NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). Supports research centers focused on advancing the diagnosis, prevention, treatment, and amelioration of human communication disorders.

PAR-25-445: NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Deafness and Other Communication Disorders ( NIDCD ) Funding Opportunity Title NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional) March 31, 2026 - Notice of Change: NIDCD Expiration of PAR-25-445, "NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional)".

See Notice NOT-DC-26-004 . April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Notice of Funding Opportunity Purpose The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for Clinical Research Center Grants designed to advance the diagnosis, prevention, treatment, and amelioration of human sensory and communication disorders.

For this announcement, Clinical Research is defined as research involving individuals with a sensory and/or communication disorder, or data/tissues from individuals with a sensory and/or communication disorder.

Examples of such research include but are not limited to, studies of the prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language.

Although the intent is that all the research will involve individuals with sensory and/or communication disorders or data/tissues from individuals with sensory and/or communication disorders, when the clinical research goal(s) warrant(s) limited departures from this intent, alternatives (e.g., non-human research, human subjects without a sensory or communication disorder, human at risk for a sensory and/or communication disorder) are possible with appropriate and strong scientific justification and in consultation with NIDCD staff.

Applications may propose a low-risk clinical trial but are not required to (optional). Non-responsive applications will not be reviewed. Prospective applicants are strongly encouraged to read this funding opportunity carefully and communicate with the scientific/research contact listed at the end of this award as early as possible to discuss their application plans.

Funding Opportunity Goal(s) To investigate solutions to problems directly relevant to individuals with deafness or disorders of human communication in the areas of hearing, balance, smell, taste, voice, speech, and language.

Open Date (Earliest Submission Date) Application Due Dates Review and Award Cycles New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date November 04, 2025 November 04, 2025 Not Applicable March 2026 May 2026 July 2026 February 02, 2026 February 02, 2026 Not Applicable July 2026 October 2026 December 2026 June 02, 2026 June 02, 2026 Not Applicable November 2026 January 2027 April 2027 October 02, 2026 October 02, 2026 Not Applicable March 2027 May 2027 July 2027 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. New Date October 03, 2026 per issuance of NOT-DC-26-004 .

(Original Expiration Date: June 03, 2028) Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the 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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Part 1. Overview Information 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 The National Institute on Deafness and Other Communication Disorders (NIDCD) at the National Institutes of Health (NIH) invites new, resubmission, revision or renewal applications for Clinical Research Center Grants (P50) in the mission areas of hearing, balance, smell, taste, voice, speech, or language.

The P50 Clinical Research Center provides a vehicle for integrated, multidisciplinary approaches to critical clinical research questions that advance the study of prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language.

The P50 provides an avenue for forming a multi-disciplinary team that is intended to bring innovative ideas and distinct perspectives to the generation and evaluation of high impact solutions to complex clinical problems. Responsive applications must include a multi-disciplinary team collaborating on a synergistic set of 3-4 research projects addressing a unifying theme.

The synergistic and substantial integration of research projects is intended to generate breakthrough solutions to the unifying problem. The research efforts are further supported by an administrative core and 1-2 optional scientific cores to ensure rigorous and efficient progress towards the center’s unifying theme. Overall, the clinical research center provides a whole that will have impact beyond the sum of its parts.

Given the complexity of the P50 Clinical Research Centers, applicants are strongly encouraged to communicate with the scientific/research contact listed at the end of this funding opportunity for guidance on responsiveness to the following required elements. Applications that are not responsive or incomplete (e.g., are missing required elements) will be withdrawn and will not be reviewed.

To be responsive to this funding opportunity, a Clinical Research Center must include the following required conceptual and structural elements. For this funding opportunity, the research being conducted must have a clinical focus, usually defined as research involving individuals with sensory and/or communication disorders or data/tissues from individuals with a sensory and/or communication disorder.

Examples include (but are not limited to) studies of the prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language.

Although the intent is that all the research will involve individuals with sensory and/or communication disorders or data/tissues from individuals with sensory and/or communication disorders, when the clinical research goal(s) warrant(s) departures from this intent, alternatives are possible with appropriate and strong scientific justification and in consultation with NIDCD staff.

In particular, studies with normal human subjects (e.g., those without a sensory or communication disorder) may be included in the research with appropriate justification that the inclusion of such data are essential for the clinical research goal(s) and/or the interpretation of the results (e.g., studies focusing on detection, diagnostic methods, or epidemiology).

Likewise, for certain clinical research objectives (e.g., studies focusing on prevention), individuals at-risk for sensory and/or communication disorders may be included when strongly justified. Non-human research may be supported when the translational nature of the research is clearly articulated. Non-human research will be limited to (at most) one project.

Across these alternative scenarios, there is an expectation that the majority of the research will focus on individuals with sensory and/or communication disorders and/or data/tissues from individuals with sensory and/or communication disorders. Clinical trials, as defined by NIH , are optional.

When a clinical trial is included, only low-risk clinical trials or Basic Science Experimental Studies involving Humans will be funded through this mechanism. Low-risk clinical trials: do not require FDA oversight, are not an NIH defined Phase III Clinical Trial, have low risks to subjects, and intend to gather scientific data/evidence to inform subsequent studies.

This NOFO also supports Basic Science Experimental Studies involving Humans ( https://grants. nih. gov/policy-and-compliance/policy-topics/clinical-trials/beshBESH ).

These studies fall within the NIH definition of a clinical trial and meet the definition of basic research. For more information about clinical trials at NIDCD, see https://www. nidcd.

nih. gov/research/clinical-studies/researchers-professionals . Synergistic and Substantial Interaction around a Unifying Theme The P50 Clinical Research Center Grant supports a research program in which an interdisciplinary team of investigators works on a clearly defined central theme of mutual scientific interest.

This mechanism facilitates economy of effort, space, and equipment, and accelerates the acquisition of knowledge by stimulating collaboration among clinical investigators whose projects are directed toward a common goal. Each research project must be unambiguously related to the central unifying theme.

The central unifying theme is a core idea, concept, problem, or question that ties together the research projects, creating a cohesive understanding and/or explanation that is greater than the sum of the individual projects. To achieve this cohesive understanding, synergistic and substantial interactions among the projects is required.

That is, the P50 Clinical Research Center is not a collection of independent research projects on a topic but rather a fully integrated set of research questions and activities conducted by a collaborative, interactive research team. For example, measures or findings from one project could be leveraged in another project or could contribute to a larger integrative analysis across projects. Other examples are possible.

In general, the integration and interaction is expected throughout all aspects of the Center’s work, from the conceptual (e.g., unifying theme) to the practical (e.g., research activities, researcher engagement). The overall P50 must provide multidisciplinary approaches to the central theme, defined as having research projects representing different disciplines, approaches and expertise.

A Center must be an identifiable, organizational unit with an administrative structure and clear lines of authority in order to facilitate coordination among Center personnel and to assure maximum accountability and efficiency in Center operations. Administrative Core (1 required). An Administrative Core is required.

The lead of the Administrative Core is also the Director of the Center who is responsible for the organization and overall operation of the Center. Scientific Cores (1-2 optional). The P50 may include 1-2 scientific cores.

Cores are not required or essential criteria. Scientific Cores (when included) provide infrastructure/support for commonly needed resources or services required by multiple projects. Examples of scientific cores include patient management, data management, or technical support (e.g., speech processing, neuroimaging, statistics, genomics).

When included, a core must serve at least two or more projects . Requests must be carefully justified and not be used to acquire additional support that duplicates existing resources already at the institution.

Although the primary goal of the scientific cores is to support the research activity in the research projects, it may be appropriate for scientific cores to contribute to a broader scientific community by disseminating best practices in their area of infrastructure/support through websites, white papers, research notes, or methods papers.

Such dissemination activities are of secondary importance and should not detract from their primary role of providing critical support to facilitate the aims of the research projects. Research Projects (3-4 required). The P50 must have three to four research projects centered on a well-defined unifying theme.

The primary research activity is to be conducted in the research projects. External Advisory Committee Each proposed Center must have an external advisory committee. The external advisory committee will provide oversight of scientific progress of the Center and guide the research plan when appropriate.

Members of the external advisory committee should not be named in new applications. Refer to Section IV. Application and Submission Information for details.

Consultation with NIDCD Staff Highly Encouraged Prior to Application Given the complexities of the P50 Clinical Centers, prospective applicants are strongly encouraged to communicate with the scientific/research contact listed at the end of this funding opportunity as early as possible to discuss how their application will incorporate all required elements.

Pre-application consultation is particularly critical when proposing a clinical trial and/or when pursuing elements requiring strong justification (as noted above in the required elements section).

Non-Responsive Applications The following applications will be considered non-responsive for this funding opportunity and will not be reviewed: Applications outside NIDCD mission areas Applications where the majority of the research does not focus on individuals with sensory and/or communication disorders and/or data/tissue from individuals with sensory and/or communication disorders Applications that include clinical trials entailing greater than low-risk Applications that do not have synergistic and substantial interaction around a unifying theme Applications that are not multidisciplinary Applications that have a scientific core or cores used by only one research project Applications that do not describe an external advisory committee in terms of general expertise and planned activities Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Budgets for new applications are limited to $1,500,000/per year direct costs, exclusive of consortium facilities and administrative costs. Renewal (type 2) grant applications may request direct cost budgets that are not greater than 10% above the budget of the last year of the existing award or $2,000,000 whichever is less; this is also exclusive of consortium facilities and administrative costs.

Revision applications requesting an additional research component to an existing P50 may not exceed the duration of the parent award or the budgetary caps as described above. Future year amounts will depend on annual appropriations. The maximum project period is 5 years NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Foreign Organizations/ International Collaborations NIH will no longer issue awards (new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025. Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors. Non-domestic (non-U.S.) Entities (Foreign Organization) 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 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 registration; 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.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

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 . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2- Definitions of Terms.

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Renewals must be submitted only after a minimum of 4 years of the project have been completed. Applications submitted before 4 years of funding have been completed will be withdrawn and not reviewed.

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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO.

See the administrative office for instructions if planning to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

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

Component Type for Submission Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application. Revision applications must include an Overall component and the components that are affected by the revision.

Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components: Administrative Core: required Scientific Cores: optional (0-2) External Advisory Committee For new applications and resubmission of a new application, in order not to restrict the pool of available scientific peer reviewers, you should not invite or name in your application potential members of your External Advisory Committee.

When preparing the application, use Component Type ‘Overall’. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted. SF424(R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall) Follow standard instructions. Project/Performance Site Locations (Overall) A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application. A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component. Specific Aims: Specific Aims are required. Provide an overview of the entire research program and describe the defined central theme and goals of the Clinical Research Center (P50).

Provide the rationale for the proposed research program. Include potential impact, any areas of special interest, and any research ideas, disease entities, and target populations to be studied. Explain the research plan for achieving the objective(s) of the overall research program and how each research project and core relates to that overall plan.

Research Strategy: Explain how this Clinical Research Center Grant (P50) application supports an investigator-initiated research program in which a multidisciplinary team of investigators works in a clearly defined central theme of mutual scientific interest.

Describe how this effort facilitates economy of effort, space, and equipment, and accelerates the acquisition of knowledge by stimulating cooperation among clinical investigators whose projects are directed toward a common goal. Describe how this overall Research Center will provide a whole that will have an impact beyond simply the sum of its parts.

Describe how the research focuses on individuals with sensory and/or communication disorders or data/tissues from individuals with a sensory and/or communication disorder.

Indicate any prior collaborative arrangements between investigators in the group; emphasizing the events that led to the current application; predict the anticipated advantages that would be gained by including the research in the proposed program; describe the overall theme of the Center and how research subprojects are related to the theme; and describe the multidisciplinary nature of the proposed research.

Letters of Support: Include any letters of support for the proposed Center by appropriate institutional officials of each performance site. These letters should include commitments of space and other resources required by the Center. A letter of agreement from existing resources (such as the CTSA PD(s)/PI(s)) should be included here if collaborative linkages are being developed between the Center and the existing resources .

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

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide ; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components.

To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

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

Administrative Core (Required) When preparing your application, use Component Type ‘Administrative Core’. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core) Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Core) Enter Human Embryonic Stem Cells in each relevant component. Research & Related Other Project Information (Administrative Core) Human Subjects: Answer only the ‘Are Human Subjects Involved?

’ and 'Is the Project Exempt from Federal regulations? ’ questions. Vertebrate Animals : Answer only the ‘Are Vertebrate Animals Used?

’ question. Project Narrative : Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required.

However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components. Project /Performance Site Location(s) (Administrative Core) List all performance sites that apply to the specific component. Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core) In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Admin Core Lead’ and provide a valid eRA Commons ID in the Credential field. The lead of the Administrative Core is also the Director of the Center, who is responsible for the organization and overall operation of the Center.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. Budget (Administrative Core) Budget forms appropriate for the specific component will be included in the application package. Note: The R&R Budget form included in many of the component types allows for up to