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)
Activity Code	P50 Specialized Center
Announcement Type	Reissue of PAR-10-047
Related Notices	July 19, 2013 - This PAR has been expired and reissued as PAR-13-277.
Funding Opportunity Announcement (FOA) Number	PAR-13-062
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.173
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 communication disorders. For this announcement, Clinical Research is defined as research involving individuals with communication disorders or data/tissues from individuals with a 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.

Posted Date	December 20, 2012
Letter of Intent Due Date(s)	January 22, 2013; April 30, 2013; September 1, 2013; December 30, 2013; May 2, 2014; September 1, 2014; January 2, 2015; May 1, 2015; September 1, 2015
Application Due Date(s)	February, 22, 2013; May 30, 2013; October 1, 2013; January 30, 2014; June 2, 2014; October 1, 2014; February 2, 2015; June 6, 2015; October, 1, 2015
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Standard dates apply.
Advisory Council Review	Standard dates apply.
Earliest Start Date	Standard dates apply.
Expiration Date	(Now Expired July 19, 2013 per issuance of PAR-13-277), Originally October 2, 2015
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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

The National Institute on Deafness and Other Communication Disorders (NIDCD) at the National Institutes of Health (NIH) invites new or competing applications for Clinical Research Center Grants (P50). This Funding Opportunity Announcement (FOA) targets applicant institutions with demonstrated ability to conduct clinical research in human communication disorders. Applications are encouraged in the seven scientific programs of the NIDCD: hearing, balance, smell, taste, voice, speech and language. The Clinical Research Center Grant (P50) supports an investigator-initiated research program in which a multidisciplinary team of investigators works in 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 cooperation among clinical investigators whose projects are directed toward a common goal. For this announcement, Clinical Research is defined as research involving individuals with communication disorders or data/tissues from individuals with a communication disorder. Examples include (but are not limited to) studies of prevention, pathogenesis, pathophysiology, detection, diagnoses or epidemiology of a communication disorders or disease.

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.

The NIDCD strategic plan http://www.nidcd.nih.gov/staticresources/about/plans/strategic/2012-2016NIDCDStrategicPlan.pdf has identified a number of research priority areas. Priority areas 3 and 4 are in the domain of clinical research. Investigators are encouraged to study topics in these priority areas such as improving outcomes for human communication, community based participatory research, implementation and dissemination research and other areas of clinical research.

The NIDCD P50 must meet 4 essential criteria listed below:

1. The research to be conducted must be clinical as defined above.

2. The P50 must have a well-defined central unifying theme consisting of three or more research subprojects with 1-2 supporting cores as appropriate; one core must be an administrative core.

3. Each research subproject must be unambiguously related to the central unifying theme. Synergistic and substantial interactions among the subprojects should be evident.

4. The overall P50 must provide multidisciplinary approaches to the central theme, defined as having research subprojects representing different disciplines, approaches and expertise.

Studies with normal human subjects (e.g., those without a communication disorder) may be included in the research only when data from normal controls are essential for interpretation of the results.

Non-human research will be allowed on an NIDCD P50 grant on rare occasions. Non-human research is limited to one subproject and only if translational or serves as a platform for translational research.

Core support can be requested as part of a P50 application to provide essential resources required by multiple subprojects, for example, patient management or speech processing technical support etc. Requests must be carefully justified and not be used to acquire additional support that duplicates existing resources already at the institution.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the PHS 398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Budgets for new P50 applications are limited to $1,500,000/year direct cost (DC). Competing renewals (type 2) P50 grant applications may request budgets (DC) that are no greater than 10% above the budget of the last year of the existing grant or $2,000,000 whichever is less. Annual budget increases should not exceed more than NIH allowances at the time of submission of the application. Salary levels in all years are limited to the NIH maximum rate. Competitive revision (supplemental) applications requesting an additional research component to an existing P50 are allowed, but may not exceed the terms of the parent award or the budgetary caps as described above.
Award Project Period	Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The maximum period is 5 years. Although the financial plans of the NIDCD provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.

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

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 research
• 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:

Lana Shekim, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd; EPS 400C
MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-5061
FAX: (301) 402-6251
Email: [email protected]

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Melissa J. Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd, EPS 400C
MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6251
Email: [email protected]

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• The Clinical Research Center Overview has a 12 page limit for the Research Strategy.
• Each Research Subproject has a 12 page limit for the Research Strategy.
• The Administrative Core and any additional Scientific Cores each have a 12 page limit for the Research Strategy. Typically, the Administrative Core requires much fewer pages.
• For Resubmission applications, an Introduction section is required:a separate 1-page Introduction is allowed for the Research Center Overview section as well as for each subproject and core.

The NIDCD P50 Research Center Program requires a multi-component application. It must consist of at least 4 components (3 research subprojects and one administrative core). Each research subproject may be a "stand alone" research project. The NIDCD P50 requires that the subprojects be inter-related creating a synergistic comprehensive center. The interrelationship among the subprojects does not mean that they depend on one another. Scientific cores are optional components. An individual research subproject is typically comparable to an R01 application. A PD/PI must serve as director of the Administrative Core.

If appropriate, scientific core(s) may be included in the P50 application. Core components are shared research resources that provide Center investigators with techniques, instrumentation, services, or resources that will enhance NIDCD mission related research to accomplish the common goals of the Center. A core component is a laboratory, facility, service, or other resource that provides support for at least two scientific research subprojects of the Center. Cores should be used primarily to support projects which are part of the Center Grant award. New research experiments or projects may not be proposed in the Cores, they must be contained in the Research Subprojects. Each core component is directed by an investigator with established expertise relevant to the support or service to be provided. Each shared scientific resource component should be clearly described in terms of the services and resources to be provided to investigators.

Renewal Applications: A comprehensive progress report is required for renewal applications. A statement describing the progress made by the Center as a regional or national research resource should be included. Each component (Overall, Scientific Subprojects, Administrative Core, and Scientific Cores) should follow PHS 398 instructions as appropriate for that section of the overall application.

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

The application should be assembled as follows:

• Face Page - describes the entire application. As the title, include the words Clinical Research Center , adding a few descriptive words (e.g., Voice Disorders and Management" etc.).
• Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (PHS 398 Form Page 2) - prepare one form to describe the overall application.
• Table of Contents - describes the entire application. Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the research subprojects first and the administrative core followed by any other core(s) last. Identify each research subproject by title; assign each research subproject a number and each core a capital letter that reflects the order in which the research subprojects and core(s) are presented in the application. Provide the name(s) of the responsible investigator(s) for each component (research subproject or core). Number the pages consecutively. Indicate the beginning page numbers for each research subproject, core and their respective budget.
• Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support- Include budget pages for the overall budget, each subproject, and each core. All budgets (overall, subproject, core, and consortium/contractual) will be in this one section, placed in the same order that the subproject and cores are listed in the table of contents, and paginated accordingly. Person months distribution table: As an aid to reviewers, the information on the person month distribution of personnel among subprojects/cores should be presented in tabular format.
• Biographical Sketches: include biographical sketches for all personnel, beginning with the PD/PI
• Resources - describes the entire application
• Research Plan - prepare a research plan for the overall component
• Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (PHS 398 Form Page 2) - prepare one form for each individual Research Subproject, Administrative Core, and Scientific Core (optional). Follow each Form Page 2 with the appropriate Research Plan.
• Research Plan - prepare a research plan for each of the individual subprojects/cores, as described below and in the PHS 398 Application Guide, with special instructions for the Research Strategy section of each component.
• Appendix for each Research Subproject and Scientific Core. Appendix materials should be organized and labeled based on the Subproject(s)/Core(s) to which they pertain. Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application GuideChecklist - describes the entire application.

Specific Aims

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 subproject 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 communication disorders or data/tissues from individuals with a 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. For renewal applications, collaborative activities if any, with other NIDCD funded Research programs should be described along with a list of joint accomplishments. In addition, for each research component of the existing Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications:

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

Specific Aims

Research Subprojects are individual scientific research subprojects, comparable to R01s. Each proposed research subproject should provide a clear description of its major goals, objectives, and how it integrates with the other research components in relation to the overall Center program’s central theme. The hypotheses to be tested should be focused and fully detailed.

Research Strategy

The design and procedures should describe the strategies proposed to accomplish the specific aims and the innovative aspects of the approach should be highlighted. A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention to a description of necessary resources, subjects, clinical populations, tissue resources, biological models, existing data sets, etc., which will be involved in the proposed studies. If core facilities are utilized, information on their use should be provided. Each subproject should describe the Significance, Approach, and Innovation in sufficient detail for evaluation by reviewers. For renewal applications, collaborative activities if any, with other NIDCD funded Research programs should be described along with a list of joint accomplishments. In addition, for each research component of the existing Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications:

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

Specific Aims

Describe how the Administrative Core administration will coordinate and manage activities across the components of the Research Center.

Research Strategy

Describe the organizational framework for the management, direction, and coordination of the Center to ensure that all proposed components and related activities will function in an optimal and synergistic manner. Include information on how this core will facilitate administration of the budget. This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core.

Describe how the administration of the overall Administrative Core will enhance the overall P50 research, including the required significance, innovation, and approach. The PD/PI provides scientific and administrative leadership for the Center, so the PD/PI must have a demonstrated ability to coordinate, integrate, and provide guidance in establishing multi-faceted research programs. Describe the administrative framework to manage the Research Center and each core, including the roles of the Research Center/Administrative Core Director and Research Subprojects and Scientific Core Directors, the lines of authority and relationship to appropriate institutional officials, how access and utilization of services will be prioritized, how potential disputes will be resolved, and how periodic evaluations will be used to improve the services. Describe how the proposed Administrative Core will foster close interactions among the various component Directors and other appropriate institutional administrative personnel.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications:

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

Specific Aims

Concisely describe how this Scientific Core will provide services to the various components in the Clinical Research Center. Describe how the scientific core will increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or promote public health advances.

Research Strategy

Describe the services and resources to be provided to investigators. The description should include a discussion of the core's contributions to the research objectives of the Center. Relevant aspects of cost effectiveness, timesaving, and increased efficiency attributable to the existence of the cores should also be addressed. A core component should support two or more of the Center’s scientific research components.

Describe how the Scientific Cores facilities or services will enhance research activities of the Clinical Research Center using this core, and add benefits to the research accomplishments; include the required significance, innovation and approach. Include how the Scientific Core will provide increased or innovative capabilities; facilitate increased productivity or effectiveness through sharing expertise or centralizing labor-intensive tasks; and/or foster collaborative or new research directions or attracting new investigators into an area. Describe each proposed technique or service in the Scientific Core, and its current status of staffing, space and equipment, should be described in enough detail to allow a comprehensive evaluation. Describe briefly existing methodologies already in use at the institution; describe in more detail methodologies new to the institution with strategies for their successful implementation. Include any developmental methods for research or training, if proposed. If applicable, include sections on quality control. The ability to articulate user benefit is a critical factor in review.

Include plans for administration, organization and proposed management of the individual Scientific Core. Include plans to implement core services, to prioritize investigator use among projects competing for core use, and to resolve potential disputes. If the core is used to train investigators in special techniques, describe the nature and extent of this training and the qualifications of core personnel to provide and oversee this training.

Discuss the potential for budgetary overlap, whether minimal or extensive, between the Research Subprojects and the Scientific Core, including personnel effort as well as other categories. If appropriate, provide a strategy for reimbursement of core services. Describe the investigator and his/her established expertise relevant to the support or service to be provided.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications:

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

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

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

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

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS 398 Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

Clinical Research is defined as research involving individuals with communication disorders or data/tissues from individuals with a communication disorder. The NIDCD P50 Research Center Program requires a well-defined central unifying theme. It must consist of at least four or more components (three research subprojects and one administrative core). The overall P50 must provide multidisciplinary approaches to the central theme, defined as having subprojects representing different disciplines, approaches and expertise. Each subproject will be scored individually. The overall P50 score is an overall evaluation, and not an average of the individual subprojects scores; the IRG will evaluate the relationship and contributions of the combined subprojects and cores to the overall theme of the Clinical Research Center.

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the research to be conducted involving individuals with communication disorders or data/tissues from individuals with a communication disorder? Is the project clearly related to the central unifying theme? To what extent is there synergy and substantial interaction between this project and all the other components?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the level of effort proposed for the PI/PD and other key personnel adequate? Are communication plans, the process for making decisions on scientific direction and procedures for resolving conflicts clearly presented? Are the roles of the PD(s)/PI(s) and other collaborators and other administrative, technical and scientific responsibilities clearly delineated?

Innovation

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

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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

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

Scientific Impact and Leadership

• Does the application provide convincing evidence that the Center, if funded, will become a leader/resource in clinical research in one of the scientific programs of the NIDCD (hearing, balance, taste, smell, voice, speech and language)?
• What is the scientific gain from combining the individual projects/cores into a P50 Center?
• How cohesive are the projects of the Center, their interrelationship and coordination?
• What are the past accomplishments of the Center or the demonstrated ability of the projects and core personnel in conducting similar programs?
• Is there evidence of established leadership in scientific research and demonstrated capabilities in program administration?
• How are internal or external advisory committees utilized to assist in making scientific/administrative decisions and evaluating progress and direction?
• What methods are used to facilitate the interaction of participating investigators and assure a cohesive program (sharing and evaluation of results, new ideas)?
• How is the academic environment? Are their sufficient resources where the research will be conducted, including space, equipment, human subjects or other resources as required for the overall center? Is there potential for interaction with scientists from other departments and disciplines?
• What is the institutional commitment to the requirements of the program, including fiscal responsibility and management capability of the institution to assist the PD/PI and his or her staff in following DHHS and NIH policy?
• Is there evidence of administrative planning and leadership capability to provide for internal quality control of ongoing research, allocation of funds, enhancement of internal communication and cooperation among the investigators involved in the program and replacement of the PD/PI if required on an interim or permanent basis?

Administrative Core

• Is the proposed Administrative Core clearly described along with short- and long-term goals and metrics that will be used to assess progress?
• Is the proposed structure well described? Are the roles of the PD(s)/PI(s) and any other committees clear? Are there plans for allocating and prioritizing fiscal and other resources and ensuring good communication across all Center components?
• Are the organizational structure and other plans for managing the Center's activities for prioritization of competing needs appropriate and clear?
• Is the Management Plan for fiscal accountability and communications between organizational components appropriate?
• Are the approaches, criteria and plans to measure, monitor, track and evaluate the progress and performance of all project activities thoroughly described and adequate to assess progress/performance?

Research Core(s)

• Does the application adequately describe the scientific rationale and process used to select the proposed research core, as well as plans and procedures to monitor and assess progress?
• If shared core facilities are proposed, do they support at least two or more projects of the proposed research activities?
• Are plans for prioritizing the use of shared facilities, for allocating availability to proposed research projects, and for ensuring they are used to the fullest extent, including access by non-Research Center (P50) investigators and institutions, feasible and clear?
• Are the qualifications, experience and commitment of key personnel for running the core facilities/activities appropriate?
• Is there documented need for the proposed cores in the context of existing facilities in the applicant institution and region?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period and the past accomplishments of the center.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

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

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

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

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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

Not Applicable

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Lana Shekim, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd; EPS 400C
MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-5061
FAX: (301) 402-6251
Email: [email protected]

Melissa J. Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd, EPS 400C
MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6251
Email: [email protected]

Christopher Myers
Chief, Grants Management Branch
Division of Extramural Activities
NIDCD, NIH
Executive Plaza South, Room 400B
6120 Executive Blvd., MSC 7180
Bethesda, MD 20892-7180
(20852 for express mail)
Telephone: (301) 435-0713
FAX: (301) 451-5365
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.