Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Deafness and Other Communication Disorders (NIDCD)
Funding Opportunity Title	NIDCD National Temporal Bone, Hearing & Balance Pathology Resource Registry (U24)
Activity Code	U24 Resource-Related Research Projects - Cooperative Agreements
Announcement Type	New
Related Notices	July 05, 2018 - This RFA has been reissued as RFA-DC-19-002. October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	RFA-DC-14-002
Companion Funding Opportunity	None
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
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 otopathology. Its fundamental purpose is to coordinate information about specimens of the human ear and its disorders. 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 research. It is not a simple database or tissue bank for human ear specimens. This FOA is appropriate for these functions specifically to enhance and promote critically needed research on the middle ear and inner ear that cannot be done in living humans. This initiative will support the Registry by cooperative agreement, to: develop a growing database to access detailed information about the location, condition, accessibility, and other bioinformatics data about new and archival tissues around the country that are available as resources for otopathology and basic research, and to respond widely to scientific and clinical researchers, disseminating information about the resources available; maintain a well-organized nationwide network of on-call experts for timely post-mortem harvesting of tissues, to develop new methods or techniques for subject recruitment and tissue procurement, and to handle pledges for tissue donation combined with relevant medical histories that will allow linking functional disorders to morphological, biochemical and genetic pathologies; coordinate information management among otopathologists including those involved in collaborations such as the current NIDCD Otopathology Network of research laboratories, to provide opportunities for short-term training experiences in otopathology laboratories, and coordinate preservation of existing valuable archival collections; provide education/outreach to the scientific community and to the public.

Posted Date	July 18, 2013
Open Date (Earliest Submission Date)	September 1, 2013
Letter of Intent Due Date(s)	September 1, 2013
Application Due Date(s)	(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 1, 2013, 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.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	(Extended to November 2, 2013 per NOT-OD-14-003), Originally October 2, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Funding opportunities to establish and maintain resources for the research community can be critical for research progress, even though funds are more limited for such resources than for research project grants. 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.

The middle and inner ears of humans are unusually hard to study because the ear is encased in the dense temporal bone of the skull. Verification of clinical diagnoses of ear disorders requires microscopic examination of ear tissues, yet such examination is nearly impossible during life. Preserving and preparing soft tissues within the hard bony matrix for microscopic study also require intricate processing techniques in a specialized laboratory, and high-quality pathological studies require obtaining tissues as soon as possible after death. Volunteer donors are needed, with adequate arrangements for immediate notification at death, and keeping track of donors for years and even decades obviously can be challenging. The NIDCD National Human Temporal Bone, Hearing & Balance Pathology Resource Registry, sometimes known simply as "the Registry", was established by NIDCD in 1992 to expand an earlier National Temporal Bone Banks (NTBB) program. For various reasons, the NIDCD now is choosing to support this ongoing effort though the U24 collaborative research activity code. The Registry is a resource activity to coordinate nationwide collection, usage, information, and public education about human temporal bone (HTB) tissues for hearing and balance research. The critical national role of the Registry was noted by the well-attended 2010 ARO Symposium on Human Otopathology and Basic Science: Partners in Translational Research." These laboratories and the expertise for evaluating otopathologic specimens are becoming rare, and the Registry is a unique interactive resource essential for clinical otopathology.

Previous initiatives: The Registry has been supported by NIDCD since 1992 by sequential 5-year contracts. Its function is not to do research but to provide a research resource. Research projects on otopathology, complementary to the Registry, have included two U24 initiatives funded by NIDCD, the Human Temporal Bone Consortium for Research Resource Enhancement from 2006-2010, and the NIDCD Otopathology Research Resource Network begun in 2010. Both involved a set of U24 cooperative agreements for collaborating otopathology laboratories to promote human temporal bone research using cellular and molecular biology, and computer-aided imaging, all of which add value to traditional histopathological approaches for tissue analysis of the ear. Enhancing modern biological and informatics approaches to temporal bone research has increased the quality and opportunities for the scientific community to use the Registry, since these initiatives required the collaborators to cooperate with the Registry.

The goal of this FOA is to continue support for the Registry as it seeks to make its services available and responsive to the needs of modern otopathology research.

The NIDCD Temporal Bone Registry is a national research resource for human otopathology. Its fundamental purpose is to coordinate information about human temporal bone specimens of the ear and its disorders. The Registry coordinates specimen collection, usage, information recording and data management of specimens, and provides public information including an up to date website about HTB research. It is not a simple database or tissue bank for human ear specimens. This funding opportunity will support and enhance this resource for critically needed research that cannot be done in living humans, by enabling the Registry to:

• develop a growing database to access detailed information about the location, condition, accessibility, and other bioinformatics data about new and archival tissues around the country that are available as resources for otopathology and basic research; and to respond widely to scientific and clinical researchers, disseminating information about the resources available;
• maintain a well-organized nationwide network of on-call experts for timely post-mortem harvesting of tissues; to develop new methods or techniques for subject recruitment and tissue procurement; and to handle pledges for tissue donation combined with relevant medical histories that will allow linking functional disorders to morphological, biochemical and genetic pathologies;
• coordinate information management among otopathologists, including those involved in collaborations such as the current NIDCD Otopathology Network of research laboratories; to provide opportunities for short-term training experiences in otopathology laboratories; and to coordinate preservation of existing valuable archival collections;
• provide education/outreach to the scientific community and to the public.

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 U24 activity code is appropriate for this funding opportunity in otopathology as a critical-need resource in the mission of NIDCD; the cooperative agreement mechanism enables program involvement to help develop this resource for increased nationwide use. Currently evolving technologies and methodologies, for example, need to be considered for handling database design, donor recruitment and tissue procurement, and information format and access for otopathology researchers.

Applicants are strongly encouraged to contact the Scientific/Research Contact (listed in Section VII, below) to discuss the interface of the Registry with the field of otopathology and with the public.

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.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIDCD intends to commit approximately $500,000 in FY 2014 for a single award, contingent upon NIH appropriations and the submission of at least one meritorious application.
Award Budget	Application budgets may request average direct costs (excluding consortium Facilities and Administrative costs) of up to $325,000 per year, with no more than $350,000 direct cost in any given year.
Award Project Period	Support may be requested for up to five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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)

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)
• 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 not eligible to apply.

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

• 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.
• 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.
• 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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the 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.

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:

Christopher Platt, Ph.D.
National Institute on Deafness and Other Communication Disorders
6001 Executive Boulevard, Rm 8311, MSC 9670
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-1804
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

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

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

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Indicate how the resource aims of the Registry can enhance research, although the Registry itself is not a hypothesis-driven research activity.

Research Strategy: Applications responsive to this FOA should describe specific ways to maintain and enhance this resource for research on the human ear and its disorders. The Registry is a resource, so to maximize the impact of the Registry, the Research Strategy should include the following required information about the scientific organization of the Registry

Need and uniqueness: A resource should 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 and short-term training in otopathology and related fields.

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 should include 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 from living donors, although the tissues from deceased individuals are exempt from some human subjects regulations. Plans should 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; and how access to the information will be allocated and protected.

Quality control: A resource should have the highest technical quality. Describe measures to monitor, control and document the quality of specimens and data, including such aspects as donor data, tissue harvesting and handling protocols, and database upgrades.

Outreach and training: Describe plans to maximize effective use of the Registry for outreach to research scientists and to the public, and to provide some short-term training opportunities utilizing Registry resources that could contribute to the field of otopathology.

Efficiency: Describe appropriate staffing plans and discuss measures for improving efficiency or offsetting some costs. Consider appropriate technology that will not become obsolete rapidly. Cost offsets via user fees are not required, but they may be considered as part of the project plan, since they could provide potential mechanisms for efficient resource allocation as well as resource sustainability.

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

Administration: A resource should be integrated with broad strategic interests of potential users on a national and international scale. Accordingly, a framework for a Scientific Steering Committee for the Registry should be proposed to provide technical and scientific expertise for guidance and feedback from a few selected researchers, although without specific names to choose until an award is made.

Milestones: Objective milestone indicators are needed to help guide the project, to ensure that the resource is meeting the community's needs, is of high quality, and is accessible. Milestones should 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, training of users, publications citing uses, etc. The milestones should include realistic quantitative goals for resource usage to be reported at the end of each annual funding period. At a minimum, include specific milestones for the end of the second year and the fourth year.

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 users (individuals, groups, or consortia) because such testimonials create conflicts and make reviewing applications significantly more difficult.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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.

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 by the Center for Scientific Review and responsiveness by the NIDCD, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDCD Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Will the proposed resource meet a significant community need by contributing substantially to the quality of research on temporal bone 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 community? Is the resource likely to improve the public awareness of human ear disorders and the need for research?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

Do the PD(s)/PI(s) have a history of service-oriented efforts outside the needs of their own research? 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?

Innovation

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?

Is the resource a unique or complementary asset to the community? Does the resource address a timely community need?

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is quality control addressed well? 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?

Environment

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?

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 for Evaluation

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?

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Deafness and Other Communication Disorders, 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 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 National Deafness and Other Communication Disorders Advisory Council (NDCDAC). 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.

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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, and any participation in collaborative projects approved by the Steering Committee (see below), with assistance from the NIDCD Program Coordinator;
• assuming accountability to the applicant organization officials and to the NIDCD for the performance and proper conduct of the research supported by the U24 in accordance with the terms and conditions of the award.
• Awardees 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:

• An NIH Program Official within NIDCD will be designated the Program Coordinator for the Registry. The NIDCD Program Coordinator for the Registry has 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 Program Coordinator:
  • convenes the initial meeting of the Steering Committee (see below), and
  • has lead responsibilities in managing and sharing 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.
  • 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.
• 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 HTB specimen acquisition or evaluation; lack of adequate data reporting or quality control; other major breach of scientific conduct; or human subject ethical issues, whenever applicable.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Assistance by a Steering Committee (SC) to include 4 or 5 members: the PI of the Registry, the NIDCD Project Coordinator as a non-voting member, and at least 2 external scientists (not at the PD/PI's institution) with appropriate understanding of otopathology as well as basic ear research. The external members are selected by agreement of the PI and the NIDCD Program Coordinator. The SC will share scientific management oversight and responsibility for facilitating the conduct and monitoring of the Registry, and reporting on Registry evaluation activities.
• The SC will meet at least yearly; the meeting(s) 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 common protocols for HTB acquisition, processing and initial evaluation;
  • policies and procedures for maintaining liaison and sharing data with otopathologists and the community;
  • standards or decision criteria for database management and data selection;
  • explicit collaborations of the Registry with other projects.
• The SC reviews HTB accrual, protocol compliance, results of audits, and regulatory requirements at the Registry, and the results of its reviews are included in the project Annual Reports to the NIDCD. Such review includes evaluating the Registry's record of meeting established milestones; of defining practices regarding access to data and publications consistent with NIDCD policies; and of promoting and fostering the inclusion of women and ethnic minorities in the donor pool and assuring the completeness of informed consent.

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.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]

Christopher Platt, Ph.D.
Program Officer, Hearing and Balance
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-1804
Email: [email protected]

Melissa Stick, Ph.D., M.P.H
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-8683
Email: [email protected]

Christopher Myers
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: [email protected]

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 Parts 74 and 92.