Part 1. Overview Information

Key Dates

All applications are due 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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

Purpose

NIDCD invites applications to organize and execute an annual conference on dissemination and implementation (D&I) research skills applicable to all NIDCD mission areas, specifically hearing, balance, taste, smell, voice, speech, and language. A cooperative agreement means that an NIDCD Program Official will be designated as Project Coordinator for the conference and will have substantial scientific programmatic involvement during the award.

Background 

Much research is devoted to developing evidence-based innovations (EBIs) that improve a person’s health and quality of life. To impact people’s lives, EBIs need to be adopted in clinical practice and everyday life. Unfortunately, wide-scale adoption of EBIs is lengthy and rare. Dissemination and implementation (D&I) science is the field of research that seeks to close this gap between research and practice. Dissemination research is defined as the scientific study of the targeted distribution of information and materials about EBI to a specific audience (e.g., practitioners, patients, policymakers). The intent is to understand how best to communicate and integrate knowledge associated with a given EBI. Implementation Science refers to a broader array of active and planned efforts to integrate evidence into practice. Implementation research focuses on understanding why clinical and community settings are not adopting and sustaining a particular EBI. In turn, implementation research uses this understanding of barriers and facilitators to develop and evaluate different strategies (or collections of strategies) to increase adoption and integration of an EBI into practice. Many fields have applied D&I research theories, approaches, and outcome measures to improve adoption and sustainment of EBIs.

To better understand the landscape of D&I in NIDCD mission areas, a 2-day virtual workshop was held on October 24-25, 2023. One insight from the workshop is that D&I research is increasing in NIDCD mission areas, but these efforts are at an early stage. The majority of D&I studies in communication disorders published to date do not include a D&I theory, model, or framework to guide the project; use a limited range of implementation strategies; and measure a narrow range of implementation outcomes. Taken together, these findings suggest a need to build expertise in D&I theories, models, frameworks, designs, approaches, and measures in NIDCD mission areas.

This funding opportunity aims to support an annual conference focused on building the D&I expertise of investigators conducting or planning on conducting research in NIDCD mission areas of hearing, balance, taste, smell, voice, speech, and language. The conference should enhance the ability of attendees to conduct high-quality D&I research in NIDCD mission areas.

Conference Objectives

Several publications (e.g., Schultes, Aijaz, Klug, & Fixsen, 2021; Tabak, Padek, Kerner, Stange, Proctor, Dobbins, Colditz, Chambers, & Brownson, 2017) and the summary of the NIDCD D&I workshop provide guidance on core D&I research elements. These core D&I elements can and should be integrated into the conference topics and activities. The overarching objective is to facilitate attendees’ ability to conduct high-quality independent or collaborative D&I research in NIDCD mission areas.

Examples of core D&I research elements include but are not limited to:

• D&I theories, models and frameworks (e.g., theories or frameworks that guide understanding of the multi-level contextual factors that influence dissemination and implementation)
• D&I strategies (i.e., methods or techniques used to enhance the dissemination, adoption, implementation, and sustainability of a clinical program or practice)
• D&I outcomes and outcome measures (e.g., acceptability, appropriateness, cost, feasibility, adoption, fidelity, reach/penetration, maintenance/sustainment/sustainability) as well as health service outcomes and outcome measures (e.g., quality, equity)
• Community engaged research approaches (i.e., research approaches that involve community partners to assist in guiding the research project, such as community advisory boards, co-design approaches, and community-based participatory research), including effective methods of involving individuals with communication disorders
• Qualitative and mixed methods, including methods appropriate for data from individuals with communication disorders
• Theories and methods to understand and reduce or eliminate health disparities, improving equity in care and outcomes

It is critical that the conference be inclusive of all NIDCD mission areas. Specifically, there should be focused efforts to recruit scientists from all NIDCD mission areas as attendees, speakers, moderators, and leaders/organizers, and this reach should be tracked as a key outcome. Likewise, conference activities should be presented in a manner that is meaningful to researchers from different mission areas within NIDCD. To facilitate this objective, a conference steering committee is required, and the committee must be involved in all aspects of planning, executing, and evaluating the conference. The committee must include representatives from all NIDCD mission areas as well as those with D&I expertise. Specific people must not be named as members of the committee in the application. Rather, the composition of the committee should be described in general terms (e.g., number of members, method for ensuring appropriate expertise across NIDCD mission areas) and the specific activities of the committee in planning, executing, and evaluating the conference should be clearly described.

Conference Logistics

Applications to this U13 are expected to follow the standard conference practices and requirements for R13 Conferences and Scientific Meetings (described below).

The NIH recognizes that the value of conferences is enhanced when persons from diverse backgrounds and perspectives are included in all aspects of conference/meeting planning and when attendees are assured of a safe, respectful, and inclusive environment free from discrimination, harassment, and other barriers that might prevent or inhibit one’s participation. NIH encourages conference grant applicants to enhance diversity by broadening the participation of individuals fr om diverse backgrounds, including those from underrepresented groups in the planning and implementation and ultimately, participation in the proposed conference. Per NIH Notice of Interest in Diversity NOT-OD-20-031, underrepresented groups include, for example, individuals from nationally (US) underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women. Applications for NIH support of conferences and scientific meetings must include a plan to enhance diversity in all aspects of conference planning and implementation. Diversity plans will be assessed during the scientific and technical merit review of the application. Though the proposed plans will not be scored individually, they will be considered in the overall impact score (see Updated Guidelines on Enhancing Diversity and Creating Safe Environments in Conferences Supported by NIH Grants and Cooperative Agreements, NOT-OD-21-053). Please note that consistent with NIH practice and applicable law, funded programs may not use the race, ethnicity, or sex of participants as an eligibility or selection criteria. The race, ethnicity, or sex of participants will not be considered by NIH in the application review process or when making funding decisions. 

NIH is also committed to changing the culture of science to end sexual harassment and other forms of harassment, including harassment on the basis of race, color, national origin, sex (including gender identity, sexual orientation, or transgender status), disability, and age in NIH-funded activities. Harassment, in any form, is detrimental and presents obstacles that hinder an individual’s ability to fully participate in science. Only in safe, respectful, and inclusive environments can individuals achieve their fullest potential and support the mission of the NIH. As stated in NOT-OD-15-152, Civil Rights Protections in NIH-Supported Research, Programs, Conferences and Other Activities, consistent with existing federal civil rights laws, it is expected that organizers of NIH-supported conferences and scientific meetings take steps to maintain a safe and respectful environment for all attendees by providing an environment free from all forms of discrimination and harassment, sexual or otherwise. It is expected that organizers of NIH-supported conferences employ strategies that seek to prevent or mitigate the effects of discrimination and harassment, sexual and otherwise. Per the NIH Grants Policy Statement 14.6.3 Plans to Promote Safe Environments at Conferences, conference grant applicants recommended for funding will be required to provide to NIH upon request as part of Just-In-Time (JIT) materials a “safety plan” that will be communicated to all conference/meeting attendees. Safety plans must include all of the following elements:

• Statement of commitment to provide a safe environment
• Expectations of behavior o Including list of behaviors considered harassing (specific emphasis on harassment, sexual, racial, ethnic, or otherwise)
• Instructions on how to confidentially report alleged violations of the expectations of behavior to conference organizers
• Description of how the organizers will assess allegations and the consequences for those who are found to violate the expectations of behavior
• Information explaining that individuals who have questions, concerns or complaints related to harassment are also encouraged to contact the conference organizer or the HHS Office for Civil Rights (OCR)
• Information about how to file a complaint with HHS OCR (see OCR’s webpage, Filing a Civil Rights Complaint).
• Information explaining that filing a complaint with the conference organizer is not required before filing a complaint of discrimination with HHS OCR, and that seeking assistance from the conference organizer in no way prohibits filing complaints with HHS OCR.
• Information explaining how individuals can notify NIH about concerns of harassment, including sexual harassment, discrimination, and other forms of inappropriate conduct at NIH-supported conferences (see NIH’s Find Help webpage).

R13/U13 applicants must also provide to NIH upon request as part of Just-in-Time (JIT) materials:

• a description of the strategy that will be used to communicate the Safety Plan to conference attendees and a plan to document allegations and resulting actions.
• information on the steps the organizers will take to ensure a safe and respectful environment for all attendees, free from discrimination and harassment

Additionally, all NIH sponsored and/or supported conferences must be held at accessible sites, as outlined by section 504 of the Rehabilitation Act of 1973 and, as applicable, the Americans with Disabilities Act of 1990. Conference registration materials should provide a questionnaire that will allow participants with disabilities to voluntarily identify any special needs, so that conference organizers can make plans to accommodate these needs.

A conference grant application is required to contain a permission-to-submit letter from NIDCD.  Applicants are urged to initiate contact well in advance of the chosen application due date and no later than 6 weeks before that date. The NIDCD contact for this process is: Holly L. Storkel, Ph.D., NIDCD, (301) 496-5061, [email protected]. Please note that agreement to accept an application does not guarantee funding. In general, NIH will not issue a conference grant award unless the Federal award date can precede the conference start date.

The website, NIH Support for Conferences and Scientific Meetings, centralizes information regarding grants for scientific conferences. 

Note: Applicants are encouraged to look at the R13 Frequently Asked Questions for a listing of common questions regarding the preparation and submission of conference grant applications.

Non-responsive applications

The following applications will be considered non-responsive for this funding opportunity and will not be reviewed:

• Applications that fail to address skills training in D&I research
• Applications that are not inclusive of all NIDCD mission areas specifically hearing, balance, taste, smell, voice, speech, and language
• Applications that don’t describe the activities of the conference steering committee
• Applications that fail to include a diversity plan
• Applications that fail to include a permission-to-submit letter from NIDCD

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

• 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 Organizations) 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 allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. 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 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed 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:

Melissa Stick, Ph.D., M.P.H.
Telephone: 301-496-8683
Email: [email protected]

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

Cover Letter: Advance permission to submit an application is required for all NIH conference grant applications, including new, resubmission, renewal, and revision applications. Cover letters for a new application cannot be recycled for a resubmission or revision; rather a new letter is required. Advance permission to submit an application should be requested early in the process and no later than six weeks before the application due date. All applicants must include the permission-to-submit letter from NIDCD. Applications that do not include the permission-to-submit letter will not be accepted for review. Note that advance permission to submit an application does not guarantee funding.

To obtain the permission-to-submit letter for this funding opportunity, contact: 

Holly L. Storkel, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: (301) 496-5061 
Email: [email protected]

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments: Diversity Plan 

Applicants must include a Diversity Plan attachment in the Other Attachment section. The PDF-formatted document must be named “DiversityPlan.pdf” (no spaces) and must not exceed 1 page in length. Applications that do not include this Plan attachment will not be accepted for review. The Plan must:

Specifically describe plans to enhance diversity by broadening the participation of individuals from diverse backgrounds, including those from underrepresented groups in the biomedical sciences (e.g., underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women), in the selection and/or makeup of:

• Organizing committee
• Speakers
• Invited participants (e.g., sessions chairs, panel discussants, etc.)
• Audience

Applicants should consider the geographical conference area from where anticipated participants will come (i.e., national, statewide), the expected size and composition of the audience, as well as the method of selection in describing efforts under the Plan and how these efforts will be assessed afterwards. Where applicable, applicants should describe the success of previous strategies to promote broad participation in the planning and implementation of conferences. 

Please note that consistent with NIH practice and applicable law, funded programs may not use the race, ethnicity, or sex of prospective program participants as an eligibility or selection criteria. The race, ethnicity, or sex of participants will not be considered by NIH in the application review process or when making funding decisions. 

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

Describe in the Personal Statement of the Biographical Sketch senior/key persons’ past experiences with enhancing diveristy by promoting broad participation in biomedical research. Describe expertise in dissemination and implementation research and/or research in NIDCD mission areas in the Biographical Sketch.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions. The appropriate NIH IC conference award contact should be consulted for guidance regarding any IC-specific budget requirements. Enter the direct costs requested. Facilities and Administrative (F&A) costs are not allowed. Provide a narrative justification for each proposed personnel position, including the role of the individual in the conference and the proposed level of effort. Include information regarding efforts to obtain funding for this conference from other sources.

Allowable Costs: Salary (in proportion to the time or effort spent directly on the conference); rental of necessary equipment; travel and per diem or subsistence allowances; supplies needed for conduct of the conference (only if received for use during the budget period); conference services; publication costs; funds to help defray registration costs for some select attendees or speakers' fees.

Non-allowable costs: Meals/food and beverages; purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment and personal expenses (such as tips; bar charges; personal telephone calls; laundry charges) dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; local participants' expenses; facilities and administrative costs/indirect costs.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy: Note that this section will be called "Conference Plan" in the system-generated Table of Contents.

Describe the objectives, specific program, and logistical arrangements for the conference. For the first convening of the conference, describe the format and list the agenda and speakers. Describe the principal dissemination and implementation (D&I) research topics and skills to be covered. Justify how a focus on those particular D&I topics and skills will prepare attendees to conduct high-quality D&I research in NIDCD mission areas. Explain how the topics and activities will foster D&I research across all NIDCD mission areas, specifically hearing, balance, taste, smell, voice, speech, and language. Provide a detailed justification for the conference, including the scientific need, timeliness, and usefulness of the conference to the scientific community.

Attendance for some individuals will be dependent on the availability of resources for family care. The application should describe plans to identify resources for childcare and other types of family care at or in close proximity to the conference site to allow individuals with family care responsibilities to attend. The information should allow attendees to make arrangements for family care as needed.

Describe the composition of the required conference steering committee, in terms of planned number,expertise of members across the NIDCD mission areas, but do not provide names of members. Members will be selected post-award with input from the NIDCD Project Coordinator. Describe the specific activities for the steering committee. Explain how the steering committee and its role in the conference will contribute to building D&I expertise in investigators conducting research in NIDCD mission areas of hearing, balance, taste, smell, voice, speech, and language. 

Estimate anticipated geographic conference area where participants will come from (i.e., national, statewide), the expected size and composition of the audience, as well as the method of selection.

Describe plans for publicizing the conference to all interested participants and, if applicable, for publishing the proceedings (note that publishing proceedings is not required). Identify related conferences held on the subject during the past 3 years and how the proposed conference is similar to and/or different from these, and why it is still necessary and useful. If this is one in a series of periodic conferences held by a permanent sponsoring organization, briefly describe and evaluate the last conference in the series.

Describe the plan for evaluating the conference, including methods or tools for gathering data, timeline for data collection, methods for interpretation, and how the information will be used in the planning of subsequent meetings. Describe benchmarks for success in meeting the conference goal of increasing D&I research in NIDCD mission areas. 

Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible:

• conference topic(s)
• tentative dates, locations, and participants
• contingency plans for future conferences dependent upon, for example, the outcome of the first year's conference or developments in the field
• role of the steering committee in guiding the development of these future offerings.

Letters of Support: Provide letters documenting the participation of the key conference participants, e.g. speakers, presenters, session moderators.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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 How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 NIDCD, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  nbsp;Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular NOFO, note the following: This funding opportunity aims to support an annual conference focused on building D&I expertise in investigators conducting or planning on conducting research in NIDCD mission areas of hearing, balance, taste, smell, voice, speech, and language. The conference should enhance the ability of attendees to conduct D&I research in NIDCD mission areas.

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.

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.

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.

2. Review and Selection Process

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 policies and practices, 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 will receive a written critique.

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.

Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the NIDCD Advisory Council. The following will be considered in making funding decisions:

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

Upon request applicants are required to submit Safety Plans as described in the NIH Grants Policy Statement (GPS) Section 14.6.3 Plans to Promote Safe Environments at Conferences. Safety Plans should be submitted via the Just-In-Time (JIT) process as described in the NIH Grants Policy Statement (GPS) Section 2.5.1 Just-in-Time Procedures. NIH staff will review all plans and must approve them prior to award.  Safety plans that are deemed incomplete or unsatisfactory will need to be corrected by the applicant and approved by NIH prior to award.

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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH 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. 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 NOFO.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients is anticipated during the performance of the activities. Milestones proposed by the recipient will be reviewed by NIDCD and mutually agreed upon and included in Terms and Conditions.

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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

• Overall direction and steering of the planning, organizing, and decision-making process for the conference in cooperation with the conference steering committee
• Execution of all aspects of conference logistics, including establishing and executing the code of conduct, ensuring appropriate accessibility, and providing resources for family care
• Providing administrative and organizational support to scientific leaders of the conference, invited speakers, and other conference participants
• Designing and executing the conference evaluation plan in cooperation with the conference steering committee
• Assuming accountability to the applicant organization officials and to the NIDCD for the performance and proper conduct of the activities supported by the U13 in accordance with the terms and conditions of the award

Recipients will retain the primary rights to information and other resources developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The NIDCD will designate staff, including a Program Officer (PO) and a Grants Management Specialist to provide normal stewardship and administrative oversight of the cooperative agreement; these two contacts will be named in the Notice of Grant Award.

An NIH Program Official within NIDCD will be designated as Project Coordinator for the conference and will have substantial programmatic involvement during conduct of this activity, as detailed below.

The NIDCD Project Coordinator will assist the recipients in various aspects relevant to the conference, such as:

• Serving as a voting member of the conference steering committee, engaging in all activities of the board and providing input on planning, executing, and evaluating the workshop
• Approving the nominations of specific members to the conference steering committee as well as the final composition of the committee to ensure representativeness across all NIDCD mission areas
• Serving as liaisons, as needed, to additional expertise, resources, etc., to facilitate the conference objectives
• Reviewing, with the Program Officer, the annual or more frequent reports on progress of conference activities

Areas of Joint Responsibility include:

• Participation in joint planning meetings, teleconferences, webinars, etc.
• Adherence to planning schedules and timelines
• Timely exchange of key planning and other information that would have a major impact on the project and its timeline.
• NIDCD program officials may participate as non-voting members on the conference steering committee.

Dispute Resolution: Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Holly L. Storkel, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: (301) 496-5061 
Email: [email protected]

Melissa Stick, Ph.D., MPH
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-8683  
Email: [email protected]

Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-4222
Email: [email protected] 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 2 CFR Part 200.