Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose

The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications from investigators for a limited competition to participate under a cooperative agreement (U01) to address epidemiological risk factors for acquired hearing loss, with a specific focus on potentially modifiable risk factors.

The Conservation of Hearing Study (CHEARS) is conducted by a research team of physicians, clinical investigators, epidemiologists, audiologists, and biostatisticians. The study is collecting data from two major ongoing cohort studies based on over 150,000 participants: the Nurses Health Study I (NHS I) and the Nurses Health Study II (NHS II). Information is obtained from Hearing Study Supplemental Questionnaires and, in a subsample of NHS II participants, from audiological assessments performed in 19 university-affiliated audiology clinics spread across the United States. Associations will be examined between reported hearing loss and/or threshold-based measures of hearing loss with a number of medical, dietary, and lifestyle factors.

The objectives of CHEARS are the following:

Aim 1: To examine prospectively the relation between regular moderate analgesic use and risk of hearing loss.

Aim 2: To examine prospectively the association between use of vitamins and risk of hearing loss.

Aim 3: To examine prospectively the association between alcohol intake and risk of hearing loss.

Aim 4: To examine prospectively the association between menopausal status and use of postmenopausal hormones and risk of hearing loss.

This is a prospective, longitudinal cohort study of risk factors for hearing loss in women. Since hearing loss is the most common sensory disorder in the U.S., affecting over 36 million adults, the identification of modifiable risk factors is a very important public health issue. There have been only a limited number of studies based on prospective data to determine common and potentially modifiable risk factors for this highly prevalent, disabling condition. In addition to noise-exposure, other factors this study will examine for association with hearing loss include analgesics, vitamins, alcohol, menopausal status and post-menopausal hormone use. Aspirin, acetaminophen and ibuprofen are the three most commonly used drugs in the U.S. The ototoxic effects of salicylates are well known. Vitamins, such as folate, A, C, D, and E, may play important roles in maintenance of hearing. Alcohol intake may have a variable impact, depending upon the level of use. Additionally, estrogen may play a role in hearing function, thus menopausal status and post-menopausal hormone use will be ascertained. These issues will be examined prospectively in two large cohorts involving over 150,000 women (Nurses Health Studies I and II). Based on questionnaires to the study population of 150,000 women, 5,000 incident cases of newly-identified hearing impairment are projected. In addition to self-report of professionally-diagnosed hearing loss in the entire study population, a subsample of approximately 3,700 women in Nurses Health Study II, with no or only mild pre-existing hearing impairment, will be selected for repeat hearing exams over a 3-year period to measure change in their hearing sensitivity. The ongoing Nurses Health Studies have collected a wealth of ancillary data in previous cycles of investigation that will be important for the complex multidisciplinary and multifactorial statistical analyses required to establish new factors that may increase the risk of (or protect against) hearing loss.

CHEARS is the only ongoing domestic multicenter clinical epidemiological research study targeting a general population of middle-aged and older adult women in the United States to prospectively study preventable risk factors and other etiologies for incident hearing loss. Although this initiative is focused on a domestic cohort, its findings will have tremendous relevance internationally as there are 1) an estimated 350 million adults worldwide with disabling hearing loss, and 2) many of these adults acquired their hearing loss due to potentially preventable exposures. Hence, findings from this study may result in public health measures that could substantially reduce the burden of adult-onset hearing loss, preserving quality of life and normal functioning for many decades of healthy life.

Subject participation and monitoring will be facilitated by the following three clinical coordinating centers participating in this epidemiological study:

1) The Channing Laboratory (administrative and computer facility), Brigham and Women’s Hospital, Boston, MA,

2) The Department of Otolaryngology, Vanderbilt University Medical Center, Nashville, TN, and

3) The Audiology Department, Massachusetts Eye and Ear Infirmary, Boston, MA

In addition to these three clinical coordinating centers, approximately 15 university affiliated audiology clinics spread across the United States have agreed to collaborate with CHEARS and to implement a standardized protocol in order to conduct full audiological assessments on the Nurses Health Study II subsample at baseline and at a follow-up audiological assessment 3 years afterwards.

This FOA is intended to continue and expand CHEARS to (a) encourage collaborations with other investigators conducting clinical epidemiological cohort studies based on high quality audiometric assessments and well standardized clinical questionnaire information, and (b) explore collaborations with other potential genetic epidemiologic or genomic studies of adult-onset hearing loss susceptibility.

A Data Monitoring and Oversight Committee will be in place to review and monitor study progress and offer advice to the study investigators and to the NIDCD.

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.

The applicant institution must currently be participating in the existing NIDCD-funded Conservation of Hearing Study (CHEARS) cooperative agreement.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  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.

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.

Eligibility is limited to current awardees of the existing NIDCD-funded CHEARS award.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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).

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

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

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows 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:

Howard J. Hoffman, MA
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-1843
Fax: 301-402-0390
Email: Hoffmanh@nidcd.nih.gov

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

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.

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

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

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

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

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

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

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

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

Specific Aims: Provide a succinct description of how the proposed work will continue to meet the scientific goals , outcomes, and impact of the ongoing CHEARS effort. Refer to Funding Opportunity description in Section I when formulating Specific Aims.

Research Strategy: Provide an overall description of the proposed organizational structure and management plans.

Describe the approach for effectively accomplishing each specific aim including the role of the clinical coordinating centers and the Data Monitoring and Oversight Committee.

Describe the approach to expand CHEARS to:

(a) encourage collaborations with other investigators conducting clinical epidemiological cohort studies based on high quality audiometric assessments and well standardized clinical questionnaire information, and

(b) explore collaborations with other potential genetic epidemiologic or genomic studies of adult-onset hearing loss susceptibility.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. 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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

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

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

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

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

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

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

Will the plans to expand the CHEARS effort to collaborate with other (a)cohort studies and (b) genomic studies of adult-onset hearing loss susceptibility add to the projects impact?

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?

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

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

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

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

Not Applicable

For renewals, progress made in the last funding period will be considered.

Not Applicable

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

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDCD in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

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

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

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

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

Any application awarded in response to this FOA will be subject to 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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

A. The Principal Investigator(s) [PIs] or awardee(s) will have primary responsibility for all aspects of their study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee (see III. Collaborative Responsibilities). The awardee(s) agree to accept close coordination, cooperation, and participation of NIDCD staff in those aspects of scientific and technical management of the study as stated in these terms and conditions.

B. The study protocol will be subject to review and acceptance (in an advisory capacity only) by the Data Monitoring and Oversight Committee (DMOC) for Observational Studies (see paragraph II.E). Upon implementation of the protocol, each field center, whether a single institution or a consortium of institutions, will follow the procedures required by the protocol regarding study conduct and monitoring, patient management, data collection, and quality control.

C. The awardee(s) will be responsible, through a Data Coordinating Center (DCC), for ensuring the provision of centralized data management and coordination assistance. The DCC is responsible for providing all data coordination and management, including quality control and analysis, using procedures and standards determined by the DCC. Specific analyses will be performed by the DCC and will be provided to the SC as the group responsible for determining which further analyses should be done. Additional analyses may be requested by the DMOC. The DCC will provide technical assistance and data management services to the field centers with respect to quality control, uniformity of data collection, management of the collective data base, and data analysis and publication. The DCC will be responsible for the acquisition and distribution of those study materials involved in the protocol. The DCC will also arrange for the appropriate approvals (when necessary) from the Food and Drug Administration (FDA) and the Bureau of Biologics (BOB) with respect to the use of investigational drugs. Any post-award changes in the selection of the facility or organization serving as the DCC will require NIDCD approval.

D. Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The NIDCD Project Scientist, on behalf of the NIDCD, will have the same access, privileges, and responsibilities regarding the collaborative data as the other members of the SC (i.e., cooperative agreement awardees).

E. Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIDCD support; or special access to project results, data, findings, or resources--may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIDCD.

F. The awardee(s) are expected to put all study materials and procedure manuals into the public domain. Awardees are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols developed by the SC and approved by the NIDCD. Review and approval by the SC will be required for all analyses prior to publication or presentation according to policies developed by the SC. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIDCD/NIH. Analyses to be performed using the data will be determined and directed by the SC in conjunction with the DCC. Field centers wishing to perform analyses of local data must also obtain the consent of the NIDCD Project Scientist for any such analyses prior to initiation. During or within three years beyond the end date of the project period of NIDCD support, unpublished data, unpublished results, data sets not previously released, or other study materials or products are to be made available to any third party only with the approval of the SC and in accordance with paragraph 1.D. Any web site developed for dissemination of information may be linked to the NIDCD web site.

G. A change in the Study Chair or Principal Investigator, in any of the key personnel identified in the Notice of Grant Award, or in the facility serving as the DCC must have prior written approval of the NIDCD Grants Management Specialist in consultation with the NIDCD Project Scientist.

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NIDCD program official will be responsible for normal stewardship of the award, as named in the notice of grant award. This program official may also serve as the Project Scientist. The NIDCD Project Scientist will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination above and beyond normal program stewardship for grants, as detailed below.

The NIDCD Project Scientist will serve as a voting member, and attend all meetings of the SC; he/she may serve on other study committees, when appropriate. The NIDCD Project Scientist may work with awardees on issues coming before the SC and, as appropriate, other committees, e.g., quality control, database coordination, educational and training programs, final data analysis and interpretation, data, tools, and technology dissemination, preparation of publications, and development of solutions to major problems. The NIDCD Project Scientist will participate in periodic on-site monitoring and will serve as a resource to the SC in the development of mechanisms and procedures for monitoring quality of diagnostic and therapeutic performance of the field centers.

The Government, through the NIDCD Project Scientist, will have access to data generated under this cooperative agreement at the end of the clinical study. The awardee will retain custody of and have primary rights to all data developed under these awards subject to regulations regarding Government rights to access.

The NIDCD Project Scientist will review the progress of the study, and of each participating facility, through consideration of the annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting.

A Data Monitoring and Oversight Committee (DMOC) will be appointed by NIDCD to provide independent recommendations regarding the continuation, modification, or termination of the study based on ethical concerns or observed adverse effects of any of the interventions under study. The DMOC membership, which must be multidisciplinary and include a statistician, will be entirely independent of the study and will be supported by special funds set aside for that purpose in the award. Nominations for members of the D DMOC may be provided by the awardees; however, authority for membership selection rests solely with the NIDCD. Conflict of interest statements, both written and oral and updated over time, will be obtained from all members of the DSMC. Individuals who have been determined by the NIDCD to have a conflict of interest will be excluded from service on the DSMC. Recommendations and summary reports of the DMOC will be forwarded to the Project Scientist, NIDCD, promptly. A summary report which does not contain confidential information will be prepared by the DMOC Executive Secretary and distributed to the Study Chair or Principal Investigator. The NIDCD is responsible for implementation of any recommendations. The DSMC will not have enforcement responsibilities.

The NIDCD reserves the right to terminate or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol, (b) a substantial shortfall in participant recruitment, follow-up, data reporting and dissemination, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which NIDCD does not concur, (d) reaching a major study endpoint substantially before schedule with persuasive statistical evidence, or (e) human subject ethical issues that may dictate a premature termination.

Areas of Joint Responsibility include:

Primary Governing Committee or Steering Committee (SC), composed of the principal investigator, who will chair the SC, as well as the principal investigators of the various clinical centers, the Data Coordinating Center (see paragraph 1.C), the lead statistician, and of the specialized core facilities (if any), and one NIDCD representative (the Project Scientist). The NIDCD Project Scientist will have voting membership on the SC and, as appropriate, its subcommittees. The SC will have primary responsibility for facilitating the conduct and monitoring of studies and reporting study results. Awardee(s) will be required to accept and implement the common protocol and procedures approved by the SC. As the components of the SC may be geographically dispersed, the SC should meet with monthly conference calls, supplemented as deemed necessary by face to face meetings.

Data Monitoring and Oversight Committee (DMOC) for Observational Studies: An independent DMOC will be appointed by NIDCD for the purpose of providing expert guidance to the study investigators and to assist NIDCD and study investigators in protecting the interests of study participants and in preserving the integrity and credibility of the study. The DMOC will provide recommendations to the NIDCD Director of the Division of Scientific Programs and the study investigators regarding the following:

Determine the adequacy and appropriateness of the proposed study protocol and procedures. The first meeting of the DMOC will focus on the current study protocol to assess its readiness for implementation. DMOC will place major focus on review of the current protocol to ensure that issues raised in the initial review of the application by the Study Section or in the secondary review by the National Deafness and Other Communication Disorders Advisory Council have been adequately addressed. Study protocols and procedures are assessed to determine their appropriateness to address the specific aims of the project. The Manual of Procedures (MOP) for the study will be reviewed and, as applicable, should include sections on: study objectives; organizational structure; data collection processes; timetable; planned pilot/feasibility studies; disease definitions; statistical analyses (including power considerations, analytic methods, and risk factor analyses); protocol procedures (including eligibility/exclusion criteria, informed consent, questionnaires, survey or exam procedures, grading or examination of graphs or other displays illustrating compliance with study procedures); data management, data transmission and quality control procedures; and study policy issues (publication policy, conflict of interest policy, data sharing, protection of human subjects). The first meeting of the DMOC will end with a request for formal approval of the protocol and participant consent form(s).

Recommend and review proposed protocol changes. Major protocol changes (i.e., sampling scheme, participant entry criteria, frequency or types of measurement) must be reviewed and must receive a formal DMOC recommendation prior to implementation. Minor protocol changes during conduct of the study will be presented prior to implementation to the DMOC Chairperson and the NIDCD Program Official to determine their study impact. The DMOC can recommend protocol changes when appropriate, based on review of the protocol or accumulating data or other relevant information. Procedural changes, those that typically would not require Institutional Review Board (IRB) approval, can be implemented without DMOC review.

Recommend/evaluate proposed ancillary or pilot/feasibility studies. Evaluate the impact of proposed studies on participant burden and ability to achieve overall study goals.

Evaluate patient safety. Determine appropriateness of procedures for notification and referral of participants for any abnormal findings.

Evaluate the informed consent document and procedures. The DMOC provides advice to the NIDCD Program Official and the investigators that the content of the consent form and the approach to informed consent are appropriate. The IRB approves the participant consent form.

Monitor performance, including recruitment, retention, overall study progress, and adherence to study protocol.

Assess data quality and quality control procedures.

Evaluate the data analytic plan.

Evaluate the publication plan, including topics and preparation schedule.

Review performance of individual centers, and if necessary, recommend actions to improve performance or terminate participation of specific centers.

Review and provide recommendations prior to submission of primary manuscripts and oral presentations that address the specific aims of the study. Study investigators will designate those manuscripts/presentations that are considered primary. Manuscripts will be sent to DMOC for review and comment at least two weeks prior to their planned submission. Abstracts for oral presentations, designated as primary, will be provided to DMOC for comment and review one week prior to their planned submission. Manuscripts that address the secondary aims of the study or the results of any ancillary study do not require DMOC review.

Review overall scientific direction of the study.

Selection of DMOC Voting Members: The aims of the study will dictate DMOC size and the types of expertise required of DMOC members. Membership will usually range from four-to-seven members. Expertise will be sought in the areas of epidemiology, survey methods, statistics, patient advocacy, and clinical expertise. The DMOC Chairperson will have experience in epidemiologic studies.

Conflicts of Interest: Any potential conflict of interest or the appearance of a conflict of interest must be documented prior to formal appointment of DMOC members and annually, thereafter. Potential conflicts may arise from interests in commercial products or services, which may be used in or could be affected by the study results. The appearance of conflict of interest may occur when DMOC members have affiliations with institutions that could benefit from the research, and this relationship can be seen as affecting objectivity in regard to study recommendations.

Non-voting Members in Attendance: The non-voting members of the DMOC are the NIDCD Program Official, principal investigator, representatives of the statistical coordinating center; and, as appropriate, representatives of resource centers (e.g., Hearing Measurements Reading Center) or those in a study leadership position. Additional investigators/consultants may be invited to the meetings as required.

Meeting Frequency: The DMOC will meet on an annual basis though often the DMOC may require two meetings in the first year. Conference calls and interim meetings may be scheduled as needed.

Meeting Format: The meeting will begin and end with a closed executive session attended by all voting members of the DMOC and the NIDCD Program Official. At the end of the closed executive session the DMOC Chairperson will verbally communicate the recommendations of the Committee to the study investigators. Adequate attendance, usually two-thirds of non-voting study members, is required.

DMOC Recommendations: Two-thirds of DMOC voting members constitute a quorum for voting recommendations. The DMOC should strive to achieve consensus in formulating specific study recommendations. Among those members present, a simple majority vote will define agreement for DMOC recommendations; dissenting and abstaining votes will be noted. DMOC recommendations regarding major protocol changes, regardless of whether these are initiated by DMOC or by the study investigators, will be sent simultaneously in a letter from the DMOC Chairperson to the NIDCD Director of the Division of Scientific Programs and the principal investigator.

Meeting Materials: The study investigators will prepare a draft agenda at least three weeks prior to the meeting. The draft agenda will be sent to the DMOC Chairperson and the NIDCD Program Official for review and comment. Meeting materials will be prepared and provided to the DMOC members at least one week prior to the meeting. Data submitted for review should be timely and of a high quality to allow the DMOC to adequately assess the integrity and progress in the study.

Meeting Minutes: The Executive Secretary, DMOC, appointed by the NIDCD Director of the Division of Scientific Programs, will be responsible for preparing draft minutes from each meeting/conference call within 14 days. The minutes will be considered final only after review and approval by the DMOC Chairperson and the NIDCD Program Official.

Dispute Resolution:

Any disagreement that may arise in scientific/programmatic matters (within the scope of the award), between award recipients and the NIDCD may be brought to arbitration. An arbitration panel will be composed of four members--one selected by the SC (with the NIDCD member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NIDCD, the third member selected by the two prior members, and the fourth panelist will be a member of the National Deafness and Other Communication Disorders Advisory Council. This special arbitration procedure in no way affects the awardees right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, Subpart D and HHS regulation at 45 CFR part 16, or the rights of NIDCD under applicable statutes, regulations and terms of the award. These special terms of award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74, and other HHS, PHS, and NIH grant administration policy statements.

Reporting Requirements

Recruitment progress (including recruitment of women, children, and specific minority groups), indices of quality control, and related operational features must be reported at regular intervals to the NIDCD program office. Annual and final reports are required as they are for any NIDCD grant award.

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

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Howard J. Hoffman, MA
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-1843
Email: hoffmanh@nidcd.nih.gov

Melissa Stick, PhD, MPH
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-8683
Email: stickm@nidcd.nih.gov

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.

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.