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-13-144

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-13-376

Companion Funding Opportunity

None

Number of Applications

An individual applicant may not submit more than one 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 Funding Opportunity Announcement (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

October 18, 2013

Open Date (Earliest Submission Date)

December 25, 2013

Letter of Intent Due Date(s)

Six weeks before the application due date

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Standard AIDS dates apply

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

January 8, 2017

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. 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.

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the 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/featured-programs/biomedical-technology-resource-centers.

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/scientific-program-areas) 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 (http://www.nigms.nih.gov/About/Overview/BBCB/BiomedicalTechnology/BiomedicalTechnologyResearchCenters.htm). 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 SF424 (R&R) 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) are not limited and are expected to 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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

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 Strategy, including a transition plan, for the final five-year period that takes this into account. 

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

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

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6

Admin Core (Use this component for the Administration) 

6

Project (Use this component for each Technology Research and Development project. Note: projects will appear in the application in the order in which they were entered in ASSIST.)

12

Training Dissem (Use this component for Training and Dissemination)

12


Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed. For this FOA, there are page limitations for the Collaborative and Service Projects Sections to be included in the Research & Related Other Project Information form of the Overall component. The following page limitations do not include references and overall Tables at the end of each section. Applicants are reminded to be informative yet succinct.

Introduction for Collaborative Projects (resubmissions only): may not exceed 1 page

Introduction for Service Projects (resubmissions only): may not exceed 1 page

Summary of Collaborative Projects: may not exceed 1 page

Summary of Service Projects: may not exceed 1 page

Description of Collaborative Project: may not exceed 1 page per Collaborative Project, for up to 10 pages total, excluding tables and references

Description of Service Project: may not exceed 1 page per Service Project, for up to 10 pages total excluding tables and references

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application must consist of the following components:

* Note: Different from PAR-13-144, Collaborative Projects and Service Projects Sections must be included as Other Attachments under Research & Related Other Project Information (Overall). Applications without Collaborative Projects and Service Projects will be considered incomplete and will not be reviewed. 

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Follow the instructions in the SF 424 (R&R) Application Guide.

Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: The application should include a succinct project summary of the proposed work. State the proposed Center's broad, long-term objective, 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.

Project Narrative: Provide the Project Narrative of the entire BTRC application.

Other Attachments: The following two attachments are required in the Overall Component. 

(1) Collaborative Projects (required): A maximum of 10 representative projects, 1 page per Collaborative Project excluding references, Introduction (1 page for resubmission applications) and Summary of the Collaborative Projects (1 page).

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.

For resubmission applications, an Introduction for the Collaborative Projects with descriptions of changes in response to the critique from the previous peer review must be included.

After the Introduction (for resubmission applications), the Summary of the Collaborative Project should be a succinct and accurate description of the goals. The overall working dynamics of the Collaborative Projects with the TR&Ds should be included. 

After the Summary for the Collaborative Projects, 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.

All applications must have at least one Collaborative Project 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 of Collaborative Projects are expected to be richer than in new applications, including participation from institutions outside of the parent institution. 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 breadth and scopes of the Collaborative Projects, in addition to the representative Projects, Tables of all Collaborative Projects should be included at the end of this section.  These tables are not counted against the page limitation.

Each entry in the tables should include: Collaborative Project PD/PI and Institution and names of all collaborators (if applicable)

For Renewal applications, Collaborative Projects from the previous funding period should be included in a separate table following the table of proposed Collaborative Projects for the next funding period.

In the body of the text for this section, begin the section with a heading indicating "Collaborative Projects." Save the entire section in a single file named "Collaborative Projects" and upload this file under Other Attachments.

Please note there is no P41 budget section allowed for the Collaborative Projects. Any costs incurred by the Technology Research and Development Projects related to the Collaborative Projects should be included under the relevant Technology and Development Project budget. Any administrative costs related to interactions with the Collaborative Projects should be included under the Administration budget.

(2) Service Projects (required): A maximum of 10 representative projects, 1 page per Service Project excluding references, Introduction (1 page for resubmission applications) and Summary of the Service Projects (1 page).

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.

For resubmission applications, an Introduction for the Service Projects with descriptions of changes in response to the critique from the previous peer review must be included.

After the Introduction (for resubmission applications), the summary of the Service Projects should be a succinct and accurate description of goals of the proposed Service Projects. How the TR&Ds are maximally leveraged should be included.

After the Summary of the Service Projects, 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 breadth and scope of the Service Projects, in addition to the representative Projects, Table(s) of all Service Projects should be included at the end of this section. These tables are not counted against the page limitation.

Each entry in the table should include: Service Project PD/PI and Institution and names of all collaborators (if applicable).

Indicate whether human subjects and/or animals are utilized in the project

For Renewal applications, Service Projects from the previous funding period should be listed in a separate table, following the table of proposed Service Projects for the next funding period. 

In the body of the text for this section, begin the section with a heading indicating "Service Projects." Save the entire section in a single file named "Service Projects" and upload this file under Other Attachments.

Please note there is no P41 budget section allowed for the Service Projects. Any costs incurred by the Technology Research and Development Projects related to the Service Projects should be included under the relevant Technology and Development Project budget. Any administrative costs related to interactions with the Service Projects should be included under the Administration budget.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan          (Overall)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component

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.

Letters of Support: Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services. Letters of support should not be included for proposed Collaborative Projects or Service Projects.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a leadership plan must be attached. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other contributors.  If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

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 SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Administration Component

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administration)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administration)

Follow the instructions in the SF 424 (R&R) Application Guide.

Research & Related Other Project Information (Administration)

Human Subjects: Answer No to the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer No to the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Administration)

List all performance sites that apply to Administration component, which should be the same as the primary performance site.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administration)

Budget (Administration)

Budget forms appropriate for the Administration component should be included in the application package.

Personnel: The budget should include a detailed justification for key personnel. The NIBIB requires the PD/PI to devote at least 3.0 calendar months to the entire Center, within which 1.2 calendar months is devoted to the Administrative Core.  For Multiple PD/PI applications, each PD/PI must devote a minimum of 3.0 calendar months to the entire Center, within which 1.2 calendar months is devoted to the Administrative Core. 

External Advisory Committee & P41 Annual Meetings: 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 the 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 will attend this meeting. Funds to support travel to this meeting should be requested in the budget.

Equipment: 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.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Administration)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component

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(s)/PI(s) of the BTRC and the BTRC staff will be organized with respect to the BTRC components: TR&D, Collaborative Projects, Service Projects, Training and 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(s) for the PD(s)/PI(s) 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.

External Advisory Committee: The External Advisory Committee (EAC) is appointed by the PD(s)/PI(s) of the BTRC and advises the PD(s)/PI(s) 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(s)/PI(s). 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 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.

Letters of Support: Do not include any letter of support here.

Resource Sharing Plan: Not Applicable.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

Planned Enrollment Report  (Administration)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administration)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Technology Research and Development (TR&D) Components

When preparing your application in ASSIST, use Component Type ‘Project’ for each TR&D Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (TR&D)

Complete only the following fields:

PHS 398 Cover Page Supplement (TR&D)

Follow the instructions in the SF 424 (R&R) Application Guide.

Research & Related Other Project Information (TR&D)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (TR&D)

List all performance sites that apply to this TR&D.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (TR&D)

Budget (TR&D)

Budget forms appropriate for this TR&D component should be included in the application package.

Personnel: The budget should include a detailed justification for key personnel under this TR&D component. The person months for each member of the BTRC staff related to this TR&D should be included here. Support for Center staff conducting Collaborative or Service Project-related work should be requested under this TR&D component. Support for graduate students and postdoctoral fellow can be requested only if they are active participants in TR&D research Projects. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100% under the entire BTRC.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (TR&D)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component

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 applications that are directly related to the NIBIB mission will be considered.  It is expected that most of the TR&D PDs/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 the overall 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 Strategy for the final five-year period that takes this into account. 

Letters of Support: Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services.

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 SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report  (TR&D)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report  (TR&D)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Training and Dissemination Component

When preparing your application in ASSIST, use Component Type ‘Training Dissem.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover  (Training and Dissemination)

Complete only the following fields:

PHS 398 Cover Page Supplement  (Training and Dissemination)

Follow the instructions in the SF 424 (R&R) Application Guide.

Research & Related Other Project Information (Training and Dissemination)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s)  (Training and Dissemination)

List all performance sites that apply to the Training and Dissemination Component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile  (Training and Dissemination)

Budget (Training and Dissemination)

Budget forms appropriate for the specific component will be included in the application package. Funds can be requested to support the development and maintenance of the Center website.

Personnel: The budget should include a detailed justification for key personnel under this component. The person months for each member of the BTRC staff related to this component should be included here. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100% under the entire BTRC.

Note: Funds to support courses given for academic or other types of credit are not allowed. Individuals benefiting from the training experience may not be paid a stipend nor may the training experience be a requirement for receipt of an academic degree.  Trainee-related costs such as stipends, fringe benefit, travel, and room and board are not allowed.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Training and Dissemination)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component

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 scientists outside 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.

Letters of Support: Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services.

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 SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

Planned Enrollment Report  (Training and Dissemination)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report  (Training and Dissemination)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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 submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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 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 SF424 (R&R) 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 - Overall

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 project proposed).

A single, overall impact score for the BTRC application will be assigned at the end of the discussion of the components. The Overall Impact 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 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 for the TR&D Project?

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

Each of 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 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? Do the Collaborative Projects provide significant applications of the BTRC technologies? Do the Collaborative Projects include an appropriate number of Collaborators from outside the applicant institution?

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 regional and/or 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?

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

Are the administrative aspects presented 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(s)/PI(s) and institution(s) to the BTRC appropriate and adequate for a center of national significance?  Is (Are) the Center PD(s)/PI(s) each committing a minimum of 3.0 calendar months to the Center?

Are the scientific and managerial credentials of the PD(s)/PI(s) 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 Overall

As applicable for the BTRC 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed BTRC 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 Guidelines for the Review of Inclusion in Clinical Research.

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 Overall

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), 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. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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