Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Deafness and Other Communication Disorders (NIDCD)

Funding Opportunity Title

NIDCD Early Career Research (ECR) Award (R21)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

New

Related Notices
  • NOT-DC-15-004 - Notice of the Replacement of the NIDCD Small Grant Program (R03) with the NIDCD Early Career Research Award (R21)
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

PAR-16-057

Companion Funding Opportunity

None

Number of Applications

Only one NIDCD Early Career Research Award (ECR) R21 application may be submitted by a PD/PI per due date. Applicants will be considered ineligible for this funding opportunity if they submit an R01, R03, R15 or any other R21 application, with NIDCD as the primary IC, for the same review cycle that the NIDCD ECR Award (R21) application is submitted. See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.173

Funding Opportunity Purpose

The NIDCD Early Career Research (ECR) Award (R21) is intended to support both basic and clinical research from scientists who are beginning to establish an independent research career. It cannot be used for thesis or dissertation research. The research must be focused on one or more of the areas within the biomedical and behavioral scientific mission of the NIDCD: hearing, balance, smell, taste, voice, speech, or language. The NIDCD ECR Award R21 grant mechanism supports different types of projects including secondary analysis of existing data; small, self-contained research projects; development of research methodology; translational research; outcomes research; and development of new research technology. Irrespective of the type of project, the intent of the NIDCD ECR Award R21 is for the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) to obtain sufficient preliminary data for a subsequent R01 application.

Key Dates
Posted Date

December 11, 2015

Open Date (Earliest Submission Date)

January 26, 2016

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

February 26, 2016, June 28, 2016, October 26, 2016,

February 28, 2017, June 27, 2017, October 26, 2017,

February 27, 2018, June 26, 2018, October 26, 2018, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

October 27, 2018

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.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

Problems accessing or using ASSIST should be directed to the eRA Service Desk.
Problems downloading forms should be directed to Grants.gov Customer Support.
Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The NIDCD Early Career Research (ECR) Award is different from other NIH R21 programs. It is restricted to clinical and basic scientists who are transitioning to, or are already in the early stages of, their independent research career. The research should be focused on one or more of the areas within the biomedical and behavioral scientific mission of the NIDCD, specifically: hearing, balance, smell, taste, voice, speech, or language. The expected outcome from projects funded under this mechanism is the acquisition of necessary preliminary data for a subsequent research project grant (R01) application.

The proposed project may or may not be hypothesis-driven since the goal is to collect the necessary preliminary data sufficient to apply for an R01 grant. The project may aid in the formulation of hypotheses and may be milestone-driven or descriptive in scope. Given that the goal is to collect preliminary data, R21 projects may be less immediately impactful or significant compared to the typical R01. It is not an expectation that this R21 project will likely "move the field forward" at this stage.

Preliminary data are not required. However, the applicant PD/PI should provide sufficient information to give confidence to the reviewers that the proposed work is feasible and that data derived from the project would likely be suitable as preliminary data for a subsequent R01 application. If preliminary data are available it is recommended that these be included.

The NIDCD ECR Award R21 may be used by beginning clinical scientists planning a future application for an NIDCD K08 or K23 mentored research career development award to demonstrate the feasibility of the research project to be proposed in their K-award application. Applicants that have already received a K award from NIDCD may reduce their effort on the K-award to no less than 50% (6 person-months based on a 12 month calendar) during the last two years of the K-award in order to become PD/PI on the NIDCD ECR Award R21 (see  NIH policy http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html). The PD/PI’s total level of effort must remain at 75% (9 person-months based on a 12 month calendar) or more across the K-award and the R21 award.  Questions regarding eligibility should be addressed prior to beginning to prepare the application by contacting the training staff member listed in Section VII. Agency Contacts.  

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New  
Resubmission

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

The combined budget for direct costs for the entire project period may not exceed $300,000. No more than $100,000 in direct costs may be requested in any single year.  

Award Project Period

The scope of the proposed project should determine the project period. The maximum period of support is 3 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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

The PD/PI must be a U.S. citizen, permanent resident or valid U.S. visa holder.  The PD/PI must be no more than 7 years beyond the date that the first professional, advanced professional, or terminal academic degree was awarded, whichever is most recent. The 7 year eligibility period will be calculated based on the MM/DD/YYYY the degree was awarded. The last application due date, not the application submission date, that falls within the 7 year eligibility period will be the last date an application may be submitted. Formal years of clinical training (Internship, Residency, and Fellowship) are not counted as part of the 7 year limit. In addition, exemption of years for clinical training is not limited to physicians.  For example, individuals with clinical training or clinical fellowship years in Clinical Molecular Genetics, Audiology, or Speech-Language Pathology are also eligible for our exemption. Under certain rare and compelling circumstances, NIDCD will accept requests for an extension to the 7-year standard eligibility period for its NIDCD ECR Award (R21) program as previously applied to the NIDCD Small Grant (R03) program (see NOT-DC-14-001). A resubmission will be allowed even if the 7 year eligibility period has expired provided the resubmission application is received within 37 months from the original submission due date based on current NIH Guidelines (NOT-OD-14-074).

The PD/PI may be an independent early stage investigator or a late-stage postdoctoral fellow still in his/her mentor's laboratory. However, if still a postdoctoral fellow, there should be a clear commitment to the provision of laboratory space and a clear indication that a transition away from the mentor is being initiated and that the research project will be transferable to another U.S. institution.

Questions regarding eligibility should be addressed prior to beginning to prepare the application by contacting the appropriate staff member listed in Section VII. Agency Contacts.

Individuals who have served as PD/PI on any NIH research grant (including an R01, R03, R15, R21, SBIR/STTR, subprojects of program project or center grants) or any other federally-funded research grant (e.g., NSF, DOE, VA) are NOT eligible for the NIDCD ECR Award Grant Program. However, former recipients of Federally-funded National Research Service Award fellowships and traineeships (i.e. F- and T- series awards) or mentored career development awards (i.e. K awards) are eligible for the NIDCD ECR Award grant program. Recipients of the K99/R00 award are not eligible to apply for the NIDCD ECR Award (R21).

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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).

Only one NIDCD ECR Award (R21) application may be submitted by a PD/PI per due date. PD/PIs who successfully obtained an NIDCD Small Grant award are ineligible for an NIDCD ECR Award (R21).

Applicants may not submit an NIDCD R01, R15 or R21 application for the same review cycle that the NIDCD ECR Award application is submitted. In such cases, the NIDCD ECR Award R21 application will be withdrawn.  

Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments. Those PDs/PIs who are in late-stage postdoctoral status and housed in their mentor's laboratory should submit documentation from their mentor indicating a clear commitment to the provision of laboratory space and a clear indication that a transition away from the mentor is being initiated and that the research project will be transferable to another appropriate U.S. institution.

SF424(R&R) Senior/Key Person Profile

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

Those PD/(s)/PI(s) with formal years of clinical training who wish to have those years excluded from the 7 year limit of eligibility should document those years of clinical training in their Biographical Sketch. The MM/DD/YYYY the terminal degree was awarded, specific dates of clinical training i.e. from MM/DD/YYYY to MM/DD/YYYY, as well as the title and location of the clinical training should be specified in the PD/PI's Biographical Sketch.

Inclusion of the mentor(s) as an investigator on the ECR Award (R21) application is discouraged and does not support the notion that the PD/PI is moving towards independence.

Modular Budget

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

The effort dedicated to the NIDCD ECR Award R21 project must be commensurate with the aims of the project. At a minimum, the PD/PI is expected to commit 25% effort (i.e. 3 person-months based on a 12 month calendar) to the project unless a compelling justification for less is provided in the budget justification section of the application. PD/PI effort may be as high as 100% (i.e. 12 person-months based on a 12 month calendar). Effort dedicated to the project reflects time commitment and may be more than the grant-supported salary committed. For example, the PD/PI may have a 25% time effort with only 10% of the PD/PI salary derived from the NIDCD ECR Award R21 with the rest coming from other sources.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Letters of Support: Include letters of collaboration as applicable. Do not include letters of recommendation.

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, with the following modification:

  • 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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The NIDCD ECR Award R21 grant is a mechanism supporting investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.  An ECR Award grant application will not have the same level of detail or extensive discussion found in an R01 application. The PD/PI should provide sufficient information to give confidence to the reviewers that the proposed work is feasible and that data derived from the project would likely be suitable as pilot data for a subsequent R01 application.

It is not expected that at this stage these data will make a significant contribution to ‘drive’ or move the field forward.  Finally, the NIDCD ECR Award program is intended for investigators who are in the beginning stages of establishing an independent research career. These PD/PIs are not expected to have the same grant writing experience as a more senior R01 funded investigator. NIDCD ECR Award projects may be less immediately impactful or significant compared to an R01.

Overall Impact

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

Scored Review Criteria

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

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?

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?

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?

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? Is there a good likelihood that the project will yield sufficient preliminary data for a subsequent R01 application?

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?  

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?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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.

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

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

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

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) Genomic Data Sharing Plan.

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

  • 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

An NIDCD ECR Grant (R21) will not be awarded to the same PD/PI during the same Council round that another federally-funded grant is awarded.

Transfer of an award to a foreign institution is not allowed. If the original PD/PI for an awarded NIDCD ECR Award (R21) leaves the project, no replacement PD/PI will be allowed.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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.

Section VII. Agency Contacts

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

Application Submission Contacts

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)
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
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

For general and eligibility questions, contact:
Bracie Watson, Jr.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: watsonb@nidcd.nih.gov

For questions regarding scientific issues:
Epidemiology, Population-Based Research, and Biostatistics:
Howard J. Hoffman
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-1843
Email: hoffmanh@nidcd.nih.gov

Hearing and Balance/Vestibular:
Janet Cyr
Peripheral Pathways, Presbycusis, Noise-induced Hearing Loss
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: cyrj@nidcd.nih.gov

Amy Donahue
Clinical Assessment and Management,
Psychoacoustics, Cochlear implants
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: donahuea@nidcd.nih.gov

Nancy Freeman
Molecular and Developmental Biology, Signal Transduction
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: freemann@mail.nih.gov

Roger L. Miller
Auditory and Other Neural Prostheses, Tinnitus
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3464
Email: millerr@nidcd.nih.gov

Christopher Platt
Central Pathways, Temporal bone
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-1804
Email: plattc@nidcd.nih.gov

Bracie Watson, Jr.
Genetics, Otitis media, Immune Mediated Disorders
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: watsonb@nidcd.nih.gov

Language:
Judith Cooper
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: cooperj@nidcd.nih.gov

Research Training:
Alberto Rivera-Rentas
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-1804
Email: riverara@nidcd.nih.gov

Taste/Smell:
Susan Sullivan
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3464
Email: sullivas@nidcd.nih.gov

Voice and Speech:
Lana Shekim
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-5061
Email: shekiml@nidcd.nih.gov

Peer Review Contact(s)

Melissa Stick   
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-8683  
Email: stickm@nidcd.nih.gov

Financial/Grants Management Contact(s)

Christopher Myers  
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713  
Email: myersc@nidcd.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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