Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Funding Opportunity Title	NIBIB Biomedical Technology Service Centers (P30)
Activity Code	P30 Center Core Grants
Announcement Type	New
Related Notices	March 5, 2014 - This PAR has been reissued as PAR-14-145.
Funding Opportunity Announcement (FOA) Number	PAR-13-249
Companion Funding Opportunity	None
Number of Applications	Individual applicants may not submit more than one NIBIB P30 Center application. However, there is no limit on the number of applications an institution may submit provided that each application is scientifically distinct. See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.286
Funding Opportunity Purpose	NIBIB will establish Biomedical Technology Service Centers (P30 Centers) that support infrastructure and resources that are needed by a diverse group of funded NIH researchers, but are not widely available. Consistent with this function NIBIB P30 Centers should engage in dissemination activities and may engage in training activities. Infrastructure and resources in an NIBIB P30 Center could range from shared biomedical instrumentation to open bioinformatics systems.

Posted Date	June 17, 2013
Letter of Intent Due Date(s)	Six weeks before the application due date.
Application Due Date(s)	Standard dates apply
AIDS Application Due Date(s)	Standard AIDS dates apply
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	January 8, 2014
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

NIBIB-supported Biomedical Technology Service Centers (NIBIB P30 Centers) ensure that independently-funded NIH investigators working in a targeted area will have access to biomedical technologies and expertise that are not widely available.

NIBIB P30 Centers must serve investigators from multiple institutions outside the applicant institution and are expected to be regional or national in scope.

Resources available in a typical NIBIB P30 Center could include, but are not limited to, specialized shared instrumentation, customized algorithms, novel tissue/organ engineering platforms or open bioinformatics systems.

NIBIB P30 Centers will not support independent scientific research or unfunded pilot studies, except for limited development of novel technologies that support the NIBIB P30 Center service mission (see "Technology Service Cores" section).

NIBIB will not support P30 Centers that focus on a specific disease, and will not support P30 Centers that involve clinical trials or patient services.

NIBIB will not support P30 Centers that overlap with pre-existing facilities at the host institution.

Consistent with their function to help the community gain access to these resources, NIBIB P30 Centers should engage in dissemination activities.

If appropriate, NIBIB P30 Centers may also engage in training activities.

NIBIB P30 Centers shall consist of one Administrative Core and one or more Technology Service Cores.

The Administrative Core coordinates the different components and activities of the NIBIB P30 Center including training and dissemination, etc.

Technology Service Cores are shared facilities that provide a needed service to investigators outside of the NIBIB P30 Center, enabling them to conduct their funded individual research projects more effectively.

Each Technology Service Core shall have an associated Research Base component consisting of projects that will utilize the Technology Service Core. Investigators using the Technology Service Cores (i.e., the "Research Base") are expected to have highly-regarded existing biomedical research programs funded by NIH Institutes or Centers, other Federal Agencies, or other nationally or internationally-recognized funding sources.

NIBIB P30 Centers have an External Advisory Committee (EAC) that advises the Program Director/Principal Investigator on current operating procedures and future directions for the NIBIB P30 Center.

Because extensive planning is required in preparing NIBIB P30 applications, prospective new applicants are encouraged to discuss their plans with the relevant NIBIB Program Directors (refer to http://www.nibib.nih.gov/Research/ProgramAreas) well before the application is prepared.

The NIBIB intends to reissue this FOA, pending availability of funds, after the transition to electronic grant submission http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-161.html.

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 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 will depend on NIH appropriations and the submission of a sufficient number of meritorious applications. On average, NIBIB anticipates funding approximately one new application every one or two years.
Award Budget	Application budgets are not limited but it is strongly recommended that applicants not request a budget of more than $600,000 in direct costs per year. In addition, up to $500,000 can be requested for equipment over the five-year duration of the grant.
Award Project Period	Support may be requested for up to five 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.

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 not 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.

Multiple PDs/PIs are not allowed. Only one PD/PI may be designated on the application. The PD/PI may not submit more than one NIBIB P30 Center application.

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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Christina H Liu, Ph.D. P.E.
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892 (20817 for courier service)
Telephone: (301) 451-7638
Fax: (301) 480-1614
Email: liuch2@mail.nih.gov

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:

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard
Suite 920, Room 956
Bethesda, MD 20892-5469 (20817 for courier service)
Telephone: (301) 496-8633
FAX: (301) 480-0675
Email: georged@nih.gov

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

• Overall: 12 pages
• Administrative Core: 6 pages
• Technology Service Core (s): 12 pages each
• Dissemination Core: 6 pages
• Training Core: 6 pages

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall Component
• Administrative Core
• Technology Service Core (s)
• Dissemination Core
• Training Core: optional

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

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

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed. The Table of Contents for the Overall Component should include all Components in this application.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed with the following additional instructions: Estimated Initial Budgets for all Components should be included in the estimated Initial Overall Budget.

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Estimated Entire Budgets for all Components should be included in the estimated Entire Overall Budget.

Funds may be requested for professional personnel, technical and support personnel, equipment, supplies, travel, consultants and web site development. Allowable items for each category are given below:

Professional Personnel: Salaries for Key personnel. The PD/PI is expected to devote at least 3 calendar months of his/her efforts to the P30 Center, with a minimum of 1.2 calendar months being devoted to the Administrative Core. The P30 Center can cover salaries for individual Technology Service Core Component Directors to the extent that they provide an essential P30 Center function. No overlap of time or effort between the P30 Center and other funded projects is permitted.

Technical and Support Personnel: Salaries for technical or support positions in the P30 Center. No overlap of time or effort between the P30 Center and other funded grants is permitted.

Equipment: Major equipment requests should be justified. Price quotes should be included for equipment costing more than $25,000. General purpose equipment requests should be included only when necessary to support visiting P30 Center investigators.

Supplies: Consumable supplies related to the operation of the P30 Center (including office materials and scientific supplies).

Travel: Domestic and foreign travel for P30 Center personnel, if the travel is directly related to the activities of the P30 Center.

Consultants: Consultants (including External Advisory Committee members) and any associated costs.

Web Site: Development and maintenance of a web site.

Service Contracts: Service Contracts for major equipment items.

Consortium/Contractual agreements: Funds may be requested for domestic subcontracts. In general, funds may not be requested for foreign subcontracts. Foreign subcontracts may be allowed if a written waiver is provided by the NIBIB Associate Director.

Note: Funds may not be requested to support courses given for academic or other types of credit. Individuals benefiting from the training programs may not be paid a stipend.

Note: Funds may not be requested for alteration and renovation, rental space, staff retreats, direct support for individual research projects, or direct support for pilot studies.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed. Start with a Biographical Sketch of the PD/PI, followed by Biographical Sketches of other investigators arranged in alphabetical order.

This section should contain all relevant Biographical Sketches for the entire application.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed. Describe the institutional commitment to the P30 Center (e.g., laboratory/office space, facilities, research funds).

Research Plan (Overall)

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

Introduction: For Resubmission Applications provide an Introduction addressing the previous peer review critique.

Specific Aims: State concisely the goals of the proposed P30 Center.

Research Strategy: NIBIB P30 Centers shall consist of one Administrative Core and one or more Technology Service Cores.

Describe the overall objectives of the P30 Center, and discuss what makes this particular P30 Center unique.

Give a brief overview of the Technology Service Cores, and evaluate the regional and national need for the Technology Service Cores.

Describe the qualifications of the PD/PI. He/she should be a highly experienced and respected scientist with demonstrated administrative capabilities and a proven track record for obtaining NIH and/or other relevant funding, as well as a track record of providing technical service to the scientific community. Only one PD/PI may be designated for a P30 Center.

For New Applications, describe the factors and events contributing to the decision to create the P30 Center.

For Renewal Applications, highlight major accomplishments from the previous funding period, and point out major changes from the original P30 Center design.

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.

Researchers are encouraged to share data obtained using the facilities of the P30 Center. Scientific and technical staff are encouraged to share information on the technologies available at the P30 Center.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Administrative Core)

A Title page with the name of the Core and the Core Director should be generated in place of the Face Page.

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

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Administrative Core)

This section should contain the Table of Contents for the Administrative Core. The Table of Contents for the entire application should be presented in the Table of Contents section of the Overall Component.

Detailed Budget for Initial Budget Period (Administrative Core)

This section should contain the Detailed Initial Budget for the Administrative Core.

Budget for Entire Proposed Period of Support (Administrative Core)

This section should contain the Entire Budget for the Administrative Core.

Biographical Sketch (Administrative Core)

All relevant Biographical Sketches should be presented in the Biographical Sketch section of the Overall Component.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Administrative Core)

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

Introduction: For Resubmission Applications provide an Introduction addressing the previous peer review critique.

Specific Aims: State concisely the goals of the proposed Administrative Core.

Research Strategy: The PD/PI of the P30 Center will be the Director of the Administrative Core.

Describe the qualifications of other staff who will be involved in the Administrative Core.

The External Advisory Committee is appointed by the PD/PI. External Advisory Committee members and the chair should be from outside the host institution, and should be rotated periodically.

Describe the role of the External Advisory Committee. The External Advisory Committee chair should be knowledgeable about the P30 Center technology and the science it serves, but should not be a member of the P30 Center staff or a major user of the P30 Center. Other committee members should be balanced among scientists knowledgeable about the P30 Center technologies, experts in the application of P30 Center technologies to biomedical research problems, and users of the technology.

For new P30 grant applications the External Advisory Committee should not be constituted prior to or during the review of the application, and potential candidates should not be approached or discussed.

For existing P30 Centers, list the current members of the External Advisory Committee, and briefly describe their qualifications.

The External Advisory Committee should meet at least annually and prepare a written report, addressed to the PD/PI, of its recommendations. This report must be supplied as part of the P30 Center Annual Progress Report.

Describe the role of any local executive committees that are proposed as adjuncts to the External Advisory Committee.

Describe the P30 Center organizational structure. Discuss the relationship of the P30 Center to the administrative structure of the grantee institution.

Describe the P30 Center operating procedures. Discuss procedures to review requests for use of the equipment and facilities, and to schedule use.

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.

Researchers are encouraged to share data obtained using the facilities of the P30 Center. Scientific and technical staff are encouraged to share information on the technologies available at the P30 Center.

All instructions in the PHS398 Application Guide must be followed. NIBIB P30 Centers do not have a minimum number of Technology Service Cores. However, if there is more than one Technology Service Core, each Technology Service Core should be considered as a separate Component and described separately.

Face Page (Technology Service Core)

A Title page with the name of the Core and the Core Director should be generated in place of the Face Page.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Technology Service Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Technology Service Core)

This section should contain the Table of Contents for the Technology Service Core. The Table of Contents for the entire application should be presented in the Table of Contents section of the Overall Component.

Detailed Budget for Initial Budget Period (Technology Service Core)

This section should contain the Detailed Initial Budget for the Technology Service Core.

Budget for Entire Proposed Period of Support (Technology Service Core)

This section should contain the Entire budget for the Technology Service Core.

Biographical Sketch (Technology Service Core)

All relevant Biographical Sketches should be presented in the Biographical Sketch section of the Overall Component.

Resources (Technology Service Core)

All instructions in the PHS 398 Application Guide should be followed.

Research Plan (Technology Service Core)

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

Introduction: For Resubmission Applications provide an Introduction addressing the previous peer review critique.

Specific Aims: State concisely the goals of the proposed Technology Service Core. .

Research Strategy: Identify the Director of each Technology Service Core, and discuss his/her qualifications. Technology Service Core Directors should be acknowledged experts with independently-funded research programs that use the Technology Service Core services. The PD/PI of the P30 Center may be Director of one (or more) of the Technology Service Cores.

The Technology Service Cores may support technicians and engineers that have the appropriate scientific or engineering skills. Examples of appropriate skills could be: operation and maintenance of the specialized shared instrumentation, development of custom algorithms, development of tissue/organ bioengineering platforms and development of open bioinformatics systems. Where appropriate, an established expert in the Technical Service Core activities could also be included as a consultant.

Describe the hardware, software and other specialized facilities available to the Technology Service Core. Technology Service Cores are expected to implement and maintain appropriate commercial equipment and off-the-shelf software, and may also utilize specially-designed equipment and software. Finally, limited developmental research is appropriate if it directly enhances the utility of the Technology Service Cores. Whenever possible, open-source software should be utilized. If an element of the support provided by the P30 Center involves software or algorithm development, it should be disseminated in open-source platforms.

Discuss the investigator usage of each Technology Service Core. The minimum requirement for establishing a Technology Service Core is significant usage by five or more investigators with independently-funded, peer-reviewed projects. The resources in the Technology Service Cores should be equitably distributed: the maximum effort that a single Technology Service Core can spend on projects directed by a single investigator is 25%.

Projects using a particular Technology Service Core form a "Research Base" for that Technology Service Core. Each Research Base must be described in detail in the Appendix.

For New Applications, each Technology Service Core should include information on preliminary studies.

For Renewal Applications, each Technology Service Core should include a Progress Report.

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.

Researchers are encouraged to share data obtained using the facilities of the P30 Center. Scientific and technical staff are encouraged to share information on the technologies available at the P30 Center.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted:

Face Page (Dissemination Core)

A Title page with the name of the Core and the Core Director should be generated in place of the Face Page.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Dissemination Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Dissemination Core)

This section should contain the Table of Contents for the Dissemination Core. The Table of Contents for the entire application should be presented in the Table of Contents section of the Overall Component.

Detailed Budget for Initial Budget Period (Dissemination Core)

This section should contain the Detailed Initial Budget for the Dissemination Core.

Budget for Entire Proposed Period of Support (Dissemination Core)

This section should contain the Entire Budget for the Dissemination Core.

Biographical Sketch (Dissemination Core)

All relevant Biographical Sketches should be presented in the Biographical Sketch section of the Overall Component.

Resources (Dissemination Core)

All instructions in the PHS 398 Application Guide should be followed.

Research Plan (Dissemination Core)

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

Introduction: For Resubmission Applications provide an Introduction addressing the previous peer review critique.

Specific Aims: State concisely the goals of the proposed Dissemination

Research Strategy: A fundamental motivation for the NIBIB P30 Center program is to apply cutting-edge technology to important biomedical research problems. The realization of this goal depends on an effective Dissemination Program.

Describe the details of the Dissemination Program. Dissemination activities should inform the scientific community about the technical capabilities of the P30 Center, and promote and enable a broader use of the technologies.

A variety of approaches can be proposed to promote dissemination. These approaches include, but are not limited to: publishing book chapters, patents, newsletters, or annual reports; conducting workshops; distributing software products; transferring technologies to other laboratories; licensing technologies to industry; and building a robust web presence.

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.

Researchers are encouraged to share data obtained using the facilities of the P30 Center. Scientific and technical staff are encouraged to share information on the technologies available at the P30 Center.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted:

Face Page (Training Core)

A Title page with the name of the Core and the Core Director should be generated in place of the Face Page.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Training Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Training Core)

This section should contain the Table of Contents for the Training Core. The Table of Contents for the entire application should be presented in the Table of Contents section of the Overall Component.

Detailed Budget for Initial Budget Period (Training Core)

This section should contain the Detailed Initial Budget for the Training Core.

Budget for Entire Proposed Period of Support (Training Core)

This section should contain the Entire Budget for the Training Core.

Biographical Sketch (Training Core)

All relevant Biographical Sketches should be presented in the Biographical Sketch section of the Overall Component.

Resources (Training Core)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Training Core)

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

Introduction: For Resubmission Applications provide an Introduction addressing the previous peer review critique.

Specific Aims: State concisely the goals of the proposed Training.

Research Strategy: The Training Program (if present and appropriate for the P30 Center) should create a cadre of biomedical researchers that are trained in the P30 Center technologies, and can effectively apply them to their own research. The academic rank of the trainees should be appropriate to the technology being disseminated, and could range from advanced graduate students, who are using the technology in their thesis projects, to faculty members and practicing physicians, who are aiming to use the technology in their research and/or clinical practice.

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.

Researchers are encouraged to share data obtained using the facilities of the P30 Center. Scientific and technical staff are encouraged to share information on the technologies available at the P30 Center.

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.

For each Technology Service Core include a Research Base in the Appendix. Describe up to 12 projects in each Research Base in detail (up to one page for each project). In addition, provide a Table that includes each project in the Research Base. Each entry in the Table should include:

• Project title
• Name of the PD/PI
• PD/PI institution
• Details of peer reviewed funding(s)
• Start and end dates for the project(s)
• Number of publications that have resulted from the project (for Renewal applications only)
• Utilization of human subjects or animals in the project (Yes/No)

For Renewal applications, projects from the previous funding period that are not being continued should be listed in a separate Table.

For Renewal applications, the Appendix should also include the most recent External Advisory Committee Report.

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 postmarked on or before the due dates in Part I. Overview Information.

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 NIBIB 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 Application Guide. This policy applies to all New, Renewal and Resubmission applications.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the P30 Center 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 P30 Center 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 P30 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the P30 Center address an important problem or a critical barrier to progress in the field? If the aims of the P30 Center 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?

Additional review criteria for NIBIB P30 Centers: Will the P30 Center have a significant influence on the biomedical research output of the funded investigators in the Research Base in ways that would not be practical for individual research projects?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the P30 Center? 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?

Additional review criteria for NIBIB P30 Centers: Is the PD/PI well qualified to effectively administer the P30 Center? Are the PD/PI, the Technology Service Core Directors and personnel appropriately trained for their respective roles? Are they able to devote adequate effort to the P30 Center activities? Do they have a history of performing services for their colleagues or the scientific community at large, outside of the needs of their own research?

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?

For NIBIB P30 Centers "Innovation" is defined as a coherent plan to ensure that independently-funded NIH investigators have access to biomedical technologies and expertise that are not widely available, but will substantially increase the productivity and the impact of the NIH-funded research.

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the P30 Center? 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 P30 Center 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?

Additional review criteria for NIBIB P30 Centers: Do the Technology Service Cores provide advanced technologies and services that are not easily available to investigators in the Research Base? Are they appropriate for the anticipated research needs of PD/PIs in the Research Base? Are plans for the administration of the P30 Center appropriate? Does the Dissemination Plan assure that the facilities and service will be widely used, with easy and fair access to appropriate users?

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?

Additional review criteria for NIBIB P30 Centers: Do the PD/PIs using the Technology Service Cores (i.e., the Research Base) have highly-regarded existing biomedical research programs funded by NIH Institutes or Centers, other Federal Agencies, or other nationally or internationally-recognized funding sources?

As applicable for the P30 Center 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

Not Applicable

Training Plan

Where the Training Plan is in place, does it ensure that a cadre of trained biomedical Researchers can apply the P30 Center technologies effectively in their own research?

As applicable for the P30 Center 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 National Advisory Council of the NIBIB. 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, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

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: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Christina H Liu, PhD, PE
National Institute of Biomedical Imaging and Bioengineering
Telephone: (301) 451-7638
Fax: (301) 480-1614
Email: liuch2@mail.nih.gov

David T. George, PhD
National Institute of Biomedical Imaging and Bioengineering
Telephone: (301) 496-8633
Fax: (301) 480-0675
Email: georged@nih.gov

Katie Ellis
National Institute of Biomedical Imaging and Bioengineering
Telephone: (301) 496-8521
Email:kellis@mail.nih.gov

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

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