Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title
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
Reissue of PAR-22-190
Related Notices
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Notice of Funding Opportunity (NOFO) Number
Companion Funding Opportunity
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.351, 93.859
Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) invites qualified academic or research institutions to apply for funding support to purchase latest equipment that will enhance and modernize research-supporting operations of existing shared biomedical research facilities. Targeted are laboratory research core facilities, animal research facilities, and other similar shared-use research spaces. The goal of this NOFO is to strengthen research-auxiliary activities of biomedical research facilities and to enhance the efficiency of their operations.

The NOFO does not support the purchase of scientific research instruments or their components, nor components of building-level infrastructure equipment that indirectly support research activities.

Key Dates

Posted Date
October 12, 2023
Open Date (Earliest Submission Date)
October 15, 2023
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
November 15, 2023 Not Applicable Not Applicable March 2024 May 2024 July 2024

All applications are due by 5:00 PM local time of applicant organization. 

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
November 16, 2023
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 How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This Notice of Funding Opportunity (NOFO) invites qualified institutions to seek funds to transform or improve the operations of existing shared research facilities through the purchase and installation of latest equipment that enable and enhance a broad range of research-supporting activities. Any equipment supported by this NOFO must be substantially used in a laboratory research core facility, animal facility, or similar shared-use research 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 facility operations. This NOFO does not support the purchase of scientific instruments or their components, nor components of building-level infrastructure equipment that indirectly support research activities (such as HVACs or power generators).

NIGMS will co-fund applications from higher education institutions that award undergraduate (B.S. or B.A.) and/or graduate degrees in biomedical sciences and have received no more than $6 million dollars per year (total costs) from NIH Research Project Grants (RPGs) in each of the preceding two fiscal years, calculated using NIH RePORTER, at the time of the application.  Applications to be considered must support research aligned with the NIGMS mission. Applications for research capacity building in Institutional Development Award (IDeA)-eligible states will be considered.  

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

The objective of this NOFO is to support the acquisition of latest, technologically advanced equipment needed to advance the operational efficacy, productivity, and throughput; improve energy efficiency, enhance or streamline operating processes and procedures in core laboratories, animal research facilities, or other shared-use research support space. Providing access to such equipment can also expand the capacity of essential support services for evolving and emerging research programs. Maintaining current functions, replacing broken equipment, and routine upgrading are not supported by this NOFO. This NOFO does not support the acquisition of scientific research instruments that acquire experimental data or any other instrument directly involved in experimental processes that lead to data collection. Some examples of such excluded instruments include, but are not limited to, spectrometers, microscopes, biomedical imagers, cell analyzers, sequencers, PCR machines, chromatography equipment, and metabolic cages. Computer and data storage systems supporting scientific data collection, storage, and analysis are also not supported by this NOFO. These instruments may be requested through ORIP’s shared instrumentation programs.

Animal research facilities are one of the targeted research areas of this NOFO. Examples of supported equipment for animal facilities include, but are not limited to:

  • Multi-functional ventilated cages and/or cage racks for small animals
  • Specialized caging system for large animals
  • Aquatic animal systems equipped with water quality assessment sensors
  • Automated feeding or watering systems to aid in consistency and accuracy of animal care
  • Robotics and automations for animal facility operation
  • Advanced, environmental-friendly, high performing or high-throughput systems such as cage, rack, bottle, and tunnel washers

A particular research interest that this NOFO supports is the modern equipment that enables detection, measurement, monitoring, recording, and reporting environmental extrinsic factors to allow experiments reproducibly conducted under similar environmental conditions and animal care, husbandry settings. Certain pieces of modern equipment used in shared animal research facilities may help assess environmental factors that potentially impact rigor and reproducibility of research procedures and outcomes. The research activities and related outcomes may be affected by environmental factors that potentially affect animal husbandry, welfare, fertility, growth, physiology, bio-behavior, and general health. These environmental extrinsic factors include, but not limited to, lighting of animal cages, ventilation, vibration, population density, aquatic animals tank size, water quality and pathogen exposure, as well as social interaction and environmental enrichment for higher animal species such as nonhuman primates. Therefore, this NOFO encourages the use of novel and modern equipment to detect, monitor, quantify, record, analyze in real-time and report these factors, as well as equipment that incorporates features to allow longitudinal assessment of environmental factors.

Examples of supported equipment that align with this interest include, but are not limited to:

  • Veterinary care devices and veterinary diagnostic systems
  • Telemetry equipment to monitor cage conditions and/or animal well-being for purposes of animal husbandry (not experimental data collection)
  • Environmental management devices that assist in the monitoring and customizing of environmental conditions, such as temperature, humidity, air flow, and lighting\

Core laboratories and specialized facilities are other spaces targeted by this NOFO. Without access to modern research facilities with well-controlled environments and furnished with specialized support equipment, many research functions are not feasible. Examples of supported modern laboratory research equipment include, but are not limited to:

  • Modern biobanking or cryopreservation equipment
  • Freezers assisted by robotic arms or other forms of automation
  • Biosafety cabinets
  • Fume hoods
  • Incubators
  • Centrifuges
  • Autoclaves or other sterilizers
  • Cryogenic gas recovery/recycling equipment (servicing two or more instruments)
  • Environmental chambers, isolators, or other chambers designed to create specialized environments
  • Bioreactors
  • Lyophilizers
  • Liquid dispensers or other automated sample preparation equipment (single piece of equipment)
  • Cryostats or other tissue sectioning equipment
  • Single piece, integrated slide staining equipment (multiple pieces for single steps in the process are not allowed)
  • Nucleic acid extraction equipment
  • Peptide or oligonucleotide synthesizers
  • 3D Printers
  • Automated cell processing equipment
  • Water purification/treatment equipment (in lab, not for an entire building)

Other equipment that modernizes, streamlines, or improves the operating efficiency of the facility is also supported. Computers or other electronics that are built into the equipment with specialized software may also be a part of the equipment request if and only if they are inseparable from the requested equipment.

Equipment supported by this NOFO 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 NOFO must benefit the larger biomedical research enterprise at the applicant institution and represent a technological step forward. 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 submission of an application. Once installed, the requested equipment should enable new and advanced 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, replacing broken equipment, and routine upgrading are not supported by this NOFO. Likewise, equipment that is normally considered to be a component of building infrastructure is not supported, e.g., HVAC systems, building-level water treatment systems, or back-up power supplies of any type. Any application that proposes general outfitting, clusters of equipment, scientific instruments or their components, and/or other non-allowed expenses will be deemed unresponsive to this NOFO and subject to withdrawal from review or consideration for funding. The acquisition of a single piece of latest equipment necessary to support specialized research-supporting activities is the goal of this NOFO. Moreover, only one facility can be supported; this NOFO does not support the upgrading of multiple facilities at a single institution. Only one type of equipment may be requested. Auxiliary items required for the physical operation of the major equipment piece are also permitted, e.g., a centrifuge with a rotor. Such auxiliary items must be dedicated to the main equipment piece, required for the main equipment piece to function, and not be capable of stand-alone operation. Multiple items of the same type of equipment are also permitted, e.g., cages racks with cages, but any request must be justified by the research-related demands on the facility and the operational capacities therein. Clusters of equipment serving a single or multiple support function(s) are not permitted, e.g., incubators, biosafety hoods, and centrifuges for cell culture. General outfitting of the support space, e.g., purchasing multiple pieces of different equipment is also not permitted under this NOFO.

Moreover, it is encouraged that all requested equipment adheres to the highest level of energy efficiency available to reduce environmental impacts.

All applicants are strongly encouraged to reach out to the Scientific/Research Contact(s) before submission of an application to discuss equipment requests and eligibility criteria. In addition, there is an FAQ and (archived) webinar providing additional guidance that can be viewed at ORIP's R24 Equipment web page.

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

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 NOFO.

Clinical Trial?

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

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 $350,000, direct costs only. Applications with a budget less than $50,000 will not be considered. For requests of multiple pieces of the same equipment, the minimum budget for each piece is $15,000. Auxiliary items required for the main equipment piece to function may be less. Since the scope of different projects will vary, it is anticipated that the size of the awards will vary.

Award Project Period

The total project period may not exceed one year. Funds will be provided in a single award with a 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 NOFO.

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)


  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
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 Grants Policy Statement Section Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • 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.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their registrations; 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.
  • – Applicants must have an active SAM registration in order to complete the 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 NOFO.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Number of Applications

Only one application per institution (normally identified by having a unique entity identifier (UEI) or NIH IPF number) is allowed. An institution that received an award under PAR-22-190 is not eligible to apply for this NOFO unless the previous award has been fully closed out by the date of submission, (November 6, 2023). In other words, only one active R24 support equipment award is permitted at a time.

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. Awards will only be made to facilities that are operational. If a facility is under renovation/construction at the time of proposal submission, a certificate of beneficial occupancy must be produced by May 1, 2024, in order to be considered for an award.

Letter from an Institutional Official

A letter from a high-ranking institutional official (e.g., Dean, Provost, President) indicating institutional financial support for the operations of the shared facility, as well as a commitment to continued software licensing beyond the first year, if applicable, must be included.


A valid quote (for each requested item) from the commercial vendor with a one-year warranty guaranteed by the manufacturer 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 the space and the utilities are appropriate for the installation and functioning of the requested equipment.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Workspace are available in Part 1 of this NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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 NOFO.

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 page limits.

1) Itemized valid manufacturer’s quote(s) and detailed budget justification. Provide quotes from manufacture(s) for the main piece of equipment and any auxiliary pieces, if applicable.

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) stating (with supporting details) that the space and the utilities are appropriate for the installation and functioning of the requested equipment.

5) A timeline (of one year duration) reflecting activities from receipt of Notice of Award to the end of the grant period.

6) (optional) An optional table of up to 12 active grants held by end-users of the facility may be included to demonstrate the need for the added support capacity. The table should include the following columns only: PI/PD, start date, end date, title, funding source, and annual direct costs. No more than 12 grants may be included in the table.

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 NOFO.

Only equipment direct costs are permitted; there is no F&A under this award. Shipping, vendor-provided installation, the first year of multi-year routine maintenance/service contracts, and a small amount of vendor-provided training are allowed, where necessary. These costs must be reflected in the vendor quote.

R&R Subaward Budget

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

Subawards are not allowed for this NOFO.

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, and iv) 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 in the facility’s existing equipment 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. If the facility will house live vertebrate animals, the facility design must be compliant with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and Guide for the Care and Use of Laboratory Animals (Guide) by balancing engineering and performance standards and setting a target for optimal practices, management, and operations while encouraging flexibility and judgment. All institutions are also required to comply, as applicable, with the standards described in the Animal Welfare Act, and other Federal statutes and regulations.

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 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, utility access, and any other requirements for the operations of the equipment. 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 in Other Attachments (4) should complement the text in this section and information on the floor plan. Issues related to the management of access to, operating the equipment, and long-term maintenance should also be addressed to demonstrate the feasibility of the project.

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 translatability 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 level of capacity in the context of the facility’s operations and services. Similarly, if auxiliary items are requested, the configuration must be described in detail and how the auxiliary items are required for the functionality of the main piece of equipment. If a time-limited software license is requested, a financial commitment towards its renewal in outward years must be also documented in the support letter from a high-ranking institutional official – see required Other Attachment (2).

Other Research Plan Section

End-user Letters of Support (LOS) are not required for this NOFO and should not be included. Reviewers will be instructed to disregard any LOS that are attached.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

  • A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

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

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

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 (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 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 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 Grants Policy Statement Section Electronically Submitted Applications.

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.

Non-allowable Costs include, but are not limited to:

  • Scientific instruments such as PCR machines, chromatography equipment, microscopes, spectrometers, biomedical imagers, cell analyzers, sequencers, and metabolic cages
  • Components of scientific instruments, e.g., NMR probes or detectors
  • Furniture
  • Disposables/consumables and supplies
  • Contractual services
  • Service contracts or other charges for routine maintenance/upkeep of the equipment or software licensing fees beyond the first year of the award
  • Equipment used for clinical/veterinary (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/scheduling systems, LIMS systems, and clinical management systems
  • Development of novel technologies
  • A&R costs and any other installation-related costs not part of the vendor quote
  • Removal costs of older equipment
  • Personnel costs
  • Travel costs
  • Equipment that is part of the building infrastructure, e.g., HVACs, plumbing, cabling, data ports, water treatment (building level), power generators, and back-up power supplies of all types

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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive 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.

For this particular announcement, note the following:

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.


Specific to this NOFO: 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, and/or the larger biomedical research enterprise at the applicant institution? How will the project remediate infrastructure deficiencies? Does the requested equipment take the facility to next level in terms of the technological solution, as opposed to simply replacing older equipment?


Specific to this NOFO: 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? 


Specific to this NOFO: Does the equipment or project revolutionize or enable operational breakthrough of the shared facility? Does the project offer innovative technical solutions/technologies unafforded by current technologies within the facility? Does the project implement green technologies? Does the project propose creative solutions to streamline operations, facilitate monitoring, reporting, and/or maintenance, 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 modernization of the facility with capabilities of detecting, measuring, monitoring, recording, and reporting environmental factors, or maintenance of the well-described and robust animal models needed to support high-quality, scientifically rigorous, and reproducible research?


Specific to this NOFO: 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 and take the facility to the next level? 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 will the equipment be utilized?


Specific to this NOFO: 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 Animals 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 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.

Not Applicable,


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


Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.


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

Not Applicable.


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

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 policies and practices, 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 NOFO. 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 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 2.4.4 Disposition of Applications.

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 NOFO 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see and

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 NOFO.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at 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. Data Management and Sharing

Not Applicable 

4. 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 NOFOs 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 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: (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: (preferred method of contact)
Telephone: 301-480-7075 Customer Support (Questions regarding registration and Workspace)
Contact Center Telephone: 800-518-4726

Scientific/Research Contact(s)

Xiang-Ning Li, M.D., Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-1744

Peer Review Contact(s)

Center for Scientific Review (CSR)


Financial/Grants Management Contact(s)

Kenneth Holiness
Grants Management Specialist
Phone: 301-480-6854

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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