Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, includingSupplemental 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.

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

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. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The NIDCD is strongly committed to developing the research career trajectories of highly promising physician and non-physician clinician-investigators in its research mission areas of hearing, balance, smell, taste, voice, speech and language. Clinician-scientists are crucial translators of both fundamental scientific advances into healthcare advances and of clinical observations into fundamental scientific discoveries as independent principal investigators and as substantive co-investigators and team scientists.

This FOA targets new and recently appointed tenure-track or equivalent clinically trained assistant professors who have demonstrated a keen interest in forging an independent clinician-scientist career track in fundamental, translational or patient-oriented research within the NIDCD research mission in tandem with clinical practice, but lack sufficient research training and experience to successfully compete for NIDCD funding through the Mentored Clinician-Scientist Development Award (K08) or Mentored Patient-Oriented Career Development Award (K23) programs. It provides such faculty members with two years of salary support for protected research career development time and limited research support to gain the scientific knowledge and hands-on laboratory or other relevant experience under the guidance of a qualified research mentor and to generate publishable preliminary data needed to forge a more sustained and advanced research career development program as a follow-up K08/K23 application. The NIDCD requires its K08/K23 applicants to have an aggregate of at least two years of prior research experience and expects that first-authored, peer-reviewed scientific publication output will have emerged from that research experience.

A pivotal point in the career paths of new clinician-scientists seeking to forge an independent research career trajectory is the transition period between completing training in a medical, surgical or allied health professional specialty and launching one's career as a junior-level faculty member. During those formative few years they face formidable changes, heavily tasked with clinical, teaching and administrative responsibilities in tandem with refining their clinical skills and developing their research programs. Scientific mentoring is a critical factor at this career juncture. A systematic review of the literature on the role of mentoring in the development of careers in academic medicine [Sambunjack et al., JAMA, 2006: 296(9): 1103-1115] revealed that individuals who had a mentor allocated more time to research, and were more likely to complete research projects, publish their research and successfully compete for grant support than their unmentored counterparts.

The NIH K08 and K23 programs have proven to be efficacious support vehicles for launching the independent research programs of promising junior clinician faculty members. In an NIDCD study examining NIH research project grant (RPG) outcomes [through Fiscal Year (FY) 2013] of NIDCD K08/K23 awardees whose last year of award was FY06-09, 90% applied for a subsequent RPG and 57% received such an award; 63% applied for R01 funding, specifically, and 40% received an R01 grant. However, many clinically trained individuals demonstrating a keen interest in forging independent research programs within the NIDCD research mission have limited prior research training and experience and would not be eligible or competitive candidates for the Institute's K08 and K23 Programs.

Very recently, the NIH Advisory Committee to the Director (ACD) Physician-Scientist Workforce Working Group recommended developing an NIH-wide career development program to help transition emerging clinician-scientists from their clinical training career phase to the junior faculty career stage. Earlier, the Conference on Research Education and Training in Otolaryngology (Grandis et al.; OHNS: 135, 361-367, 2006) recommended the establishment of institutional awards providing two years of start-up mentored support for junior tenure-track faculty in otolaryngology planning to submit K08/K23 applications. Similarly, both a recent working group (June 2013) of the leadership of NIDCD-supported T32 programs in otolaryngology departments and the American Triological Society (January 2014) recommended establishing a small-scale, two-year "pre-K08/K23" career transition program submitted late in the clinical training period [final residency year or postresidency fellowship year(s)] or within the first two years of a new faculty appointment, and activated upon the faculty appointment, to provide support for protected research time early in the academic career.

 

 

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.

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

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

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 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

This initiative is intended for clinically trained individuals with limited prior research training and experience in the health/life sciences. Typically, they will have had less than an aggregate of approximately two years of full-time research training and experience since beginning their postgraduate health professional education. Candidates for this award must have a health-professional doctoral degree. Such degrees include, but are not limited to, the MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice. Individuals with the PhD or other doctoral degree (AuD, PsyD) in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. This initiative is not intended for individuals holding a dual/combined clinical and research doctoral degree (e.g., MD/PhD), except if the PhD training was in a discipline outside of the biomedical and behavioral sciences.

Candidates for this award must have completed their clinical training and be within the first three years of their tenure-track or equivalent assistant professorship appointment prior to receiving an award. However, candidates who have accepted faculty position offers may also apply for this K22 award from their future institution during the final year of their postgraduate clinical training, e.g., clinical residency/fellowship or postresidency fellowship, or during the period of an academic instructorship appointment. Offers of faculty positions that are contigent upon receiving a K22 award are not an acceptable level of institutional commitment for purposes of this program initiative.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

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

Individuals are eligible for a K22 award if they have been, or currently are, the PD/PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the specific aimsor research goals of an R03 or R21 grant. Individuals are NOT eligible to apply if they have pending an application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals are not eligible to apply 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.

At the time of award, the candidate must have a "full-time" appointment at the academic institution. While candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their career development and research training during the mentored phase, surgeon candidates must dedicate a minimum of 50% of full-time professional effort to the research and career development activities associated with this K22 program.Candidates may engage in other duties as part of the remaining 50% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

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. 

Before submitting the application, the candidate must identify a primary mentor within the home institution who will supervise the proposed career development and research experience. Having a primary mentor on-site will facilitate regular in-person contact in the mentoring relationship. The mentor should be an active, accomplished investigator in the area of the proposed research with a successful record of scientific accomplishment, Federal research funding, and scientific mentoring (preferably including the mentoring of junior clinically trained faculty members), 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. When additional expert guidance is needed for the conduct of the proposed Research and Career Development Plan, one or more additional mentor(s) may be recruited to constitute a mentoring team. Furthermore, if the designated primary mentor is a non-clinician, candidates shall identify a secondary member who is an accomplished clinician-scientist to serve as a role model and provide career planning/building guidance to the candidate, including preparation of the subsequent K08/K23 application.

Institutional Environment

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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 strongly encouraged to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address and telephone number of the PI
• Name(s) and affiliation(s) of the mentor and other key personnel
• Participating institution(s)
• Name and title of this funding opportunity

The letter of intent should be sent to:

Daniel A. Sklare, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
Telephone: 301-596-1804
Fax: 301-402-6251
Email: [email protected]

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

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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.

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.

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.

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.

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

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

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

• Describe the candidate's commitment to a research career trajectory within the Research Mission of the NIDCD.
• Describe prior training and how it relates to the objectives and long-term plan of the candidate to forge an independent clinician-scientist career track.
• Describe the candidate's research interests and experiences to this point in his/her career.
• Provide evidence of the candidate's potential to develop into an independent clinician-investigator in an academic setting.
• Describe the professional responsibilities/activities beyond the minimum required 9 person-months (75% full-time professional effort) commitment to the career development award [for surgeons: 6 person-months (50% full-time professional effort)]. Explain how these responsibilities and activities will help ensure career progression to achieve research indepdendence as a clinician-investigator.

Career Goals and Objectives

• Describe the candidate's current and long-term research and career objectives under this award and beyond it.
• Describe a systematic plan that shows a logical progression from prior research and training experiences to the research and training experiences during the K22 award period, to the projected subsequent K08/K23 award period, and then to independent clinician-investigator status.
• Explain how this career development award will contribute to the candidate's long-term career goal to become a clinician-investigator and, in the short-term, to crafting a strong K08/K23 application in follow-up to K22 funding.

Candidate's Plan for Career Development/Training Activities During Award Period

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. The sponsor/mentor may form a mentoring team to assist with the development of a program of study or to monitor the candidate's progress through the career development program.
• Describe the career development plan and how it fits with the candidate's goals, current professional responsibilities and prior experience. Candidates should propose a structured career development program of didactic training (e.g., directed study/tutorials, semester-long courses, short courses) and/or laboratory-based training and instruction in research techniques and technologies/tool areas. A systematic plan, specifically tailored to meet the needs of the candidate, should be presented for obtaining the necessary scientific background, hands-on research, research design and data analysis experience, oral presentation skills, and grantwriting skills leading up to preparation of a K08/K23 application and, in the longer term, for launching an independent research career trajectory. Specifically, a graduate level course in biostatistics and research design should be integrated into Year One of the Career Development Plan.
• Candidates should also receive guidance in the career-building, time management, and laboratory/research program management skills needed for building a successful independent research career trajectory and for advancing their careers in academia. A timetable with defined milestones, extending beyond the two-year award period, for the preparation and submission of a K08 or K23 application should be presented in the application

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).
• The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019.
• Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.

Statements and Letters 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:

Plans and Statements of Mentor and Co-mentor(s)

• The candidate must name a primary mentor who, together with the candidate, is responsible for planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors, as appropriate to the goals of the program.
• The primary mentor should be recognized as an accomplished investigator in the proposed research area and have a record of success in training and placing independent investigators.
• The mentor should have sufficient independent research support to cover the costs of the proposed research project, in excess of the allowable costs of this award.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the early-stage mentored stage of his/her career to preparing a K08/K23 application, in the trajectory toward independent research investigator status, during the project period of the award; and 4) a plan for monitoring the candidate's research, publications, and progression towards independence.
• Similar information must be provided by any named co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
• The mentor must agree to provide annual evaluations of the candidate's progress as required in the annual progress report.

Letters of Support from Collaborators, Contributors and Consultants

• Consultant and Collaborator (if applicable): Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants are not required to provide their biographical sketches, but may if deemed helpful. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• Any other opportunities for the candidate's professional growth should also be documented in these statements.

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

• The sponsoring institution must define and document a strong, well-established research program related to the candidate's area of interest, including a high-quality research environment with key faculty members and staff capable of productive collaboration with the candidate.
• Describe the facilities, supplies, equipment, and human resources that will be available to the candidate in the sponsoring institution, including any resources that are within an institution-wide center, such as a Clinical and Translational Science Award (CSTA).
• Describe how the research environment of the institution is particularly suited to enhance the development of the candidate's research career as an independent clinician-scientist and the pursuit of the proposed career and research plans. Include information on relevant courses, research seminars and/or colloquia offered within the institution.
• Describe the specific community that will directly contribute to the candidate's career development, including faculty, postdocs, students, technicians and other contributing personnel.

Institutional Commitment to the Candidate's Research Career Development

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award or a subsequent K08/K23 award.
• Provide a statement assuring that the candidate will be able to commit a minimum of 9 person-months per year (75% of full-time professional effort) [for surgeons, a minimum of 6 person-months (50% of full-time professional effort)] to the research and career development program. The remaining effort should be devoted to activities related to the development of the candidate's career as an independent clinician-scientist, e.g. clinical responsibilities, teaching and administration.
• Provide assurance that the candidate will have appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed Research and Career Development Plan.
• Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development and plans.
• Candidates who have been offered and have accepted a faculty position, but are not yet appointed, shall include a letter from the Department Chair outlining the institutional commitment to the candidate, including the start-up package to be provided to the candidate and its timeline. The letter should also describe the specific allocation of time (on a weekly and/or monthly basis) that the candidate will devote to K-award activities, if awarded, and to clinical and other non-K-award activities.

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

• A sound research project must be provided that is consistent with the candidate's level of research development and the objectives of his/her career development plan, and that is of appropriate scale to be accomplished during the two-year award period. The research description should demonstrate the significance of the research and the soundness of the approach, as well as the ability of the candidate to carry out the research under the mentorship of the sponsor(s).
• The application must also describe the relationship between the mentor's research and the candidate's proposed research plan.
• The application should state the significance, innovation and approach of the proposed research project. The Research Strategy should provide a detailed rationale, experimental approach, and expected/alternative outcomes for the proposed study. The application should provide a clear description of how the data will be analyzed, power calculations, potential problems that may be encountered and how the approach will be modified should these potential problems materialize.
• If patient-oriented research is proposed, the candidate should describe plans for the recruitment and retention of subjects (when applicable) and plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. In addition, the following shall be described: The pool of subjects available for study; access to the patient population, recruitment strategies; any potential obstacles; any relationship between the clinical and research activities that involve these patients; and, the potential clinical impact of the research.
• The application should describe how the projected research accomplishments of the K22 award period will enable the candidate to follow-up with a well-conceived K08 or K23 application.

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.

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 NOT-OD-11-079). 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.

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) using ASSIST or other electronic submission systems. 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.

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-012 and NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

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

Reviewers should provide their assessment of the likelihoodthat the proposed career development and research plan will enhance the candidate's potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

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

• Does the candidate have the potential for becoming a successful independent clinician-investigator who will contribute significantly to research in the scientific mission areas of the NIDCD?
• Are the candidate's level of research experience and exposure appropriate for this award?
• Is there evidence of the candidate's commitment to meeting the program objectives to acquire the competencies needed to prepare a follow-up K08/K23 application?
• Do the letters of reference address the above review criteria, and are these supportive of the potential of the candidate to become an independent clinician-investigator?
• Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring
• Is the Career Development Plan consistent with the candidate's research and career goals?
• Are the content, scope and phasing of the Career Development Plan, including both formal coursework, seminars, technical workshops, directed study, laboratory experiences, appropriate when considered in the context of prior training/research experience and the stated training objectives for achieving research independence?
• Is the plan likely to contribute substantially to the scientific development of the candidate and prepare the candidate to prepare a cogent follow-up K08/K23 application that will lead to scientific independence?
• Does the Career Development Plan adequately address skills and experiences required for developing a successful independent research career trajectory beyond those elements directly related to the research (e.g., grantwriting, networking, oral presentation, lab and research program management)?
• Is there adequate assurance that the candidate will receive at least 75% protected time (50% for surgeons) for research career development? Are the non-research (i.e., clinical, teaching, administrative) commitments of the candidate described in terms of the actual time commitment required to fulfill these?
• Are there adequate plans for monitoring and evaluating the candidate's research and career development progress?
• Are appropriate and feasible timelines delineated for the candidate's progress, including beyond the period of the award (i.e., preparation of the follow-up K08/K23 application)?

Research Plan

• Are the proposed research question, design, and methodology of sound scientific and technical merit?
• Is the research plan relevant to the candidate's stated research career objectives?
• Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?
• Will the research plan provide the candidate with a skill set and preliminary data appropriate as a platform for crafting a cogent follow-up K08/K23 application and lead to research independence?
• Does the research plan include an adequate description of data analysis, expected results, approach to data interpretation, alternative hypotheses, potential problems and solutions to those problems?
• Is the research project proposed sufficiently distinct from the mentor's research to enable the candidate to employ it as a platform for both a follow-up K08/K23 research plan and an independent research trajectory?

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

• Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
• Does the mentor(s) adequately address the candidate's potential and his/her strengths and areas needing improvement?
• Is there adequate description of the quality and extent of the mentor's proposed role in providing guidance and advice to the candidate?
• Are the research career development activities and mentoring plan tailored to and adequate to achieve the candidate's needs?
• Are there adequate plans for monitoring and evaluating the candidate's progress toward independence?
• Is active/pending support for the proposed research project appropriate and adequate?
• Does the mentor or mentoring team have appropriate research and training experience to successfully guide the candidate in his/her research and career development?
• Are the roles of any named consultants and/or collaborators specified, and are they qualified, appropriate and sufficient, along with the mentor(s), to fulfill the candidate's research and career development needs?

Environment & Institutional Commitment to the Candidate

• Is there clear commitment of the sponsoring institution to ensure that a minimum of 9 person-months per year (75% of the candidate's full-time professional effort) (50% professional effort/6 person-months for surgeons) will be devoted directly to the research and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of clinical, teaching, and administrative responsibilities, as applicable?
• Is the institutional commitment to the long-term career development of the candidate from the mentored to the independent investigator career stages appropriately strong?
• Are the research facilities, resources and training opportunities, including faculty capable of providing scientific and career mentorship and productive collaboration with the candidate adequate and appropriate?
• Is the environment for scientific and professional development of the candidate suitable and of high quality?
• Is the oversight mechanism within the institutional environment adequate and appropriate to ensure the successful progress of the candidate toward his/her research and career development goals?

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.

Post-K22 Award Timetable for K08/K23 Application Preparation

Is a timetable with defined milestones, extending beyond the two-year K22 award period, for the preparation and submission of a follow-up K08 or K23 application presented in the application, and is it adequate and appropriate?

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

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

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant's career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow's instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the 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 for initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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. 

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. More specifically, for K Awards, visit the Research Career Development ("K") Awardees section of the NIH Grants Policy Statement.

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.

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.

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 submission date to ensure that planned research is within the NIDCD Research Mission and that the proposed career development plan is consistent with the FOA programmatic requirements.

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)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

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

Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
Email: [email protected]

Daniel A. Sklare, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-1804
Email: [email protected]

Melissa Stick, Ph.D., MPH
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-8683
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 Parts 74 and 92.