NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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) 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.
• o 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

An individual applicant may not serve as PD/PI, including Multiple PD/PI, on more than one application to this FOA at any time.

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 NCBIB Awards will be restricted to a total of fifteen years.

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST 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.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Behrouz Shabestari, Ph.D.
National Institute of Biomedical Imaging and Bioengineering
Telephone: 301-451-6771
Email: [email protected]

Available Component Types	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)	6

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 Projects	10
Description of Service Projects	5

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
• Administrative: required
• Technology Research and Development projects: required; minimum of three. While there is no maximum, no more than four 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, 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 project to the overall theme and goals of the program. Define the synergy among the TR&D projects.

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

Other Attachments: The following two attachments (Collaborative Projects and Service Projects) are required. Applications without these required Collaborative Projects and Service Projects attachments will be considered incomplete and will not be reviewed.

(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 description of up to 10 representative Collaborative Projects, 1 page per Collaborative Project, for a maximum of 10 pages, excluding references, and tables of all proposed CPs. 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. Table of all CPs should be included at the end of this section. The tables are not counted against the page limitation.

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

The development of new biomedical research tools is most effective when pursued in the context of challenging problems that drive the technology forward. Collaborative Projects (CP) serve as the primary driver for technology development in the Center. CPs should be selected based on their appropriateness as drivers and testbeds for the Center's new technology and their potential for significant biomedical impact. CPs should present substantial technical challenges that make the work in the CPs difficult to solve with current approaches thus pushing the Center to develop new technology. This collaborative work is expected to lead to joint publications and, in some cases, patents. The collection of CPs driving the push-pull interaction of the new technology in the TR&D projects should be broad in scope and involve a variety of biomedical research areas. The Center is expected to be responsive to a collaborative user community who are funded by sources outside of the Center award, such as NIH or other public or private funding entities. It is expected that the vast majority of the CPs will be led by investigators not associated with the Center.

Note: Interactions with biomedical researchers that only make use of the technology and expertise of the Center 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 project should be included within the relevant TR&D Project.

The one-page Summary of the Collaborative Projects section should be a succinct and accurate description of the overall goals. The overall working dynamics of the CPs with the TR&D projects should be included. Within the Summary, the investigators should describe criteria for recruiting/including new CPs and rotating existing CPs into SPs or out of the Center during the award period. While it is expected that all the CPs would have funding support in place at the time of P41 application submission, there is no 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 descriptions of up to 10 representative CPs (one page per CP) should be clearly numbered and begin with the following information:

• CP#, 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 one-page description of each representative CP should briefly state the aims of the CP and clearly explain what significant biomedical research advancement would be addressed using the Center's newly developed technology that cannot be accomplished with already existing technology. The push-pull, iterative relationship between the CPs and the related TR&D Project(s) should be clearly described. For Renewal applications, the existing CPs should report on progress made during the prior funding period, and new activities should be identified.

Subject to the technological and/or clinical limitations of the projects and consistent with the desired national impact for a Center, it is expected that the CPs have a national geographic distribution. In Renewal applications, the breadth of CPs is expected to be richer than in new applications, including greater national geographic distribution.

CPs will be evaluated on how they advance and stimulate Center technological development (push-pull).

New applications must include a minimum of five CPs. Renewal applications must include a minimum of 10 CPs. Up to 10 representative CPs should be described (1 page per CP). For new applications, each TR&D project must be driven by at least one CP, for renewal applications, each TR&D project must be driven by at least two CPs. A CP may drive more than one TR&D project.

If the Center is proposing more than 10 CPs, list all CPs in a Table (including the representative 10 CPs and any additional CPs) at the end of this CP 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)
• CP# and 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.

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 Center may not provide funding for work accomplished in the CPs. Any costs incurred by the TR&D projects related to the Center's push-pull collaboration with the CPs should be included under the relevant TR&D project budget. Any administrative costs related to interactions with the CPs should be included under the Administration budget.

Note: Consistent with the Center being a national resource, the vast majority of CPs should be from outside of the awarding institution (provided the proposed technology permits outside collaboration).

(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 description of up to 10 representative Service Projects, one-half page per Service Project, excluding references, for a maximum of five pages, and tables of all proposed SPs. 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. Table of all SPs should be included at the end of this section. The tables are not counted against the page limitation.

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.

With a concentration of tools, instrumentation, software, methods, and expertise, a Center is expected to actively engage biomedical and clinical researchers to provide broad access to Center capabilities. The collection of Service Projects is expected to be broad in scope and involving a variety of biomedical research areas. Subject to the technological and/or clinical limitations of the Center technology and consistent with the desired national impact for NCBIB, it is expected that the SPs have a national geographic distribution. In Renewal applications, the breadth of SPs is 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 Center and do not drive the development of new technologies or devices of the Center. SPs may include access to expertise in the Center for consultation and data interpretation, access to software and associated technical support, or access to instrumentation. It is expected that Center support will be acknowledged in publications resulting from SPs, regardless of whether Center staff are listed as authors. That acknowledgement should use the NIBIB grant number.

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

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&D projects are maximally leveraged in support of the SPs. Within the summary, the investigators should describe criteria for recruiting/including new SPs and rotating existing SPs out of the Center 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 all 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 descriptions of up to 10 representative SPs (one-half page per SP) should be clearly numbered and begin with the following information, followed by sufficient information to allow the evaluation of the need for the Center technologies in the proposed projects:

• SP# and 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, tools, and technology provided by the TR&D projects to the SPs would be unique, beyond state of the art, and not readily available elsewhere. Applicants should clearly explain what significant biomedical research need would be addressed using the Center'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 will be evaluated on how they leverage the TR&D projects to expand their research objectives.

New applications must include a minimum of five SPs. Renewal applications must include a minimum of 10 SPs. Up to 10 representative SPs should be described (one-half page per SP).

If the Center is proposing more than 10 SPs, list all SPs in a Table (including the 10 representative SPs and any additional SPs) at the end of this SP 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.

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 Center may not provide funding for work accomplished in the SPs. Any costs incurred by the TR&D projects related to the provision of technologies to the SPs should be included under the relevant TR&D 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.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment of the Overall Component in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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 Center.

Research Strategy: A Center 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 Center, point out what makes their Center 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 Center. For Renewal applications, include a brief summary of the Center'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:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined 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, there must be 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 within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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, 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 are allowed under Other Attachments:

• Samples of the forms to be filled out by collaborators and users of the Center.

Instructions on how users are to acknowledge support provided by the Center 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, the PDs/PIs in a multiple PD/PI application must devote a combined 1.2 person months to the Administration component. Applications that do not propose to devote these minimums will be considered ineligible and not go forward to review.

External Advisory Committee & P41 Biannual Grantees 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 will be a Biannual Grantees Meeting for cross-cutting NCBIB science and technologies for broader community engagement. It is expected that the PD/PI and one other senior member of the NCBIB 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 Center 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 Center. This section should be broken down into: Organizational Structure and Staff Responsibilities, Center Operating Procedures, External Advisory Committee, and Institutional Support. Applicants for the final five-year Renewal should be aware that, should an award be made, NIBIB funding for the Center will end in five years and should propose a Research Strategy for the final five-year period that takes this into account and describe an adequate Transition Plan.

Organizational Structure and Staff Responsibilities: Describe the Organizational Structure of the Center. Indicate the relationship of the Center to the administrative structure of the grantee institution. Describe how the PD(s)/PI(s) of the Center and the staff will be organized with respect to the Center components: TR&D projects, Collaborative Projects, Service Projects, Training and Dissemination, and general Center administration. Describe plans for designation of a replacement(s) for the PD(s)/PI(s) should the need arise.

Center Operating Procedure: Describe Center Operating Procedures. Include criteria and mechanisms to review requests for the use of the equipment and facilities in the Center, 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: Each Center must have an External Advisory Committee (EAC). The EAC members are appointed by the PD(s)/PI(s) of the Center. The EAC 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 Center facilities. The EAC chair should be knowledgeable about the Center's technology and the science it serves but must not be a member of the Center staff or a significant collaborator of the Center. Other committee members should be balanced among: (1) scientists knowledgeable about the Center technologies, (2) experts in its application of the Center technologies to biomedical research problems, and (3) users of the technology. The NIBIB Program Director will be an ex officio member of the EAC and must be included in the EAC meeting.

The EAC chair and members must be from outside the host institution(s). Inclusion of collaborators on the EAC is not prohibited but should be limited. 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). The EAC report must be supplied as part of the Center Annual Progress Report. Awardees should schedule their EAC meeting in a timely manner to meet this reporting requirement.

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: Describe support in a letter from the institutional officials.

Letters of Support: Provide Letters of Support for the administration component, for example, from institutional officials explaining and 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:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

External Advisory Committee Report: For Renewal applications, upload the Center's most recent EAC report and recommendation in the Appendix. Name the file "EAC report".

When involving human subjects research, clinical research, and/or NIH-defined 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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 Center is the group of TR&D Projects that serves as the foundation for all other Center activities. It is expected that the TR&D projects will relate to each other and yield a synergistic aspect to the Center.

It is understood that a Center is an inherently multidisciplinary enterprise that requires the integration of multiple approaches to complex technical and biomedical challenges. It is expected that the lead PIs will be well-established in the field with a history of NIH and/or other major funding and that most of the TR&D projects 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 projects)

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 projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (TR&D projects)

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 projects)

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 projects)

• 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 projects)

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 project component. The person months for each member of the Center staff related to this TR&D project should be included here. Support for Center staff conducting Collaborative or Service Project-related work should be requested under this TR&D project 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 Center.

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 projects)

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, beyond state-of-the-art, an important area for research and development, and likely to advance the frontiers of biomedical research. Unique aspects of the research and technology development 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 interaction and synergistic relationship between TR&D projects and Collaborative Projects should be indicated. This should include CPs that are interacting with the TR&D project and indicate the technologies/tools received from the TR&D project.

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 Center. Applicants for the final five-year Renewal should be aware that Center 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. Letters of support should not be included for proposed Collaborative Projects or Service Projects.

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: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (TR&D projects)

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.

PHS Assignment Request Form (TR&D projects)

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, tool, and software by scientists outside the Center. A Center must allocate sufficient resources for training both specialists and non-specialists to accomplish the broadest-possible use of the new tools.

The overall goal of Center training is expected to be twofold: to improve the general understanding of the Center'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 Center. A defining feature of training activities is the direct interaction between Center 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 Center personnel and the researcher.

Examples of successful approaches include hands-on laboratory experience such as residencies in the Center 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 Center'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 Center 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 Center dissemination activities must acknowledge NIBIB grant support. That acknowledgement should use the NIBIB grant number.

Website Requirement: A renewal Center is expected to have a robust web presence that clearly acknowledges support from the NIBIB. Applications for a new Center should have a plan for such a website. The website should provide information about:

• The Center'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
• Link to training and workshop information and registration
• The availability of software, reagents, and other resources (as applicable)
• Links to other related NIH funded P41 Centers and links to the NIBIB's NCBIB program web page.
• For Renewal applications, include a link to a list of all publications, patents, licenses that have resulted from the center's efforts since its inception.
• Links to the list of all CPs and SPs since its inception, including graphical distribution map

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:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Technology Training and Dissemination)

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.

PHS Assignment Request Form (Technology Training and Dissemination)

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 applicants requesting $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/national-centers-biomedical-imaging-and-bioengineering . As part of this process, applicants must contact the NIBIB Scientific / Research Contact and submit a white-paper at least 12 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. Any instructions provided here are in addition to the instructions in the policy.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the proposed Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria.

The Overall Impact score should not simply be the average of the individual scores of the components, but rather should consider the review criteria listed here and under each of the components listed below. In determining this overall impact score, the goals of the NCBIB, the uniqueness of the NCBIB in terms of its intellectual and technological capabilities and community engagement should be considered.

Does the proposed Center address important technology development needs of the research community that it will serve? Is there strong synergy among TR&D projects? Is there strong synergy between the TR&D projects and the Collaborative Project(s) in advancing the technology? Is there a strong plan for community engagement via training and dissemination activities? What makes this proposed center unique in terms of its intellectual and technological capabilities? Can these resources be obtained elsewhere? Will the proposed Center have a national impact and a wide geographic reach?

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 the prior research that serves as the key support for the proposed project rigorous? 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, and likely to advance the frontiers of biomedical research?

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? Are the TR&D lead PIs well-established in the field of the proposed technologies? Do they have an independent research program supported by a history of NIH and/or other major funding? 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? Does the project present strong preliminary data? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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? 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 individuals of all ages (including children and older adults), 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 Center? Is there clear and strong push-pull interaction with one or more (for new applications) or two or more (for renewal applications) Collaborative Projects? Does the TR&D deliver new technology impactfully advancing research in the CPs?

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

Study Design

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?

Data Management and Statistical Analysis

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?

As applicable for the TR&D projects proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

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)?

RFA/PAR only: Additional Review Criteria may be added and should be explained to the applicant in Section IV.2. Use Heading 4 indent for the names of the criteria.

For research that involves human subjects but does not involve one of the 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 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 TR&D projects 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 individuals of all ages (including children and older adults) 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 application.

For Renewals, the committee will consider the progress made in the last funding period and the response of the Center to the recommendations of its External Advisory Board.

Not Applicable

Component Scoring

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 challenge and motivate new technological research and development in the TR&D projects? Do these Center-provided technologies advance the research efforts of the CPs? Is there a significant push-pull, iterative interaction between the CPs and related TR&D projects to drive further development of additional new technologies and tools in TR&D projects? Do the Collaborative Projects provide significant scientific breadth of driver applications for the Center technologies? Does the Center provide unique tools or technologies to address the significant biomedical research needs of the collaborative projects? Do the Collaborative Projects have an appropriate national geographic distribution? Do the CPs have appropriate funding support?

For Renewal applications, does the proposed Center have an appropriate balance between time and effort spent on Collaborative Projects and Service Projects? Was significant progress during the previous grant period in terms of publications by CPs alone or jointly with the Center? Have the Collaborative Projects exhibited high level of push-pull interaction with the Center?

Service Projects Review Criteria

Are the equipment and technology provided by the Center to the Service Projects unique and beyond state-of-the-art for the field? Do the equipment and technology meet significant biomedical research needs of the service projects? Do the SPs provide significant scientific breadth for the Center technologies? Do the Service Projects have an appropriate national geographic distribution? Do the SPs have appropriate funding support? If the Center proposes cost-sharing plans for sharing costs by the users, including fee-for-service systems, is the plan appropriate?

For Renewal applications, was there significant progress in the SPs resulting from their utilization of the Center's technology?

Technology Training and Dissemination Review Criteria

Are plans to provide training opportunities and dissemination appropriate? Is there a direct and meaningful interaction between Center personnel and the trainees? Does the application describe an appropriate plan so that non-specialists can make the best possible use of the new technologies? For Centers that are developing software, is the software portability, open source, well-documented, user-friendly, and readily available to the user community? Have there been appropriate efforts to make both non-expert and expert communities aware of the new technology? Are sufficient resources allocated for Training and Dissemination?

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

Administration Review Criteria

Are the qualifications of the Center PD(s)/PI(s) and other senior key personnel appropriate to lead the P41 Center and coordinate all 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 Center 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 Center 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 Center appropriate and adequate for a center of national significance?

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 Center 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?

Transition Plan: For final five-year Renewal applications, reviewers will consider the appropriateness of the transition plan and research plan given that the NIBIB funding for the Center will not be renewed at the end of the final five-year period.

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 application.

For Renewals, the committee will consider the progress made in the last funding period and the response of the Center to the recommendations of its External Advisory Board.

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 to the appropriate NIH Institute or Center. 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 appropriate 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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that 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.

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/.

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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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

Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

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 RPPR, 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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Behrouz Shabestari, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-6771
Email: [email protected]

Theresa Cruz, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9233
Email: [email protected]

Manana Sukhareva, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-3397
Email: [email protected]

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: [email protected]

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

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.