National Resource Network for the Study of Human Auditory and Vestibular Disorders is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD) / National Institutes of Health (NIH). This cooperative agreement seeks to advance NIDCD's mission by continuing to support a collaborative network that serves as a critical national technological resource for auditory and vestibular researchers using human inner and middle ear tissues for basic and clinical studies …

Expired RFA-DC-23-002: NIDCD National Human Ear Resource Network (U24 Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. 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 National Human Ear Resource Network (U24 Clinical Trial Not Allowed) U24 Resource-Related Research Projects – Cooperative Agreements Notices of Special Interest associated with this funding opportunity NOT-DC-22-006 - Notice of Intent to Publish a Funding Opportunity Announcement for NIDCD National Human Ear Resource Network (U24) Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose The objective of this Funding Opportunity Announcement (FOA) is to fund laboratories to create a collaborative network, NIDCD National Human Ear Resource Network, to serve as a national technological resource for auditory and vestibular researchers who use human inner and middle ear tissues for a range of basic and clinical studies.

The Network will also serve as a nucleus for expanding the use of human temporal bones in the research community and to facilitate communication and collaboration between laboratories, both Network laboratories and non-Network laboratories, using human temporal bones.

The Network laboratories will develop and provide technical services for procuring, preparing, sectioning and distributing high-quality human ear tissues; develop and disseminate techniques for improved tissue preservation and processing; and optimize methods for visualizing human middle and inner ear structures, including cellular and membranous components; upload digitized temporal bone images to NIDCD-approved databases for wide dissemination; provide opportunities for technical instruction in the special skills needed to prepare ear tissue for use from post-mortem human temporal bones; provide outreach to the scientific and clinical communities to promote the use of human temporal bones in their research and to facilitate the use of resources maintained and developed under this initiative.

In addition, applications from individual laboratories may propose research to improve current techniques for the processing and use of human temporal bones. A cooperative agreement will coordinate interactions between the Network laboratories and the research community to maximize impact while avoiding duplicative efforts.

This national resource will benefit a broad spectrum of research projects, including clinical and translational, by providing a critical link towards the translation of animal studies to the human ear and eventually the clinic, supporting the NIDCD mission to help prevent, detect, diagnose, and treat deafness and other communication disorders.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 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 Funding Opportunity Announcement.

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

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

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.

Funding Opportunity Description The objective of this FOA is to fund laboratories to create a collaborative network, NIDCD National Human Ear Resource Network, to serve as a national technological resource for auditory and vestibular researchers who use human inner and middle ear tissues for a range of basic and clinical studies.

The Network will also serve as a nucleus for expanding the use of human temporal bones in the research community and to facilitate communication and collaboration between laboratories, both Network laboratories and non-Network laboratories, using human temporal bones.

The Network laboratories will develop and provide technical services for procuring, preparing, sectioning and distributing high-quality human ear tissues; develop and disseminate techniques for improved tissue preservation and processing; and optimize methods for visualizing human middle and inner ear structures, including cellular and membranous components; upload digitized temporal bone images to NIDCD-approved databases for wide dissemination; provide opportunities for technical instruction in the special skills needed to prepare ear tissue for use from post-mortem human temporal bones; provide outreach to the scientific and clinical communities to promote the use of human temporal bones in their research and to facilitate the use of resources maintained and developed under this initiative.

In addition, applications from individual laboratories may propose research to improve current techniques for the processing and use of human temporal bones. A cooperative agreement will coordinate interactions between the Network laboratories and the research community to maximize impact while avoiding duplicative efforts.

This national resource will benefit a broad spectrum of research projects, including clinical and translational, by providing a critical link towards the translation of animal studies to the human ear and eventually the clinic, supporting the NIDCD mission to help prevent, detect, diagnose, and treat deafness and other communication disorders.

In 2016, NIDCD issued RFA-DC-17-001 and made a single award to establish one laboratory as a national technological resource for auditory and vestibular researchers who use human inner and middle ear tissues for a range of basic and clinical studies.

In 2019, the NIDCD Workshop "Visualizing the Human Inner Ear" further addressed the ongoing need for human temporal bone tissue with a break-out group of invited workshop participants entitled “Multiuse of Human Temporal Bones and Molecular Profiling”.

This group discussed, in detail, the continued need for high-quality post-mortem human inner and middle ear tissue across the lifespan and from diverse populations for both basic research and clinical studies.

They also emphasized the need to coordinate the use of this precious resource, the need to standardize protocols, and the need to expand upon the dwindling number of skilled personnel in the USA who are trained to process this tissue.

In addition, in 2020, NIDCD issued a Request for Information inviting input and suggestions from stakeholders throughout the scientific research, advocacy, and clinical practice communities on NIDCD’s support of human temporal bone resources and research activities ( NOT-DC-20-005 ).

NIDCD also held a series of virtual meetings in 2020 with external subject matter experts to discuss the scientific and clinical communities’ needs for human temporal bones for the next 5-10 years. From these activities, the need for high-quality human temporal bone specimens and the need to expand the number of laboratories skilled at the processing of human temporal bones were resounding themes.

Meeting these needs will assure that scientists and clinicians will have access to the human tissue that they need to support NIDCD’s scientific mission and to improve human health.

The purpose of this FOA is to fund laboratories to create a collaborative network to serve the auditory and vestibular basic and clinical research communities as a resource , by improving the quantity, quality and availability of human inner and middle ear specimens, by developing and sharing advances in methods and techniques for human ear tissue processing, by depositing scanned temporal bone images to widely accessible databases, and by providing technical instruction and outreach, all to enhance opportunities for needed research on human ear tissues.

Currently, the NIDCD supports the NIDCD National Temporal Bone, Hearing and Balance Pathology Resource Registry ('the Registry') as a separate U24 award. The Registry is an information center that coordinates and archives data about recruited temporal bone donors and location of specimens nationwide, and maintains a network of contacts for timely procurement of tissue.

The Registry serves as a database, which does not obtain or process specimens or do research. Creating a complementary national research resource network to acquire and improve processing of human middle and inner ear tissues is a related, but distinct, activity designed to provide technological improvements for new research contributions from a wide range of investigators.

A network of national technological laboratories as a resource for human ear tissue research will create opportunities that generate benefits across a range of specific disciplines and diseases.

Increased availability of high-quality samples and improved analytical and visualization approaches to human ear tissues will enable more direct tests of the validity of animal models for genetic and physiological disorders of hearing and balance in humans, and could encourage new collaborations between researchers on animals and humans.

Dissemination of best practices and increased availability of technical training will improve the capabilities of basic or clinical researchers and laboratory staff, and could make it easier for those currently working only in animals to pursue research on humans.

Advantages of such a network include: Increasing the available numbers of human temporal bones that are well prepared for subcellular or molecular analyses could enable new studies focused on sensory structure and function in both normal and pathological human ear tissues.

Recent advances have shown how biochemical, immunological and molecular markers can be applied to human cochlear and vestibular tissues from human temporal bones, increasing the usefulness of specimens and clinical cases available for microscopic analysis. New techniques to reprocess embedded temporal bone specimens now make archival specimens as well as newer tissue available for study.

In addition, rapid digitization of slides from human temporal bone specimens allows researchers to easily share and access microscopic data using web-based platforms and software. Optimizing the visualization of human inner and middle ear structures could provide a dramatic advance in clinical assessment of pathology and potential diagnostics.

New information at cellular resolution from tissues from normal and disordered ears could clarify details such as cellular changes over time in properties of bone or soft tissues, reactions to cochlear implant electrodes, or morphological features related to fluid distribution in the inner or middle ear.

Validity tests for animal models: To understand human disorders, it is crucial to analyze human tissues, and technically well-prepared human tissues could allow validation tests of specific predictions from animal models to human disorders from trauma, disease or genetics.

Numerous projects currently using non-human mammalian models are asking research questions with ultimate clinical relevance, and incorporating analysis of human specimens into the research would add substantial value in translating the animal work toward human applications.

Increased interest in human ear tissues: Interest in human ear research could be increased by dissemination of best practices and new technologies, and by providing opportunities for technical instruction in the special skills for post-mortem human ear tissue preparation.

Investigators lacking experience with human tissues could obtain technically well-prepared human tissues for questions related to their own research, and/or receive technical instruction in processing human ear tissues themselves. Removing technical hurdles could allow researchers previously unable to study human ear tissue to modify their research programs to include human studies.

Some specific areas of opportunity may include, but are not limited to, those listed below: protocols to improve procurement and early processing, to increase the numbers of available human ear tissues with minimal post-mortem times and optimal initial fixation priority for processing tissues from donors with well-documented medical histories regarding hearing or balance, or from populations under-represented in genotype or phenotype in currently archived collections including samples from across the lifespan access to already processed archival and new tissues by facilitating their availability to researchers, or distribution of tissue preparations to interested researchers who do not have access to human temporal bone preparation facilities and technicians techniques for human ear research at the molecular level (DNA, RNA, proteins) tests for alternative tissue embedding methods comparable or better in optical quality and archival durability relative to current methods non-destructive imaging techniques for ear tissues within the temporal bone at the cellular level of resolution, allowing optical sectioning and digital reconstruction in three dimensions imaging methods to clarify microscopic structure in soft cellular and membranous tissues as well as in harder bony or cartilaginous tissues within the temporal bone including studies on animals, with translational potential for human application processing of human tissue samples identically to those from animals, for directly testing the validity of particular animal models for human disease and disorders best practices for obtaining, processing and analyzing human ear tissues, and ensuring compliance with relevant regulations governing human specimens hands-on technical instruction for preparing and examining post-mortem human middle and inner ear tissues for basic and clinical research, to expand the pool of laboratory staff and researchers available to bring expertise and best practices to research projects on human ears dissemination of techniques feasible for animal laboratories to use for analyzing human middle and inner ear tissues, to stimulate interest of researchers who can bring new approaches or concepts to the field of human otopathology.

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

Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.

2 for additional information about the substantial involvement for this FOA. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

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 NIDCD intends to commit $2.

4M in FY2023 to fund up to 4 awards. Applications must be less than $500,000 direct costs per year. Budgets need to reflect the actual needs of the proposed project and may include human temporal bone procurement costs.

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 FOA.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) 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 Institutions) are not 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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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.

SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application. Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM.

By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and 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 his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. 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 SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 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 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 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Melissa Stick, Ph. D. , M.

P. H. National Institute on Deafness and Other Communication Disorders (NIDCD) Telephone: (301) 496-8683 All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. PD(s)/PI(s) should document in their biosketch(s) the ability to provide the proposed resources on a national scale.

All instructions in the SF424 (R&R) Application Guide must be followed. Budget must include travel funds for attending an annual Steering Committee meetings and a proposed workshop in years 2 and 4. Budgets may include costs for human temporal procurement.

All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Describe how the proposed services, instructional opportunities and outreach activities will enhance opportunities for needed research on human ear tissues and provide a resource to the auditory and vestibular scientific and clinical communities.

Address the following four points and include timelines for each of these activities, congruent with the amount of work proposed: Improve access for the auditory and vestibular research community to human ear tissues from temporal bone specimens: For example, improve and promote timely procurement, preparing and processing of new specimens, and appropriate re-processing of archived specimens.

Distribution of, and prioritization of requests for well-prepared human temporal bone tissues to researchers who lack adequate access to facilities for human temporal bone preparation. Digitization of temporal bone slides and uploading those images and donor health information to the Registry or other NIDCD-designated resource, and assist researchers seeking to validate animal models for human relevance.

The inclusion of human temporal bones from diverse populations is highly encouraged. Optimize/develop techniques and methods for human temporal bone tissue preparation/use and disseminate protocols: For example, optimize/develop molecular and cellular marking and visualization techniques that allow direct comparisons of fresh and archived human tissues with those from animal models.

Optimize/develop methods for the use of human temporal bones for genetic studies. Disseminate 'best practices' protocols for procurement, preservation, preparation and use of human ear tissues from temporal bones, and encourage animal researchers to include human tissues into their analyses. For newly developed techniques, outline how these are state-of-the-art, and how they will significantly advance the auditory and vestibular fields.

Provide technical instruction for the scientific and clinical communities to increase the number of individuals at all career stages, including technicians, skilled in the processing and use of human temporal bones: For example, short-term and longer-term instruction with hands-on training, virtual training, and archived videos in the labor-intensive techniques and skills needed for processing human ear tissues from temporal bones and their use.

Instruction opportunities to attract investigators toward using human middle and inner ear tissues for basic and clinical research. Outline the innovative approaches that will be used for technical instruction.

Provide outreach to the scientific and clinical communities to promote the use of human temporal bones in their research and to facilitate the use of resources maintained and developed under this award : This should include fostering communication among all researchers utilizing human temporal bones including laboratories that are not part of the NIDCD National Human Ear Resource Network.

Outline how the proposed outreach activities will make use of innovative strategies to reach the largest possible audience, including other laboratories using human temporal bones.

Although the purpose of this FOA is to provide resources for the scientific and clinical communities, within the scope of the required four points listed above, applications may include hypothesis-driven work towards the improvement of human temporal bone use, processing or visualization.

Studies on animal temporal bones may be included, if appropriate, but the main focus of the application must be on human inner and middle ear tissues and any animal temporal bone studies should be well integrated with the proposed human temporal bone work. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

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

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov. 4. Submission Dates and Times Part I.

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

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5.

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

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 . 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII . All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof 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