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 Research Core Centers (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of PAR-10-077

Related Notices
  • July 25, 2013 - See Notice NOT-DC-13-007. Effective October 1, 2013, NIDCD will no longer accept P30 applications
  • September 28, 2012 – See Notice NOT-OD-12-161. NIH Announces Plans to Transition to Electronic Submission of Multi-Project Applications
Funding Opportunity Announcement (FOA) Number

PAR-13-024

Companion Funding Opportunity

None

Number of Applications

An institution may apply for more than one award only for different user groups working in different NIDCD mission areas within the same institution, as described in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.173

Funding Opportunity Purpose

The NIDCD P30 Core Center contains one or more research-serving cores providing centralized resources and facilities for funded R01 research projects. Although no funds are provided for direct support of research projects, a P30 helps to integrate and promote research in existing funded projects, and may include multi-disciplinary and regional collaborations. A Core Center must be an identifiable organizational unit either within a single grantee institution or representing a consortium of cooperating institutions (e.g., geographic or web-based). The Center may serve as an “intellectual hub” to stimulate cooperative research, to increase the effectiveness, capabilities or productivity of current research, and/or to promote new research directions through collaborations. Individual research cores of the Core Center may provide for sharing technical expertise or centralizing labor-intensive tasks common among several investigators (PD(s)/PI(s)); staffing, training and maintenance of shared equipment or resources, including tools or staffing to enhance activities such as recruitment databases for clinical projects; or problem-solving through innovative technical solutions using the most current methodologies. NIDCD P30 funds do not provide patient services, support unfunded pilot studies, or facilitate research other than for funded user projects, unless directly related to advancing the potential of the Core Center itself. P30s are encouraged to provide benefits to other core centers or the larger community through sharing data or technology.

Key Dates
Posted Date

November 23, 2012

Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

February 1, 2013; June 3, 2013; October 1, 2013; February 3, 2014; June 2, 2014; October 1, 2014; February 2, 2015, June 1, 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 25, 2013 per NOT-DC-13-007), 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description
 
Purpose

The NIDCD P30 Core Center grant contains one or more research-serving cores providing centralized resources and facilities for funded R01 research projects. Although no funds are provided for direct support of research projects, a P30 helps to integrate and promote research in existing funded projects, and may include multi-disciplinary and regional collaborations. A Core Center must be an identifiable organizational unit either within a single grantee institution or representing a consortium of cooperating institutions (e.g., geographic or web-based). The Center may serve as an “intellectual hub” to stimulate cooperative research, to increase the effectiveness, capabilities or productivity of current research, and/or to promote new research directions through collaborations. Individual research cores of the Core Center may provide for sharing technical expertise or centralizing labor-intensive tasks common among several projects; staffing, training and maintenance of shared equipment or resources, including tools or staffing to enhance activities such as recruitment databases for clinical projects; or problem-solving through innovative technical solutions using the most current methodologies. NIDCD P30 funds do not provide patient services, support unfunded pilot studies, or facilitate research other than for funded user projects, unless directly related to advancing the potential of the Core Center itself. P30s are encouraged to provide benefits to other core centers or the larger community through sharing data or technology.

Specific Areas of Research Interest

Biomedical sciences are increasingly interdisciplinary, with collaborators and technologies converging from different fields for new approaches to research questions with public health importance. A research core can provide a facility, service or training for a group of investigators to conduct their individual research more efficiently. Through interaction with others, sharing resources may lead to new research paradigms and projects. A research core can create new collaborations by offering specialized services not easily duplicated in an individual laboratory, or by offering an approach that brings clinicians together with basic research scientists. A Core Center combines one or more research cores for a group of R01 investigators to enhance their research, consolidate resources, avoid duplication of efforts, and/or contribute to cost effectiveness by providing a service with lower cost and higher quality than could be attempted for independent projects by several individual Program Director(s)/Principal Investigator(s) PD(s)/PI(s). The design and purpose of each research Core Center may vary in how it serves its users.

Scientific knowledge to be achieved: An NIDCD P30 Core Center will increase the productivity and impact of research in R01 projects of the core users, and will form a collaborative environment to increase scientific interactions. A strong research base of funded projects is a qualifying requirement and a major factor in obtaining a P30 award. Any institution or consortium applying for a P30 grant should have an active, established program in basic, translational, clinical, outcomes and/or epidemiological biomedical or behavioral research in one or more of the NIDCD mission areas of hearing, balance, smell, taste, voice, speech or language. A Core Center may focus its resources and training on a group of investigators in a single one of these areas, or on a broad range of investigators with some shared approaches to widely different questions.

Objectives of this research program: Although not performing research itself, a Core Center makes facilities available for research services and provides relevant technical expertise to groups of investigators with common needs. Each research core within the Center must be used extensively for a minimum of 3 "qualifying" R01 projects; to qualify, the R01 must be for research in or closely related to  NIDCD mission areas, and have sufficient time before expiration to benefit from the core facilities (see Section IV.2, Application Submission Information for details). "Extensive" use normally means for more than 25% of the core usage time.  PDs/PIs holding qualifying R01s are expected to have priority for core use, but no single PD/PI may use a single core more than 50% of the time even if holding more than one qualifying grant. Projects that are not qualifying grants but still federally funded also may use the cores as time permits.

The application must establish an Administrative Shell to manage the Center with sufficient organizational structure to coordinate and integrate the P30 activities of the individual cores, promote scientific advances and new collaborations, determine the distribution and utilization of funds, and provide advice to the Core Center Director about the P30 activities. The Core Center Director directs the Administrative Shell of the Center as the PD/PI for the P30, and is responsible for the overall organization and operation of the P30. Individual research core Directors are responsible for their respective research core administration and integration with the Center. Administration of the Core Center and each research core should address efficient and fair prioritization of access to the core services and facilities, resource sharing, and quality controls when appropriate.

Types of approaches: The resources provided by research cores can include, but are not limited to, sharing of technical expertise (e.g., histology, population genetics, bioinformatics, statistics, automated brainstem response); centralization of labor-intensive tasks (e.g., genotyping, human subject recruitment and assistance with regulatory issues, database management); staffing, maintenance and training of shared equipment or complex resources (e.g., confocal microscopy, electron microscopy, virtual reality lab, sound-field laboratory, brainscan imaging); and providing innovative technical solutions using state-of-the-art methodologies/technologies (e.g., engineering, imaging, novel software and hardware development).

Additional Information

Limited developmental research may be allowed in a research core with prior NIDCD approval if it is directly related to enhancing the functioning, utility or methodology of the core. Major multi-user equipment should be requested elsewhere from the NIH (Shared Instrumentation Grant S10 Program, NIH PAR-13-008. Collaborations among other NIH supported P30s are encouraged.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the 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

The NIDCD P30 has budgetary caps based on the number of grants that qualify as the Center’s biomedical research base. Direct costs are capped at $1.5, $2.0, or under $2.5 million over 5 years, for a research base minimum of 6, 12, or 18 qualifying R01 grants, respectively. (See Application and Submission Information, Section IV.2 for details.) Renewal applications may not exceed the stated caps. Competitive revision (supplemental) applications requesting an additional research core to an existing P30 are allowed, but may not exceed the term of the parent award or the budgetary caps as described above.

Award Project Period

The scope of the proposed project should determine the project period, but the maximum period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Other

Foreign Institutions

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

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. One institution (identified by having a unique DUNS number or NIH IPF number) may apply for more than one award only for different user groups working in different NIDCD mission areas within the same institution. No R01 grants may be counted as qualifying for more than one P30.

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:

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

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.

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:

The letter of intent should be sent to:

Christopher Platt, Ph.D.
Division of Scientific Programs
National Institute on Deafness & Other Communication Disorders
6120 Executive Blvd., EPS-400 
Bethesda, MD 20892-7180 (for U.S. Postal Service)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1804
FAX: (301) 402-6251
Email: plattc@nidcd.nih.gov

Application Submission

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 Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., EPS 400C
Bethesda, MD 20892-7180 (for U.S. Postal Service)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-8683
FAX: (301) 402-6251
Email: stickm@nidcd.nih.gov

Page Limitations

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

Supplemental Instruction for the Preparation of Multi-Component Applications

The NIDCD P30 Research Core Center requires a multi-component application. The application must describe the Research Base overview, the Administrative Shell, and one or more Research Cores. Present these components in order separately, using PHS 398 Form Pages as required. Follow all instructions for all the headings in the PHS 398 Application Guide. The particular sections shown below are where additional instructions differ from the PHS 398 Application Guide.

Face Page for the Entire Application

Submit only one Face Page for the entire application. In the Title block, item 1, include the words “Core Center” as part of the title, preferably adding a few descriptive words (e.g., “Core Center for Human Communication”, “Core Center for Sensory Transduction”, etc.). For each individual component, use an individual cover page, not an NIH Face Page.

Core Center Research Base Overview Component

Include the overall Core Center facilities and Research Plan as follows

Face Page (Overview Component)

Do not use the NIH "Face Page"; for the cover page title use “Core Center Research Base Overview”.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Overview Component)

Follow all instructions in the Application Guide, but note the following additional instructions:

Description (Project Summary): Describe how this Core Center will serve its biomedical research base through the services of the proposed Research Cores

Project/Performance Sites: Describe briefly the availability and proximity of the Research Core facilities for the qualifying research projects using them. Provide details for each component in its own section on Resources.

Senior/Key Personnel: List the PD(s)/PI(s) to be Core Center Director(s), any Associate or Co-Director for the Center (if applicable), and each Research Core Director. Also list Other Significant Contributors; these include each PD/PI holding a qualifying R01 grant listed in the research base (see below for qualifying definition). Include Biosketches (below) for all these individuals.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Overview Component)

Use form pages as directed for the overall Core Center initial year and overall 5-year plan, with justifications, and do not repeat these elsewhere in the application. Include here budget lines for the Administrative Shell and each of the Research Cores, providing further budget details for each component in its own section on Budget. Future year budget requests must not exceed cost escalations specified by the NIH.

Maximum allowable costs: The budgetary cap for a P30 application is based on the number of grants that qualify as the Center’s biomedical research base. To qualify, a grant must be of the R01 type from NIH only, for research in or closely related to NIDCD mission areas, with at least one year of funding remaining at the time of submission; no-cost extension time does not qualify. Institutions holding six or more qualifying R01s  at least four of which must be NIDCD funded, may request direct costs totaling no more than $1.5 million over a five year period; those holding twelve or more R01s, at least eight of which must be NIDCD funded, may request direct costs totaling no more than $2.0 million over five years; those holding eighteen or more R01s, at least twelve of which must be NIDCD funded, may request direct costs totaling less than $2.5 million over five years. Yearly budgets may vary, but the sum for all years requested must not exceed the particular 5-year cap determined by the number of qualifying R01 grants in the P30 research base. No single year may request $500,000 or more of direct costs, and no single year may exceed 25% of the 5-year cap.  A modular budget format is not allowed for any of the P30 components. Renewal applications may not exceed the stated caps.

Other budget limitations: Travel requests for scientific, technical, or administrative staff are allowed only for training needed specifically to enhance or maintain operations of a research core. This training must take place in a focused, intensive session, course or workshop, as opposed to a session at a national meeting or the equivalent. P30 funds are not for travel for scientific speakers for seminars unless explicitly related to technical development of core services. Multi-user equipment requests generally are not appropriate for the P30, but should use other mechanisms (e.g., NIH Shared Instrumentation Grant). Some equipment requests are allowed when justified by documenting available equipment within the institution, and by describing clearly how requested equipment will provide core services. In addition, the potential for cost-sharing must be explored before submission and the results of such exploration (i.e., institutional commitment demonstrated through cost sharing) must be stated clearly in the application.

Consortium/Contractual Costs: Funds may be requested for some subcontracts, but P30s may not subcontract to foreign organizations. Funds may not be requested for alteration and renovation, rental space, staff retreats, direct support of individual research projects, direct support for pilot studies, salary and support for central institutional administrative personnel or secretarial support that is usually paid from institutional overhead charges, travel of investigators, or page and publication charges for staff investigators. Applications from institutions that have a Clinical and Translational Science Award (CTSA) from NIH may wish to identify the CTSA as a resource for conducting the proposed research. In such a case, include a letter of agreement from the PD/PI of the CTSA, documenting space or cost-sharing arrangements at the applicant institution. In addition to the overall budget included in the Core Center Research Base component, each Research Core component and the Administrative Shell component require a separate detailed budget.

Requests are allowed for technical staff time that is related to effort on the research core, and may include up to 100% salary support from the P30. Requests are allowed for limited support for administrative staff time only when the duties described relate directly to managing the P30 activities.

Revision applications requesting an additional research core to an existing P30 are allowed, but may not exceed the term of the parent award or the budgetary caps as described above for the parent award.

Biographical Sketches (Overview Component)

Place individual Biosketches in alphabetical order. Do not duplicate these pages in the individual Research Cores. Include 'Other Support' in the individual Biosketches.

Resources (Overview Component)

Describe existing environment and facilities briefly in the context of how the Core Center will use or change existing access, space and usage; include space maps as needed, letters of institutional commitment.

Research Plan (Overview Component)

Use this section to describe how this overall Core Center will serve its biomedical research base to provide a whole that will have an impact beyond simply the sum of its parts.

Specific Aims: Concisely state how the goals and objectives of the Core Center will enhance the research base. Include potential impact, any areas of special interest, and any research ideas, disease entities, and target populations to be studied.

Research Strategy: Describe how the Core Center will serve its research base, including the required significance, innovation, and approach. Include an overview of the scientific focus of current R01 projects in the research base of the Core Center with enough detail for reviewers to judge the extent and the interrelationships of ongoing research. Important features include interactions among Center members, the quality and productivity of the research programs, and demonstrated or potential interdisciplinary collaborations. Address how establishment of a Core Center will further extend, stimulate and provide added dimensions to the current research activities. For discussion, group the research included in the base into aggregates of projects with similar overall goals and objectives, since an assessment of the research base is important as a primary criterion in evaluating applications. The qualifying grants have been through peer review already as R01s, establishing the quality of the individual funded projects, so important aspects will be: (1) interactions and interrelationships of the research efforts; (2) uses and benefits of core services; and (3) plans to continue/develop productive collaboration among Core Center investigators. Documentation of a collaborative environment may be included (listing co-authored publications from PDs/PIs, with required PMCIDs).

As part of the Research Strategy, include a table of Qualifying R01 Grants.An institution must have an adequate biomedical research base to apply for a Core Center. An application requires a minimum number of R01 qualifying grants for each of the three possible levels of budget request, as described in Section IV.2 on maximum allowable costs, above. Include a Table of these Qualifying Grants, listed alphabetically by PD/PI. To qualify, the R01 grant must have at least one year of support remaining at the submission date of the P30 application; grants in no-cost-extensions, and a grant that is not an R01 do not qualify. (Some grants equivalent to R01s might qualify, e.g., R00, U01; NIDCD should be consulted prior to submission.) Use columns for the PD(s)/PI(s) last name, the PD(s)/PI(s) effort in person-months on the R01, the grant number (in the form R01DC000000), the “project end date” (not just the current year of support), the annual direct cost, and the grant title. Use one row for each grant (a PD/PI holding more than one grant will appear on more than one row), and ‘wrapping’ text within columns is allowed. Provide a total for current year direct costs for all qualifying grants listed for the proposed P30 Core Center. For listed qualifying grants that are not funded by NIDCD, add a justification sentence at the bottom of the table for each, stating how it relates to NIDCD mission areas. If relevant, a second table may be included for Additional Funded Projects planning some use of Research Core facilities; these may be supported by grants other than R01s (e.g., R03, R21, K08), and from agencies other than NIH.

As part of the Research Strategy, include a Preliminary Studies/Progress Report. This part of the Approach for the Core Center Research Base is primarily for competing renewals or competitive revisions. For new applications, this section may be shorter and may include examples of previous/ongoing services/techniques that have provided increased productivity within the research environment. For renewal applications, this section can document the impact the Core Center has had from enabling new research accomplishments, shared resources, new collaborations, and other outcomes. Provide information on core usage and other benefits to the scientific research enterprise, and note any specific problems in core administration and management.

Protection of Human Subjects: As part of this section, include a Table of Assurance DocumentationIn many cases the research cores enhance research on human subjects supported by grants with already completed or exempt IRB review. Include a table listing by PD/PI and grant number the status of human subject (IRB) committee approval dates for each relevant research project using the Core Center facilities. This review or exemption designation documentation is sufficient, provided the IRB determines that the research is not substantially modified by the Core. Explicitly state if no work is done by the Core Center that goes beyond the protocols of the participating R01s on human research, or if there is no human research involved. Otherwise, if a Core has activities not covered by current R01 approvals, follow the PHS 398 Instructions for Protection of Human Subjects in respect to 45 CFR Part 46. Do not duplicate the information here in the individual Research Core sections, but refer back to this table as needed.

Vertebrate Animals: As part of this section, include a Table of Assurance Documentation. In many cases, the research cores enhance vertebrate animal research supported by grants with already completed IACUC review. Include a table listing by PD/PI and grant number the status of animal usage (IACUC) committee approval dates for each relevant research project using the Core Center facilities. This review documentation is sufficient, providing the research is not substantially modified by the Core. Explicitly state if no work is done by the Core Center that goes beyond the protocols of the participating R01s on vertebrate animal research, or if there is no vertebrate animal research involved. Otherwise, if a core has activities not covered by current R01 approvals, follow the PHS 398 Instructions for Compliance on Animal Welfare. Do not duplicate the information here in the individual Research Core sections, but refer back to this table as needed.

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.

Administrative Shell

Use regular PHS 398 form pages to describe the “Administrative Shell” that will manage the overall Core Center. The instructions listed below are only for those sections with information different from the Application Guide.

Face Page (Administrative Shell)

Do not use the NIH "Face Page"; for the cover page title use “Administrative Shell”.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Administrative Shell)

Personnel: The PD/PI of the P30 and its Administrative Shell is the Core Center Director. List only administrators and staff for the Core Center (not individual Cores). Do not duplicate Biosketches, which already are provided in the earlier section. If Research Core Directors also help administer the overall Core Center, list them as well.

Detailed Budget for Initial Brudget Period and Budget for Entire Proposed Period of Support (Administrative Shell)

Include only the Administrative budgets for the Core Center initial year and for the 5-year plan, with justifications, and do not repeat these elsewhere in the application. Administrative leadership is not expected to require more than 0.5 to 1.2 person-months), unless strongly justified by activities that go distinctly beyond usual administrative functions. Budget constraints are the same as given earlier for the Core Center.

Resources (Administrative Shell)

Include any particular administrative facilities and environment features not covered earlier for the overall Core Center.

Research Plan (Administrative Shell)

Specific Aims: Describe briefly how the Core Center administration will coordinate and manage activities across the Research Cores, and have an impact on the research infrastructure.

Research Strategy: Describe how the administration of the overall Core Center will enhance the research base activities, 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 Core Center and each core, including the roles of the Center Director and Research 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 Shell will foster close interactions among the Core Center Director, Research Core Directors, the PD(s)/PI(s) of the funded grants utilizing the core, appropriate institutional administrative personnel, and other members of the institution holding the P30.

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.

Research Cores

Present each proposed Research Core separately in the regular form PHS398 format. The instructions listed below are only for those sections with information different from the Application Guide.

Face Page (Research Cores)

Do not use the NIH "Face Page"; for the cover page use a descriptive title of a few words (e.g., “Core 1: Imaging”, “Core A: Human Recruitment”, etc.).

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Research Cores)

Personnel: The named Core Director of each Research Core is its PD/PI. A Research Core Director should have the scientific expertise and leadership skills necessary to be the primary decision-maker for that core’s management, both technical and administrative, but a Research Core Director is not required to be the PD/PI on a current NIH grant. The requested percent effort is expected to be relatively low (0.5 to 1.2 person-months). Any request for a Research Core Director at more than 1.2 person-months effort must be justified by activities beyond typical administrative functions; institutional commitments for levels beyond 1.2 person-months that are not requested from the NIDCD should be noted. Include needed support for time and salary of technical personnel or positions to be filled in the Research Core. Do not repeat the Biosketches already presented earlier for the Core Center.

Detailed Budget for Initial Brudget Period and Budget for Entire Proposed Period of Support (Research Cores)

Budget: Use budget form pages as directed for the initial year and 5-year plan with justifications, and do not repeat these elsewhere in the application. Include any issues of overlap and accounting strategies for future expenses and mechanisms for reimbursing core services, if appropriate.

Supplies: Consumable supplies directly related to the operation of the cores (photographic supplies, electronics parts, machine shop stock, tissue culture media, glassware, chemicals, animals, etc.) are allowed. Some equipment purchases are allowable, including upgrades to obsolescent instruments in the Core, and fabrication of Core-specific instrumentation or devices. Restrictions on travel, equipment, subcontracts, alterations, pilot studies, and administrative staff remain the same as described above for the Core Center.

Resources (Research Cores)

Include any particular equipment or spaces particular to the Research Core not covered earlier in the facilities and environment for the overall Core Center, and describe the convenience, accessibility and distance of Core resource locations from the various core users.

Research Plan (Research Cores)

Specific Aims: Concisely describe how this Research Core will provide new services to the individual R01s beyond what is currently available, and/or increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or promote public health advances. Include impact beyond the qualifying users, if applicable to other users of the core.

Research Strategy: Describe how the Research Core facilities or services will enhance research activities of the projects using this core, and add benefits to the research accomplishments; include the required significance, innovation and approach. Include how the Research 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, including bridging basic and clinical goals or attracting new investigators into an area. Describe each proposed technique or service in the Research 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. A number of NIDCD-funded investigators larger than the required minimum of three using each core to some degree may strengthen the request. The ability to articulate user benefit is a critical factor in review.

Table of Projected Use: Provide a table listing all R01 projects, with a column for PD/PI name, for grant number, and for an estimate of the percentage of Core resource time used by each funded project. No single core may be used more than 50% of the time by a single PD/PI even with multiple projects. PDs/PIs holding the qualifying R01s are expected to have priority for core use.  If a proposed research core is not to be used 100% of the time, clarify why the expected amount is less.

Include plans for administration, organization and proposed management of the individual Research Core. Administrative organization is a critical issue in review of the application. 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 user R01 projects and the Research Core, including personnel effort as well as other categories. Specifically address the strategies for deciding what expenses will be charged to the P30 versus the participating research grants, and describe how budgetary expenses for the user R01s, or any other funding mechanisms with potential overlap, will or will not be modified upon receipt of the P30 award. If appropriate, provide a strategy for reimbursement of core services. NIDCD program and grants management staff may negotiate with both the P30 Director and R01 PDs/PIs who utilize P30 facilities regarding potential budgetary overlap.

Human Subjects and/or Vertebrate Animals: Do not duplicate the information here in the individual research cores from the Tables and text for the Core Center sections on these points, but refer back to those tables as needed. If not applicable, mark these sections N/A, and explicitly state that no human or vertebrate animal research is involved with this core.

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.

Appendix for the Entire Application

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 Guide.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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:

This is a multi-component application to develop a center with shared facilities, so evaluation of the component cores is integrated with the administrative shell into the overall impact score of the center. The review also includes the potential impact of the individual cores on the research projects using them; of the core center on the research capabilities of the institutions involved; and of the core center on the national effort in the mission areas of NIDCD.

Component Scoring: As part of the initial scientific review, reviewers will rate each individual research core including its management with an overall score, as well as the overall Core Center; the scores will appear in the summary statement.  The Administrative Shell of the whole Core Center will be rated only as "Acceptable" or "Unacceptable", but the administration quality will contribute to the overall score for the Core Center.  Since the NIDCD is interested in funding only the best research cores, component research cores scored as lower quality might not be funded even if recommended within a strong overall P30 Core Center application.

 
Overall Impact - Overall

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).

Scored Review Criteria - Overall

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? How will the core support and enhance ongoing research projects beyond currently available resources, promote collaborative research and/or attract new investigators to research in communication disorders, provide enhanced or increased efficiency of services, and/or offer services that are new, unique or otherwise unavailable on individual R01s? Are components well designed to enhance potential collaborations leading to public health advances? How well does each individual core fit in and contribute to the overall Core Center?

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? Do the Core Center Director and key personnel have the training, leadership, commitment and ability to devote the required time and effort to the core?

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? Does the Core Center use innovative ways to communicate, to allocate resources, to promote new cross-departmental or multi-disciplinary collaborations, or to integrate activity among the research cores or across basic and clinical fields?

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? Although they need not share a common “theme”, are the research cores well integrated into the Core Center? Are there plans to establish and maintain communication and cooperation among the Core Center investigators? Are there adequate administrative management plans for the Core Center and the research cores, including implementation, allocation, user prioritization, quality control and utilization, home institution fiscal and academic administration?

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? Isthe institutional commitment appropriate?

Additional Review Criteria - Overall

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.   

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.

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.

Additional Review Considerations - Overall

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.   

2. Review and Selection Process

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:

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:

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

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

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.

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, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Scientific/Research Contact(s)

Christopher Platt, Ph.D.
Division of Scientific Programs
National Institute on Deafness & Other Communication Disorders (NIDCD)
6120 Executive Blvd., EPS 400 
NIH, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-1804
FAX: (301) 402-6251
Email: plattc@nidcd.nih.gov

Peer Review Contact(s)

Melissa Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., EPS 400C
NIH, MSC 7180
Rockville, MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6251
Email: stickm@nidcd.nih.gov

Financial/Grants Management Contact(s)

Christopher Myers
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., EPS 400B
NIH, MSC 7180
Rockville, MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-6251
Email: myersc@nidcd.nih.gov

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.

Authority and Regulations

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.


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