NIDCD Research Grants for Translating Basic Research into Clinical Practice (R01 Clinical Trial Optional) is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD). Supports research grants aimed at translating basic research findings into clinical practice, including treatments for aphasia.

RFA-DC-25-002: NIDCD Research Grants for Translating Basic Research into Clinical Practice (R01 Clinical Trial Optional) 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 National Institute on Deafness and Other Communication Disorders ( NIDCD ) Funding Opportunity Title NIDCD Research Grants for Translating Basic Research into Clinical Practice (R01 Clinical Trial Optional) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity 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 4, 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 Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) provides an avenue for basic scientists, clinicians, and clinical scientists to jointly initiate and conduct research projects that translate basic research findings into clinical practice for better human health.

The scope of this NOFO includes a range of activities that will impact the diagnosis, treatment, and prevention of disorders within NIDCD’s scientific mission. Connection to the clinical condition must be clearly established and the outcomes of the proposed work must have the potential for practical clinical impact in the near term.

Given the emphasis on translation to clinical practice, early engagement with end users (e.g., practicing clinicians, patients) in real-world environments in which these approaches will be employed is expected. 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 and other communication processes, primarily through the support of basic and applied research in anatomy, audiology, biochemistry, bioengineering, epidemiology, genetics, immunology, microbiology, molecular biology, the neurosciences, otolaryngology, psychology, pharmacology, physiology, psychophysics, speech-language pathology, and other scientific disciplines.

The NIDCD supports: (1) Research into the evaluation of techniques and devices used in diagnosis, treatment, rehabilitation, and prevention of disorders of hearing and other communication processes; (2) research into prevention and early detection and diagnosis of hearing loss and speech, voice, and language disorders and research into preventing the effects of such disorders by means of appropriate referral and rehabilitation; (3) research into the detection, treatment, and prevention of disorders of hearing and other communication processes in the elderly population and its rehabilitation to ensure continued effective communication skills; and (4) research to expand knowledge of the effects of environmental agents that influence hearing or other communication processes.

Small Business Innovation Research (SBIR) program: To increase private sector commercialization of innovations derived from Federal research and development; to encourage small business participation in Federal research and development; and to foster participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.

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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO). 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. 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 One goal of NIH-sponsored research is to improve human health. To do so, basic scientific discoveries must be translated into practical, clinical applications.

As part of its mission, NIDCD encourages the translation of basic biomedical or behavioral research discoveries in the areas of hearing, balance, smell, taste, voice, speech and language into new clinical tools, prostheses, assistive devices, behavioral therapies or interventions and medications. Translational research requires collaborations and interactions between basic and clinical scientists.

These interactions provide the platform for the bidirectional exchange of ideas and stimulate new avenues of research for both areas. Substantial advances have been made in understanding basic biomedical (e.g., cellular, molecular, genetic) and behavioral (e.g., perception, cognition, attention, motor) aspects of NIDCD scientific mission areas.

After basic scientific findings have been peer-reviewed and published and connections to the clinical condition are apparent, intentional work to translate those findings into clinical practice is necessary. This NOFO encourages milestone-driven applications that support the translation of peer-reviewed and published basic research findings into clinical applications that improve human health in the NIDCD mission areas.

Applications may focus on prevention, diagnostics, therapeutics, medical procedures, and/or behavioral modifications that overcome existing challenges and improve clinical care in the areas of hearing, balance, smell, taste, voice, speech and language.

Research conducted under this NOFO is expected to include human subjects, however, in rare occasions, preclinical studies in non-human models are allowed, with prior NIDCD approval, when a subsequent clinical trial is anticipated in the near term. Applicants proposing studies with a non-human model must contact the Research/Scientific Contact listed in this NOFO at least 6 weeks prior to submission to receive NIDCD approval.

The letter of NIDCD approval must be included with the application at the time of submission, or the application will be withdrawn without review. See Section IV for additional details. Investigator-initiated low-risk clinical trials addressing the mission and research interests of NIDCD are responsive to this NOFO.

NIDCD clinical trials applications determined to have higher risk must use the U01 funding mechanism through the NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) program announcement PAR-24-050 and subsequent reissues. For more information on clinical trials, including how NIDCD defines low- and high-risk clinical trials, please see https://www. nidcd.

nih. gov/research/clinical-studies/researchers-professionals/know-what-is-available Collaborative translational research between basic scientists and clinicians or clinical scientists is strongly encouraged.

The connection to the clinical condition must be clearly established, and the impact on the diagnosis, treatment, or prevention of a disorder of hearing, balance, voice, speech, language, taste and/or smell in human subjects should be directly addressed by the research project.

The scope of this NOFO allows for a range of activities that translate peer-reviewed and published basic research findings to practical clinical impact on the diagnosis, treatment, or prevention of deafness and other communication disorders. Possible goals in an application may include, but are not limited to: Biochemical, electrophysiological, and behavioral assays to enhance diagnostic capabilities.

Pharmacology, toxicity, and pharmacokinetic analysis for candidate therapeutics that have demonstrated potential for the treatment of communication disorders in humans. Preclinical research for dosage studies and toxicity when a subsequent Phase I/II clinical trial is anticipated in the near term and if the non-human studies have received NIDCD pre-approval.

Translation of new tools and techniques for better diagnostics or therapeutics including, but not limited to, neuroprosthetic devices, drug delivery devices, neuro-electrical stimulators and recording devices. Translation of laboratory-based screening tests into improved ways to identify individuals at risk for a communication disorder to allow for early intervention.

Translation of published basic research findings into new clinical applications that support precision approaches to intervention and improve prognostic efficacy. Implementation of discoveries from biological, psychological, social sciences and other related areas into innovative prevention, diagnosis, and treatment paradigms, including early engagement of end users (e.g., clinicians, patients).

Modification of laboratory measures of function or laboratory treatment protocols for use in clinical settings. This NOFO is not intended for outcomes/health services research, the extension of ongoing clinical studies, the optimization of existing clinical protocols (in the absence of new basic discovery), early-stage translational studies that seek to obtain proof of concept data, or high-risk clinical trials.

Basic discovery research or projects that are addressing the underlying mechanism of a disease are not responsive to this NOFO. Examples of applications that would not be responsive and will not be reviewed include, but are not limited to: Applications that do not address NIDCD's scientific mission areas. Projects based upon basic research that has not been published in a peer-reviewed scientific journal.

Research in which the relevance to a clinical condition is not established. Research which does not state appropriate milestones to monitor progress of the project. Hypothesis-driven mechanistic discovery research.

Applications that include non-human studies that are missing the NIDCD approval-to-submit letter in their application. See Other Attachment (Approval to Submit Letter) in section IV. 2.

Applications that are missing a Milestone Plan. See Other Attachment (Milestone Plan) in section IV. 2.

Projects proposing high-risk clinical trials. See https://www. nidcd.

nih. gov/research/clinical-studies/researchers-professionals/know-what-is-available for NIDCD's definition of a high-risk clinical trial. Renewals or extensions of work previous funded in response to RFA-DC-22-001 , PAR-18-533 , PAR-17-184 , or PAR-14-009 .

See Section III. All applicants are encouraged to contact the Research/Scientific Contact listed below at least 6 weeks in advance of submission to determine if their project is well aligned with the intent of this NOFO. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications are strongly encouraged to have both basic scientists and clinicians or clinician scientists serving as PD/PIs for joint conduct of these translational research projects. Ideally, a collaborative arrangement would involve two principal investigators, one with expertise in basic science and the other in clinical science, to realize the fullest potential for translation.

Additional relevant expertise may include biostatistics, bioinformatics, bioengineering, health economics, epidemiology, imaging, pharmacology, pharmacogenetics, psychology, regulatory expertise, etc. Multi-disciplinary and multi-institutional studies are encouraged, as appropriate. Academic-industrial collaborations are also encouraged to support commercialization after completion of the project.

Given the emphasis on translation to clinical practice, early engagement with end users (e.g., practicing clinicians, patients) in real-world environments in which these approaches will be employed is expected. Applicants must utilize a milestone-based structure for projects submitted to this NOFO, rather than the hypothesis-driven format used in more traditional R01s.

This structure will allow applicants to delineate a series of project work stages, identify criteria for completion of each work stage and provide contingency plans for each work stage. It is critical that the applicant include the criteria and contingency plans that will be used to determine milestone completion before proceeding to the next phase of the project.

Applications that do not include a Milestone Plan (Other Attachment, Section IV. 2) will be considered nonresponsive and withdrawn without review. See Section VIII.

Other Information for award authorities and regulations. 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 The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NIDCD anticipates funding an estimated 2-3 awards in FY25 for $2M.

The maximum funding per grant must be less than $500,000 direct costs per year, unless prior approval from NIDCD is obtained. Application budgets need to reflect the actual needs of the proposed project. Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application.

The scope of the proposed project should determine the project period. The maximum 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 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) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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 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.

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 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 ). Renewals will not be accepted for this NOFO including renewals for applications awarded under the previous NOFOs of this initiative, including RFA-DC-22-001 , PAR-18-533 , PAR-17-184 or PAR-14-009 . New applications that are an extension of work previously funded by this NOFO or RFA-DC-22-001 , PAR-18-533 , PAR-17-184 , or PAR-14-009 will not be accepted.

Projects may only receive a total of 5 years of support from this NOFO and previous NOFOs of this initiative, which are listed above. Following five years of support, applicants should seek continued funding for the projects using other NIDCD- or NIH-issued NOFOs. 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 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.

Other attachment (Approval to Submit Letter) : Advance approval to submit an application is required for PD/PIs proposing studies using non-human models. Letters for a new application cannot be recycled for a resubmission or revision; rather a new letter is required. Advance approval to submit should be requested by contacting the Research/Scientific contact listed in this NOFO.

Contact should be made early in the process and no later than six weeks before the application due date. With their application, all applicants proposing studies with non-human models must include the approval-to-submit letter from the NIDCD Research/Scientific contact. Name the pdf formatted letter “ApprovalToSubmit.

pdf” and submit as an attachment. Applications using non-human models that do not include the approval-to-submit letter will not be accepted for review. Note that advance approval to submit an application does not guarantee funding.

Other attachment (Milestone Plan) : Applicants must provide a one-page Milestone Plan which delineates a series of project stages and identifies criteria that will be used to determine milestone completion before proceeding to the next stage of the project. A timeline should also be included as part of this plan.

Contingency plans for each work stage should be included in the Research Strategy of the application and not in the Milestone Plan attachment. The plan should be named “MilestonePlan. pdf” and submitted as an attachment.

Applications that do not include the Milestone Plan attachment or that have a Milestone Plan attachment that exceeds one-page in length will not be accepted for review. 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: The specific aims section should include a summary of what is being translated and how the outcomes can influence clinical practice.

Applicants must describe the translational nature and scope of the project and include descriptions of the connection to a clinical condition and potential for translation of basic research findings into new clinical tools. Applicants must provide a milestone-based structure for the project. A Milestone Plan (see Section IV.

2, Other Attachment) that delineates a series of project stages and identifies criteria for completion of each work stage is required. Contingency plans for each work stage should be included in the Research Strategy of the application and not in the Milestone Plan attachment. a For clinical trials: The timeline should take into account all stages of the project including start-up activities, enrollment, and follow-up assessment.

Projects should describe existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) that would increase the efficiency of participant enrollment and data collection.

Multiple PD/PI Leadership Plan: If a multi-PD/PI application, describe the organizational structure between the PD/PIs and describe procedures that ensure the partnership is maintained throughout the duration of the project. Describe plans for sharing of data, recognition, and intellectual property rights among the investigators. Describe how communication will be handled across institutional boundaries.

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. The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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. 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. Section 2- Study Population Characteristics 2.

5 Recruitment and Retention Plan Applications proposing recruitment of human subjects must propose innovative and proactive recruitment strategies for involving participants who are underserved, understudied or minority health and health disparity populations, as applicable and justified by the scientific goals of the project.

Providing only the demographic breakdown of the geographic area in which the science will be conducted is often not sufficient; a recruitment plan to engage appropriate populations should be included. 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. Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide. 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 NIDCD, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. In order to expedite review, applicants are requested to notify the NIDCD Referral Office by email at [email protected] when the application has been submitted.

Please include the NOFO number and title, PD/PI name, and title of the application. 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