National Institutes of Health (NIH)
National Institute on Deafness and Other Communication
Funding Opportunity Title
NIDCD Research Grants for Translating Basic Research into Clinical Tools (R21)
R21 Exploratory/Developmental Research Grant Award
Reissue of FOA PAR-08-018
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestics Assistance (CFDA) Number(s)
The NIDCD is encouraging applications which translate basic research findings into clinical tools for better human health in the NIDCD mission areas of hearing, balance, smell, taste, voice, speech and language. The intent of this Funding Opportunity Announcement (FOA) is to provide a new avenue for basic scientists, clinicians and clinical scientists to jointly initiate and conduct translational research projects. The scope of this FOA includes a range of activities to encourage translation of basic research findings which will impact the diagnosis, treatment and prevention of communication disorders. Multi-institutional, multi-disciplinary, and academic-industrial collaborations studies are encouraged. This FOA is not intended for outcome studies, the extension of ongoing clinical research studies, the optimization of current clinical protocols, or pre-translational studies. Connection to the clinical condition must be clearly established and the outcomes of the grant must have practical clinical impact.
October 8, 2010
Open Date (Earliest Submission Date)
January 22, 2011
Letter of Intent Due Date
January 22, 2011; September 21, 2011, May 22, 2012, January 22, 2013 and September 22, 2013
Application Due Date(s)
February 22, 2011; October 21, 2011, June 22, 2012, February 22, 2013 and (Extended to November 1, 2013 per NOT-OD-14-003), Originally October 22, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
June 2011, February 2012, October 2012, June 2013 and February 2014
Advisory Council Review
October 2011, May 2012, January 2013, October 2013 and May 2014
Earliest Start Date(s)
December 2011, July 2012, March 2013, December 2013 and July 2014
(Extended to November 2, 2013 per NOT-OD-14-003), Originally October 23, 2013
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
NATURE AND BACKGROUND
The goal of NIH sponsored research is to improve human health. To improve human health, basic scientific discoveries must be translated into practical applications. As part of its mission, the NIDCD encourages the translation of basic biomedical or behavioral research discoveries in the field of deafness and other communication disorders into new clinical tools, prostheses and assistive devices, behavioral therapies or interventions, and medications. This FOA, which is a re-issuance of a previous NIDCD translational research FOA, continues efforts to support the translation of basic research findings into clinical tools for better human health in the NIDCD mission areas of hearing, balance, smell, taste, voice, speech and language.
A bench-to-bedside approach to translational research requires collaborations and interactions between basic scientists (delivering new information on the mechanisms underlying disease) and clinical scientists (providing information and observations about the nature, progression and treatment of disease). These interactions provide the platform for the bidirectional exchange of ideas and stimulate new avenues of research for both the basic, as well as the clinical, scientist. As basic scientists become more informed about clinically relevant findings and utilize to the fullest extent possible clinical considerations in the conceptualization of a basic research program, the potential for translation of basic research findings into clinical tools is maximized. When the basic research has reached a stage where connections to the clinical condition become apparent, the translational research studies, most often requiring multidisciplinary efforts, can begin.
Substantial advances have been made in understanding both basic biomedical (e.g., cellular, molecular, genetic, systems) and behavioral (e.g., perception, cognition, attention, motor) aspects of deafness and other communication disorders. This FOA is designed to support research efforts that allow for these basic science gains to progress into better clinical tools for human health. The purpose of this FOA is to support collaborative translational research among basic scientists, clinicians and clinical scientists that has the potential to bring advances derived from basic science into clinical applications for improved diagnosis, treatment and prevention of disorders of hearing, balance, smell, taste, voice, speech or language.
Translational research is the application of discoveries from basic biomedical and behavioral research toward the diagnosis, treatment or prevention of human disease, with the ultimate goal of improving public health. For the purposes of this FOA, connection to a human clinical condition must be clearly established and clearly stated. The application should seek to translate basic research findings (behavioral or biological) which are known to be directly connected to a human clinical condition, to a practical clinical impact. This FOA is not intended for Phase I/II clinical trials of preliminary efficacy, the extension of ongoing clinical studies, the optimization of current clinical protocols, or pre-translational studies (early stage proof of concept or developmental work premature to direct clinical relevance).
The objective of this FOA is to provide support for R21 investigator-initiated research studies that translate basic research findings into better clinical tools for human health. Such tools or technologies must overcome existing obstacles and should provide improvements in the diagnosis, treatment or prevention of a disease process. The research must be focused on a disease/disorder within one or more of the NIDCD scientific mission areas: hearing, balance, smell, taste, voice, speech or language. The scope of this FOA allows for a range of activities (see definition above) encouraging the translation of basic research findings to practical impact on the diagnosis, treatment and prevention of deafness and other communication disorders.
This FOA encourages the development of collaborative partnerships among scientists who study basic biological and behavioral processes, those who study the etiology, diagnosis, treatment and prevention of deafness and other communication disorders, and those who study the delivery of services to individuals with these disorders. Applications are expected to have both basic scientists and clinicians or clinician scientists included as key personnel (although exceptions may be allowed, they must be sufficiently justified within the application) for joint exploration, initiation and conduct of translational research projects. Multi-institutional, multi-disciplinary, and academic-industrial collaborations studies are encouraged.
Research conducted under this FOA may include laboratory studies with human subjects. Preclinical studies in animal models are allowed only for candidate therapeutics that have previously demonstrated potential for the treatment of communication disorders. Activities may include, in addition to the requisite research studies, networking activities designed to initiate and explore potential research collaborations between basic and clinical scientists, such as cross-site visits and workshops.
Possible goals include, but are not limited to:
The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.
The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.
Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.
Applicants should demonstrate that a research partnership between basic and clinical researchers exists or state how such a partnership will be developed and maintained. It is expected that applications will have both basic scientists and clinicians or clinician scientists included as key personnel and that exceptions be clearly justified within the application. The minimum collaborative arrangement would involve two investigators, although larger numbers of collaborators are encouraged, as appropriate. Due to the collaborative nature of these projects, applicants should include plans for sharing of recognition among the investigators and for future developments ensuing from these projects.
Research teams should be based on the nature of the translational research goals and should not be limited by departmental or geographical boundaries. Collaborations among different institutions are encouraged, and applicants must note how communication will be handled across institutional boundaries so that actual collaborative research partnerships can occur. In addition to the primary expertise of the basic and clinical scientist, additional relevant expertise may include biostatistics, bioinformatics, bioengineering, health economics, epidemiology, imaging, pharmacology, pharmacogenetics, psychology, regulatory expertise, etc. Because the outcome of the studies may lead to commercialization of a product, academic-industrial collaborations are also encouraged.
Applicants may utilize a milestone-based structure for projects submitted in response to the FOA, rather than the hypothesis-driven format used in more traditional R21s. This format will allow applicants to delineate a series of project stages, identify criteria for completion of work stages and provide contingency plans for each work stage. It is important that the applicant include the criteria and contingency plans that will be used to determine milestone completion before proceeding to the next phase of the projects. Applications in response to the FOA will likely not address underlying mechanisms of disease and may indeed be non-mechanistic research.
Applicants should clearly state what is being translated and how the outcomes can impact clinical practice.
Application Types Allowed
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
The total project period for an application submitted in response to the FOA may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.
Award Project Period
The maximum period is 2 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
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
NForeign (non-U.S.) components of U.S. Organizations are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (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
All Program Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Number and title of this funding opportunity
The letter of intent should be sent to:
Amy Donahue., Ph.D.
6120 Executive Blvd, EPS 400C, MSC 7180
Rockville, MD 20892-7180
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
Individuals are required to comply with instructions for the Resource Sharing Plans (Data Sharing Plan, Model Organisms Sharing Plan, and Genome Wide Association Studies (GWAS) Sharing Plan as provided in the SF424 (R&R Application Guide).
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide,
Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via 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 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 SF 424 (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.
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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.
In order to expedite review, applicants are requested to notify the NIDCD Referral Office by email at email@example.com when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are both basic and clinical scientists contributors to the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Are the research aims and approach appropriate for translational research?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Has the applicant described the translational nature and scope of the project? Is the connection to a clinical condition clearly established? Is it likely that the results produced by the application will support the translation of basic research findings into new clinical tools? Is the research that is being translated of high quality? Does the research team have appropriate expertise to implement the translation? Are the basic science areas and/or paradigms that are being translated appropriate to the clinical condition?
Milestone Driven Applications
For milestone-driven applications, are the steps and milestones clearly defined? Are criteria provided that will be utilized in determining milestone completion before proceeding to the next phase of the project? Are contingency plans provided for each work stage?
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.
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.
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.
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.
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/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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) (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications will:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Deafness and Other Communication Disorders Advisory Council . The following will be considered in making funding decisions:
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
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 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.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NGA. 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.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
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)
Amy Donahue, Ph.D.
National Institute on Deafness and Other Communication Disorders(NIDCD)
Melissa Stick, Ph.D., MPH
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301 496-8683
Mr. Christopher Myers
National Institute on Deafness and Other Communication Disorders(NIDCD)
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.
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