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 On Hearing Health Care (R21/R33)

Activity Code

R21/R33 Phased Innovation Award

Announcement Type

Reissue of RFA-DC-10-002

Related Notices

  • April 15, 2013 - This RFA has been reissued as RFA-DC-14-001.
  • March 13, 2013 - See Notice NOT-DC-13-003. The National Institute on Deafness and Other Communication Disorders (NIDCD) intends to reissue this FOA to encourage research and increase infrastructure support leading to accessible and affordable hearing health care (HHC).

Funding Opportunity Announcement (FOA) Number

RFA-DC-12-003

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.173

FOA Purpose

This funding opportunity announcement (FOA) issued by National Institute on Deafness and Other Communication Disorders (NIDCD) invites Exploratory/Developmental Phased Innovation (R21/R33) grant applications to support research and/or infrastructure needs leading to more accessible and affordable hearing health care (HHC).  For the purposes of the working group and this FOA, “hearing health care” includes assessment (including screening) and nonmedical treatment and rehabilitation of HL, including hearing aid selection and fitting and aural rehabilitation (counseling, auditory training).  The proposed research aims should lead to the delivery of better healthcare access and outcomes and be directed to solutions that are effective, affordable and deliverable to those who need them.  Outcomes research and health services research related to accessible and affordable hearing health care are also responsive to this FOA.  This FOA provides support for up to two years (R21 phase) for preliminary /development studies, followed by possible transition of up to four years of expanded research and development support (R33 phase).  The total project period for an application submitted in response to this FOA may not exceed five years.  This FOA requires measurable R21 milestones.

Key Dates
Posted Date

May 19, 2011

Open Date (Earliest Submission Date)

September 30, 2011

Letter of Intent Due Date

September 30, 2011, May 29, 2012, January 28, 2013

Application Due Date(s)

October 31, 2011, June 29, 2012, February 28, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February 2012, October 2012, June 2013

Advisory Council Review

May 2012, January 2013, October 2013

Earliest Start Date(s)

July 2012

Expiration Date

March 1, 2013

Due Dates for E.O. 12372

Not Applicable

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.

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

Purpose

This FOA calls for research to increase accessible and affordable hearing health care.  The overarching emphasis is on the acquisition of knowledge that can be rapidly translated into new or enhanced approaches for service delivery systems, assessments or interventions leading to accessible and affordable hearing health care (HHC).  Applications should be focused on delivering better healthcare access and outcomes and should seek solutions that are effective, affordable and deliverable to those who need them.  Research is needed to develop new and/or test innovative adaptations of current approaches and practices.  These adaptations should be implementable and sustainable in clinical and community practice settings beyond the research environment and may have the potential to address disparities in health care. Outcomes research and health services research related to accessible and affordable hearing health care are also responsive to this FOA. 

Because this is a new research area for the NIDCD scientific community, there will likely be a need to attain preliminary data or conduct early-stage developmental activities before moving to a full scale project. The Exploratory/Developmental Phased Innovation (R21/R33) grant mechanism is appropriate for this purpose.  It provides opportunity for creating, developing and strengthening new and necessary collaborations, provides opportunity for acquisition of preliminary data, and allows for milestone-driven research, supporting a phased research project with a stepped approach for implementation.

Applications focusing on accessible and affordable HHC not requiring a phased research approach are encouraged to apply under the following two program announcements:

NIDCD Research on Hearing Health Care (R01) http://grants.nih.gov/grants/guide/pa-files/PA-10-253.html or (R21) http://grants1.nih.gov/grants/guide/pa-files/PA-10-254.html

Background

Hearing loss (HL) is among the leading public health concerns.  Approximately 17% of American adults (36 million people) report some degree of HL.  HL is the third most prevalent chronic health condition facing seniors.  While studies have demonstrated the benefit of hearing aids, fewer than 20% of those with HL who require intervention and treatment seek help for their condition.  Untreated HL has social and economic ramifications.  Most hearing aid users have lived with HL for over 10 years and their impairments have progressed to moderate-to-severe levels before seeking a hearing aid. For many reasons, the needs of the vast majority of adults with hearing loss are not being met.  There is both urgency and opportunity to address the research needs in HHC.  America is aging and by 2026, 30% of the US population will be over 55 and 18% will be over 65.  A concomitant increase in hearing aid candidates, many of whom will have an initial hearing loss of mild to moderate level and will be active in the workforce, is expected.  

Since its inception, NIDCD has funded considerable research on hearing loss and hearing aids.  However, very little research has addressed the hearing health care system, including accessibility and affordability.  Increasing HHC accessibility and affordability and improving HHC outcomes require interactions and exchanges between numerous scientific disciplines, technological innovation, and clinical practice.  This is an unmet need in the NIDCD research portfolio.  Research focusing on the HHC system can lead to measureable improvements not only in the individual patient's health, but also to more sustainable cost-effective models of HHC delivery as well.  Outcomes research, which seeks to determine to what degree an intervention works in general, real-world settings, such as in diverse populations among varying provider and clinical practice settings, will yield insights at the level of the individual patient.  Health services research, which seeks to examine the impact of organization, financing and management of health care services on the delivery, quality, cost, access to and outcomes of such services, will yield insights at the system level.  Both research approaches are needed for progress leading to better HHC.

As an initial response to the topic of HHC, NIDCD sponsored a research working group on Accessible and Affordable Hearing Health Care for Adults with Mild to Moderate Hearing Loss on August 25-27, 2009.  The purpose of the working group was to develop a research agenda to increase accessibility and affordability of HHC for adults with mild to moderate HL, including accessible and low cost hearing aids.  For the purposes of the working group and this FOA, “hearing health care” includes assessment (including screening) and nonmedical treatment and rehabilitation of HL, including hearing aid selection and fitting and aural rehabilitation (counseling, auditory training).  The working group focused on adults with mild to moderate HL.  Members of this group are least likely to have had hearing screening/assessment and are least likely to be using hearing aids, the primary treatment modality for individuals with chronic sensorineural HL, even when they report substantial hearing difficulties.  This is due to many reasons, including the perceived and actual benefits, cost, stigma, and value (benefit relative to price) associated with hearing aids.  Yet, individuals with mild to moderate HL seeking amplification can benefit substantially from their devices with appropriate fitting and counseling.

HHC access can be confusing to the consumer, with ill-defined professional roles and competing financial interests among provider groups.  Multiple entry points to the HHC system include family practitioners, audiologists, hearing aid specialists, otolaryngologists, and direct web access, as well as magazine, newspaper and television ads.  In the US there are no readily accessible low cost hearing screening programs, and access to low cost aids exists only on the web, or through newspaper or magazine ads.

Limited scientific data are available on the specific impact of cost on hearing aid adoption (usage) rates, yet cost is considered to be one of the primary reasons for non-adoption of hearing aids.  While the definition of “affordable” remains undetermined, there are likely different price points for different segments of the population.  A recent industry survey found a price range per aid between $1,182 and $2,876 and a recent consumer survey showed consumers spending $1,800 to $6,800 for a pair of hearing aids.  In general, hearing aids have an average life of four to six years.  A hearing aid wearer, over the wearer’s lifetime, may spend tens of thousands of dollars acquiring and maintaining hearing aids.  Thus, hearing aids can be among the most expensive items purchased by many Americans with HL, after their home or car.  Medicare does not cover the cost of hearing aids.  Most insurance programs do not cover hearing aids and of those that do, most pay only a portion of the costs.  Many individuals who cannot afford hearing aids rely on service club organizations, hearing aid loaner banks, and various other philanthropic organizations.

The NIH Director has identified “Using Science to Enable Health Care Reform” as one of 5 thematic areas for the NIH, noting that quality affordable health care for all Americans cannot occur without significant advances in the underlying science that will enable effective and efficient disease prevention and diagnosis, as well as better and cheaper treatments to be identified.  Challenging the assumption that the best HHC is synonymous with the most advanced technology, especially for adults with mild to moderate HL, may help to make HHC more accessible for those who can least afford it.  Further, the NIH mission includes closing the gaps in health disparities.  NIH/NIDCD research and the emergent solutions should address the needs of all Americans, including the underserved, economically disadvantaged and less advantaged.

New opportunities brought forth by changing technologies make automated hearing screening and full-scale audiometry a possibility and also make it likely that audiometry, real-ear measurements, hearing aid programming and fitting can be packaged and performed on one chip, reducing both necessary resources and costs.  Hearing aid service delivery paradigms now include store-front hearing aid sales, as well as internet sales.  Telemedicine (including internet) opportunities now exist not only for remote audiometric testing and but also for hearing aid fitting and management.  Further, if a large proportion of individuals with HL sought HHC, there would be a shortage of audiologists to meet that need.  Convenient care clinics, providing convenient access to basic care for the most common acute conditions, are now a part of the healthcare access landscape and provide an example of new routes of access and service delivery paradigms.

The NIDCD research working group on Accessible and Affordable Hearing Health Care for Adults with Mild to Moderate Hearing Loss identified research recommendations in 10 areas: Access, Screening, Assessment, Innovative Hearing Aid Technology and Outcomes, Patient Variables and Outcomes, After-Care, Delivery Systems, Workforce and Training of Hearing Health Care Providers, Medical Evaluation/Regulatory Issues and Overarching Topics.  Potential applicants are encouraged to review the summary of the working group report with the accompanying research recommendations at:  http://www.nidcd.nih.gov/funding/programs/09HHC/summary.htm

Many of the articulated research needs may be appropriate for the Exploratory/Developmental Phased Innovation (R21/R33) grant application to support research and/or infrastructure needs.  Addressing the research needs will require increased research interaction and collaboration among the many relevant parties (e.g., researchers, audiologists, hearing aid dispensers, otolaryngologists, health services, industry, professional and patient-advocacy organizations) as well as infrastructure support and expertise.  This FOA is one of several NIDCD research initiatives created in response to the working group recommendations. 

The purpose of this FOA is to encourage research and increase infrastructure support leading to accessible and affordable hearing health care.  The overarching emphasis is on the acquisition of knowledge that can be rapidly translated into new or enhanced approaches for service delivery systems, assessments or interventions.  Applications should be aimed at delivering better healthcare access and outcomes and should seek solutions that are effective, affordable and deliverable to those who need them.  This includes the development of low-cost technologies (e.g., low-cost hearing aids, hand held hearing screeners), research on access and possible new delivery systems (e.g., telehealth, internet hearing aid fitting and management, kiosk, convenient care clinics), research on system barriers for HHC access (e.g., availability of services, cost, location, insurance coverage, referral network) as well as behavioral research at the individual patient level (e.g., variables influencing one’s perceived need for HHC).  Solutions should be implementable and sustainable in settings beyond the research environment and should have the potential to address disparities in health care.  Generally, health disparities populations include racial and ethnic minorities, low socioeconomic populations, and rural populations. 

Infrastructure support may include support for the creation of research partnerships among interested organizations (e.g., academia, health care organizations, industry, and professional and patient organizations). It may include the development of practice-based networks, bringing new stakeholders, such as health care systems, community-based clinics and private practitioners, into the planning and conduct of research related to accessible and affordable HHC, as well as seek support to develop methods for identifying, recruiting and enrolling, patients, clinicians and health care clinics into research and developing processes for creating pooled clinical data across institutions or multiple health care systems to analyze characteristics of patient populations, clinicians, and health care settings.  

Responsive R21/R33 applications must be milestone driven and may include, but are not limited to, the following questions:

The developmental and/or piloting portion of the research occurs during the R21 phase of the research plan and implementation and/or further research/development occurs within the R33 phase.  Transition from the R21 to the R33 is dependent on completion of milestones delineated in the application and subsequently negotiated with NIDCD staff (see Section IV.6).  At the end of a successful R21/R33, it is expected that there will be measurable and documented advances leading to accessible and affordable HHC.  If the application proposes infrastructure development, the organizational structure and information on how investigators will access the support activities should be delineated.  Patient access, recruitment services and data collection issues may be included as part of the R21/R33 application. 

For example, in the R21 portion of the application the PD/PI may propose pilot work in which investigators may propose and pilot hearing aid fitting using a new delivery system.  Upon proof of the feasibility, the R33 would provide funds to assist in a research paradigm on a larger scale population.  A second example might be one in which a new screening technology is developed/or refined.  Upon completion of the technology development and readiness (R21 phase), the R33 would then provide funds to research the utilization of this tool in a larger clinical population.  A third example may be one in which in the R21 phase, questionnaires are developed and piloted addressing barriers to access and utilization of HHC services.  Upon completion, the R33 phase would utilize the questionnaire in a research paradigm.  A final example would be an R21 phase used for initial development of practice-based networks of audiology clinics and the R33 phase could be the further infrastructure development and culminating with the implementation of a pilot study.

This announcement seeks to encourage outcomes research (also defined as effectiveness research) and/or health services research.  Outcomes research seeks to determine to what degree an intervention works in general, real-world settings, such as in diverse populations among varying provider and clinical practice settings.  It may also include evaluation of economic impacts linked to health outcomes.  This research typically employs broader inclusion criteria, has fewer restrictions for participation and research outcomes often include variables such as functional status, well-being, quality of life, cost, health care resource use, etc.  Health services research seeks to examine the impact of organization, financing and management of health care services on the delivery, quality, cost, access to and outcomes of such services.  Studies may include research focused on the varying factors that impact access, utilization, and quality and outcomes of hearing health care services.  This FOA also encourages Community-Based Research practices and encourages inclusion and attention to the needs of special populations (elderly, low socioeconomic status, disparities, rural, second language populations).

This announcement applies only to research applications addressing issues in support of HHC for adults.  Studies including individuals with HL greater than mild or moderate (severe HL) are allowed under this FOA if the project results or outcomes will also have an impact on adults with mild to moderate HL.   

Applications proposing a Phase I or Phase II clinical trial with intent to lead to a Definitive Phase III clinical trial are not appropriate for this FOA. It is however possible that the results of the R21/R33 could serve as an entry into the NIDCD clinical trial program. Information on funding mechanisms for the NIDCD clinical trial program can be found at: http://www.nidcd.nih.gov/research/clinicaltrials/

Questions about the suitability of applications should be addressed to the research/scientific (program) contact listed in the "Agency Contacts" section.  Investigators are strongly encouraged to contact program staff to ensure that their applications are responsive.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDCD intends to commit $500,000 to make two awards in FY2012.  For future years, NIDCD anticipates making two awards per fiscal year, contingent on future year funding.

Award Budget

Support for the R21 phase cannot exceed two years and direct costs are limited to $275,000 over the R21 two-year period, with no more than $150,000 in direct costs in any single year of the R21 phase.  The R33 phase may not exceed four years and direct costs are limited to $1.4 M with no more than $375,000 in direct costs in any single year of the R33 phase.

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed five years.  Awards will support milestone-driven exploratory/feasibility studies (up to two year R21 phase), with possible rapid transition to expanded research and development (up to four year R33 phase).  Applications for R21 or R33 support alone are not responsive to this FOA. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

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 registrations.

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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/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.

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 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. Initial applications to RFA-DC-12-003 must be submitted as new applications.  If an application is unsuccessful and additional receipt dates remain, resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

Letter of Intent

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
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Amy M. Donahue, Ph.D.
6120 Executive Blvd, EPS 400C, MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-402-3458
Email: Donahuea@nidcd.nih.gov

Required and Optional Components

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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

R&R Budget Component

The R21/R33 Phased Innovation Award application must be submitted as a single application with one Research & Related Budget component.

PHS 398 Cover Page Supplement Component

The R21/R33 Phased Innovation Award application must be submitted as a single application with one PHS398 Cover Page Supplement component.

PHS 398 Research Plan Component

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

Research Strategy

Within the Research Strategy, applicants should include a brief justification statement addressing the relevance of the aims to accessible and affordable HHC.  Within the Research Strategy, applicants should describe both the R21 Phase and the R33 Phase, including the R21 milestones they aim to achieve in order to proceed to the R33 phase.The milestones proposed in the application should be well described, quantifiable, and scientifically justified to allow program staff to assess progress in the R21 phase and readiness for the R33 Phase.

The Research Strategy section should have a clear demarcation of the R21 and R33 portions of the proposal.  There should be separate specific aims and separate research design and methods for the R21 and R33 phases.  It is not necessary to repeat background information or details of methods in the R33 section that were provided in the R21 section. 

The first section of the Research Strategy will be the R21 Phase.  This section must include milestones, specific estimates of expected progress during the R21 phase, including a timeline, a discussion of the suitability of the milestones for assessing success in the R21 Phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 Phase.  Milestones should be specific, quantifiable and scientifically justified; they should not be simply a restatement of the R21 specific aims.

The second component of the Research Strategy will be the research plan for the R33 Phase.  The R33 Phase must be described in sufficient detail to permit reviewers to assess the significance and innovation of the proposed work and the strength of the experimental design.  If appropriate, a method for determining sample sizes for the R33 Phase using power calculations based on the outcome of the R21 Phase must be clearly stated.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

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.

Foreign Organizations

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.

3. Submission Dates and Times

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.

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 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.

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

In order to expedite review, applicants are requested to notify the NIDCD Referral Office by email at stickm@nidcd.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Specific Instructions for Preparing a Combined R21/R33 Phased Innovation Award Application

Applicants are encouraged to include all information required for adequate evaluation for reviewers. However, in the event that a technology is not yet patent protected and the applicant does not wish to include complete details, the application should at a minimum provide a demonstration of the capabilities of the proposed approach.

Preliminary Data: The R21 component of an R21/R33 application will be considered exploratory, so that extensive preliminary data from the applicant’s own laboratory are not required.  However, the project must be based on a strong rationale, and the applicant should provide evidence that the proposed approach and methods are feasible.  The R21 Phase provides time for necessary preliminary work, for example, the substantial modification of approaches, methods and technology. Although preliminary data are not required for an R21/R33 application, they may be included.

For the R21/R33 Phased Innovation Award application, the initial review group will evaluate the specific goals for each phase and the feasibility milestones that would justify expansion to the R33 phase.  A single impact/priority score will be assigned to each discussed application. For the R21/R33 application the initial review group may recommend that only the R21 phase be supported, based on concerns related to the application’s specific goals and the feasibility milestones justifying the expansion to the R33 phase.  Recommended deletion of the R33 phase by the review panel or presentation of inadequate milestones in the application may negatively affect the merit rating of the overall application.

The milestones proposed in the application should be well described, quantifiable, and scientifically justified to allow program staff to assess progress in the R21 Phase.  The milestones will be considered in evaluating the approach proposed by the investigator.  A discussion of the milestones relative to the progress of the R21 Phase and the implications of successful completion of the milestones for the R33 phase should be included.  Applications lacking this information, as determined by the NIH staff, will not be reviewed.  The clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones are critical. 

Prior to award, the Program Officer will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement.  The Program Officer and the applicant will negotiate and agree on a final set of R21 milestones.  These will be incorporated into the terms and conditions of the award and will be the basis for judging the success of the R21 work. For funded applications, when the R21 phase has been completed, the Project Director/Principal Investigator (PD/PI) will submit a progress report to the Program Officer.  The progress report should clearly indicate which milestones were or were not completed successfully. In the latter case, an explanation should be provided as to why the milestone was not met. Receipt of this progress report will trigger an administrative program review that will determine whether or not the R33 should be awarded.  The release of R33 funds will be based on NIDCD-approved successful completion of negotiated scientific milestones, on program priorities, and on the availability of funds.

For funded applications, peer review is not anticipated between the two phases of the project, although NIDCD staff reserves the right to conduct a program review with outside opinions.

Both conventional development applications and high-risk, high-reward applications are encouraged. Dependent upon the nature of the risk in the application, success rates in moving to the R33 stage are expected to vary.

The R21 and R33 cannot be funded in the same fiscal year.

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.

For this particular announcement, note the following:

The R21/R33 Phased Innovation grant supports exploratory/developmental investigations of novel approaches, tools, or technologies that have the potential for significant impact on more accessible and affordable HHC.  An R21/R33 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/R33 applications; however, they may be included if available.

The initial review group will evaluate the specific goals for each phase and the feasibility milestones that would justify expansion to the R33 phase.  A single impact/priority score will be assigned to each discussed application. For the R21/R33 application the initial review group may recommend that only the R21 phase be supported, based on concerns related to the application’s specific goals and the feasibility milestones justifying the expansion to the R33 phase.  Recommended deletion of the R33 phase by the review panel or presentation of inadequate milestones in the application may negatively affect the merit rating of the overall application.

Overall Impact

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).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Investigator(s)    

Are the PD/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?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

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?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

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

Milestones

Are the steps and milestones clearly defined? Are the milestones feasible, well developed and quantifiable with regard to specific goals and accomplishments? 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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not applicable

Revisions

Not applicable

Additional Review Considerations

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

2. Review and Selection Process

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. Review assignments 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 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:

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 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, CCR 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of  an award as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Amy Donahue, Ph.D.
Division of Scientific Programs
NIDCD
6120 Executive Blvd, EPS 400C MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-345
Fax: (301) 402-6251
Email: donahuea@nidcd.nih.gov   

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)

Amy Donahue, Ph.D.
Division of Scientific Programs
NIDCD
6120 Executive Blvd, EPS 400C MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
Fax: (301) 402-6251
Email: donahuea@nidcd.nih.gov

Peer Review Contact(s)

Melissa Stick, Ph.D., MPH
Division of Extramural Activities
NIDCD
6120 Executive Blvd, EPS 400C MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
Fax: (301) 402-6250
Email: stickm@nidcd.nih.gov

Financial/Grants Management Contact(s)

Mr. Christopher Myers
Division of Extramural Activities
NIDCD  
6120 Executive Blvd, EPS 400B MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
Fax: (301) 402-1758
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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