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-12-003
Related Notices	June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	RFA-DC-14-001
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.173
Funding Opportunity Purpose	This funding opportunity announcement (FOA) 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). 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 and health services research 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.

Posted Date	April 15, 2013
Open Date (Earliest Submission Date)	September 24, 2013
Letter of Intent Due Date(s)	September 24, 2013, May 24, 2014 and January 24, 2015
Application Due Date(s)	(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 24, 2013, June 24, 2014 and February 24, 2015, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Standard Dates Apply
Advisory Council Review	Standard Dates Apply
Earliest Start Date	Standard Dates Apply
Expiration Date	February 25, 2015
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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 translated into new or enhanced approaches for 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. Research applications may address HHC in the context of a medical model as well as a psychosocial model of hearing loss. Outcomes research and health services research related to accessible and affordable HHC 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 obtain 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 not requiring a phased research approach are encouraged to apply under a different funding mechanism (e.g., investigator initiated R21 or R01).

Hearing loss (HL) is among the leading public health concerns. Approximately 17% of American adults (36 million people) report some degree of HL. Untreated HL has social and economic ramifications, yet these ramifications require better understanding and documentation. 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. 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 the number of individuals with hearing loss, many of whom will be active in the workforce, is expected.

Since its inception, NIDCD has funded considerable research on prevention, treatment and intervention for hearing loss and hearing aids. However, very little research has addressed the hearing health care system, including accessibility, affordability, and outcomes. This is a significant need in the NIDCD research portfolio. Such research will require the engagement of numerous scientific disciplines, the utilization of technological innovations, and the evaluation of current clinical practices. Research focusing on the HHC system can lead to measureable improvements not only in the individual's health and outcomes, but also to more sustainable cost-effective models of HHC delivery. Outcomes research, which seeks to determine whether and 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. 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 have received counseling or use hearing aids, the primary treatment modality for individuals with 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 can benefit substantially with appropriate fitting and/or counseling.

The 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 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 collaboration among various relevant parties (e.g., researchers, audiologists, hearing aid dispensers, otolaryngologists, primary care physicians, public health researchers, health services researchers, 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 and improved outcomes. This includes research on the development of technologies (e.g., low-cost hearing aids), screening (e.g., effectiveness in typical primary care settings), access and management through new delivery systems (e.g., telehealth, internet, kiosk, convenient care clinics), system barriers (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, patient outcomes). 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, practice-based research networks, community based health care organizations, industry, and professional and patient organizations). It may also include support for creating pooled clinical data sets across institutions, agencies, or health care systems to analyze characteristics of patient populations, provider or health care settings and patient outcomes.

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

• What factors influence a patient’s perceived need for HHC and motivate individuals to seek HHC?
• What are the patient-centered factors that impact access to and outcomes of HHC, including the unique needs and concerns across the lifespan and among different cultures or special populations (e.g., perceived need, personal attitudes, stigma, and socioeconomic status)?
• What are the barriers for patients accessing the HHC system (e.g., availability of services, cost, subsidy available, complexity, market forces, location, healthcare insurance coverage, and referral network)?
• Do various points of access to HHC (e.g., self-referral, identification by screening program, direct access, referral to HHC professionals) affect outcomes and do these differ for different populations?
• What is the effectiveness of screening in various settings (primary care offices, community centers, pharmacies, internet screening, convenient care clinics)?
• What are the most effective methods of increasing follow-up rates and uptake of recommended treatments after screening?
• How can effective rehabilitative interventions be successfully delivered in the community?
• What is the minimal technology that will achieve success with hearing aid users?
• What is the difference in outcomes among low cost try-and-select, individually programmed, trainable, and full-feature high-cost devices for varying patient population groups and for individual patients?
• What variables (technology-centered and patient-centered) predict success, or lack of success, with amplification or other rehabilitative paradigms?
• What follow-up information and patient education components provide maximum benefit to patients with direct to consumer hearing aids?
• What are the opportunities to use new health care delivery models, including the internet and telehealth, for HHC?
• How can current delivery systems (including the system and the provider) be modified to increase accessibility and affordability and provide improved outcomes of HHC?
• Develop a low-cost self-testing, self-fitting hearing aid (considering technology, patient characteristics, selection, fitting and aftercare).
• Develop accessible hearing screening paradigms for adults with mild to moderate HL, considering both available technology and target populations.
• Do the existing FDA requirements for medical evaluation and clearance prior to hearing aid procurement provide significant protection to patients or create a significant barrier to access?
• Develop research infrastructure supporting research on HHC accessibility and affordability (databases, practice networks, multidisciplinary teams).

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 contingent on successful 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 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 technology is developed/or refined. Upon completion of the technology development and readiness (R21 phase), the R33 would evaluate 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.

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. This FOA also encourages Community-Based Research practices and encourages inclusion and attention to the needs of special populations (elderly, low SES, 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 NIDCD program staff to ensure that their applications are responsive.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIDCD intends to commit $500,000 in FY 2014 to make two awards. For future years, NIDCD anticipates making two new 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 $400,000 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). Conversion to the R33 phase is contingent upon satisfactory progress towards meeting and achieving the R21 milestones, programmatic review, and the availability of funds.

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

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are 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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• 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.

Applications to RFA-DC-14-001 must be submitted as new applications.

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.

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 NIDCD 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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Amy M. Donahue, Ph.D.
Telephone: 301-402-3458
Email: [email protected]

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

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

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

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: The R21/R33 Phased Innovation Award application must be submitted as a single application with a Research & Related Budget form.

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: The R21/R33 Phased Innovation Award application must be submitted as a single application with one PHS398 Cover Page Supplement form.

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

Specific Aims: Specific aims for both the R21 Phase and the R33 Phase should be contained in the Specific Aims section and must be clearly demarcated.

Research Strategy:

• The Research Strategy will describe both the R21 and R33 phases of the research as well as the Milestones.
• Within the Research Strategy, applicants should include a brief justification statement addressing the relevance of the aims to the FOA and the R21 Milestones.
• The Research Strategy section should have a clear demarcation of the R21 and R33 phases of the application. There should be 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 will be the R21 Phase. This section will include the background, evidence of feasibility of the proposed approach, and the approach for the R21 Phase. This section must also include milestones, specific estimates of expected progress during the R21 phase that includes 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 section of the Research Strategy will be 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.

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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness 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 [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

The Specific Aims page should list the aims of both R21 and R33 Phases.

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. Thus, clarity and completeness of the application with regard to specific goals and the feasibility of each phase and the Milestones are critical. A single overall impact/priority score will be assigned to each discussed application. Milestones that are not sufficiently rigorous scientifically to be valid for assessing progress in the R21 phase will reflect poorly on the scientific merit of the application as a whole. 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. Deletion of the R33 phase by the review panel or presentation of inadequate milestones in the application may affect the merit rating of the application.

R21 Phase

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, or technology. Although preliminary data are not required for an R21/R33 application, any preliminary data that will support or justify the proposed hypothesis, rationale or development plan may be included. 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.

Milestones

The Milestone section must include milestones, specific estimates of expected progress during the R21 phase that includes 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. Stating well-defined, measurable milestones is critical to the application. Milestones should be specific, quantifiable, and scientifically justified; they should not be simply a restatement of the R21 specific aims. The milestones will be considered in evaluating the approach proposed by the investigator. Applications lack Milestones will not be reviewed.

Milestones will vary depending on the nature of the proposed research, and should be tailored to the specific research goals. The clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones are critical. These milestones will be evaluated in the peer review process. 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. Any negotiated actions must be mutually agreed upon by the applicant (Authorized Organizational Representative (AOR), the PD/PI, and the NIDCD program and grants officer prior to the award of the R21 phase. These will be incorporated into the terms and conditions of the award and will be the primary basis for judging the success of the R21 work. Funded applicants are solely responsible for planning, directing, and executing the proposed project.

Transition to the R33 Phase of the Award

For funded applications, the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) will submit an AOR-approved R33 transition package to the NIDCD Grants and Program Officer. The R33 transition package should describe progress and completion of the initial R21 milestones and a clear description of how those goals were met. This 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 and discuss the impact upon the R33 research goals. Receipt of this progress report will trigger an NIDCD administrative program review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on original R21/R33 peer review recommendations, successful completion of mutually agreed upon 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, but NIDCD 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.

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

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 behavioral or biomedical research. 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, such data may be included if available. 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 overall impact/priority score will be assigned to each discussed application.

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

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

Significance

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

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

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

Approach

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

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?

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.

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

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) 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 of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned 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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

Amy Donahue, Ph.D.
Division of Scientific Programs
NIDCD
Telephone: (301) 402-345
Fax: (301) 402-6251
Email: [email protected]

Melissa Stick, Ph.D., MPH
Division of Extramural Activities
NIDCD
Telephone: (301) 496-8683
Fax: (301) 402-6250
Email: [email protected]

Mr. Christopher Myers
Division of Extramural Activities
NIDCD
Telephone: (301) 435-0713
Fax: (301) 402-1758
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.