired under this FOA must benefit the larger biomedical research enterprise at the applicant institution. The application narrative should demonstrate that the request for the equipment is driven by the demands of active areas of biomedical research at the institution. The facility may serve investigators whose research is supported by NIH, other Federal agencies, private foundations, institutional funds, or other sources. Current NIH research funding is not a requirement for a successful application. When functional, the requested equipment should enable new capabilities, offer innovative technological solutions, or enhance support operations, as well as benefit the user community and multiple research projects of many investigators. Maintaining current functions and replacing broken equipment are not supported by this FOA.

The acquisition and installation of advanced equipment, or an integrated system of equipment, necessary to support specialized research-supporting activities must be a main part of the response to this FOA. An integrated system of equipment is one in which the components, when used in conjunction with one another, perform a function that no single component can provide. These components must be dedicated to their combined function and not used independently. Multiple items of the same equipment, such as cage racks, or containment isolators, are also permitted, but any request must be justified by the research-related demands on the facility and the operational capacities therein. Moreover, it is encouraged that all equipment requests adhere to the highest level of energy efficiency available for the particular item to reduce environmental impacts. General outfitting of the support space, for example, by purchasing unrelated pieces of equipment is not permitted under this FOA.

Acquisition costs of the equipment must be a significant portion of the application budget. Limited-in-scope alterations and renovations (A&R) are allowed. In such cases, the A&R should be a small part of the budget and must be directly related to ensuring the proper installation and function of the requested equipment – see Section III.3. Additional Information on Eligibility for the specifics of this requirement.

All applicants are strongly encouraged to reach out to the Scientific/Research Contact(s) before submission of an application to discuss the equipment requests and eligibility criteria.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets must reflect the actual needs of the proposed project. The maximum award budget is $400,000 of direct costs. Applications with a a request of direct costs less than $25,000 will not be considered. For requests of multiple pieces of the same or different equipment, the minimum budget for any given piece is $10,000. Since the scope of different projects will vary, it is anticipated that the size of the awards will vary. A&R support for minor projects may be included, if applicable, but shall not exceed 15% of the equipment costs (after educational discount is applied) or $40,000 whichever is smaller.

Personnel costs are limited to the PD/PI only and are applicable to the cases when A&R support is justified. The PI’s effort level should be commensurate with the scope of the A&R project and is expected not to exceed 0.36-person month.

Award Project Period

The total project period may not exceed one year. Funds will be provided in a single award with a up to 12-month budget and project period.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

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

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

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

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

The PD/PI does not need to have an NIH research grant or any other research support. The PD/PI may be a core or an animal research facility 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. Typically, the PD/PI will be a scientist with a leadership role in overseeing or managing the shared-use facility and relevant scientific or technical expertise (documented in the biographical sketch) related to the requested technology.

Multiple PDs/PIs are not allowed under this FOA.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

Location – Shared-use Facility

The equipment must be placed in a core facility, an animal research facility, or other shared used space to ensure that it supports research-related needs of a broad institutional research community. A letter from a high-ranking institutional official (e.g., Dean, Provost, President) indicating institutional financial support for the operations of the shared facility must be included.

Quotes

A valid quote (for each requested item) from the commercial vendor with one-year free warranty and appropriate academic discounts, is required and must be included in the application. The quote must specify the model number, describe the technical requirement for the installation and operation, and itemize accessories, as applicable.

Letter from the Director of Planning, Design and Construction

A letter from the Institutional Director of Planning, Design and Construction (or equivalent) is required. The letter should state (with supporting details) that space and the utilities are appropriate for the installation and functioning of the requested equipment – if no A&R are proposed, or that the proposed modifications are technically feasible and appropriate to make the requested equipment functional.

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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments (Required)

Other Attachments do not count towards the page limit but please do not include additional text to circumvent that limit.

1) Itemized valid manufacturer’s quote(s) and budget justification. Provide quotes from manufacture(s) for all items of equipment requested. Also, describe and justify any costs associated with the installation of the equipment and the modification of space or building systems (as applicable) to ensure proper functioning of the equipment.

2) A letter from a high-ranking institutional official (e.g., Dean, Provost, President) indicating institutional financial support for the operations of the shared facility and research activities conducted therein. If any term-limited software licenses are requested, a detailed financial commitment to support renewal of licenses in outward years must be demonstrated.

3) An 8.5” x 11” (letter size) image of the floor plan – see Research Plan section for details.

4) A letter from the Institutional Director of Planning, Design and Construction (or equivalent) - see the Additional information on Eligibility for the content of this letter.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Modular budget is not allowed for this FOA.

R&R Subaward Budget

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

Subawards are not allowed for this FOA.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

The Research Plan should describe i) the shared-used facility where the proposed equipment will be installed, ii) demonstrate novel capabilities or operational innovation that will be enabled by the equipment, iii) justify the request by research-related needs, iv) and describe long-term plans for the maintenance and usage of the equipment.

The Description of the Facility should include information about the location of the facility, areas of research supported, types of research services offered, and the research community that depends on services provided by the facility. The PD/PI should demonstrate that the facility is used on a shared basis and describe its role in supporting the institutional research enterprise. The areas of science supported by the facility should be outlined to illustrate how the equipment request is driven by research-related demands. Research supported by NIH, other Federal agencies, private foundations, or other sources should also be summarized. Deficiencies of the facility’s existing physical infrastructure, that limit the services it offers and the research-related activities it supports, should serve as the basis for the justification of the modernization needs.

The Modernization Plan should describe the equipment requested and demonstrate that the chosen model(s), when installed, will optimally address current deficiencies, and meet research-driven demands. Technical specification of the equipment together with its demands on building systems (HVAC, electrical, plumbing) should also be described to demonstrate the feasibility of the project. The use of green technologies offering savings in energy, water, and other functional efficiencies should also be addressed.

The proposed location of the equipment should be described.

In addition, a floor plan indicating the proposed location of the equipment must be attached – see required Other Attachment 3) – to demonstrate that the location meets the space and accessibility requirements for the operations of the equipment. If A&R of the space or modifications of utilities are required for the proper installation and functioning of the equipment, the floor plan (required to be uploaded in Other Attachments) must indicate the proposed changes to demonstrate that architectural and engineering standards will be met. Challenges associated with refurbishing or altering of space should be described along with their proposed solutions in this Research Plan narrative. Do not include such text directly on the floor plan to circumvent the page limits. A letter from the Institutional Director of Planning, Design and Construction (or equivalent) in Other Attachment 4) should complement the text in this section and information on the floor plan. The letter should state (with supporting details) that space and the utilities are appropriate for the installation and functioning of the requested equipment – if no A&R are proposed, or that the proposed modifications are technically feasible and appropriate to make the requested equipment functional.

Issues related to the management of access to, operating the equipment, and long-term maintenance should also be addressed to demonstrate the utility of the project.

If personnel costs related to the A&R project are requested, the text should outline the PD/PI’s responsibilities related to overseeing of the project and justify the level of the related effort.

Justification of the Equipment Requested should describe how the proposed equipment will remedy the infrastructure’s deficiencies, improve the facility’s operations, modernize the facility’s environment, or streamline its management. If the project is located at an animal research facility, planned improvements in animal management, maintenance, or care should be presented and connected (as applicable) to improvements in the rigor, reproducibility, and translation of the animal-based research.

If applicable, the PD/PI should describe NIH-funded research awards that will benefit from the project. The PD/PI should demonstrate broader benefits for the user community. To add to the justification, the PD/PI should also demonstrate how the project will benefit institutional biomedical research programs over the long term.

Especially, if multiple items of the same type of equipment are requested, the narrative should show the need for that capacity in the context of the facility’s operations and services. Similarly, if an integrated system is requested, specific workflows that would be enabled by the configuration must be described in detail and justified by the research-related demands of the facility users. If a time-limited software license is requested, a financial commitment towards its renewal in outward years must be also documented in a support letter from a high-ranking institutional official – see required Other Attachment 2).

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

A&R Costs

A&R costs are limited to efforts related to modifications of utilities or space required for the installation and proper functioning of the equipment. This FOA limits the scope of A&R efforts to (15% of the costs of the requested equipment or $40,000 whichever is smaller). If the requested equipment is a part of a broader modernization project, a letter from a high-ranking institutional official must document the project.

Personnel Costs

The personnel costs are limited to the PD/PI only and are applicable to the cases when A&R support is justified. The PD/PI’s effort level should be commensurate with the scope of the A&R project and is expected not to exceed 0.36-person months.

Non-allowable Costs include:

  • Scientific instruments such as microscopes, spectrometers, biomedical imagers, cell analyzers, sequencers, and metabolic cages
  • Office furniture
  • Disposables/consumables and supplies
  • Equipment used for clinical (billable) care
  • Equipment that is not commercially available and does not have a manufacturer’s warranty valid for at least one year
  • Institutional administrative management systems, clinical management systems
  • Development of novel technologies
  • A&R costs that are not directly related to the installation or functioning of the requested equipment
  • Personnel costs (other than limited to overseeing the minor A&R project requested in this application)

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

 

Post Submission Materials

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

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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. For example, a project that by its nature is not innovative may be essential to advance a field.

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for this FOA:

Does the project address an important area in need of modernization? How will successful completion of the project enable advancement in operations of the facility or improve its efficiencies? How will the project benefit the shared-use facility, NIH-funded biomedical research, or the larger biomedical research enterprise at the applicant institution? How will the project remediate infrastructure deficiencies?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for this FOA:

Does the PD/PI have scientific or technical expertise in research fields supported by the facility? Does the PD/PI have the scientific or technical expertise required to operate and oversee the use of the equipment? Does the PD/PI have suitable standing within the institutional structures to oversee and successfully complete the project? How well justified is the PD/PI’s level of effort related to overseeing the requested A&R project (as applicable)?

 

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for this FOA:

Does the project offer innovative technical solutions/technologies? Does the project implement green technologies? Does the project propose creative solutions to streamline operations, modernize services of the facility, or provide new capabilities, as opposed to general outfitting of the space? If the modernization of an animal facility is proposed, will the project contribute to the maintenance of the well-described and robust animal models needed to support high-quality research?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for this FOA:

Is the requested equipment well-justified by research-related needs and functions of the facility? Will the project, if accomplished, deliver solutions to mitigate existing deficiencies of the facility that go beyond basic outfitting of the facility? How will the project modernize, optimize, or add new capabilities to the operations of the facility? Are alternative solutions explored and the proposed approaches contrasted with them? How well will the available utilities and existing infrastructure support the requested equipment? How well are the technical considerations of modification of utilities and alteration of space described (as applicable)? How well will these technical solutions meet the demands for the installation and proper functioning of the equipment? How well will the equipment be utilized?

 

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Will the institutional environment in which the facility will operate contribute to the probability of success in facilitating the research projects it serves? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the facility proposed? Will the equipment benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

In addition, for this FOA:

How efficiently is the facility operated and how responsive is it to users’ needs? How well does the facility serve the institutional research community and user groups? How well aligned is the institutional commitment towards the facility with the long-term research support needs? How well will the equipment be managed?

 

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.

   

For research that involves human subjects but does not involve one of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

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.

 

Not Applicable

 

Not Applicable

 

Not Applicable

 

Additional Review Considerations

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

 

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 assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

 

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).

 

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

 

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.

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 will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Council of Councils . 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 distribution of various types of supported facilities and equipment.
  • 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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.

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.

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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that 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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

Karen Duca, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-4511
Email: karen.duca@nih.gov

C. Ashley Barnes, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0783
Email: ashley.barnes@nih.gov

Peer Review Contact(s)

CSR FOA Peer Review Contact
Center for Scientific Review (CSR)
Email: foa_reviewcontact@csr.nih.gov

Financial/Grants Management Contact(s)

Gavin Wilkom, M.I.M.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-7078
Email: wilkomg@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.


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