Expired PA-14-091: NIDCD Research on Hearing Health Care (R01)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Deafness and Other Communication Disorders (NIDCD)
Funding Opportunity Title	NIDCD Research on Hearing Health Care (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of PA-10-253
Related Notices	May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062. March 07, 2017 - This PAR has been reissued as PA-17-202. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	PA-14-091
Companion Funding Opportunity	PA-14-090, R21 Exploratory/Developmental Grant
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 FOA encourages Research Project Grant (R01) applications from institutions/organizations to support research leading to accessible and affordable hearing health care (HHC). The overarching emphasis is on the acquisition of knowledge that can be rapidly translated into new or enhanced approaches for access, assessment or interventions with a goal to delivering better hearing health care outcomes. Applications should seek quality approaches that are effective, affordable and deliverable to those who need them as well as implementable and sustainable in settings beyond the research environment.

Key Dates

Posted Date	February 5, 2014
Open Date (Earliest Submission Date)	May 5, 2014
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, 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	New Date March 07, 2017 per issuance of PA-17-202. (Original Expiration Date: May 8, 2017)
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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Hearing loss (HL) is a leading public health concern. Approximately 17 percent of American adults, or 36 million people, report some degree of HL. HL is the third most prevalent chronic health condition facing seniors. Yet, fewer than 20 percent of those with HL who require assistance seek intervention for their condition. Untreated HL can have serious psychosocial and economic ramifications. Before seeking a hearing aid (HA), most HA users have lived with HL for more than 10 years and their impairment has progressed to moderate-to-severe levels. For many reasons the needs of the vast majority of adults with HL are not being met. There is an urgency to address the Nation s needs in hearing health care (HHC). America is aging, and by 2026, 30% of the U.S. population will be over age 55 and 18% will be over 65. A concomitant increase in the number of hearing-impaired individuals who are HA candidates, many of whom will have an initial hearing loss of mild to moderate level and will be active in the workforce, is expected. The National Institute on Deafness and Other Communication Disorders (NIDCD) is actively seeking to address this public health problem.

The NIDCD Senate Report Language for FY2013 appropriations strongly urges NIDCD to support research grants that could lead to less expensive hearing aids, so such aids could become accessible and affordable to more people." In addition, Healthy People 2020, a U.S. Department of Health and Human Services (HHS) activity that provides science-based, 10-year national objectives for promoting health and preventing disease, includes increasing the adoption rate of HA usage as a HP2020 goal. The NIH mission includes closing the gaps in health disparities. NIH/NIDCD research and the emergent solutions should address the needs of all Americans, including the underserved, economically disadvantaged and less advantaged. The NIDCD is committed to addressing all of these recommendations and goals through well-developed and targeted research initiatives.

To further explore this problem, the NIDCD/NIH convened a research working group on Accessible and Affordable Hearing Health Care for Adults with Mild to Moderate Hearing Loss in August, 2009. The purpose of the working group was to develop a research agenda to increase the accessibility and affordability of HHC for adults with mild to moderate HL. The working group focused on adults with mild to moderate HL. Members of this group are least likely to have had hearing screening/assessment and are least likely to be using HAs, the primary treatment modality for individuals with chronic sensorineural HL, even when they report substantial hearing difficulties. This is due to many reasons, including the perceived and actual benefits, cost, stigma, and value (benefit relative to price) associated with HAs. Even when a HA is obtained, its use may be curtailed or discontinued because of perceived lack of benefit, interference from background noise, or sound quality.

HHC access can be confusing to the consumer, with multiple entry points, ill-defined professional roles and competing financial interests among provider groups. Limited scientific data are available on the specific impact of cost on hearing aid adoption (usage) rates, yet cost is considered to be one of the primary reasons for non-adoption of hearing aids. Consumers often spend between $4,000 and $6,000 for a pair of hearing aids, and in general, hearing aids have an average life of only four to six years. Medicare does not cover the cost of hearing aids. Most insurance programs do not cover hearing aids and of those that do, most pay only a portion of the costs. Many individuals who cannot afford hearing aids rely on service club organizations, hearing aid loaner banks, and various other philanthropic organizations. This is not an acceptable public health solution.

Changes brought forth by new technologies and delivery systems provide opportunities to reduce both necessary resources and costs. Audiological assessment and hearing-aid fitting and management processes are moving toward automation. Automated hearing tests telephone-, computer-, or Internet-based including speech-in-noise testing, are more viable now than in the past. Technological advances make it likely that audiometry, real-ear measurements, hearing aid programming and fitting can be packaged and performed on one chip. Telemedicine (including internet) and mHealth opportunities now exist for remote audiometric testing and hearing aid fitting and management

The working group participants provided the NIDCD an extensive inventory of research recommendations designed to increase the accessibility and affordability of quality HHC in the United States. Research recommendations were outlined 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. A summary of the working group report with the accompanying recommendations can be found at: http://www.nidcd.nih.gov/funding/programs/09HHC/summary.htm.

Addressing the research needs will require increased research interaction and collaboration among the many relevant parties (e.g., researchers, audiologists, professional and patient-advocacy organizations) as well as infrastructure support and expertise.

Purpose

The purpose of this FOA is to encourage research leading to accessible and affordable hearing health care. The overarching emphasis is on the acquisition of knowledge that can be rapidly translated into new or enhanced approaches for access, assessment or intervention. Applications should seek quality solutions that are effective, affordable and deliverable to those who need them as well as implementable and sustainable in settings beyond the research environment. The goal is delivering better hearing health care outcomes.

Specific research areas include, but are not limited to those listed below:

What are the barriers for patients accessing the HHC system (e.g., availability of services, cost, subsidy available, complexity, market forces, location, health care insurance coverage, and referral network)?
What are the patient-centered factors that impact access to 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 factors influence a patient s perceived need for HHC and motivate individuals to seek HHC?
What are the technology-centered factors that determine the penetration and utilization rate of hearing aids and how do these vary among various age, cultural, and socioeconomic groups? What are the minimal technologies and features needed to achieve success?
What are the necessary components of assessment batteries (auditory, cognitive, psychosocial) to fit hearing aids and guide other interventions? Are there differences in accuracy and quality between audiometry conducted in various health care settings and using various means of delivery (face-to-face, language-free, internet, mHealth)?
Which hearing screening method (face-to-face, telephone, internet, language-free, emerging technologies, questionnaire, audiometric, speech in noise) has the best sensitivity and specificity and also results in the highest rate of follow-up of individuals seeking device or behavioral interventions and for what populations?
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 and methodologies, including the internet, telehealth, mHealth and convenient care clinics, for HHC? How can current HHC delivery systems (including the system and the provider) be utilized or modified to increase accessibility and affordability?
Develop a low-cost self-fitting hearing aid (considering technology, patient characteristics, selection, fitting and aftercare).
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?

This announcement also seeks to encourage outcomes 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. In contrast to clinical trials, this research typically employs broader inclusion criteria, has fewer restrictions for participation and research outcomes often include variables such as functional status, well-being, quality of life, cost, health care resource use, etc. Health services research seeks to examine the impact of organization, financing and management of health care services on the delivery, quality, cost, access to and outcomes of such services. Studies may include research focused on the varying factors that impact access, utilization, and quality and outcomes of hearing health care services.

This FOA encourages community-based research as well as inclusion and attention to the needs of special populations (elderly, low SES, disparities, rural, second language populations).

This FOA targets research addressing adults with HL. Studies including adults with HL greater than mild or moderate (severe HL) are encouraged under this FOA if the project results or outcomes will also have a direct relevance to adults with mild to moderate HL.

Section II. Award Information

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 Renewal Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period	The maximum project period is 5 years.

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

Section III. Eligibility Information

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
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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.
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.

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application 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.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

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

Required and Optional Components

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.

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