Department of Health and Human Services


Part 1. Overview Information
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 Resource Centers (P41)

Activity Code

P41 Biotechnology Resource Grants

Announcement Type

Reissue of PAR-10-153

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-13-144

Companion Funding Opportunity

None

Number of Applications

An individual applicant may not submit more than one BTRC 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

This FOA encourages grant applications for Biomedical Technology Resource Centers (BTRCs) that are funded using the P41 mechanism. BTRCs conduct research and development on new technologies that are driven by the needs of basic, translational, and clinical researchers. BTRCs also make their technologies available, train members of the research community in the use of the technologies, and disseminate these technologies broadly.

Key Dates
Posted Date

March 19, 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

(Now Expired October 18, 2013 per issuance of PAR-13-376), Originally 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. See NOT-OD-12-161 and NIH’s Applying Electronically website for more information.

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

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) uses the P41 mechanism to support Biomedical Technology Resource Centers (BTRCs) that can address the need to accelerate the development and dissemination of new technology at the national level. BTRCs create critical and  unique technologies that are at the forefront of their respective fields, and apply these technologies to a broad range of basic, translational, and clinical research. Details concerning current NIBIB BTRCs can be found at http://www.nibib.nih.gov/Research/ResourceCenters.

A BTRC may be developed in a specific, narrow technological area, or it may utilize an integrated approach to the development of tools and methods across a broader line of inquiry. In either case, a BTRC assembles a critical mass of both technological and intellectual resources with the intent of exploiting advances in instrumentation and methodology for biomedical research. This is accomplished through a synergistic interaction of technical and biomedical expertise, both within the BTRC and with other leading laboratories.  Working iteratively with Collaborative Projects, a BTRC should develop and optimize new tools and methods targeting these projects' specific biomedical research problems that are otherwise difficult to tackle using existing tools and methods. This intense push-pull relationship between technology development and biomedical problem-solving collaborative projects defines the BTRCs as fundamentally different in character from laboratories engaged in investigator-initiated research that may have more narrowly defined goals.

A BTRC also must provide Service and Training to outside investigators and must disseminate the technology and methods it has developed. These efforts require the commitment of far greater financial and personnel resources to non-science activities than is expected for other types of research efforts. The goal of these efforts is to export the technology and expertise of the BTRC into the broader community, achieving a wider impact on biomedical research. Industrial partnerships are not required, but they are welcome when appropriate.

Because extensive planning is required in preparing the BTRC applications, prospective new applicants should discuss their plans with the relevant NIBIB Program Directors (refer to http://www.nibib.nih.gov/Research/ProgramAreas) on the appropriateness of their applications to the P41 mechanism well before (i.e. 4-6 months) further actions are taken.

The National Institute of General Medical Sciences (NIGMS) has a similar program that supports BTRCs. Details about that program can be found at Biomedical Technology Research Centers (BTRC) - National Institute of General Medical Sciences. Applicants who are interested in submitting an application to the NIGMS program need to use NIGMS' application procedures rather than those in this announcement.

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

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. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and costs of the applications received.

Award Budget

Direct costs (excluding equipment) vary among applications. Typical direct costs for BTRCs range between $600,000 and $750,000. In addition to the direct costs, a total cost for equipment up to $500,000 can be requested for the duration of a five-year project period.

Award Project Period

Support may be requested for up to five years. Two renewals may be requested, for a total of up to fifteen 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

Governments

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  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 least 6 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.

Multiple PDs/PIs are not allowed. Only one PD/PI may be designated on the application.  Additionally, a PD/PI may not submit more than one BTRC application.  

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.

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:

Renewals. Applicants may submit a Renewal application.  However, NIBIB BTRC Awards will be restricted to a total of fifteen years.  Applicants for the final five-year Renewal should be aware that BTRC funding will not be extended past the end of the final five years, and should propose a Research Plan for the final five-year period that takes this into account. 

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 the following address.

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

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 five copies of the Appendix CD (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html) must be sent in one package 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

Page Limitations

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.

Supplemental Instructions for the Preparation of Multi-Project Applications

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

A complete BTRC application should consist of the following components:

**Note: Different from PAR-10-153, Training and Dissemination Sections have been merged.

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page

Include the number and title of this FOA in item/line 2 of the PHS 398 application face page.

The Face Page of the PHS 398 Form is intended to be used for the BTRC application and should not be used as a cover page for individual components of the application.  Instead, a Title Page with the name of the component and when applicable, leader and his/her affiliated institution, should be used to demarcate each individual component.

Project Summary, Performance Sites, and Key Personnel

Under Project Summary, state the proposed center's broad, long-term objectives, specific aims, and the significance to the field of Biomedical Imaging and/or Bioengineering.  Define the relevance of each proposed TR&D to the overall theme and goals of the program. List all performance sites and all Key Personnel and Other Significant Contributors for the entire P41, beginning with the PI/PD and then listing all other Key Personnel alphabetically. Include all TR&D leaders, co-leaders, co-investigators, and consultants and consortium collaborators (if applicable and if these individuals will devote measurable effort to the project).

Table of Contents

Modify the PHS 398 Form Page 3 to enable reviewers to find each component of the application easily including each TR&D, Collaborative Projects, Service Projects, Training & Dissemination, and Administration.

Detailed Budget for Initial Budget Period; Budget for Entire Proposed Period of Support

Prepare a detailed composite budget for all requested support categories for the first years using Form Page 4 and a summary budget for the entire proposed period of support using Form Page 5 of the PHS 398 application. Prepare detailed and summary budgets for individual TR&D projects, Training & Dissemination, and Administration.  If applicable, provide additional budget pages pertaining to Consortium/Contractual arrangements (following the standard PHS 398 instructions).

The detailed budget should be completed as described in the PHS 398 instructions.  Funds may requested for the following components: TR&Ds, Training and Dissemination and Administration. (1) Under individual TR&D, support for graduate students and postdoctoral fellow can be requested only if they are active participants in TR&D research projects. (2) Under Dissemination, support for the development and maintenance of a website should be included. (3) Under Administration, funds should be requested as consultant costs to support the travel expenses of the External Advisory Committee (EAC) members to attend the annual meeting. The funds for EAC meeting will be restricted for this purpose and may not be re-budgeted without prior approval by Program Staff. Additionally, there is an annual meeting of BTRC PDs/PIs in the Washington, DC area. It is expected that the PD/PI and one other senior member of the BTRC attend this meeting. Funds to support travel to this meeting should be requested in the budget.

No support may be requested in the application for activities conducted outside of the BTRC in the collaborating laboratories.  However, support for Center staff conducting Collaborative Project-related work should be requested. The outside investigators of Collaborative and Service projects must derive support for their projects from sources outside the BTRC. Funds to support courses given for academic or other types of credit may not be requested. Individuals benefiting from the training experiences may not be paid a stipend nor may the training experience be a requirement for receipt of an academic degree.

The budget should include a detailed justification for key personnel. The NIBIB requires the PD/PI to devote at least 3 person-months (25% effort) to the Center. The person months for each member of the BTRC staff should be broken down by component (TR&D projects, Collaborative Projects, Service Projects, Training and Dissemination).

A justification should be supplied for the equipment requested for the Center. Price quotes should be included for major items of equipment costing more than $25,000. The budget justification section should include an evaluation of alternative instruments or manufacturers along with a discussion of the proposed procurement plan.

Major equipment purchases (more than $500,000 over the course of the project period) often require support from other sources when the BTRC Program is unable to fund the entire request. Plans for such shared funding should be detailed in the application.

Biographical Sketches

Compile all biographical sketches after the Overall Budget, starting with the PD(s)/PI(s) followed by all other investigators in alphabetical order. Do not repeat biographical sketches in the individual Projects.

Research Plan

Overview of the Proposed BTRC

Introduction: For Resubmission applications address the previous peer review critique (Summary Statement).

Specific Aims: State concisely the goals of the proposed BTRC

Research Strategy: A BTRC is expected to take on the role of being a national leader in its field in the development and dissemination of technologies. Applicants should describe the long-term goals and overall objectives of the BTRC, point out what makes this particular BTRC unique in terms of its intellectual and technological capabilities, and give a projected timetable for technology development. For New applications, include information on factors and events contributing to the decision to create the BTRC. For Renewal applications, include a brief summary of the BTRC’s progress. 

Resource Sharing Plan: Not Applicable.

Technology Research and Development (TR&D)

Each TR&D Project must include the following Sections.

Introduction: For Resubmission applications, each TR&D project must address the previous peer review critique (Summary Statement).

Specific Aims: State concisely the goals of the proposed TR&D project.

Research Strategy: The central activity of a BTRC is the group of TR&D Projects that serves as the foundation for all other BTRC activities. The mission of a BTRC may range from the narrowly-focused advancement of a single technology area to the development of a general class of technologies. It is understood that a BTRC is an inherently multidisciplinary enterprise that requires the integration of multiple approaches to complex technical and biomedical challenges. Hence, an element of high risk (and potentially high payoff) may be present in one or more of the TR&D Projects. Only scientific and technological proposals that are directly related to the NIBIB mission will be considered.  It is expected that most of the TR&D PD/PIs will have significant research experience and have an independent research program. 

TR&D Projects are most effective when they respond to the emerging needs of the biomedical research community. To encourage synergistic interaction, the application must include Collaborative Projects that serve as test-beds for TR&D Projects. The push-pull relationship between TR&D Projects and Collaborative Projects should be clearly delineated.

A BTRC must propose at least three and typically less than seven TR&D Projects. Since it is expected that these projects will involve multi-disciplinary science and engineering, the projects are not required to be physically located at a single site. If more than one site is involved, provide evidence of strong communication and collaboration among distant sites.

For New applications, each TR&D Project should include information on Preliminary Studies as part of the Approach section. 

For Renewal applications each TR&D Project should include a Progress Report as part of the Approach section, and new activities should be identified. List the investigator(s) who will be primarily responsible for each project, and describe the relationship between the TR&D Projects and theoverall goals of the BTRC.  Applicants for the final five-year Renewal should be aware that BTRC funding will not be extended past the end of the final five years, and should propose a Research Plan for the final five-year period that takes this into account. 

Protection of Human Subjects: The instructions in PHS 398 must be followed when describing experiments involving human subjects. The BTRC is responsible for obtaining relevant IRB approvals for all TR&D Projects, regardless of whether Collaborative and Service Projects have separate approvals. 

Vertebrate Animals: The instructions in PHS 398 must be followed when describing experiments involving animal. The BTRC is responsible for obtaining relevant IUCAC approvals for all TR&D Projects, regardless of whether Collaborative and Service Projects have separate approvals. 

Resource Sharing Plan: Individual TR&D is 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.

Collaborative Projects (CP)

Introduction: For Resubmission applications, the Introduction must address the critique from the previous peer review (Summary Statement).

Specific Aims: The Specific Aims is meant to serve as a succinct and accurate description of the goals and overall working dynamics of the Collaborative Projects component with the TR&Ds.

Research Strategy: The development of new biomedical research tools is most effective when pursued in the context of challenging problems that drive the technology forward. A Collaborative Project is an interaction between BTRC personnel and investigators from outside the BTRC, and should be selected on the basis of their appropriateness as test-beds for new technology and their potential for significant biomedical impact. Collaborative Projects should present substantial technical challenges that make the problem difficult to solve with current approaches. There should be an iterative push-pull relationship between TR&D Projects and Collaborative Projects, advancing both the technology and the biomedical projects. Such efforts are expected to lead to joint publications and, in some cases, patents.

Note: Collaborations with biomedical researchers that make use of the technology and expertise of the BTRC, but are not intended to serve as a primary driver for technology development, should be included as Service Projects. Purely technical collaborations focused on advancing some aspect of TR&D should be included within the relevant TR&D Project.

The collection of Collaborative Projects served by the new technology should be broad in scope and involve a variety of biomedical research areas. The BTRC is expected to be responsive to a user community whose members are primarily grantees and contractors funded by NIH and other funding agencies.

Up to 10 Collaborative Projects can be presented in detail. The description of each Collaborative Project should be clearly numbered and begin with the following information:

The description of each Collaborative Project should include a brief description of Collaborative Project and the portion of the Project that is relevant to this BTRC application.  The focus of the description should be the push-pull relationship between the Collaborative Projects and the related TR&D Project(s). For Renewal applications, the existing Collaborative Projects should include a Progress Report as part of the Approach section, and new activities should be identified.

New applications should have at least one CP for each TR&D Project. It is possible that one Collaborative Project could drive more than one TR&D Project. In Renewal applications, the number and breadth (both scientific and geographic) of Collaborative Projects are expected to be richer than in new applications. Collaborative Projects that have already been funded will be evaluated on how they advance and stimulate BTRC technological development. Projects that have not been funded should include more detail in how the relevant research activities are supported and will be evaluated on the scientific merit of the research proposed, as well as on their impact on a TR&D Project. It is expected that most of the Collaborative Projects would be funded projects.

To demonstrate the breath and scopes of the Collaborative Projects, in addition to the representative Projects, Tables of all Collaborative Projects should be included in the Appendix as instructed.

Resource Sharing Plan: Individual Collaborative Project is 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.

Service Projects (SP)

Introduction: For Resubmission applications, the Introduction must address the critique from the previous peer review (Summary Statement).

Specific Aims: State concisely the goals of the proposed Service Projects component. The Specific Aims page is meant to serve as a succinct and accurate description of how the TR&Ds are maximally leveraged.

Research Strategy: With a concentration of tools, instrumentation, software, methods, and expertise, a BTRC is expected to actively engage biomedical and clinical researchers to provide broad access to BTRC capabilities. The primary purpose of the Service Projects is therefore to provide access to the advanced technologies created in the BTRC, which are presumably not available elsewhere. The collection of Service Projects served should be broad in scope and involve a variety of biomedical research areas with significant geographical distribution.

Different from Collaborative Projects, Service Projects generally exploit the more mature capabilities of the BTRC and do not drive the development of new technologies or devices of the BTRC. Service Projects may include access to expertise in the BTRC for consultation and data interpretation, access to software and associated technical support, and access to instrumentation for routine work. Service Projects may also provide assistance to other laboratories or institutions as they build their own independent capabilities. It is expected that BTRC support will be acknowledged in papers resulting from Service Projects, regardless of whether BTRC staff are listed as authors. That acknowledgement should use the NIBIB grant number.

Note: The P41 mechanism is not intended to support a BTRC that is predominately focused on routine service. The BTRC should strive to conduct the major portion of its Service Projects with researchers who are outside the applicant institution.

A representative sampling of up to 10 Service Projects should be presented. The description of each Service Project should be clearly numbered and begin with the following information, followed by sufficient information to allow the evaluation of the need for the BTRC technologies in the proposed projects:

For Renewal applications, each existing Service Project should include a brief Progress Report and new activities should be identified.

Service Projects that have already been funded will be evaluated on how they leverage the TR&Ds to expand their research objectives. Pilot or unfunded Service Projects should include more detail on how the relevant research activities are supported and will be evaluated on the scientific merit of the research proposed. If a charge-back system is imposed to the Service Projects, descriptions of alternative plans for the pilot or unfunded Service Projects should be included.

To demonstrate the breath and scope of the Service Projects, in addition to the representative Projects, Tables of all Service Projects should be included in the Appendix as instructed.

Resource Sharing Plan: Individual Service Project is 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.]

Training and Dissemination

A fundamental motivation for the BTRC program is to develop and apply cutting edge technology to important biomedical research problems. A critical step in meeting this objective is to share the new technologies and methods established in the TR&Ds, CPs and SPs through training and dissemination.

Introduction: Resubmission applications must address the previous peer review critique (Summary Statement).

Specific Aims: State concisely the goals of the proposed Training and Dissemination component.

Research Strategy:

Training:Training is generally necessary to facilitate use of the new technology and software by scientistsoutside the BTRC. A BTRC must allocate sufficient resources for training both specialists and non-specialists to make the best possible use of the new tools.

The overall goal of BTRC training is expected to be twofold: to improve the general understanding of the BTRC’s technologies in the appropriate population, and to create a cadre of biomedical researchers trained in the technology so that they can effectively apply it in their own research.

Plans for training should be presented in the application, but no specific methods or activities are prescribed. The choice of approaches should be informed by the special constraints and opportunities presented by the individual BTRC. A defining feature of training activities is the direct interaction between BTRC personnel and the trainee. Note that activities such as web-based self-service tutorials would fall under Dissemination, since there is no direct interaction between BTRC personnel and the researcher.

Examples of successful approaches include hands-on laboratory experience such as residencies in the BTRC laboratories, seminars and lectures, and short courses or symposia offered independently or in conjunction with society meetings attended by the user community. Another example would be workshops that bring together researchers from academic institutions, hospitals and industry for discussions on the BTRC’s technology. Because of the increasing importance of translational and clinical research, plans for training researchers involved in those efforts are strongly encouraged.

Dissemination: Dissemination activities should have two overall objectives: informing the scientific community about the technical capabilities and accomplishments of the BTRC, and promoting and enabling a broader use of the technologies. A variety of approaches could be proposed to meet these goals. These approaches include, but are not limited to: publishing articles, books, patents, newsletters, annual reports, or special issues of technical journals; issuing press releases; presenting research results at meetings; conducting workshops and conferences; distributing software products; transferring technologies to other laboratories; licensing technologies to industry; and web-based training modules and tutorials. All BTRC dissemination activities must acknowledge NIBIB grant support. That acknowledgement should use the NIBIB grant number.

Website Requirement: All BTRCs are expected to have a robust web presence that clearly acknowledges support from the NIBIB. The website should provide information about:

In Centers that are developing software, emphasis should be placed on producing portable, well-documented, user-friendly software that is readily available and has user support. NIBIB encourages sharing of source codes, consistent with the NIH data-sharing policy and achieving the goals of this program. Although software is not required to be open source, if a restrictive license will be used to distribute the software, a written justification is expected in the application.

For Renewal applications, a progress report on Training and Dissemination should be included as part of the Approach section, and new activities should be identified.

Resource Sharing Plan:  Dissemination activities 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.

Administration

Introduction: Resubmission applications must address the previous peer review critique (Summary Statement).

Specific Aims: State concisely the goals of this component.

Research Strategy: The application should describe the administrative structure of the BTRC. This section should be broken down into: Organizational Structure and Staff Responsibilities, BTRC Operating Procedures, the External Advisory Committee, and Institutional Support. If relevant, a Transition Plan is required at the end of Research Strategy.

Organizational Structure and Staff Responsibilities: Describe the Organizational Structure of the BTRC. Indicate the relationship of the Center to the administrative structure of the grantee institution. Describe how the PD/PI of the BTRC and the BTRC staff will be organized with respect to the BTRC components: TR&D, Collaborative Projects, Service Projects, Training, Dissemination, and general BTRC administration. Describe the scientific and technical expertise of the staff that will operate, maintain, and develop the BTRC capabilities, and specify the distribution of each staff member’s effort across the different components.  Describe plans for designation of a replacement for the PD/PI should the need arise. 

BTRC Operating Procedure: Describe BTRC Operating Procedures. Include criteria and mechanisms to review requests for the use of the equipment and facilities in the BTRC, and to schedule use once it has been approved. Describe criteria and methods for prioritizing and selecting Collaborative Projects as well as Service Projects. Include samples of the forms to be filled out by collaborators and users. Include instructions on how users are to acknowledge support provided by the BTRC in any resulting publications.

If a charge-back system that results in program income is planned, a description of how costs are to be shared by the users should be included. Additionally, special administrative requirements that apply to program income must be observed. Program income means gross income earned by the recipient that is directly generated by a supported activity or earned as a result of the award (additional information is available in 45 CSR 74.2 and 74.24, which can be obtained by searching the Code of Federal Regulations at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. An estimate of the amount and source of program income expected to be generated as a result of the BTRC must be included on the “Checklist Page” of all renewal and non-competing continuation applications. Net program income earned during a budget period must be reported on the long-form Financial Status Report (except for program income earned as a result of inventions, to which special rules apply). Costs incident to the generation of program income may be deducted from gross income to determine program income, provided these costs have not been charged to the award.

External Advisory Committee: The External Advisory Committee (EAC) is appointed by the PD/PI of the BTRC and advises the PD/PI on future directions for the Center, particularly in planning additional grant applications and in setting priorities for allocation of BTRC facilities. Each BTRC must have an EAC. The committee chair should be knowledgeable about the BTRC's technology and the science it serves, but should not be a member of the BTRC staff or a significant collaborator of the BTRC. Other committee members should be balanced among: (1) scientists knowledgeable about the BTRC technologies, (2) experts in its application of the BTRC technologies to biomedical research problems, and (3) users of the technology. The NIBIB Program Director will be an ex officio member of the EAC.

EAC members and the chair should be from outside the host institution. NIBIB encourages the inclusion of scientists who are not affiliated with the BTRC; however, inclusion of collaborators on the EAC is not prohibited. Membership should be rotated periodically. The EAC should meet at least annually and prepare a written report of its recommendations, addressed to the PD/PI. This report must be supplied as part of the BTRC Annual Progress Report.

The role of the EAC should be described. The committee's role in advising on instrument purchases, reviewing Collaborative and Service Projects for merit and appropriateness, and allocating instrument time should be presented. For Renewal and Resubmission applications, names of current committee members and a brief description of their qualifications should be included. For New applications, potential EAC members should not be contacted or appointed prior to submission of the application; however, the scientific disciplines of anticipated committee members should be described. The application should not list the names of potential members of the EAC.

A local executive committee, or other local committees, may be proposed as an adjunct to the EAC. The function and meeting schedule for these committees should be described in this section.

Institutional Support: Provide information regarding the level and detail of institutional support from the parent institution, such as funded faculty or administrative or technical support positions, facility and/or space commitments, monetary assistance, etc.

Transition Plan (Plans for the Future): A brief transition plan, which describes a plan for the Center beyond the final five-year period, must be included in the final five-year renewal application. The Transition Plan should include brief rationales for the vision of the Center at the end of the five-year funding cycle.  If the plan is to continue the resource, strategies for continued funding should be provided.

Resource Sharing Plan: Not Applicable.

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.

Table(s) of Collaborative Projects: Each entry in the tables should include:

For Renewal applications, Collaborative Projects from the previous funding period (including those that are not part of the Renewal application), should be included in a separate table following the table of new Collaborative Projects.

Table(s) of Service Projects: Each entry in the table should include:

For Renewal applications, Service Projects from the previous funding period, including those that are not part of the Renewal application, should be listed in a separate table, following the table of new Service Projects. 

External Advisory Committee Report: For Renewal applications, include copies of the BTRC’s most recent External Advisory Committee Report.

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 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.

Requests of $500,000 or more for direct costs in any year

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

Neither a site visit nor an applicant interview is guaranteed as part of the review of the BTRC application. The written application must be complete and able to stand on its own.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the BTRC 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 projects proposed). A single, overall impact/priority score for the BTRC application will be assigned at the end of the discussion of the components. The overall score should not simply be the average of the individual scores, but rather should take into account the synergy of the individual components. In determining this final score, the goals of the BTRC, the stage of development of the BTRC technology, and community engagement should be taken into account.

Scored Review Criteria for the TR&D Projects

Each TR&D Project receives a separate overall impact/priority score.

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 TR&D project address an important problem or a critical barrier to progress in the field? If the aims of the TR&D project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the technology dynamically evolving, state-of-the-art, an important area for research and development in its own right, and likely to advance the frontiers of biomedical research? Is there synergy between the TR&D project and the Collaborative Projects in advancing the technology? How is this project unique? Is the technology already broadly available?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the TR&D 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?  

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?  Will the technology from the TR&D result in new knowledge or capabilities for end-users? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the TR&D 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 TR&D 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?  Is there a clear push-pull interaction with one or more of the Collaborative Projects?

For Renewal applications, is there significant progress during the past grant period?

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?  Will the environment foster a multi-disciplinary collaboration in pursuit of the technology solution? 

Component Scoring

The following components are scored as a whole regardless of the number of activities subsumed within the component: Collaborative Projects, Service Projects, Training and Dissemination, Administration.

Collaborative Projects Review Criteria

Do the Collaborative Projects provide significant applications of the BTRC technologies? Do the Collaborative Projects motivate further technological research and development in the BTRC, in other words, is there a significant push-pull relationship between the CPs and related TR&Ds?  

For Collaborative Projects that are currently not funded, what is the level of scientific merit of the research proposed that will enhance the technological development of related TR&Ds?

For Renewal applications, does the BTRC have an appropriate balance between time and effort spent on Collaborative Projects and Service Projects, and is there significant progress during the previous grant period?

Service Projects Review Criteria

Is the BTRC available to outside users? Are the equipment and technology utilized for Service Projects state-of-the-art? Do the equipment and technology meet significant biomedical research needs? Do the Service Projects have a national geographical distribution? For BTRCs that do a substantial amount of service, are the plans for sharing costs by the users, including fee-for-service systems, appropriate? For pilot or unfunded Service Projects, is the alternative plan for user fees appropriate?

For Renewal applications, is there significant progress during the previous grant period? Do Service Projects represent national scope and impact?

Training and Dissemination Review Criteria

Are plans to provide training opportunities and dissemination appropriate? Is there a direct and meaningful interaction between BTRC personnel and the trainee? Are sufficient resources allocated for Training, so that non-specialists can make the best possible use of the new technologies?

For BTRCs that are developing software, is the software portable when appropriate, well-documented, user-friendly, and readily available to the user community?

Have there been efforts to make both non-expert and expert communities aware of the new technology?

For Renewal applications, have there been reasonable results to date related to Dissemination and Training?  Is the Center website easy to find? Does the material on the website provide useful information to the biomedical research community? Has there been reasonable and timely progress in this area?

Administration Review Criteria

Are the qualifications of the Center PD/PI and other senior key personnel appropriate to lead the P41 and coordinate all P41 activities? Is the Center PD/PI an established researcher with the ability to ensure quality control and the experience to effectively administer and integrate all components of the program? Is the Center PD/PI fully established at the applicant institution?

Are the administrative aspects presented in the written application appropriate and adequate? Is the space set aside for the BTRC and the laboratory facilities, including those available to visiting scientists, appropriate and adequate? If a charge back system is proposed, is the system appropriate? In the case of a Renewal application, is the usage of the instruments developed and supported by the BTRC appropriate and adequate? Are instruments in place and operational, and are staff members currently on site?

Is the commitment of the PD/PI and institution(s) to the BTRC appropriate and adequate for a center of national significance?

Are the scientific and managerial credentials of the PD/PI and the credentials of other key professional and technical staff appropriate?

For New applications, are the plans for the External Advisory Committee appropriate?

For Renewal applications, is the role of the External Advisory Committee appropriate? Do the members of the External Advisory Committee have sufficient breadth and ability to take an effective role in the review and guidance of BTRC operations? Is there evidence that the External Advisory Committee is active? Are there plans for rotation of the members of this committee?

If other committees, such as a local Executive Committee, are proposed, are the composition and organizational plans for these committees adequately described? How they will benefit the BTRC?

Additional Review Criteria

As applicable for the projects 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

Additional Review Considerations

As applicable for the BTRC 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.

Transition Plan

For final five-year Renewal applications, reviewers will consider the appropriateness of the transition plan and research plan given that the BTRC will not be renewed at the end of the final five-year period.

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) convened by the NIBIB 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 to the NIBIB 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:

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)

Christine Kelley, Ph.D.
Director, Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
Telephone: (301) 451-4778
Fax: (301) 480-1614
Email: kelleyc@mail.nih.gov

Christina H Liu, Ph.D. P.E.
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
Telephone: (301) 451-7638
Fax: (301) 480-1614
Email: liuch2@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Angela Eldridge
Office of Grants Management
National Institute of Biomedical Imaging and Bioengineering
Telephone: (301) 451-4793
Fax: (301) 480-4974
Email: aeldridge@mail.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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