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

Establishing a national laboratory resource for auditory and vestibular researchers will benefit all those who use human inner and middle ear tissues for a range of basic and clinical studies. The Laboratory will develop and provide technical services for procuring, preparing, sectioning and distributing high-quality human tissues; develop and disseminate techniques for improved tissue processing; develop imaging methods for human middle and inner ear structures, including cellular and membranous components; and provide opportunities for technical instruction in the special skills needed to prepare ear and use tissues from post-mortem human temporal bone donations. A cooperative agreement will coordinate interactions with the basic and clinical research community and maximize impact while avoiding duplicative efforts. This resource will benefit a broad spectrum of research projects by providing critical technological improvements to analyze human ear tissues, with an impact on translational work and eventually the clinic, for the NIDCD mission to help prevent, detect, diagnose, and treat deafness and other communication disorders.

Structural details of the inner ear sensory organs for hearing and balance are difficult to study in humans because these soft tissues are encased in the dense temporal bone of the skull. The cochlea and the vestibular system are not readily accessible for biopsy or by non-invasive techniques that preserve function in living subjects. The value of otopathology in understanding ear diseases and disorders is without question, yet studies of human auditory and vestibular tissues are limited by the uneven quality of preservation and preparation of donated post-mortem specimens. These restrictions seriously limit progress in understanding pathology of the organs of hearing and balance in humans. Many investigators have relied instead on animal studies for experiments, but the necessary human relevance of such studies has not been forthcoming, and a few reported human results are significantly different from those in animals. The critical need to relate findings from animal models to human ear disorders has been emphasized repeatedly in various research meetings as well as the recent NIDCD Strategic Plan. The 2015 NIDCD Research Workshop: "Synaptopathy and Noise-Induced Hearing Loss: Animal Studies and Implications for Human Hearing" emphasized the need for human data to reveal structural correlates of genetic and physiological disorders of the human ear as well as to visualize the consequences of therapeutic treatments including drugs and devices. However, technological challenges in acquisition, processing, and visualization of human ear tissues are not trivial, and very few temporal bone labs still prepare new human material. The purpose of this U24 is to create a single national laboratory to serve the auditory and vestibular basic and clinical research communities more broadly, by improving the quantity, quality and availability of human specimens, by developing and sharing advances in methods and techniques for human ear tissue processing, by developing technologies for non-invasive imaging, and by providing technical instruction, all to enhance opportunities for needed research on human ear tissues.

NIDCD continues to support the NIDCD National Temporal Bone, Hearing and Balance Pathology Resource Registry ('the Registry') as a separate U24 award. The Registry is an information center that coordinates and archives data about recruited temporal bone donors and location of specimens nationwide, and maintains a network of contacts for timely procurement of tissue. The Registry serves as a database, which does not obtain or process specimens or do research. Creating a complementary national research resource to acquire and improve processing of human middle and inner ear tissues is a related but distinct activity designed to provide technological improvements for new research contributions from a wide range of investigators.

A national technological laboratory as a resource for human ear tissue research will create opportunities that generate benefits across a range of specific disciplines or disease. Increased availability of high-quality samples and improved analytical and visualization approaches to human ear tissues will enable more direct tests of the validity of animal models for genetic and physiological disorders of hearing and balance in humans, and could encourage new collaborations between researchers on animals and humans. Dissemination of best practices and increased availability of technical training will improve the capabilities of basic or clinical researchers and laboratory staff, and could make it easier for those currently working only in animals to pursue research on humans. There are at least four areas of opportunity:

1) Increased availability

Increasing the available numbers of temporal bones that are well prepared for subcellular analyses could enable new studies focused on sensory structure and function in both normal and pathological human ear tissues. Recent advances have shown how biochemical and molecular markers can be applied to human cochlear and vestibular tissues from human temporal bones, increasing the usefulness of specimens and clinical cases available for microscopic analysis. Multiple antibodies now can be used in single sections of tissue, with markers allowing new levels of subcellular resolution, showing specific relationships of cellular elements far beyond those available from traditional stains. New techniques to reprocess embedded temporal bone specimens now make archival specimens as well as newer tissue available for study.

2) Improved visualization

Developing new techniques for non-invasive imaging could provide a dramatic advance in clinical assessment of pathology and potential diagnostics. New information at cellular resolution from living patients on normal and disordered ears could clarify details such as cellular changes over time in properties of bone or soft tissues, or reactions to cochlear implant electrodes, or morphological features related to fluid distribution in the inner or middle ear.

3) Validity tests for animal models:

To understand human disorders it is crucial to analyze human tissues, and technically well-prepared human tissues could allow validation tests of specific predictions from animal models to human disorders from trauma, disease or genetics. Numerous projects currently using non-human mammalian models are asking research questions with ultimate clinical relevance, and incorporating analysis of human specimens into the research would add substantial value in translating the animal work toward human applications.

4) Increased interest in human ear tissues:

Interest in human ear research could be increased by dissemination of best practices and new technology, and by providing opportunities for technical instruction in the special skills for post-mortem human ear tissue preparation. Investigators lacking experience with human tissues could obtain some technically well-prepared human tissues for questions related to their own research, and/or receive technical instruction in processing human ear tissues themselves.

Removing technical hurdles could allow researchers previously unable to study human ear tissue to modify their research programs to include human studies.

Some specific targets of opportunity could include, but are not limited to, those listed below:

• protocols to improve procurement and early processing, to increase the numbers of available human ear tissues with minimal post-mortem times and optimal initial fixation
• priority for processing tissues from donors with well-documented medical history regarding hearing or balance, or from populations under-represented in genotype or phenotype in currently archived collections
• access to already processed archival and new tissues by facilitating their availability to researchers at various locations, or distribution of tissue preparations to interested researchers who do not have access to human temporal bone preparation facilities and technicians themselves
• techniques for human ear research at the molecular level (DNA, RNA, proteins) including immunocytochemistry and multi-antibody labeling for analyzing cellular, synaptic and subcellular features of the middle and inner ear for archival as well as fresh human specimens
• tests for alternative tissue embedding methods comparable in optical quality and archival durability to current methods using celloidin, which is becoming and increasingly scarce material
• non-destructive imaging techniques for ear tissues within the temporal bone at the cellular level of resolution, allowing optical sectioning and digital reconstruction in three dimensions.
• non-invasive imaging methods to clarify microscopic structure in soft cellular and membranous tissues as well as in harder bony or cartilaginous tissues within the temporal bone of living specimens. Such studies could include animals, with translational potential for human application
• application of new imaging technologies (optical, sonic, magnetic, etc.) to examine the ear in living patients by in situ examination at adequate resolution for accurate evaluation of common clinical disorders of the inner and middle ear (such as Meniere's disease, otitis media, labyrinthitis, endolymphatic hydrops, otosclerosis, semicircular canal dehiscence, perilymph fistula)
• processing of human tissue samples identically to those from animals, for directly testing the validity of particular animal models for human disease and disorders
• best practices for obtaining, processing and analyzing human ear tissues, and ensuring compliance with relevant regulations governing human specimens
• hands-on technical instruction for preparing and examining post-mortem human middle and inner ear tissues for basic and clinical research, to expand the pool of laboratory staff and researchers available to bring expertise and best practices to research projects on human ears
• dissemination of techniques feasible for animal laboratories to use for analyzing human middle and inner ear tissues, to stimulate interest of researchers who can bring new approaches or concepts to the field of human otopathology
• provision for the distribution limited high-quality specimen preparations for researchers who do not have access themselves to adequate human temporal bone preparation facilities.

Such points lead to potentially broad benefits for the NIDCD basic and clinical research community.

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)
• 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.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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).

Applicants must obtain 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, including Supplemental Grant Application Instructions 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
Telephone: 301-496-1804
Fax: 301-402-6251
Email: [email protected]

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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:

Research Strategy: Address the following four points in the application, including specific detailed timelines for each of these:

1) Improve access for the auditory and vestibular research community to human ear tissues from temporal bone specimens: Improve and promote timely procurement, preparing and processing of new specimens, and appropriate re-processing of archived specimens. Distribute a limited number of well-prepared laboratory tissues to funded researchers who lack adequate access to facilities for human temporal bone preparation. Exploit use of the Registry for information about currently archived tissues and their access by the community, and promote collaborations between researchers seeking to validate animal models for human relevance.

2) Optimize tissue preparation techniques: Include molecular and cellular marking and visualization techniques that allow direct comparisons of fresh and archived human tissues with those from animal models. Disseminate 'best practices' protocols for procurement, preservation and preparation of human ear tissues from temporal bones, and encourage animal researchers to include human tissues into their analyses.

3) Develop tools to exploit new technologies and methods to image and visualize human middle and inner ears in situ: Targets for imaging techniques should include soft cellular tissues, membranes and fluids, as well as hard bony tissues. While animal work will likely be needed, the development should lead toward non-invasive imaging at cellular resolution of human ear tissues in situ and in life.

4) Provide technical instruction for the community: Short-term and longer-term instruction with hands-on training should be available for technicians in the labor-intensive techniques and skills needed for processing human ear tissues from temporal bones. Instruction opportunities also should be available to attract investigators toward using human middle and inner ear tissues for basic and clinical research.

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.

• All applications, regardless of the amount of direct costs requested for any one year, should address 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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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.

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. 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDCD Referral Office by email at [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-13-030.

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.

For this particular announcement, note the following:

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is 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? Will the proposed project meet a significant community need by contributing substantially to the quality of research on the ear (in neuroscience, otopathology and other clinical and basic sciences involving the inner and middle ear, etc.)? Will the proposed services and instructional opportunities convincingly add value to the community?

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? How well are they positioned to provide the proposed project resources, and to integrate their efforts with broader strategic interests of potential users on a national scale?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Is the project a unique or a complementary asset to the scientific and clinical community?

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? Are the plans feasible for the appropriate scales of proposed technical services, of development of new resources, of dissemination to the broader community, and of technical instruction?

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?

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.

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.

Not Applicable

Not Applicable

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDCD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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. 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. 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.

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.

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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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 External Experts (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 Laboratory;
• Managing the Laboratory functions, with assistance on 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.]
• 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 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 Laboratory, 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) group with relevant scientific expertise to provide feedback to the PI and NIDCD on Laboratory 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 sharing the broad programmatic issues of the Laboratory, although the awardee has lead responsibilities in laboratory tasks and activities;
• Has access to data generated under this Cooperative Agreement and periodically may review the data and progress reports. NIDCD staff may use information obtained from the data for preparation of internal reports of the activities of the study;
• Serves as a resource to provide scientific/programmatic support by participating in the design of the activities, advising in management and technical performance, or participating in the preparation of publications;
• Reviews, with the Program Officer, the annual or more frequent reports on progress of laboratory activities.
• The NIDCD reserves the right to adjust funding, withhold support, suspend, terminate or curtail a study or an award in the event of a failure to comply with the Terms and Conditions of Award; substantial shortfall in acquisition or dissemination of tissues; 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; in planning and delivering technical instruction; and in developing policies and procedures for interactions with the wider community.
• Periodic reviews at least yearly of the Laboratory's record of meeting established timelines for tissue procurement and preparation, technology development and technical instruction; of interactions with the National Temporal Bone Registry and the wider community; and of practices regarding access to data 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.

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.

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 Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 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)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Janet Cyr, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: [email protected]

Melissa Stick, Ph.D., M.P.H.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-8683
Email: [email protected]

Christopher Myers
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 Part 75.