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 Hearing Healthcare for Adults: Improving Access and Affordability (R21/R33 Clinical Trials Optional)
Activity Code
R21/R33 Phased Innovation Award
Announcement Type
New
Related Notices
  • November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice NOT-OD-18-228.
  • August 1, 2018 - Notice of Correction of Peer Review and Council Dates in RFA-DC-19-001. See Notice NOT-DC-18-008.
Funding Opportunity Announcement (FOA) Number
RFA-DC-19-001
Companion Funding Opportunity
None.
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.173
Funding Opportunity Purpose
This funding opportunity announcement (FOA) encourages Exploratory/Developmental Phased Innovation (R21/R33) grant applications to support research and/or infrastructure needs in emerging scientific areas leading to more accessible and affordable hearing health care for adults with mild to moderate hearing loss. The proposed research aims should be milestone-driven and lead to better hearing healthcare, targeting enhanced access and affordability, in an effort to improve outcomes for adults with hearing loss. The total project period for an application submitted in response to this FOA may not exceed five years. This FOA provides support for up to two years (R21 phase) for preliminary/developmental studies, followed by possible transition of up to four years of expanded research and development support (R33), although the total duration of the award may not exceed five years. This FOA requires measurable R21 milestones.
Posted Date
July 3, 2018
Open Date (Earliest Submission Date)
September 04, 2018
Letter of Intent Due Date(s)
September 4, 2018
Application Due Date(s)
October 4, 2018, June 4, 2019, February 4, 2020, October 4, 2020, June 4, 2021 , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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
New Dates February-March, 2019, October-November 2019, June-July 2020, February-March 2021, October-November 2021
Advisory Council Review
New Dates May 2019, January 2020, October 2020, May 2021, January 2022
Earliest Start Date
Expiration Date
June 05, 2021
Due Dates for E.O. 12372
Not Applicable.
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Purpose:

This FOA requests research to increase accessible and affordable hearing health care (HHC). In this context, HHC refers broadly not only to hearing technology but also to the systematic and comprehnsive hearing-related services involved in diagnosis, treatment, auditory rehabilitation, and counseling of individulas with hearing loss, as well as other services that collectively allow the individual to maximize his or her communication outcomes. The overarching emphasis is on the acquisition of knowledge that can be translated into new or enhanced approaches for HHC. Applications should focus on delivering better healthcare access and outcomes and should seek solutions that are effective, affordable, and deliverable to those in need. Research is needed to develop or test new and 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 span HHC in the context of a medical model to 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 some aspects of this research area are new 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).

Background:

Hearing loss is a major public health issue, and yet it remains a neglected part of most mainstream models of healthcare. In 2015, nearly 7% of the world’s population had disabling hearing loss, a stark uptick from estimates just two years prior. In the United States (U.S.) alone, some 30 million people (13%) have measurable hearing loss, which includes nearly two thirds of individuals aged 70 and older. Recent estimates place the US economic burden of adult hearing loss from lost productivity and excess medical costs in the billions of dollars. Hearing loss has been associated with loneliness, depression, and declining physical function, and there is a growing association linking sensory decline with cognitive faculty and, possibly, dementia. Despite this, most people with hearing loss do not seek or do not receive hearing health care. Since its inception, the National Institute on Deafness and Other Communication Disorders (NIDCD) has prioritized supporting basic and translational research into the normal and disordered mechanisms of hearing and hearing loss, as well as science focused on the care and re/habilitation of persons of all ages with hearing loss. Despite these efforts, little attention was given to systematically exploring hearing health care access, delivery, and affordability. In August 2009, NIDCD convened a working group charged with developing a research agenda to increase accessibility and affordability of hearing health care for adults with mild to moderate hearing loss. The group generated a comprehensive list of research recommendations that identified gaps in evidence-based practice at all levels of the HHC pipeline, for both the consumer and the clinician. This launched a focused and formalized effort from NIDCD to develop a research agenda and portfolio around improving accessible and affordable hearing health care. Following the NIDCD working group, a National Academies of Sciences Engineering and Medicine (NASEM; previously Institute of Medicine IOM) consensus study titled "Hearing Health Care for Adults: Priorities for Improving Access and Affordability", was published in 2016. At nearly the same time, the President’s Council of Advisors on Science and Technology (PCAST) developed an independent report, "Aging America & Hearing Loss: Imperative of Improved Hearing Technologies". The overlapping and consistent initiatives and recommendations related to improving hearing healthcare from both non-government and government agencies represented a unique and compelling opportunity for the field. Following these reports, in August 2017, H.R. 2430 was signed into law, which directs the U.S. Food and Drug Administration (FDA) to create a first-of-its-kind category of over-the-counter hearing aids for adults with perceived mild to moderate hearing loss. The field of clinical audiology and auditory rehabilitative science is changing quickly and dramatically, and rigorous scientific research is needed to address the many lingering and new questions surrounding this public health issue. Many of the articulated research needs identified by NASEM and PCAST, in addition to the NIDCD working group, may be appropriate for an Exploratory/Developmental Phased Innovation (R21/R33) grant mechanism 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 NIDCD working group and NASEM recommendations.

Scope:

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, NIDCD open speech signal processing tools), 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, conditions with comorbid conditions in addition to hearing loss, and rural populations.

Infrastructure support may include 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 to accessing the HHC system (e.g., availability of services, cost, availablility of subsidies, 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 (e.g., 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 (e.g., 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 (i.e., over-the-counter) 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 consumer-friendly metric of hearing loss that captures perceived functional impairment and allows the consumer to track benefit from intervention(s).
  • Develop a low-cost self-testing, self-fitting hearing aid (considering: technology, patient characteristics, selection, fitting and aftercare).
  • Develop hearing assistive technology platforms that utilize universal design concepts for the user interface.
  • Develop accessible hearing screening paradigms for adults with mild to moderate hearing loss, considering both available technology and target populations.
  • Develop research infrastructure supporting research on HHC accessibility and affordability (e.g., 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 phase to the R33 phase is contingent on successful completion of milestones delineated in the application and is subsequently approved by 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 must be delineated. Patient access, recruitment services and data collection issues may be included as part of the R21/R33 application.

As an 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 phase would provide funds to assist in a research paradigm on a larger 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 phase 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, and often includes 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, quality, and outcomes of HHC.

This FOA also encourages Community-Based Research practices and encourages inclusion and attention to the needs of special populations (e.g., elderly, low socioeconomic status, disparities, rural, second language populations, conditions with comorbid conditions in addition to hearing loss).

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

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.

See Section VIII. Other Information for award authorities and regulations.
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.

Clinical Trial?
Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards
NIDCD intends to commit $500,000 in FY {2019 to fund two awards.
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.

The total duration of the award (R21 and R33 phases) may not exceed five years.

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 years (R21 phase), with possible rapid transition to expanded research and development up to four years (R33 phase), but the total duration of the project may not exceed five years. Conversion to the R33 phase is contingent upon approval by NIDCD based on 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 from this FOA.

1. Eligible Applicants

Eligible Organizations

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
Foreign Institutions

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

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 
Required Registrations

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.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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(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.

3. Additional Information on Eligibility

 

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) 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.

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 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:
 
Kelly King, Au.D., Ph.D.

National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Fax: 301-402-6251
Email:kingke@nidcd.nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
 

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

R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
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 must 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 must 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 as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

 

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIDCD Referral Office by email atstickm@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

General Information about a Combined R21/R33 Phased Innovation Award 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, and subsequent pilot testing. 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 by 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 specific estimates of expected progress during the R21 phase that includes a timeline, a description of the milestones and discussion of their suitability 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 that 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 discuss the final set of R21 milestones, which must ultimately be approved by NIDCD staff. Any negotiated actions must be mutually agreed upon by the applicant (Authorized Organizational Representative (AOR)), the PD/PI, and the NIDCD program and grants officers 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 PD(s)/PI(s) will submit an AOR-approved R33 transition package to the NIDCD Grants and Program Officers. 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(s) was not met and discuss the impact upon the R33 research goals. Receipt of this transition package 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, program priorities, and 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.

Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

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 investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R21/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Reviewers will assign a single impact score for the entire application, which includes both the R21 and R33 phases.

The R21/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R21/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will assign a single impact score for the entire application, which includes both the R21 and R33 phases.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact
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).
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.

 

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

 

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

 

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?

 

In addition, for applications involving clinical trials

For all CT FOAs, add the following questions, after the standard questions for the Environment review criterion. If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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

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?

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

 

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

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

 

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

 

Not Applicable.

 

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

 

Not Applicable.

 

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).

 

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)  Genomic Data Sharing Plan (GDS).

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

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

2. Review and Selection Process 

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

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE)

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award
Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)
Kelly King, Au.D., Ph.D. 

National Institute on Deafness and Other Communication Disorders (NIDCD) 

Telephone: 301-402-3458

Email:kingke@nidcd.nih.gov

Peer Review Contact(s)
Melissa J. Stick, Ph.D., M.P.H.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-8683
Email:melissa_stick@nih.gov
Financial/Grants Management Contact(s)
Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-0909
Email:
myersc@mail.nih.gov
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 Part 75.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.