Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations

National Institute on Deafness and Other Communication Disorders (NIDCD)
Funding Opportunity Title
Limited Competition: NIDCD National Temporal Bone, Hearing & Balance Pathology Resource Registry (U24 Clinical Trial Not Allowed)
Activity Code
U24 Resource-Related Research Projects – Cooperative Agreements
Announcement Type
Reissue of RFA-DC-14-002
Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-DC-19-002
Companion Funding Opportunity

None.

Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.173
Funding Opportunity Purpose

The NIDCD Temporal Bone Registry is a national research resource for human auditory and vestibular research. Its fundamental purpose is to coordinate information about specimens of the human ear and to recruit potential temporal bone donors. The Registry coordinates specimen collection, information recording and data management of specimens, and provides public information, including an up-to-date website about human ear specimens for research. It is not a simple database or tissue bank for human ear specimens. Applications are encouraged that will enhance, promote, and support critical research on the human middle and inner ear that cannot be done in living humans. Use of temporal bone specimens also provides an opportunity for translation from critical animal models to human models for auditory and vestibular research. This initiative will support the Registry by cooperative agreement, to:

  • continue to develop and maintain a growing database for access to detailed information about the location, condition, and other bioinformatics data about new and archival human temporal bone tissues around the country that are available as resources for auditory and vestibular research;
  • communicate with scientific and clinical researchers to disseminate information about the resources available;
  • maintain a well-organized nationwide network of on-call experts for timely post-mortem harvesting of temporal bone tissues;
  • develop and implement a strategy for receipt of harvested tissue by nearby temporal bone laboratories;
  • develop new methods or techniques for donor recruitment and post-mortem tissue procurement;
  • communicate with ‘pledges’ for tissue donation combined with relevant medical histories that will allow linking functional disorders to morphological, biochemical and genetic pathologies;
  • provide education/outreach to the scientific community and to the public about temporal bone donations.
Posted Date
July 5, 2018
Open Date (Earliest Submission Date)
September 23, 2018
Letter of Intent Due Date(s)
Not applicable.
Application Due Date(s)
October 23, 2018; June 24 , 2019 by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)
Not Applicable.
Scientific Merit Review
February-March, 2019; October-November 2019
Advisory Council Review
May, 2019; January, 2020
Earliest Start Date
Expiration Date
June 25, 2019
Due Dates for E.O. 12372
Not Applicable.
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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Funding opportunities to establish and maintain resources for the research community can be critical for research progress. The NIH supports U24 Resource-Related Research Projects for research activities that are not hypothesis-driven, to provide data, materials, tools or services that are essential for timely, high-quality and cost-efficient progress in a scientific field.

In pursuit of its mission, NIDCD supports basic, translational, clinical and outcomes research on hearing and balance, in normal and diseased states, including basic cellular/molecular biology and genetics research in neuroplasticity, neurodevelopment, neurodegeneration, and studies aimed at detection, prevention, and treatment of otological and neurotological diseases and disorders.

The NIDCD National Temporal Bone, Hearing & Balance Pathology Resource Registry, known as the ‘Registry’, is an important scientific resource for the auditory and vestibular communities, whose fundamental purpose is to coordinate information regarding human temporal bones that are available to study, to recruit additional temporal bone donors, and to arrange and for the procurement of the donated specimens upon death of the donor.  The human middle and inner ear is unusually hard to study as the ear is encased in the dense temporal bone of the skull; moreover, the soft tissues cannot be readily accessed by routine biopsy or other techniques on living subjects.  Modern biological approaches to ear diseases and disorders require obtaining tissues as soon as possible after death, because adequate donor arrangements are needed for immediate Registry notification and harvest at death. Currently evolving technologies and methodologies need to be considered for handling database design, donor recruitment, tissue procurement, tissue placement, and information format and access for scientific researchers. 

The Registry was established by NIDCD in 1992 to expand an earlier National Temporal Bone Banks program.  The Registry is a resource activity to coordinate nationwide collection, usage, information, and public education about human temporal bone tissues for hearing and balance research. Since 2013 the Registry has been supported through the U24 cooperative resource activity code.

The U24 is appropriate for this funding opportunity in otopathology as a critical-need resource in the mission of NIDCD. In addition,the cooperative agreement mechanism enables NIDCD involvement to continue developing this resource for increased nationwide use. The 2015 NIDCD Workshop: "Synaptopathy and Noise-Induced Hearing Loss: Animal Studies and Implications for Human Hearing" emphasized the need for human temporal bone data to validate comparisons with discoveries from animal models, as well as to reveal structural correlates of genetic and physiological disorders of the human ear and consequences of therapeutic treatments including drugs and devices. Currently evolving technologies and methodologies need to be considered for handling database design, donor recruitment, tissue procurement, tissue placement, information format, and access for scientific researchers. 

The goal of this FOA is to continue support for the Registry as it seeks to make temporal bone specimens and accompanying information available and responsive to the needs of auditory and vestibular research. Therefore, only recipient organizations previously funded under RFA-DC-14-002 are eligible to apply.

To this end, this FOA will support the Registry to:

  • continue to develop and maintain a growing database for access to detailed information about the location, condition, and other bioinformatics data about new and archival human temporal bone tissues around the country that are available as resources for auditory and vestibular research;

  • communicate with scientific and clinical researchers to disseminate information about the resources available;

  • maintain a well-organized nationwide network of on-call experts for timely post-mortem harvesting of temporal bone tissues;

  • develop a strategy for receipt of harvested tissue by nearby temporal bone laboratories;

  • develop new methods or techniques for donor recruitment and tissue procurement;

  • communicate with ‘pledges’ for tissue donation combined with relevant medical histories that will allow linking functional disorders to morphological, biochemical and genetic pathologies;

  • provide education/outreach to the scientific community and to the public about temporal bone donations.

See Section VIII. Other Information for award authorities and regulations.
Funding Instrument
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
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?
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 $425,000 in FY 2019 to fund one award.
Award Budget
Application budget should not exceed $425,000 in direct costs in each year.
Award 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

Eligible Organizations
Only recipient organizations previously funded under RFA-DC-14-002 are eligible to apply.
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 
Required Registrations

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. 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.
  • System for Award Management (SAM) (formerly CCR) – 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.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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.

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.  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 NOT-OD-11-101)

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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.
 

All instructions in the SF424 (R&R) Application Guide must be followed.

Detailed budget justification, including the role of all paid personnel, must be included. Funds can be used to cover temporal bone procurement costs and shipping to temporal bone laboratories. Funds can be used to coordinate temporal bone donations through more than one institution through the use of subcontracts.
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 The Registry is a resource for auditory and vestibular scientists. Applications responsive to this FOA must describe specific ways to maintain and enhance this resource for research on the human ear and its disorders. To maximize the impact of the Registry, the Research Strategy must include the following required information about the organization of the Registry.

Need and uniqueness:  A resource must meet a demonstrable and timely community need, so the potential impact on the scientific community should be described.  Factors also could include known work that has used the Registry, its database or website, or other evidence for community usage or community interest for basic and clinical scientists.  (Do not provide letters of support here; see below.)  Include information about how further development of the Registry and its database will provide a complementary resource that does not duplicate other efforts to enhance research.

Access:  Indicate how broad access to the Registry will be made available to all investigators, for clear purposes that are understood by the providers and the users.  As a resource, the Registry must include cost-effective mechanisms for dissemination and advertisement of resources and services to the community of basic and clinical investigators, as well as to the general public.

Appropriate attention is needed to regulations on human subject protections and confidentiality of data collected.  Plans must describe how the registry will coordinate donor recruitment and tissue procurement; how and where donated tissues and related data will be handled, evaluated, archived and protected; fair distribution of the donated tissues, and how to access the information will be allocated and protected.

Quality control:  Measures must be described to monitor, control,document, and increase the quality of specimens and data, including such aspects as donor data, tissue harvesting and handling protocols, and database upgrades for the resource.

Outreach:  Describe plans to maximize effective use of the Registry for outreach to research scientists and to the public. Describe in detail how donor recruitment will be enhanced to increase donations and to include the targeting of underrepresented populations or clinically informative populations.

Efficiency: Describe appropriate staffing plans and discuss measures for improving efficiency or offsetting some costs. Consider appropriate technology that will not become obsolete rapidly. 

Overall, enhancements to consider must include features for increasing donor participation, imaging and informatics in the design and content of the database, and optimizing the scale and efficient use of existing resources for research.

Administration:  Details must be provided for the role of any personnel receiving support from this award. The resource must be integrated with broad strategic interests of potential users on a national and international scale.  Accordingly, a framework for a Steering Committee for the Registry must be proposed to provide technical and scientific expertise for guidance. Accordingly, a framework for a Steering Committee for the registry must be proposed to provide technical and scientific expertise for guidance. If a Steering Committee is already in place, please list the names, affiliations, and dates of service for current and former members.  Do not name individuals who may be considered in the future for Steering Committee membership.

Milestones:  Objective milestone indicators are needed to help guide the project, and to ensure that the resource is meeting the community's needs, is of high quality, and is accessible.  Applications must include quantifiable metrics for ongoing improvement, and to gauge the impact of usage on the scientific field.  Examples could include tracking growth of the collection information (new donors, new tissues, etc.), requests for services, successful use of the resource data, the number of users, publications citing uses, etc.  The milestones must include realistic quantitative goals for resource usage to be reported at the end of each annual funding period. 

Letters of Support: Limit letters of support to only those who are named in the application (e.g., collaborators, senior/key personnel and other significant contributors) and are expected to contribute in a substantive way to the execution of the proposed resource.   Do NOT provide letters from potential or previous users (individuals, groups, or consortia) .

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, should 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.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or 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. with the following additional instructions:

Delayed Onset Study

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 DUNS number it provides 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 NIDCD, NIH. Applications that are incomplete, non-compliant and/or non-responsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIDCD Referral Office by email atstickm@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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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).
Scored Review Criteria
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 there a strong scientific premise for the project? 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?

 

How well does the proposed resource meet a significant community need by contributing substantially to the quality of research on human temporal bones and the ear (otology, audiology, and other clinical and basic sciences involving the inner and middle ear, etc.)? Will the proposed services and outreach convincingly add major value to the research community? Is the resource likely to improve the public awareness of human ear disorders and the need for research and for temporal bone donors?

Does the proposed Resource address the needs of the research projects 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 resource?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

 

Does the PD(s)/PI(s) have a history of service-oriented efforts outside the needs of their own research to facilitate oversight of this resource? Are they uniquely positioned to provide the proposed resource, and to integrate their efforts with broader strategic interests of potential users on a national and international scale?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Registry? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing archival research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the Center 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 Registry? Does the applicant have experience overseeing selection and management of subawards, if needed?

 

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 PD(s) PI(s) have a history of service-oriented efforts outside the needs of their own research to facilitate oversight of this resource? Are they uniquely positioned to provide the proposed resource, and to integrate their efforts with broader strategic interests of potential users on a national and international scale?

Does the application propose novel organizational concepts, management strategies, or instrumentation] in coordinating the research resource the Registry 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 organizational concepts, management strategies or instrumentation proposed?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?

 

How is quality control addressed and is it adequate? Evaluate the plans for how accessible the resources are to the scientific community. Will the resources be broadly accessible? Are the plans for resource sharing satisfactory, including protections for data? Are the plans for the administrative framework and Steering Committee appropriate for the resource? Are the personnel well justified?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Registry will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the 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?

 

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 children, justified in terms of the scientific goals and research strategy 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 Registry will operate contribute to the probability of success in facilitating the research community it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Registry proposed? Will the Registry benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria
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.

Milestones

Does the application have a plan in place for evaluation of the resource activity? Are the proposed milestone metrics appropriate for assessing the ongoing value of the proposed resources?

 

For research that involves human subjects but does not involve one of the six 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 six 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.

 

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 children 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.

 

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.

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

For Renewals, the committee will consider the progress made in the last funding period.

 

Not Applicable.
Additional Review Considerations
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.

 

Not applicable.

 

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), 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:
  • 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.
  • Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. 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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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.

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 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

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 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 awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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 Steering Committee (see below), and handling of data, including appropriate sharing of methods and data with the community;
  • 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 by the Registry;
  • Managing the Registry functions, with assistance on project scope decisions from the NIDCD Project Coordinator;
  • 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.
  • During the period of support, Awardees (Recipient Organization) will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
  • Awardees (Recipient Organization) will be required to, at the end of the project period, supply a useable copy of the electronic records, database, and developed software to NIDCD.  The NIDCD may share these records with other future recipient organizations.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • An agency program official or IC Program Officer (PO) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
  • Additionally, an NIH program official within NIDCD will be designated the Project Coordinator for the Registry and will have substantial scientific programmatic involvement during conduct of this activity, through technical assistance, data sharing and analysis, composition of reports, and advice and coordination.

The NIDCD Project Coordinator:

  • Convenes an initial on-site meeting with the PD/PI and team, and the Program Officer as observer;
  • Invites a group of External Experts (EE) with relevant scientific expertise to provide feedback to the PI and NIDCD on Registry activities. This group will include 2-4 scientists or clinicians (not at the PD/PI's institution) with appropriate understanding of basic and clinical ear research. The external members are selected by agreement of the PI and the NIDCD Project Coordinator.
  • Has lead responsibilities in the broad programmatic issues of the Registry, although the awardee has lead responsibilities in Registry 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 Program Officer, the annual or more frequent reports on progress of Registry 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 temporal bones; lack of adequate data reporting or quality control; other major breach of scientific conduct; or human subject ethical issues, whenever applicable.

Areas of Joint Responsibility include:

  • Teleconferences between the PI(s) and Project Coordinator at least quarterly to discuss progress. The Program Officer may be included.
  • Meetings at least yearly between the PI(s) and the Project Coordinator, with the PO and the External Experts (EE) group all acting as a Steering Committee (SC) to discuss progress and any modifications in the operating plans based on progress or other factors. The PO remains a non-voting member of the SC, in any issues requiring a vote. These meetings may be in conjunction with other national or NIH meetings.
  • Responsibilities of the SC include but are not limited to assistance in developing documentation for best practices for tissue procurement, processing and initial evaluation; in evaluating and developing procedures or techniques in relation to expected timelines; fostering the inclusion of women and ethnic minorities in the donor pool; and in developing policies and procedures for interactions with the wider community.
  • Periodic reviews, at least yearly, of the Registry's record of meeting established timelines for donor recruitment, tissue procurement, database entries, researcher access of database, dissemination of information; gathering information from any existing temporal bone banks or databases; dissemination of temporal bones to laboratories for processing.
  • Identify repositories of temporal bones along with integration into the current registry of their location and medical records.
  • Assess and implement practices regarding access to data, safety of data, temporal bone registry, and publications consistent with NIDCD policies.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award 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 awardee. This special dispute resolution procedure does not alter the awardee'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, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
Awardees (Recipient Organization) will be required to, at the end of the project period, supply a useable copy of the electronic records, database, and developed software to NIDCD.  The NIDCD may share these records with other future recipient organizations.
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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000.  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 Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, 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 processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)
Amy Poremba, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-1804
Email:porembaa@mail.nih.gov
Peer Review Contact(s)
Melissa Stick, Ph.D., M.P.H.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-8683
Email:stickm@mail.nih.gov
Financial/Grants Management Contact(s)
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.
Authority and Regulations
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.


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