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 Research Career Enhancement Award for Established Investigators (K18)

Activity Code

K18 Career Enhancement Award

Announcement Type

Reissue of PAR-10-162

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

PAR-13-186

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.173

Funding Opportunity Purpose

The purpose of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to enable established, proven investigators to augment or redirect their research programs through the acquisition of new research skills to answer questions relevant to the hearing, balance, smell, taste, voice, speech and language sciences.

Key Dates
Posted Date

April 10, 2013

Open Date (Earliest Submission Date)

May 12, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply  

Advisory Council Review

Standard dates apply  

Earliest Start Date

Standard dates apply  

Expiration Date

May 9, 2016

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, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), 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.


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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 overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to help ensure that a diverse pool of highly trained, experienced scientists remains current in state-of-the-art techniques, evolving technologies and fundamental, translational and clinical research frontiers, and is available in appropriate numbers to address the Nation's biomedical, behavioral and clinical research needs in hearing, balance, smell, taste, voice, speech and language.  This intiative provides candidates with protected time and mentored guidance to augment or redirect their research career trajectories within the NIDCD research mission.

Established investigators often express an urgent need for compensated protected time and mentored training to augment their research capabilities and to keep their research programs in-step with emerging technologies and evolving scientific frontiers and, thereby, competitive for continued NIH funding.  The Ruth L. Kirschstein National Research Service Awards (NRSAs) for Individual Senior Fellows (F33) program provides one option for fulfilling that need.  This K18 initiative provides an alternative and potentially more flexible approach.

This FOA focuses on established investigators holding the academic rank of Associate Professor or Professor, or the equivalent in non-academic research settings, who have records of scientific accomplishment and independent research support (past and/or present).  Its purpose is to provide such investigators with support for short-term, intensive periods of mentored research experience over a period of six- to twenty-four months to acquire new research capabilities in the study of hearing, balance, smell, taste, voice, speech and language.  Such experiences, typically undertaken during an academic sabbatical year, will afford candidate investigators protected time to: 1) enrich and expand their expertise and research programs through retooling in new techniques, emerging technologies, and/or scientific areas; 2) redirect their research programs in new trajectories within the NIDCD scientific mission; and/or, 3) catalyze research collaborations in new research directions.  It is expected that this initiative will lead to new and augmented research programs competitive for NIH funding.  In addition to serving as a short-term career development vehicle for investigators within the NIDCD Extramural research community, this program is also intended for investigators working outside of the hearing, balance, smell, taste, voice, speech, and language sciences who wish to add trajectories within the NIDCD scientific mission to their overall research programs.

The research career enhancement experience shall take place in a host laboratory, whether in the candidate's home institution (i.e., in which the candidate holds his/her primary appointment) or in another institution with the appropriate resources to provide the proposed research career development experience.  In both cases, the tutelage of a well-qualified sponsor/mentor (or team of mentors/sponsors) is required.  In most cases, the applicant and proposed mentor(s) and host laboratory will not have had previous research collaborations.  The sponsoring institution (i.e., the institution of the host laboratory for the K18 experience) must demonstrate a commitment to provide the environment, research resources and protected time needed by the candidate to perform the activities included in the research and career development plans.  Similarly, the candidate's Department Chair (at the home institution) must provide a letter confirming that the candidate will be provided the requisite protected time to pursue the proposed research enhancement experience.

The research career development experience proposed must have the potential to substantially augment the research capabilities of the candidate at his/her home institution, and provide new research opportunities and benefits that would not be achievable through a collaborative research grant with the mentor(s).  The research career enhancement experience should be tailored to the individual needs and level of experience of the candidate, and will generally incorporate two components: 1) didactic (e.g., directed study/tutorials, semester-long courses, short courses, seminar series, journal clubs) and/or laboratory-based training/instruction in the new discipline, techniques or technologies; and, 2) a small-scale research project in the host laboratory.  The laboratory experience may comprise fundamental, translational or clinical/patient-oriented research (including epidemiologic, outcomes and health services research.

The candidate is required to devote at least half-time (50%) effort to the program, allowing for a meaningful research career development experience, over a period of six months to two years.  The allowance for a part-time commitment of professional effort will enable candidates to hold their ongoing research grants (if applicable) and meet their academic responsibilities in a limited capacity, and in accordance with NIH policy, as they pursue the career enhancement program.

Special Note: Prospective applicants are strongly encouraged to consult with NIDCD staff well in advance of applying for this award to ensure that their applications meet the Institute's programmatic requirements.

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

NIDCD anticipates funding 3-5 awards, corresponding to a projected total of $600,000 per year.

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below.

Award Project Period

Generally, the research experience shall span a contiguous period of six months to two years.

Other Award Budget Information
Salary

NIDCD will contribute up to the legislatively mandated salary cap in effect at the time of award per year toward the salary of the career award recipient. The total salary provided by the award will be prorated based on a full-time, 12-month staff appointment and the support period requested.

K18 award recipients may hold independent research support, either Federal or private, concurrently with this award, and may derive additional compensation for effort from other Federal sources or awards.  However, the total salary derived from all Federal sources may not exceed the legislatively mandated salary cap, and the total percentage effort cannot exceed 100%.  

The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

The sponsoring institution may supplement the NIDCD salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

Other Program-Related Expenses

NIDCD will contribute $40,000  per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

NIH grant 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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

The sponsoring institution may be private (profit or nonprofit) or public.

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 must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and 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. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Candidates for this award must have a research or health-professional doctoral degree, or a combined health-professional and research doctoral degree.  This award is intended for well-established investigators at the academic rank of Associate Professor or Professor, or the equivalent in non-academic settings, who have established records of independent, peer-reviewed Federal or private research grant funding.  Applicants are not required to have active research grant support at the time of application for this award.

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.

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

Candidates may submit research project grant (RPG) applications concurrently with their K18 application. However, applicants for this program may not concurrently apply for any other PHS award that  duplicates the provisions of this FOA.

Individuals are eligible to apply for this FOA if they have been or are currently a PD/PI on an NIH research grant (such as R01, R29, P01) or a subproject leader on a Program Project (P01) or Center Grant (P50), or a non-NIH equivalent to these grants/awards.  K18 award recipients may hold independent research support, either Federal or private, concurrently with this award and may derive additional compensation for effort from other Federal sources or awards.  However, the total salary derived from all Federal sources may not exceed the maximum legislated salary rate and the total percentage effort cannot exceed 100%.

The candidate is required to devote at least 6 calendar months (50% of full-time professional effort) to the K18 program, but may devote their full-time (12 calendar months) effort to it.  For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056.  The allowance for a part-time commitment of professional effort will enable candidates to hold their ongoing research grants (if applicable) and/or meet their academic responsibilities in a limited capacity, and in accordance with NIH policy, as they pursue the career enhancement program.  However, the total effort cannot exceed 100%, and all other activities must be consistent with the goals of the K18 award.  Applicants should describe any clinical, administrative, teaching, mentoring or grant-related research commitments they intend to maintain during the period of the award, and the arrangements to be made with the home institution and/or the sponsoring institution to ensure the requisite protected time for this award period.  Generally, the research experience shall span a contiguous period of six months to two years.  However, a six-month research experience may be apportioned over two successive summer semesters (of three months each), provided the experience is pursued on a full-time (100%) basis during these periods. 

Level of Effort

At the time of award, the candidate must have a “full-time” appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the “full time” requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036

Mentor(s)

Before submitting the application, the candidate must identify a mentor who will guide the proposed career development and research experience.  The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. The mentor, or a member of the mentoring team, should have a successful track record of mentoring. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The mentor should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan should include items such as classes, seminars, directed study arrangements, and opportunities for interaction with other groups and scientists.  The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.

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, 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 (R&R) Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

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

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.  

Other Project Information

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.  

R&R Budget

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.

PHS 398 Cover Letter

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.  

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.

PHS 398 Checklist

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.  

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Candidate Information

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

Candidate’s Background

Career Goals and Objectives

Career Development/Training Activities During Award Period

Training in the Responsible Conduct of Research

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.

Statements of Support

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Statements by Mentor, Co-mentor(s), Consultants, Contributors

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Description of Institutional Environment

Institutional Commitment to the Candidate’s Research Career Development

Research Plan

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

 Research Strategy

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.

Letters of Reference

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the Notice). Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

3. Submission Dates and Times

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.

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.

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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

Overall Impact

Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact score.

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.

Candidate

Has the candidate provided evidence of excellence as an independent investigator, including his/her record of research support and publication output?
Does the candidate show evidence of a high level of commitment to meeting the program's career enhancement objectives?
Does the candidate have high potential for successfully augmenting his/her research career capabilities and in becoming an outstanding contributor to the research field relevant to the proposed research enhancement experience?

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

Is the career development plan appropriate in its content, scope, duration, and phasing for the candidate's stated career development goals?
Is there a high likelihood that the proposed program will contribute substantially to the advanced research career enhancement of the candidate?

Is an appropriate level of the candidate's professional effort to the career development plan documented in the application?

Research Plan

Is the proposed research project appropriate for the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?
Is the research plan, including the research question, specific aims, design and methods, of high scientific and technical merit?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Are the mentor(s) research qualifications, scientific stature, experience, and mentoring track record appropriate for the candidate's research career development needs?
Does the mentor(s) adequately address the above review criteria in his/her statement?
Are the nature and extent of mentorship proposed adequate and appropriate, and is the commitment of the mentor(s) to the candidate's advanced research career development appropriate?
Does the mentor(s) have a history of research productivity and support, and a prior track record in research mentoring?

Environment & Institutional Commitment to the Candidate

Are appropriate and high-quality research resources and training opportunities available to the candidate at the sponsoring institution?
Is there clear commitment from both the candidate's home institution and sponsoring institution to ensure that the requisite effort of the candidate will be devoted directly to the research career enhancement activities described in the application?
Is there strong institutional commitment to fostering the advanced research career development of the candidate?
Are there unique features of the scientific environment of the sponsoring institution and host laboratory that will benefit the proposed research and career development plan (e.g., useful collaborative arrangements, special equipment or analytic methods, unique subject populations)?

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application now presented, taking into consideration the responses to critiques and 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.   

Training in the Responsible Conduct of Research

 Taking into account the circumstances of the candidate, including the more senior level of experience of candidates for this award, the reviewers will evaluate plans for instruction in responsible conduct of research (RCR), as well as past record of instruction in RCR, as appropriate.  Reviewers will specifically address the Format, Subject Matter, and Frequency of instruction, as detailed in NOT-OD-10-019.   Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the NIDCD. 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 National Deafness and Other Communication Disorders Advisory Council. The following will be considered in making funding decisions:

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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. 

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

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

It is particularly important to consult with the NIDCD Scientific/Research Contact well in advance of the planned application date to ensure that the research to be proposed in the application is within the NIDCD research mission and that the planned career development plan is consistent with the FOA programmatic requirements.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Daniel A. Sklare, Ph.D.
Research Training Officer
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-1804
Email: sklared@nidcd.nih.gov

Peer Review Contact(s)

Melissa J. Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-8683
Email: melissa_stick@nih.gov

Financial/Grants Management Contact(s)

Christopher Myers

Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-0909
Email: myersc@mail.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 Parts 74 and 92.


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