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 using ASSIST or an institutional system-to-system solution; 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.

It is critical that applicants follow the Multi-Project (M) 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.

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

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) uses the P41 mechanism to support Biomedical Technology Resource Centers (BTRCs) that accelerate the development and dissemination of new biomedical technology. It is expected that BTRCs would have a nationwide impact. 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/or clinical research. Details concerning current NIBIB BTRCs can be found at https://www.nibib.nih.gov/research-funding/biomedical-technology-resource-centers.

A BTRC assembles a critical mass of both technological and other intellectual resources with the intent of advancing the development of instrumentation and methodology for biomedical research. NIBIB BTRCs may develop new technologies for use in biomedical research or clinical application(s). This is accomplished through a synergistic interaction of technical and biomedical expertise, both within the BTRC and with other laboratories outside of the BTRC.

The central components of any BTRC are the Technology Research and Development (TR&D) projects. These projects serve as the foundation of all the activities within the BTRC. TR&D projects should be at the cutting edge of the technological field and respond to the emerging needs of the biomedical research community. TR&D projects are scientifically distinct, but are not stand-alone projects, thus they should build on and strengthen the synergistic interactions within the BTRC.

The BTRC application must include Collaborative Projects (CPs) that serve as technology test-beds for the cutting-edge technology developed in TR&D projects. Working in a push-pull, interative relationship with CPs, a TR&D project should develop and optimize new tools and methods to address specific biomedical research problems that are otherwise difficult to tackle using existing tools and methods. It is expected that the CPs driving the science of each TR&D project would present important challenges to the TR&D.

The BTRC application must include Service Projects (SPs) that serve as users of the well-developed and stable technologies of the BTRC. SPs make use of the technology and expertise of the BTRC, but are not intended to serve as primary drivers for technology development.

Unless there are technological and/or clinical limitations to distributing the TR&D technology, the CPs and SPs should each have a national geographic distribution. The national geographic distribution of the CPs and SPs in new applications may be somewhat limited, but, as BTRCs mature, it is expected that there will be a broad national distribution.

A BTRC also must provide training to outside investigators and 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. An illustration of the interactions among the required components of a BTRC can be found at NIBIB's BTRC website: (https://www.nibib.nih.gov/research-funding/biomedical-technology-resource-centers.)

This combination of TR&D projects, the intense push-pull relationship between technology development and biomedical problem-solving CPs, and the deployment of technologies through biomedical problem-solving SPs, together with training and dissemination, are what set apart BTRCs from other investigator-initiated research that generally have more narrowly defined goals (such as R01s).

As 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/scientificprogramareas) to determine the appropriateness of their applications to the P41 mechanism and the NIBIB mission. It is recommended that these discussions occur at least 4-6 months prior to application.

To maintain a balance between the conflicting demands of nurturing new technology areas versus providing for sustained development in established areas, NIBIB limits funding for BTRCs to 15 years. PD(s)/PI(s) whose BTRCs have reached the funding period limit are allowed to submit a new BTRC application that demonstrates substantial changes to the focus of technology development efforts. Guidelines outlining the substantial changes that would be expected from a previously funded BTRC to constitute a new application can be found at https://www.nibib.nih.gov/sites/default/files/P41%20New%20Center%20Guidelines.pdf

Like the NIBIB, the National Institute of General Medical Sciences (NIGMS) has a program that supports Biomedical Technology Research Resources. Details about that program can be found at Biomedical Technology Research Resources (BTRRs)-National Institute of General Medical Sciences (https://publications.nigms.nih.gov/btrrs/searchresultsall.asp). Applicants who are interested in submitting an application to the NIGMS program need to use NIGMS application procedures rather than those in this announcement.

See Section VIII. Other Information for award authorities and regulations.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

Applicant Organizations

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.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.

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.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Renewals: Applicants may submit a Renewal application. However, NIBIB BTRC Awards will be restricted to a total of fifteen years.

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to:

Antonio Sastre
National Institute of Biomedical Imaging and Bioengineering
Telephone: 301-402-1373
Email: sastrea@mail.nih.gov

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
Tech Train Dissem (Use this component for Technology 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 Other Attachments of 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.

Various Sections	Page Limits
Introduction for Collaborative Projects (resubmissions only)	1
Introduction for Service Projects (resubmissions only)	1
Summary of all Collaborative Projects	1
Summary of all Service Projects	1
Description of Collaborative Project (Maximum number of collaborative projects: 10)	1 page per Collaborative Project, up to 10 pages total. Page limits do not apply to references.
Description of Service Project (Maximum number of service projects: 10)	Half page per Service Project, up to 5 pages total. Page limits do not apply to references

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 should consist of the following components:

• Overall: required
• Administration: required
• Technology Research and Development: required; minimum of 3. While there is no maximum, no more than 5 are recommended
• Technology Training and Dissemination: required

* Note: 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.

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.

Complete entire form.

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

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. 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): Resubmission applications must provide an Introduction section (1 page). All applications must provide a Summary of the Collaborative Projects (1 page) and a maximum of 10 representative Collaborative Projects, 1 page per Collaborative Project, excluding references.

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 (CP) 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. CPs should present substantial technical challenges that make the problem difficult to solve with current approaches. Such efforts are expected to lead to joint publications and, in some cases, patents. The collection of CPs driving the push-pull of the new technology in the TR&D should be broad in scope and involve a variety of biomedical research areas. The BTRC is expected to be responsive to a collaborative user community whose members are grantees and contractors funded by NIH and other funding sources.

Note: Collaborations with biomedical researchers that only make use of the technology and expertise of the BTRC, and are not intended to serve as a primary driver for technology development, should be included as Service Projects (see (2) Service Projects). Purely technical collaborations focused on advancing some aspect of TR&D should be included within the relevant TR&D Project.

Resubmission applications must include a Introduction for the CP section with description of changes in response to the critique from the previous peer review.

The Summary of the CP should be a succinct and accurate description of the overrall goals. The overall working dynamics of the CPs with the TR&Ds should be included. Within the summary, the investigators should describe criteria for including new CPs and rotating existing CPs out of the BTRC during the award period. While it is expected that the vast majority or all of the CPs would have funding support in place at the time of P41 application, there is not an expectation that this funding must be in place for the entire proposed duration of the P41 funding period.

After the Summary for the CPs, the description of each CP should be clearly numbered and begin with the following information:

• Title
• Collaborating Investigator's name and Institution
• Funding status of the project, including:

- Grant number
- Project period dates
- Source of funds
- Program Director(s)/Principal Investigator(s) name, if different from the collaborating Investigator.

The description of each CP should include a brief description of the CP and the portion of the Project that is relevant to the BTRC application. The focus of the description should be the push-pull relationship between the CPs and the related TR&D Project(s). For Renewal applications, the existing CPs should report on progress made during the prior funding period, and new activities should be identified.

All applications must have at least one CP for each TR&D Project. It is possible that one CP could drive more than one TR&D Project. Subject to the technological and/or clinical limitations of the projects and consistent with the desired national impact for BTRCs, it is expected that the CPs would have a national geographic distribution. In Renewal applications, the number and breadth of CPs are expected to be richer than in new applications, including greater national geographic distribution. CPs that have funding support will be evaluated on how they advance and stimulate BTRC technological development (push-pull). CPs that do not have funding support will be evaluated on the scientific merit of the research proposed, as well as on their push-pull impact on a TR&D Project.

To demonstrate the breadth and scope of the CPs, in addition to the representative Projects, Tables of all CPs 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
• Names of all collaborators (if applicable)
• Title of the project
• TR&D Project(s) that interact with the project
• Start and finish dates for the project
• External funding status of the project
• In the case of renewal applications, number of publications that have resulted from the project.
• Indicate whether human subjects and/or animals are utilized in the project

For Renewal applications, CPs from the previous funding period should be included in a separate table following the table of proposed CPs for the next funding period. This table will not be counted against the page limitation.

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 CPs. The BTRC may not provide funding for work accomplished in the CPs. Any costs incurred by the Technology Research and Development Projects related to the BTRC's push-pull collaboration with the CPs should be included under the relevant Technology and Development Project budget. Any administrative costs related to interactions with the CPs should be included under the Administration budget.

(2) Service Projects (required): Resubmission applications must provide an Introduction section (1 page). All applications must provide a Summary of the Service Projects (1 page) and a maximum of 10 representative Service Projects, half a page per Service Project, excluding references, for a maximum of 5 pages.

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 (SPs) is, therefore, to provide access to the unique advanced technologies created in the BTRC, which are not available elsewhere. The collection of Service Projects served are expected to be broad in scope and involving a variety of biomedical research areas. Subject to the technological and/or clinical limitations of the projects and consistent with the desired national impact for BTRCs, it is expected that the SPs would have a national geographic distribution. In Renewal applications, the number and breadth of SPs are expected to be richer than in new applications, including greater national geographic distribution.

Different from CPs, SPs generally exploit the more mature capabilities of the BTRC and do not drive the development of new technologies or devices of the BTRC. SPs may include access to expertise in the BTRC for consultation and data interpretation, access to software and associated technical support, or access to instrumentation. It is expected that BTRC support will be acknowledged in papers resulting from SPs, 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 SPs with researchers who are outside the applicant institution.

Resubmission applications must include a one-page Introduction for the SP section with description of changes in response to the critique from the previous peer review.

The Summary of the SP section should be a succinct and accurate description of goals of the proposed SPs. Also, it should describe how the TR&Ds are maximally leveraged in support of the SPs. Within the summary, the investigators should describe criteria for including new SPs and rotating existing SPs out of the BTRC during the award period. If a chargeback system is imposed to the SPs, describe the plans for sharing costs with the users. While it is expected that the vast majority or all of the SPs would have funding support in place at the time of P41 application, there is not an expectation that this funding must be in place for the entire proposed duration of the P41 funding period.

After the Summary of the SPs, the description of each SP 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:

• Short title
• Service Project PD/PI and Institution
• Funding status of the project including:
• Grant number
• Project period dates
• Source of funds
• PD/PI's name (if different from the Service Project PD/PI).

Applicants should clearly explain how the equipment and technology used by the SP would be state of the art and not readily available elsewhere, without duplicating information submitted on Equipment attachment. Applicants should clearly explain what significant biomedical research need would be addressed by the use of the BTRC's technology. For Renewal applications, each existing SP should report on progress made during the prior funding period and new activities should be identified.

SPs that have funding support will be evaluated on how they leverage the TR&Ds to expand their research objectives. Pilot or SPs that do not have funding support should include more detail on how the relevant research activities are supported and will be evaluated on the scientific merit of the research proposed.

To demonstrate the breadth and scope of the SPs, in addition to the representative Projects, Table(s) of all SPs 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).
• Title of the project
• TR&D Project(s) that interact with the project
• Start and finish dates for the project
• External funding status of the project
• In the case of renewal applications, number of publications that have resulted from the project.
• Indicate whether human subjects and/or animals are utilized in the project

For Renewal applications, SPs from the previous funding period should be listed in a separate table, following the table of proposed SPs for the next funding period. This table will not be counted against the page limitation.

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 SPs. The BTRC may not provide funding for work accomplished in the SPs. Any costs incurred by the Technology Research and Development Projects related to the provision of technologies to the SPs should be included under the relevant Technology and Development Project budget. Any administrative costs related to interactions with the SPs should be included under the Administration budget.

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.

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.

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.

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 be 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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

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.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a delayed onset study record.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: 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.

Other Attachments: The following can be uploaded under Other Attachments:

• Samples of the forms to be filled out by collaborators and users of the BTRC.
• Instructions on how users are to acknowledge support provided by the BTRC in any resulting publications.

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will 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 person months to the entire Center, within which 1.2 person months must be devoted to the Administration component. For Multiple PD/PI applications, all PDs/PIs must devote a minimum of 3.0 person months each to the entire Center. From within this time commitment, all PDs/PIs in a multiple PD/PI application must devote a combined 1.2 person months to the Administration component.

External Advisory Committee & P41 Biannual Meetings: Funds should be requested as consultant costs to support the travel expenses of the External Advisory Committee (EAC) members to attend the annual EAC 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 biannual 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 biannual 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.

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 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.

If a chargeback 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 must 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:

Letters of Support: Provide Letters of Support for the administration component, for example, from institutional officials affirming the institutional support.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans 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.

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

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Project'

The central activity of a BTRC is the group of TR&D Projects that serves as the foundation for all other BTRC activities. It is expected that the TR&D projects will relate to each other and yield a synergistic aspect to the BTRC.

It is understood that a BTRC is an inherently multidisciplinary enterprise that requires the integration of multiple approaches to complex technical and biomedical challenges. An element of high risk (and potentially high payoff) may be present in one or more of the TR&D Projects. It is expected that most of the TR&D PDs/PIs will have significant research experience and have an independent research program.

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:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (TR&D)

Enter Human Embryonic Stem Cells in each relevant component.

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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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

List all performance sites that apply to the specific 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 (TR&D)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (TR&D)

Budget forms appropriate for the specific component will be included in the application package.

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: Since it is expected that these projects will involve multidisciplinary 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.

Each TR&D Project should show that it addresses an important problem or critical barrier to progress in the field, and show the scientific premise for the project. Applicants should show how scientific knowledge, technical capability, and/or clinical practice would be improved if the aims of the TR&D project are achieved. The applicants are expected to show how successful completion of the aims would change the concepts, methods, technologies, treatment services, or preventative interventions that drive the field.

The applicants need to demonstrate that the technology is 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. Unique aspects of the project and the technology should be clearly outlined. Additionally, the applicants need to demonstrate how the technology from the TR&D project would result in new knowledge or capabilities for end users.

Additionally, the push-pull synergistic relationship between TR&D Projects and Collaborative Projects should be indicated.

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 describe progress made during the prior funding periods 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) who are 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 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.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a delayed onset study record.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Tech Train Dissem '

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

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Technology Training and Dissemination)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Technology 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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Technology Training and Dissemination)

Budget forms appropriate for the specific component will be included in the application package.

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 (Technology 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:

• The BTRC’s research focus and capabilities
• Contact information
• How to establish Collaborative and Service Projects
• A section on current newsworthy items directed to the general public
• Links to online tutorials
• The availability of software, reagents, and other resources (as applicable)
• Links to other related NIH funded P41 Centers and links to the NIBIB BTRC program web page.
• For Renewal applications, include a link to a list of all publications that have resulted from the center's efforts since its inception.

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, description of progress in Training and Dissemination during the recent funding period should be included as part of the Approach section, and new activities should be identified.

Letters of Support: Attach all appropriate letters of support for the Technology Training and Dissemination Component, 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) who are 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 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.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a delayed onset study record.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

This initiative is not subject to intergovernmental review.

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

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

Applications must be 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

For applications with budget of $500,000 or more in direct costs in any year (excluding consortium F&A), there is a white-paper process to facilitate NIBIB staff consideration. Description of the NIBIB P41 program and white-paper process can be found at: https://www.nibib.nih.gov/research-funding/biomedical-technology-resource-centers. As part of this process, applicants must contact the NIBIB Scientific / Research Contact 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.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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 BTRC proposed). Since NIBIB BTRCs may develop new technologies for use in biomedical research or clinical application(s), reviewers are expected to evaluate the impact of the BTRC accordingly.

Insert program-specific introductory text with the preface, For this particular announcement, note the following: . Do not insert review criteria, instructions to applicants, or review considerations in this text block. For multi-component research applications, be sure to identify those criteria that will be considered in the overall score by clearly identifying additional review criteria and additional review considerations for each component.

For this particular announcement, note the following: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

(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 TR&D Project that by its nature is not innovative may be essential to advance a field.

Does the TR&D Project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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 Project(s) in advancing the technology? What are the unique aspects of this project, and the technology?

In addition, for applications proposing clinical trials: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the TR&D Project? If Early Stage Investigators or those 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?

In addition, for applications proposing clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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? To what extent is the proposed TR&D Project on the cutting edge of the technology field? To what extent will the technology from the TR&D Project result in new knowledge or capabilities for end users?

In addition, for applications proposing clinical trials: Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the TR&D Project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the TR&D Project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

To what extent does the TR&D Project synergize with other TR&D Projects within the BTRC? Is there a clear push-pull interaction with one or more of the Collaborative Projects?

In addition, for applications proposing clinical trials: Does the application adequately address the following, if applicable:

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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? If more than one site is involved, is there evidence of strong communication and collaboration among distant sites?

In addition, for applications proposing clinical trials: If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Each of the following components is 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 scientific breadth of driver applications for the BTRC technologies? Do the Collaborative Projects have an appropriate national geographic distribution? Do the CPs have appropriate funding support? 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? For Renewal applications, do the Collaborative Projects exhibit high level of network interaction with the BTRC?

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 an appropriate national geographical distribution? Do the SPs have appropriate funding support? For BTRCs that propose cost sharing are the plans for sharing costs by the users, including fee-for-service systems, appropriate?

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

Technology 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 Training and Dissemination? 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 person months to the entire Center? Is (Are) the Center PD(s)/PI(s) committing a combined 1.2 person months to the Administration component?

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?

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.

Specific to applications proposing clinical trials: Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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.

When the proposed BTRC involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

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).

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) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

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

As part of the scientific peer review, all applications:

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

Applications will be assigned to 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:

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

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials by law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nig.gov/ClinicalTrials_fdaaa/.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Behrouz Shabestari, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-6771
Email: shabestb@mail.nih.gov

Theresa Cruz, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9233
Email: cruzth@mail.nih.gov

Manana Sukhareva, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-3397
Email: sukharem@mail.nih.gov

Angela Eldridge
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4793
Email: aeldridge@mail.nih.gov

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.