Utilizing Equipment to Study Environmental Extrinsic Factors and Enhance Rigor and Reproducibility of Animal Research (R24, Clinical Trials Not-Allowed)

Utilizing Equipment to Study Environmental Extrinsic Factors and Enhance Rigor and Reproducibility of Animal Research (R24, Clinical Trials Not-Allowed) is sponsored by NIH. Supports research to enhance rigor and reproducibility in animal research through equipment utilization.

PAR-24-167: Utilizing Equipment to Study Environmental Extrinsic Factors and Enhance Rigor and Reproducibility of Animal Research (R24, Clinical Trials Not-Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 Utilizing Equipment to Study Environmental Extrinsic Factors and Enhance Rigor and Reproducibility of Animal Research (R24, Clinical Trials Not-Allowed) R24 Resource-Related Research Projects June 17, 2025 - Notice of Change to the Instructions for Purpose and Scope in PAR-24-167 "Utilizing Equipment to Study Environmental Extrinsic Factors and Enhance Rigor and Reproducibility of Animal Research (R24, Clinical Trials Not-Allowed)".

See Notice NOT-OD-25-125 March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 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 . Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3.

Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The Office of Research Infrastructure Programs (ORIP) invites grant applications from core facilities, resource centers, animal vivaria, or individual investigators of other shared resources to systematically study the roles of critical environmental extrinsic factors in biological, behavioral, and treatment studies using animal model species, with the objective of enhancing the rigor and reproducibility of animal research.

The research area must be broadly applicable to the scientific interests of two or more NIH Institutes or Centers (ICs) and must evaluate the biological processes that impact multiple organ systems in order to align with the ORIP’s NIH-wide mission and programs. The program supports the acquisition or update of modern equipment for measuring, monitoring, recording, and reporting environmental, biological or biobehavioral variables.

The equipment requested must be capable of recording and reporting multiple parameters simultaneously. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

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 How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Rigor and Reproducibility in animal studies are key to the successful application of knowledge towards improving health outcomes.

It is known that a rigorous animal study design must consider intrinsic variables related to animal models such as sex, age, and genetic background as well as extrinsic factors related to animal facilities including environmental conditions such as temperature, humidity, noise, and lighting (brightness and light/dark cycle) as well as housing conditions such as size and material of cages/pens/tanks, housing density (number of animals per cage/pen/tank), spacing between cages/pens/tanks, bedding material and density, and cleaning schedules.

However, the effects of extrinsic factors are complex, involve multi-level interactions, and are understudied and under-documented.

A final report of an Advisory Committee for the NIH Director, charged to advise how NIH can help researchers improve the rigor, transparency, and reproducibility of research involving animals, recommended that “NIH should encourage and support work to better understand, monitor, record and report important extrinsic factors related to animal care that may impact research results” ( https://acd. od. nih.

gov/working-groups/eprar. html , 2021).

ORIP, in collaboration with other NIH ICs, recently organized a three-day workshop entitled “Enhance Rigor and Reproducibility in Animal Research by Managing Extrinsic Factors” to identify gaps, opportunities, and new approaches in husbandry of commonly and widely used animal models; to gauge the roles of relevant environmental factors and conditions on animal study outcome; and to explore the need for novel instruments, equipment, and infrastructure for animal research core facilities ( https://orip.

nih. gov/about-orip/workshop-reports , 2022). It was concluded that systematic studies are needed to provide crucial data regarding the impact of environmental extrinsic factors on rigor and reproducibility of animal research.

This Notice of Funding Opportunity (NOFO) addresses the gap of needed research equipment and rigorous study design to systematically investigate extrinsic factors and their impact on experimental outcomes in animal research.

Therefore, proposed studies and outcomes must be applicable to two or more NIH ICs and must be relevant to multiple research areas, diseases, or processes that impact multiple body systems over the lifespan of the animal model.

Projects should focus on animal species which are most widely used by the biomedical community such as zebrafish for aquatic species, mice and rats for rodents, and pigs and rhesus macaques for large animal species. Studies must include monitoring and managing of extrinsic factors with potential significant impact on biological outcomes.

Priority will be given to proposals providing high quality preliminary data indicating potential effect(s) on rigor and reproducibility of the proposed research. Proposed projects are also expected to support the purchase of modern equipment to manage, measure, and study relevant extrinsic factors in rigor and reproducibility of animal studies.

Furthermore, applications must address the need for the proposed equipment and to study extrinsic factors critical for the biomedical research community. The application must describe the resource gaps and needs, including key extrinsic factors and housing environments depending on animal model, as well as equipment and modern technology for monitoring and studying the impacts of extrinsic factors and housing environments.

The emphasis should be on state-of-the-art technologies and equipment that can monitor and report multiple parameters simultaneously. Priorities will be given to proposals that allow longitudinal real time assessments.

To foster a collaborative multidisciplinary environment and promote cost effectiveness, the equipment should be integrated into a core facility, resource center, animal vivaria, or other shared resource if the application is from an individual investigator.

Applications that monitor and study the impact of single extrinsic factor on research outcomes or that predominantly address the research interests of one NIH IC but are only peripherally related to the research interests of other ICs will not be acceptable for this NOFO.

Applications responding to this NOFO should: Record and study effects of more than one extrinsic factor that impacts the outcome, rigor and reproducibility of animal research. Describe the potential impact of proposed study outcomes and associated recommendations on the broad biomedical research community, and the relevance of the generated resources and technologies/tools to related scientific disciplines.

Describe plans to document, analyze and share results of the proposed studies with the biomedical research community. Examples of research projects suitable for this NOFO, include, but are not limited to: Studies of critical environmental extrinsic factors related to experimental conditions using animal models that affect the reproducibility and rigor of basic and translational studies.

Examples of such extrinsic factors include but not limited to water quality, temperature, lighting parameters and regimen, movement or vibration, and noises. Studies to investigate how biological mechanisms are affected by specific extrinsic factors that are mediating physiological responses and contributing to rigor and reproducibility.

Studies using Smart tank/cage systems to investigate the experiment outcome under various animal housing, husbandry, and environmental conditions. Of special interest are development of the AI approaches for the complex data analysis and interpretation.

Development of measurable biomarkers, behavioral changes, and physiological parameters affected by extrinsic factors that enhance animal well-being, research reproducibility, and translational relevance of animal models. Examples of projects that WILL NOT be supported under this NOFO include: Studies that relate strictly to one specific disease or research area or are primarily relevant to the mission and programs of a single NIH IC.

Studies which use animal model species other than zebrafish for aquatic species, mice and rats for rodents, and pigs and rhesus macaques for large animal species. Research studies and equipment that focus only on one extrinsic factor or record and analyze a single biological parameter. Projects in which the requested equipment is not well justified and not capable of conducting multiparameter testing and recording of extrinsic factors.

Program Directors/Principal Investigators (PD/PIs) planning to submit applications to this NOFO are strongly encouraged to contact the scientific contacts prior to submission (see Scientific/Research Contacts in Section VII. Agency Contacts) about the responsiveness and appropriateness of their potential application. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance 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 How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. 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. Application budgets are not limited but need to reflect the actual needs of the proposed project.

Applicant can request up to $400,000 in direct cost for the purchase of equipment and research activities in the first year and up to $400,000 in direct costs for research activities for each subsequent year. The maximum duration of the proposed project is 4 years and must be justified by the need of the project.

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 Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information 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 SAM. gov 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 Grants. gov 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.

Grants. gov – Applicants must have an active 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 their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1. 2 Definition of Terms.

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). 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 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 How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Specific Aims: State concisely the research goals of the proposed project and summarize the expected outcome(s), including the impact of the results on various research field(s).

Describe the critical need for the proposed equipment. Provide preliminary or published data, if available, that indicate potential effect(s) of the extrinsic factors to be investigated on rigor and reproducibility of animal studies. Describe plans to test the effects of study outcomes on the rigor and reproducibility of animal studies (see: https://www.

nih. gov/research-training/rigor-reproducibility ) whenever appropriate for the model system used; describe approaches, if available, for analyzing potential sex differences of study outcomes on the rigor and reproducibility of animal studies.

Describe the rationale for assays and functional analyses proposed to evaluate the mechanism underlying the effects of extrinsic factors on physiological and behavioral outcomes in experimental conditions using animal models. Provide experimental details and available expertise. Describe the strengths and limitations of each assay and functional analysis, plans to validate the results, and alternative strategies if not successful.

Describe how extrinsic factors will be monitored, managed, recorded and analyzed using innovative computational approaches. Justify the need for the requested equipment. To promote cost effectiveness, describe efforts to encourage optimal sharing and foster a collaborative multidisciplinary environment regarding the requested equipment.

These efforts can include integration of equipment in a core facility, resource center, animal vivaria or other shared resource if from individual investigators. Statistical and analytical approaches should be described clearly and completely. Comment on the potential impact of the research data and information generated on the broad biomedical research community.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - 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 How to Apply - Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Animal strains/stocks and biomaterials used should be held to the highest standards to optimize reproducibility of studies and assure scientific rigor and transparency; all strains/stocks should be thoroughly characterized and documented and include additional quality control measures.

A critical component of improving research reproducibility is to develop approaches for unique identification of the research resources in public databases, including publications. If applicable, applicants should register catalogs of their resources with current resource tagging and identification initiatives, such as FORCE 11 ( https://force11. org/group/resource-identification-initiative/ ).

Applicants should also work with investigators to encourage the use of Research Resource Identifiers (RRIDs) assigned by SciCrunch (h ttps://scicrunch. org/res ources) in their publications and reports. Appendix: Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

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 How to Apply - Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. 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.

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 Grants Policy Statement Section 2.

3. 9. 2 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 How to Apply – Application Guide . 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7. 9.

1 Selected Items of Cost . 7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide .

Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Section III.

Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance.

For assistance with application submission, contact the Application Submission Contacts in Section VII. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 How to Apply - 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 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 NOFO, note the following: 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).

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? Specific to this NOFO: Will the proposed project systematically study the roles of critical environmental extrinsic factors play in biological, behavioral, and treatment studies using animal models?

Will the information generated have the potential to serve the needs of investigators in a variety of research areas? Will the application be able to improve rigor and reproducibility of animal studies? Was sufficient justification provided to support proposed purchase or update of the equipment to monitor, manage and record extrinsic factors?

Do the proposed resources or resource-related research aims meet the needs of broad research areas supported by two or more NIH ICs? 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?

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? Are the effects of proposed extrinsic factors understudied and under-documented? 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? Specific to this NOFO: Were adequate plans to test the effects of study outcomes on the rigor and reproducibility of animal studies provided?

Was a sufficient rationale for assays and functional analyses proposed to evaluate the mechanism underlying the effects of extrinsic factors on physiological and behavioral outcomes in experimental conditions using animal models provided? Were the strengths and limitations of each assay and functional analysis, plans to validate the results, and alternative strategies if not successful described?

Did the proposal describe how extrinsic factors will be monitored, managed, recorded and analyzed using innovative computational approaches? Will the equipment provide longitudinal real-time monitoring and reporting of