Transformative Non-Invasive/Minimally Invasive Technologies for Imaging the Olfactory System Across Scales (R01 CT Optional) RFA-DC-27-003

Transformative Non-Invasive/Minimally Invasive Technologies for Imaging the Olfactory System Across Scales (R01 CT Optional) RFA-DC-27-003 is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD) and National Institute of Biomedical Imaging and Biomedical Engineering (NIBIB). This program supports research on transformative non-invasive or minimally invasive technologies for imaging the olfactory system.

While focused on imaging, it has implications for diagnostics related to sensory function.

RFA-DC-27-003: Transformative Non-Invasive/Minimally Invasive Technologies for Imaging the Olfactory System Across Scales (R01 CT Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Funding Opportunity Title Transformative Non-Invasive/Minimally Invasive Technologies for Imaging the Olfactory System Across Scales (R01 CT Optional) R01 Research Project Grant Check for any recent Notices of NIH Policy Changes that may impact application requirements.

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 National Institute on Deafness and Other Communication Disorders (NIDCD), with the National Institute of Biomedical Imaging and Bioengineering (NIBIB) aims to support the development and/or adaptation of transformative in vivo high-resolution/high specificity imaging of the human olfactory system.

Currently, there are limited non-invasive/minimally invasive technologies available for imaging the living human peripheral and central olfactory system with high spatial and temporal resolution. Imaging the olfactory system in the laboratory and in the clinic is essential to understanding underlying biological mechanisms as well as the etiology of an olfactory disorder.

Such imaging has proven challenging due to the olfactory system’s unique anatomical and functional characteristics such as restricted accessibility, multiple cell types, and low signal resolution. Addressing these challenges requires multimodal approaches including leveraging existing advanced tools and technologies and developing new tools tailored for the olfactory system.

Recent advances in minimally invasive and non-invasive imaging technologies, such as cell specific biomarkers, fluorescence imaging, specialized endoscopes, optical and acoustic imaging, molecular imaging, and hemodynamic and diffusion imaging have the potential to transform our ability to image and investigate the peripheral and central olfactory system in the living human with superior temporal and spatial resolution and eventually improve diagnostic accuracy of olfactory disorders.

Applications must leverage advanced non-invasive/minimally invasive imaging technologies to visualize peripheral (e.g., olfactory- and non-olfactory epithelium) and central olfactory (e.g., olfactory bulb) targets at a level previously unattainable. In addition, projects should engage multidisciplinary teams combining expertise in olfaction, biomedical imaging, biochemistry, bioengineering, and biophysics, as appropriate.

Funding Opportunity Goal(s) To investigate solutions to problems directly relevant to individuals with deafness or disorders of human communication in the areas of hearing, balance, smell, taste, voice, speech, and language.

The National Institute on Deafness and Other Communication Disorders (NIDCD) supports research and research training, including investigation into the etiology, pathology, detection, treatment, and prevention of disorders of hearing, smell, taste and other communication processes, primarily through the support of basic and applied research in anatomy, audiology, chemical senses, biochemistry, bioengineering, epidemiology, genetics, immunology, microbiology, molecular biology, the neurosciences, otolaryngology, psychology, pharmacology, physiology, psychophysics, speech-language pathology, and other scientific disciplines.

Open Date (Earliest Submission Date) 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 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.

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. Use Grants. gov 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 The purpose of this Notice of Funding Opportunity (NOFO) is to invite applications that focus on development and/or adaptation of transformative in vivo high-resolution minimally invasive or non-invasive imaging technologies that capture detailed visualization/characterization of human olfactory targets, from the nose to the brain, with superior temporal and spatial resolution or specificity than previously possible.

These techniques would provide clinicians with tools to determine whether a smell disorder stems from changes in the peripheral or central olfactory system, improving diagnostic accuracy, potential therapeutic development, and early identification of neurodegenerative disease.

Imaging the olfactory system in the laboratory and in the clinic is essential to understanding the biological mechanisms as well as the etiology of an olfactory disorder. However, there are currently limited non-invasive/minimally invasive technologies available for imaging the living human peripheral and central olfactory system with high spatial and temporal resolution or specificity.

The olfactory system presents unique technological challenges due to factors such as restricted accessibility, multiple cell types, and low signal resolution. Consequently, clinicians often resort to invasive surgical biopsies to assess the olfactory epithelium within the nasal cavity.

Addressing these technological challenges requires multimodal approaches that leverage existing advanced tools and develop new ones tailored specifically for the olfactory system. Recent advancements in minimally invasive and non-invasive imaging technologies have the potential to transform our ability to image and investigate the peripheral and central olfactory systems in living humans.

These technologies include cell specific biomarkers, fluorescence imaging, specialized endoscopes, optical and acoustic imaging, molecular imaging, hemodynamic and diffusion imaging. These advancements promise superior temporal and spatial resolution, which could eventually improve the diagnostic accuracy and treatment of olfactory disorders.

In September 2024, NIDCD collaborated with NIBIB to host a workshop on transformative non-invasive/ minimally invasive technologies for imaging the olfactory system across scales . The workshop included presentations from experts in the field of olfactory science and the field of imaging technologies.

Presentations highlighted key challenges for imaging the living human peripheral and central olfactory system with high spatial/temporal resolution or specificity and featured advances and opportunities in imaging technologies that range in depth, spatial resolution, temporal resolution, and availability of molecular probes.

In the peripheral olfactory system, advances in technologies such as photoacoustic tomography, dynamic micro-optical coherence tomography, and fluorescent markers offer non-invasive tools to obtain detailed images of the nasal lining and olfactory tissue.

Traditional in-vivo imaging technologies lack the resolution to differentiate between olfactory and respiratory epithelial tissues in the human nasal cavity due to their proximity to each other, their composition of multiple cell types, and the difficulty in reaching their location with non-invasive or minimally invasive methods. Fluorescence-based techniques may help address these challenges.

For example, preclinical studies show promise in using unique olfactory epithelial enzymes to turn non-fluorescent compounds into fluorescent markers. Although this technique has not yet been studied in humans, it could allow researchers to distinguish between respiratory and olfactory epithelial as well as between neuronal, stem, and supporting cell types.

In addition, recent advances in brain imaging techniques such as high-performance MRI scanners have improved our ability to study central targets such as the olfactory bulb, an area that remains difficult to image with traditional methods due to its small size, deep location, and interference from adjacent air pockets and bone.

Custom development of other brain imaging methodologies—such as metabolic imaging, molecular imaging, and diffusion imaging — could further enhance resolution, coverage, sensitivity, and chemical specificity in studying the olfactory system. Research Objectives and Scope Advances in imaging technologies hold great promise for the future of olfactory system research and clinical diagnostics.

By overcoming current limitations, these innovations could significantly improve our understanding and treatment of olfactory disorders. Applications submitted to this NOFO must leverage advanced non-invasive/minimally invasive imaging technologies to visualize peripheral (e.g., olfactory- and non-olfactory epithelia) and central olfactory (e.g., olfactory bulb) targets at a resolution previously unattainable.

Projects should engage multidisciplinary teams combining expertise in olfaction, biomedical imaging, biochemistry, bioengineering, biophysics, as appropriate. Note: only low-risk clinical trials will be funded through this mechanism. Low-risk clinical trials: Typically, do not require an Investigational New Drug (IND) or Investigational Device Exemption (IDE) from the FDA.

A clinical trial with an IND or IDE that is otherwise determined to be a low-risk trial may be considered.

Applications responsive to this announcement include, but are not limited to, the following general topics: Non-invasive high-resolution imaging of peripheral olfactory targets: Projects that focus on developing and/or adapting non-invasive, high-resolution techniques that allow real-time visualization of the entire olfactory epithelium in humans to help distinguish between peripheral and central causes of olfactory dysfunction.

Studies to develop sophisticated sensors and probes and other minimally invasive diagnostic tools to objectively assess olfactory status and dysfunction in the clinic, moving beyond traditional methods.

Projects that capitalize on recent advances in non-invasive approaches such as photoacoustic tomography, dynamic micro-optical coherence tomography, and fluorescence probes for visualizing and quantifying changes in shallow peripheral targets including the nasal and olfactory epithelium, potentially reducing the need for invasive biopsies and improving diagnostic accuracy.

Non-invasive imaging that provides cellular specificity: Projects that develop novel non-invasive imaging providing cellular specificity to visualize the differences between the olfactory and non-olfactory epithelium in living humans. Projects that combine deep learning methods with new fluorescence probes to enhance preclinical research and inform the development of diagnostic tools for olfactory loss.

Non-invasive high-resolution imaging of olfactory targets beyond the periphery: Projects that capitalize on recent advancements in brain imaging technologies for visualizing targets in the central nervous system, such as the olfactory bulb.

Brain imaging methodologies that are highly valuable to a holistic understanding of olfactory function, such as metabolic imaging, molecular imaging, and diffusion imaging, are of particular interest. Custom development of brain imaging methods to span a wide range of resolutions, sensitivities, coverage, and chemical specificity is essential for the comprehensive study of the olfactory system.

Technological integration: The integration of optical and acoustic technologies with high-performance f/MRI and computational tools to provide new insights into how the olfactory system functions, both peripherally and centrally. These tools should enable detailed visualization and characterization of olfactory targets and pathways.

Multi-scale studies that incorporate various levels of analysis, from microscopic to macroscopic scales, and a temporal dimension to understand olfactory changes over time.

Prior Consultation with Scientific/Research Staff Applications Not Responsive to this NOFO The following types of applications are not responsive to this NOFO and will not be reviewed: Applications that focus on imaging tools and technologies that have no explicit translation potential to image the olfactory system of living humans.

Studies that do not include innovative non-Invasive/minimally invasive technologies to enable new possibilities for imaging the olfactory system at a resolution not previously attainable. Studies in non-mammalian species. Studies that are considered high-risk clinical trials.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. 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. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards Issuing IC and partner components intend to commit an estimated total of $2 million to fund 2-3 awards per year. Application budgets are limited to $500,000 in direct costs each year. The scope of the proposed project should determine the project period.

The maximum project period is 5 years. 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 - Includes all types 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 Foreign Organizations/International Collaborations 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 not 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 the 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.

Foreign organizations must obtain a NATO Commercial and Government Entity (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. All PD(s)/PI(s) must be registered with ORCID .

The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

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 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 (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ). 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. 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.

An "Other Attachment" of up to 1-page entitled “Team management plan” must be included as a separate attachment in pdf format. NIH strongly encourages applicants to form multidisciplinary teams that combine expertise in olfaction, biomedical imaging, biochemistry, bioengineering, biophysics, as appropriate.

This multidisciplinary team should be able to address the details of the plans and experiments, and to execute the research strategy. An organizational structure that clearly defines the team structure and relationships among the various components should be described in the team management plan and illustrated in an organizational chart.

This plan should also describe the governance and organizational structure of the leadership team, including communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts.

For publications, policies to address the ordering and recognition of authors, and decisions about what material to publish, consistent with the interests of commercial partners (where applicable), should be presented. The team management plan should establish a Scientific Steering Group that consists of representatives from each of the partnering organizations and meets regularly to discuss project status, problems, and directions.

Those individuals identified in the team management plan, who together would have intellectual and leadership responsibilities, would likely be members of the Scientific Steering Group. Plans for enhancing the abilities and opportunities for investigators to work across disciplinary boundaries should also be included. Applications lacking this required item will be deemed incomplete.

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: Applications to this NOFO must focus on development and/or adaptation of transformative in vivo high-resolution minimally invasive or non-invasive imaging technologies that capture detailed visualization of human olfactory targets/tissues, from the nose to the brain, with superior temporal and spatial resolution than previously possible.

All applications are required to include the following points, which must be incorporated within the page limits of the Research Strategy: Describe the transformative tools and technologies to be developed or adapted for greatly improved visualization of olfactory targets/tissues, in the context of current challenges in assessing olfactory status and dysfunction in clinical settings and proposed novel solutions.

Detail performance improvements to include resolution, sensitivity, coverage, and cellular/chemical specificity compared to current capabilities, and their potential impact on diagnosis and treatment. If applicable, justify and detail non-human experimental components, explaining why non-human species are used and the translation potential and pathway to image the olfactory system in living humans.

Provide a detailed timeline and milestones for completion of tractable research goals, strategic goals, and key stages of progress for the project, including the technology translation into a clinical setting for non-invasive use with living humans. 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 .

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page .

The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. 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.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4.

1. 35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.

hhs. gov . 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 announcement, note the following: This R01 will support the development and/or adaptation and pre-clinical testing of transformative in vivo high-resolution minimally invasive or non-invasive imaging technologies that capture detailed visualization of human olfactory targets, from the nose to the brain, with superior temporal and spatial resolution than previously possible and ultimately improve diagnostic accuracy and treatment of olfactory disorders.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. Factor 1.

Importance of the Research (Significance and Innovation) Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.

Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study. Evaluate the extent to which innovation influences the importance of undertaking the proposed research.

Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field. Evaluate whether