National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
U24 Resource-Related Research Projects – Cooperative Agreements
See 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)
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.
March 6, 2022
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| April 06, 2022 | Not Applicable | Not Applicable | July 2022 | October 2022 | December 2022 |
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.
Not Applicable
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.
Objectives
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.
Background and Need
Structural details of the inner ear sensory organs for hearing and balance are difficult to study in humans because these soft tissues are encased in the dense temporal bone of the skull. The cochlea and the vestibular system are not readily accessible for biopsy or by non-invasive techniques that preserve function in living subjects. The value of human temporal bone specimens and otopathology in understanding ear diseases and disorders is without question, yet studies of human auditory and vestibular tissues are limited by the uneven quality of preservation and preparation of donated post-mortem specimens. These restrictions seriously limit progress in understanding pathology of the organs of hearing and balance in humans across the lifespan. The critical need to relate findings from animal models to human ear disorders has been emphasized repeatedly in various forums as well as the current NIDCD Strategic Plan.
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.
Benefits
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:
- Increased availability:
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.
- Improved visualization:
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.
Areas of Opportunity
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.
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.
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?
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.
1. Eligible Applicants
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
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
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
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.
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.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
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).
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.Letter of Intent
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
Email: stickm@ms.nidcd.nih.gov
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
R&R Budget
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.
R&R Subaward Budget
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.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy:
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.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
- No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and 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.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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 an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIDCD Referral Office by email at stickm@ms.nidcd.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Does the proposed resource address the needs of the research and clinical communities that it will serve? Is the scope of activities proposed for the resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research community?
Specific to this FOA: To what extent will the proposed services, instructional opportunities, and outreach activities enhance opportunities for needed research on human ear tissues?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the proposed resource activities? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing auditory and/or vestibular research? Do the investigators demonstrate significant experience with coordinating collaborative basic and/or clinical research? If the application is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the proposed resource activities? Does the applicant have experience overseeing selection and management of subawards, if needed?
Specific to this FOA: How well are the PD(s)/PI(s) positioned to provide the proposed project resources on a national scale?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the application propose novel approaches in coordinating the research and clinical need that the resource will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of methodology proposed?
Specific to this FOA: How innovative are the proposed approaches for technical instruction? How well do the proposed outreach activities make use of innovative strategies to reach the largest possible audience? If new techniques are developed, are those techniques state-of-the-art and will they significantly advance the auditory and vestibular fields?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research and clinical needs the resource will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the proposed resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Specific to this FOA: How satisfactory and feasible are the plans for the distribution of human temporal bone specimens to researchers, including the prioritization of requests? How effective are the proposed plans to disseminate protocols for human temporal bone tissue processing and use? Do the investigators outline adequate plans for the digitization of human temporal bone slides and uploading of those images and accompanying donor health information to appropriate databases for use by other investigators? How appropriate are the proposed optimized or newly developed techniques for temporal bone tissue preparation and use? To what extent does the application consider the use of human temporal bones from diverse populations? Are the proposed plans to provide technical instruction to the scientific and clinical communities feasible and to what extent will they likely increase the number of individuals skilled in the processing and use of human temporal bones? To what extent will proposed outreach efforts reach the largest audience possible including other laboratories using human temporal bones? If proposed, how feasible is the hypothesis-driven work to improve the use of human temporal bones? If the proposed work includes animal temporal bones, how well is that work integrated with human temporal bone studies? Is the timeline for each aim congruent with the amount of work proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Will the institutional environment in which the resource will operate contribute to the probability of success in facilitating the research and clinical communities it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the resources proposed? Will the resource benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDCD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NDCD Advisory Council. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
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The PD(s)/PI(s) will have the primary responsibility for:
- Accepting and implementing the goals, priorities, protocols, procedures, and policies agreed upon, including methods and requirements recommended by the External Experts (see below), and handling of data, including appropriate sharing of methods and data with the scientific and clinical communities;
- Including information on harvested human temporal bones in the Registry or other NIDCD-designated repository and made available to researchers following current best practices;
- Scanning and uploading human temporal bone slides to the Registry or other NIDCD-designated repository and provide accompanying medical information from the temporal bone donor, if available;
- Monitoring and maintaining appropriate records for protocols, informed consents, assurances, and annual certifications of Institutional Review Board (IRB) review and approvals for protection of human subjects and confidential information obtained;
- The PD/PI must be willing to collaborate with other recipients of this U24 initiative, to participate in planning and attending workshops and symposia, to serve on the Steering Committee (see below) and be bound by its decisions, and to share data and research resources with each other, the NIDCD (see Section IV.6), and the scientific community. Each individual U24 budget must include travel funds for attending the Steering Committee meetings, and proposed workshops in years 2 and 4;
- Assuming accountability to the applicant organization officials and to the NIDCD for the performance and proper conduct of the activities supported by the U24 in accordance with the terms and conditions of the award, with assistance on scientific scope decisions from the NIDCD Scientific Officer;
- Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIDCD Scientific Officer:
- An NIH program official within NIDCD will be designated the Scientific Officer and will have substantial scientific programmatic involvement during the conduct of this activity, through technical assistance, data sharing and analysis, the composition of reports, and advice and coordination;
- Additionally, an NIDCD Program Official (PO) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice;
- Convenes an initial on-site or virtual meeting with the PD/PI and team and with the PO as an observer;
- Invites External Experts with relevant scientific expertise to serve on the Steering Committee (see below). External Experts will include 2-3 scientists or clinicians (not at the PD/PI's institution or the institution of other recipients from this FOA) with the appropriate understanding of basic and clinical ear research. The external advisors are selected by the NIDCD Scientific Officer;
- Has lead responsibilities in sharing the broad programmatic issues, although the recipient has lead responsibilities in laboratory tasks and activities;
- Has access to data generated under this Cooperative Agreement and periodically may review the data and progress reports. NIDCD staff may use information obtained from the data for preparation of internal reports of the activities of the study;
- Serves as a resource to provide scientific/programmatic support by participating in the design of the activities, advising in management and technical performance, or participating in the preparation of publications;
- Reviews, with the PO, the annual or more frequent reports on the progress of award scientific activities;
- The NIDCD reserves the right to adjust funding, withhold support, suspend, terminate or curtail a study or an award in the event of a failure to comply with the Terms and Conditions of Award; substantial shortfall in acquisition or dissemination of tissues; shortfall in uploading scanned human temporal images into the NIDCD-designated repository; lack of adequate data reporting or quality control; other major breaches of scientific conduct; or human subject ethical issues, whenever applicable.
Areas of Joint Responsibility include:
- Teleconferences or video conferences between the PD(s)/PI(s) and NIDCD Scientific Officer at least quarterly to discuss progress. The PO may be included in these meetings;
- The PD/PI of an award from this FOA will be a member of the "NIDCD National Human Ear Resource Network " (called the Network) and will serve as a member of the Steering Committee. The Steering Committee will be formed for scientific management and oversight of network-specific collaborative activities. The full members of the Steering Committee will be a PD/PI from each U24 awards from this FOA, the NIDCD Scientific Officer, and two to three External Experts who will be selected by NIDCD Scientific Officer to provide additional expertise and perspective beyond that represented by the Network laboratories. The PO is not a full member of the Steering Committee and cannot vote, however, the PO may be present at Steering Committee meetings. The Chair of the Steering Committee will be determined by NIDCD staff.
- The Steering Committee will have the major responsibility for identifying collaborations across the Network and facilitating and monitoring the Network as a cohesive entitiy. In addition, the Steering Committee will facilitate developing documentation for best practices for tissue procurement, processing and initial evaluation; in evaluating and developing procedures or techniques in relation to expected timelines; in planning and delivering technical instruction; and in developing policies and procedures for interactions with the wider community;
- The Steering Committee will have one to two formal meetings each year, typically one at a Network member laboratory or held virtually, and one at a major scientific meeting, along with more frequent teleconferences at times to be determined. These meetings will serve to update the Steering Committee on the progress of the individual awards and among other topics, to discuss problems, best practices, and ways to engage the broader scientific community;
- Established timelines for tissue procurement and preparation, technology development and technical instruction; of interactions with the Registry or other NIDCD-designated entities as well as the wider scientific community; and of practices regarding access to data and publications consistent with NIDCD policies;
- Each full member of the Steering Committee will have one vote. The PO is a non-voting member of the Steering Committee. Recipient members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Amy Poremba, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-1804
Email: amy.poremba@mail.nih.gov
Melissa Stick, Ph.D., M.P.H.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: (301) 496-8683
Email: stickm@ms.nidcd.nih.gov
Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: (301) 435-0713
Email: myersc@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.
and Human Services (HHS)
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