Part 1. Overview Information

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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from 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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. 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.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background and Purpose

Promoting diversity in the scientific workforce is critical to the success of the National Institutes of Health (NIH) mission and is consistent with the mandates of the 21st Century Cures Act. In addition, building the Nation’s capacity to drive innovation and technology development is critical to sustaining the biomedical engineering, imaging, and technology (BEIT) workforce and innovation needs of the United States. The U.S. National Academies of Sciences, Engineering, and Medicine reported that ~3.4 million technical jobs would be open in 2022, and the national workforce needs to be prepared to fill these essential positions (National Science Board 2019). 

The  National Institute of Biomedical Imaging and Bioengineering (NIBIB) recognizes that scientists and students from diverse backgrounds and life experiences bring different perspectives, ideas, creativity, and research interests to address complex scientific problems. See, Notice of NIH's Interest in Dviersity, NOT-OD-20-031, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html. Benefits of a diverse scientific workforce include fostering scientific innovation, enhancing global competitiveness, building robust academic structures, enhancing the research ecosystem, advancing the participation of underserved populations, and strengthening public trust. It is vital that the current population of scholars entering the scientific workforce have the skills, resources, and opportunities to address questions impacting human health. 

HBCUs are instrumental in contributing to the intellectual landscape of the United States. From 2010-2020, over 25% of U.S, Black doctorate recipients in science and engineering earned their bachelor's degree from an HBCU (Einaudi 2022). Furthermore, HBCUs and researchers at HBCUs play an important role in supporting scientific research and innovation, particularly on diseases and conditions that disproportionately impact racial/ethnic minorities and other U.S. populations that experience health disparities, though HBCUs often lack sufficient funding to conduct and sustain cutting-edge health-related research (Hoppe 2019).  The NIBIB recognizes the role that HBCUs play in preparing future bioengineers and imagers for the scientific workforce and is committed to enhancing the biomedical engineering, imaging, and technology research capacity at HBCUs.

This BEITA initiative will strengthen the research capacity, prepare students for BEIT careers, including those who may be from groups historically underrepresented in engineering and imaging, develop stronger connections with the BEIT community, and stimulate technology development and innovation in bioengineering and imaging at HBCUs. This NOFO will support HBCUs to develop or enhance their BEIT capacity by using a two-staged, phase approach to support planning and initial activities in Phase I and full-scale activities in Phase II (see below).

Program Description

The primary goal of this capacity building initiative is to support the development of innovative and high-impact biomedical engineering, imaging, and technology at HBCUs. Through this initiative, technology development research infrastructure will be accelerated in HBCUs; the diversity of the BEIT research workforce landscape will be enhanced; and innovation and creativity will be amplified by bringing new researchers and thus novel ideas and discoveries into the BEIT field. Additional outcomes from the HBCU BEITA support may also include an increase in research for underserved communities that often experience health disparities, as well as an increase in NIH grant support by researchers participating in this program. 

Applicants of this funding opportunity should detail their plan to enhance biomedical engineering and imaging academic structures and research capacity. Supporting HBCUs to design impactful programs and approaches that meet the unique needs and goals of their institutions is the hallmark of the HBCU BEITA initiative. Applicants are encouraged to develop a holistic approach, include milestones, goals, and timelines, and ensure institutional commitment is in place so that this program becomes embedded into the institution’s academic fabric. Examples of potential activities, academic structures, and programs that could be supported by this initiative include, but are not limited to, establishing new and/or enhancing existing:

• Institutional capacity for biomedical engineering, imaging, and technology development;
• Maker spaces, technologies, instruments, partnerships;
• Expand the BEIT workforce: faculty and student research support, career pathways, mentoring, and training opportunities;
• BEIT curriculum, course offerings, or degree granting programs;
• BEIT innovation, entrepreneurship, and commercialization activities;
• Partnerships with relevant collaborators and stakeholders in private and/or public sectors.

This NOFO will support HBCUs that propose to develop a new or build on an existing BEIT academic structure. Applications can focus on technology development and/or specific research topics, e.g. technology centers for cancer, cardio vascular disease, diabetes, maternal health, etc.

NIBIB interests include the development and integration of advanced BEIT for the improvement of human health and medical care. NIBIB supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. Applicants may propose BEIT programs that focus on a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to review NIBIB's scientific program area of interest (https://www.nibib.nih.gov/research-funding) and are strongly encouraged to contact the NIBIB Scientific/Research Contact, listed below, to discuss the alignment of their proposed work with program goals, as well as any budgetary concerns.

UG3 Phase I: This NOFO will utilize a UG3/UH3 cooperative agreement mechanism for a two-stage, one-application approach to develop a full-scale biomedical engineering, imaging, and technology acceleration program. Phase I, the planning and initiation phase, will provide up to $300,000 direct costs per year not to exceed three years, to plan for and demonstrate the ability to fulfill the goal of operationalizing a sustainable BEITA program in Phase II. In the application, institutions are expected to clearly demonstrate how they will develop or enhance an impactful BEITA program which will strengthen their research capacity and accomplish the activities in their milestone and timeline(s). During the UG3 phase, successful awardees may: (a) plan for the organization and implementation of a full-scale BEITA program, (b) develop plans and initiate recruitment of essential faculty, as well as hire a program manager, (c) identify and begin to purchase equipment that will be used in Phase II, (d) establish and/or enhance plans for providing research experiences to students, courses, career development and BEIT development and practicum opportunities, (e) develop a plan for program sustainability, (f) as well as initiate other activities germane to their long-term BEITA plan. In addition, applications must include a well-developed plan for administrative management of the program, demonstrable institutional support for BEITA sustainability, and scientific growth among the BEITA research faculty and students.

UH3 Phase II: In Phase II, the implementation phase, applicants should build on the elements planned and initiated in Phase I, leading to an impactful BEITA program. While many elements between the two phases will be coherent, new elements introduced in Phase II are allowed. The UH3 component of the grant application should clearly address how the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) will implement a full-scale BEITA program, impact the fabric of the academic institution and BEIT scientific workforce, as well as detail the scientific technology development component of the BEITA program. For more information, see the PHS 398 Research Plan Section of the NOFO. Phase II budgets may be up to a maximum of $1,000,000 in Direct Costs per year, not to exceed four years.

Transition from the UG3 Phase to UH3 Phase

Applicants and recipients of UG3 funding should note that the UG3 award does not guarantee subsequent UH3 funding. Only UG3 projects that have met the agreed to milestones, goals, and other requirements negotiated between the NIH and the applicant prior to the initial UG3 phase funding will be considered for transition to the UH3 Phase.

Investigators will be required to submit a non-competing application for transition to the UH3 Phase (Phase II) detailing their accomplishments in achieving the UG3 milestones. Continued support for Phase II will depend on programmatic review of the accomplishments, milestones achieved, the overall impact of the updated plans for fully implementing the BEITA program, and the demonstration of the feasibility of executing the goals and activities of the full-scale BEITA program. In addition, successful administrative management of the program and demonstrable institutional support for BEITA sustainability will be considered. There may be an assessment of research and equipment space via a site visit conducted before NIBIB releases funds for the Phase II award. If the awardee has had substantial progress towards agreed upon milestones and has a favorable programmatic review, the BEITA program may be funded and supported in Phase II for up to four years. Phase II support may be used for the continuation and/or expansion of activities initiated in Phase I or otherwise planned and approved in the application. Final funding decisions for the UH3 phase will also consider the availability of funds.

The criteria that will be used to determine which of the Phase I projects will be continued into Phase II will include:

• Successful achievement of the defined milestones and goals for the Phase I period of the project;
• Feasibility and impact of full-scale BEITA program in Phase II;
• Identification and commitment of faculty and administrative management of the BEITA program;
• Demonstrable student interest in the BEITA program;
• Initiation and updated plan for technology and equipment purchases, development, and utilization;
• Updated plan for institutional support and long-term program sustainability;
• agreement on updated timeline, milestones, and budget for the UH3 phase.

Program Governance: Awards made under this NOFO will be cooperative agreements (see Section VI.2. Cooperative Agreement Terms and Conditions of Award). Close interaction with the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)), awardee institution, and the NIH will occur during the award period.

Awardee institutions will be expected to establish a Steering Committee consisting of the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) and selected internal faculty chosen by the awardee institution along with the NIH Project Scientist(s). The Steering Committee will be responsible for the direction of the BEITA program and will meet in person at least two times per year. The Steering Committee will identify and address concerns, assess overall program progress including faculty recruitment, student and faculty engagement, explore opportunities for scientific growth and collaboration, program direction, and other issues as they arise.

Evaluation Plan: The awarded institution should develop an evaluation plan with clear timelines and milestones to monitor and evaluate the performance of all components of Phase I and Phase II and progress of the investigators and students it supports. Strategies to identify and remedy deficiencies such as poor performance and lack of progress should be described.

Plan for Advisory Committees: Each BEITA program must establish an External Advisory Committee (EAC) consisting of at least six members (including the chair) from the BEIT community with expertise directly relevant to specific goals of the program. A representative from NIH will serve as an ex officio member of the EAC. Responsibilities of the EAC include, but are not limited to, evaluating the progress of the institution's academic environment, development, implementation, and evaluation the BEITA program; assessing progress of recruitment of relevant faculty and students and plans for capacity building; assessing adequacy of resources, such as equipment and space, for faculty and student technology innovation; and reviewing outcomes and progress to maximize programmatic impact. The EAC should meet in person at a minimum annually and more frequently remotely as needed. Potential EAC members should not be contacted or appointed prior to submission of the application; however, the expertise of anticipated committee members should be described in the application. The application should not list the names of potential members of the EAC.

Technical Assistance Webinar

NIBIB will conduct a Technical Assistance webinar for all potential applicants to be held in late 2023. Please see the NIH Guide regarding the future webinar date.

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

Section II. Award Information

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

Higher Education Institutions

• Historically Black Colleges and Universities (HBCUs)

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 not 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 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 registrations; 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.

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

This 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.

The 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).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

• 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:

Albert Avila, PhD
Telephone: 301-496-8804
Email: albert.avila@nih.gov

Page Limitations

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments:

Milestone Plan:

Applications must also include a Milestone Plan for both the UG3 and UH3 phases. The Milestone Plan should be no more than 2 pages in length.

The filename "Milestone Plan.pdf" must be used and will be reflected in the final image bookmarking for easy access by reviewers. Applications that do not include the Milestone Plan will be considered incomplete and will not be reviewed.

• Provide detailed milestones for the anticipated attainment of each programmatic goal and activity for both the UG3 and UH3 phases.
• A timeline (Gantt chart) including milestones and goals is required for both the UG3 and UH3 phases.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

The budget should include a detailed justification for key personnel. The PD/PI must serve a minimum level of effort of at least 3.6 person months (PM). If submitting a multiple PD/PI application, the PD/PIs must devote a combined minimum of 3.6 PM. Applications that do not propose to devote these minimums will be considered ineligible and not go forward to review.

Travel Funds: The budget should include funds to support travel for BEITA program activities, including but not limited to supporting the participation of PD(s)/PI(s), faculty, students, and additional staff members. Travel should support the intent and goals of the grant application.

Other: Funds should be allocated for expenses related to the formation and travel needs of the External Committee.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

The UG3/UH3 application must be submitted as a single application, but milestones, goals, and activities must be clearly organized into two phases: UG3 (Phase I, planning and initiation) and UH3 (Phase II, implementation). While many of the activities will build throughout the overall project, to clearly distinguish between the two phases, applicants should specify separate UG3 and UH3 information in each subsection of the PHS 398 Research Plan as appropriate. Clarity and completeness of the application regarding specific milestones, goals, and the feasibility of milestones for each phase are critical. Note that the peer-review panel will assign a single impact/priority score to the application.

Specific Aims: Applicants should address what specifically will be implemented during the proposed funding periods, what area(s) of BEIT research the academic structure will be set up to investigate and how the institutional research capacity and academic structure will be impacted. Specific aims should be scientifically appropriate for the overall purpose of the BEITA program. Separate aims for both the UG3 and UH3 Phases are not required; however, the applicant must clearly detail the milestones, timeline, goals, and activities for each phase of the project. In the event of an award, the PD/PI and NIH staff will negotiate a final list of milestones and budget for each year of support. The proposed milestones for the UH3 phase may be revised in the UH3 transition application, as activities in the UG3 phase progress.

Research Strategy:

The overall Research Strategy section of the grant application should include these overarching elements with clear descriptions of what will be accomplished in each phase of the award. Elements in the UG3 and UH3 phases must be coherent and address:

• the institutional vision and anticipated impact of the BEITA program;
• how the BEITA program will strengthen the institution's research and training capacity;
• how the institution will prepare students for BEIT career paths;
• specific area(s) of technology development, innovation, and utilization;
• scaling up and implementing BEITA plans over the full project period;
• approach and steps that will be taken by the institution to ensure long-term sustainability of the program;
• how BEITA faculty will expand their research program and gain independent grant support;
• details of approach, including, but not limited to plans for:
  • accomplishing the milestones and goals of the BEITA program;
  • regular communication and coordination among program faculty;
  • utilizing and/or improve the existing institutional infrastructure;
  • recruitment of personnel with relevant expertise to facilitate the BEITA program;
  • how feedback from the EAC will be considered and implemented in the program.

Letters of Support:

Applications are expected to include letters from the appropriate high-ranking applicant institutional official(s) (including from the partnering institutional components, if applicable) that:

• Indicate the commitment of the applicant institution to the BEITA goals and how the activities will be integral to the broad institutional vision for BEIT research and student academic opportunity.
• Specify any institutional support, for example financial support, dedicated space, salary support for professional or administrative staff, interface with other grants, programs, and initiatives.
• Indicate the commitment of the institution to participate in activities intended to foster and enhance BEITA programmatic coordination, communication, and collaborations, as well as participate more broadly with the scientific enterprise.
• Each institution/organization should also state its commitment to overcoming any administrative obstacles to the implementation of the application. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, curriculum integration, and resources needed for the success of the planned BEITA program.The letter should also discuss the institution's plans for sustaining an active BEITA program after the active funding period.
• If the proposed programmatic activities included collaborations, letters of support from the related institution(s)/organization(s)/hospital(s) should be provided. The letter(s) should briefly describe the support for the program and capacity building.

The Letters of Support attachment should begin with a table of letter authors, their institutions, and the type of each letter (institutional commitment or resources; collaboration or role in the project).

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.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• 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.

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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). 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. 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 and responsiveness by NIBIB, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 8 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. As part of this process, applicants must contact the NIBIB Scientific Contact and submit a formal request at least 8 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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.

For this announcement, note the following:

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

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project 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.

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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: Recipient 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals 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 information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. 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.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws 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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
• Overseeing all aspects of the award including management of resource sharing, preparing comprehensive progress reports, scheduling meetings with NIH program staff, and other duties as necessary.
• Defining objectives and approaches, and for planning, conducting, analyzing, interpreting, drawing conclusions on their studies and accomplishments, publishing and sharing the results.
• Developing and proposing rigorous milestones that will be achieved during the project period.
• In cases when NIH program staff request information, recipients agree to provide the necessary content.
• Communicating regulatory meeting dates and agenda to the NIH program staff and inviting their participation.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NIH Project Scientist(s) will have substantial scientific/programmatic involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
• NIH Project Scientist(s) provides input on the milestones and makes recommendations regarding their finalization.
• The Program Officer, with advice from others managing the HBCU BEITA Initiative, will make decisions on project continuation based on staff recommendations, programmatic prioritization, and budget considerations. If justified, future year milestones may be revised based on progress, partnerships, and information obtained during the previous year. If, based on the progress report, a funded project does not meet the milestones, funding for the project may be discontinued. In addition to milestones, the decision regarding continued funding will also be based on the overall robustness of the entire project that adequately allows an interpretation of the accomplishments (regardless if they have been captured in the milestones), overall progress, and program priorities, and availability of funds.

Areas of Joint Responsibility include:

• Clarifying and negotiating the milestones, timelines, and budget, if necessary.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. 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.

4. Reporting

When multiple years are involved, recipients 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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: https://www.era.nih.gov/need-help (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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Albert Avila, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8804
Email: Albert.Avila@nih.gov

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

Mutema Nyankale
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 240-921-3990
Email: mutema.nyankale@nih.gov 

Section VIII. Other Information

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

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 and 2 CFR Part 200.