This Funding Opportunity Announcement (FOA) encourages grant applications for Biomedical Technology Resource Centers (BTRCs). BTRCs are national resource centers for conducting research and development on new technologies that are driven by the needs of basic, translational, and/or clinical researchers. BTRCs also make their technologies available to other investigators, train members of the research community in the use of the technologies, and disseminate the technologies broadly.

PAR-23-235: National Centers for Biomedical Imaging and Bioengineering (NCBIB) (P41 Clinical Trials Optional)

Posted Date: July 28, 2023 Expiration Date: September 08, 2026

Related Notices:

• March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.
• April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Part 1. Overview Information

Participating Organization(s): National Institutes of Health (NIH) Components of Participating Organizations: National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Funding Opportunity Title: National Centers for Biomedical Imaging and Bioengineering (NCBIB) (P41 Clinical Trials Optional) Activity Code: P41 Biotechnology Resource Grants Announcement Type: Reissue of PAR-20-169 Notice of Funding Opportunity (NOFO) Number: PAR-23-235 Companion Notice of Funding Opportunity: None

Assistance Listing Number(s): 93.286

Notice of Funding Opportunity Purpose: This Notice of Funding Opportunity (NOFO) encourages grant applications for National Centers for Biomedical Imaging and Bioengineering (NCBIB). NCBIB are national resource centers for conducting research and development on new technologies that are driven by the needs of basic, translational, and/or clinical researchers. NCBIB also make their technologies available to other investigators, train members of the research community in the use of the technologies and disseminate the technologies broadly.

Key Dates:

All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Due Dates for E.O. 12372: Not Applicable

Required Application Instructions: It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) uses the P41 mechanism to support National Centers for Biomedical Imaging and Bioengineering (NCBIB) to accelerate the development and dissemination of new biomedical technology. It is expected that each Center would have a nationwide impact. NCBIB creates critical and unique technologies that are at the forefront of their respective fields and enable researchers to apply these technologies to a broad range of basic, translational, and/or clinical research. Information on current NCBIB can be found at https://www.nibib.nih.gov/research-funding/featured-programs/ncbib/supported-centers

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

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

NCBIB interacts with Collaborative Projects (CPs) that serve as technology drivers, users, and testbeds for the cutting-edge technology developed in TR&D projects. Working in a push-pull, iterative relationship with CPs, a TR&D project should develop and optimize additional new tools and methods to address specific biomedical and/or clinical research problems that are otherwise difficult to address using existing tools and methods. The research needs of the CPs should drive the technology development in each TR&D project by presenting important technology-development challenges to the TR&D project. The new technologies developed in TR&D projects should advance the research efforts of the CPs.

NCBIB provides their technology to Service Projects (SPs) that serve as users of the well-developed and stable technologies of the Center. SPs make use of the technology and expertise of the Center but are not intended to serve as primary drivers for technology development.

Unless there are technological and/or clinical constraints that limit the distribution of the technology developed in the TR&D projects, the CPs and SPs should have a national geographic distribution. The national geographic distribution of the CPs and SPs in new Centers may be somewhat limited initially, but, as the Center matures, it is expected that there will be a broad national distribution.

A Center must provide training and dissemination with the goal of exporting their technology and expertise to the broader community to achieve a wide impact on biomedical research. Training should be provided to researchers and end-users at various levels of clinical and scientific expertise, including clinicians, scientists, graduate students, postdocs, and junior faculties. Another important aspect of a Center is dissemination of information on its newly developed technologies and methods. These training and dissemination efforts require the commitment of greater financial and personnel resources to non-science activities than is expected for other types of research efforts. Industrial partnerships are not required, but they are welcome when appropriate. An illustration of the interactions among the required components of a Center can be found at NIBIB's NCBIB website: NIBIB P41 NCBIB Components.

The synergistic combination of TR&D projects, the intense push-pull interaction between continuously innovative technology development of the Center and biomedical problem-solving CPs, the deployment of technologies through biomedical problem-solving SPs, together with training and dissemination, set apart NCBIB from other investigator-initiated research (such as research supported R01s) that generally has more narrowly defined goals.

Because extensive planning is required in preparing the Center applications, it is strongly recommended that prospective new applicants discuss their plans with the relevant NIBIB Program Director (refer to Scientific Program Areas at https://www.nibib.nih.gov/research-funding) to determine the appropriateness of their applications to the P41 program and the NIBIB mission. It is strongly recommended that these discussions occur at least 4-6 months prior to the application due date.

To maintain a balance between the conflicting demands of nurturing new technology areas versus providing for sustained development in established areas, NIBIB limits funding for NCBIB to 15 years.

Clinical Trials: For applications submitted that propose clinical trials, this NOFO will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. This NOFO will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Applicants are strongly encouraged to contact the Scientific/Research contact for this NOFO for guidance in advance of submitting an application to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial projects that each IC supports.

National Institute of General Medical Sciences (NIGMS) is not a participant in this NOFO but has a similar program that supports Biomedical Technology Development and Dissemination Centers. Details about that program can be found at PAR-23-110: Biomedical Technology Optimization and Dissemination Center (BTOD)(RM1-Clinical Trial Not Allowed) (nih.gov). Applicants who are interested in applying for the NIGMS program need to follow the NIGMS application procedures rather than those in this announcement. Applicants are encouraged to explore both the NIBIB and NIGMS programs, and contact Institute staff for guidance in determining which program is a better fit for their proposed Center.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Funding Instrument: Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed:

• New
• Renewal
• Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial? Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget:

• Direct costs (excluding equipment) are not limited and are expected to vary among applications. Typical direct costs for NCBIB range between $600,000 and $750,000.
• In addition, up to $500,000 can be requested for special-purpose equipment during a five-year funding period. This budget is restricted only for acquiring special-purpose equipment.

Award Project Period: Support may be requested for up to five years. Applicants may submit a Renewal application. However, NIBIB NCBIB Awards will be restricted to a total of fifteen years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations:

• Higher Education Institutions
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
• 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)
• Local 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)
• Federal Governments
  • 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 Organization

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

Required Registrations:

Applicant organizations: Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.
• 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.
• Unique Entity Identifier (UEI): A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons: Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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.

Eligible Individuals (Program Director/Principal Investigator): Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

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 NOFO at any time.

2. Cost Sharing: This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility:

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

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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

Section IV. Application and Submission Information

1. Requesting an Application Package: 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 NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission: It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity 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.

Page Limitations: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications: The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application.

Additional page limits are described in the SF424 Application Guide and the Table of Page Limits must be followed. For this NOFO, 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
| Collaborative Projects (New Applications)