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 SF424 (R&R) 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to establish a National Institute of Biomedical Imaging and Bioengineering (NIBIB) Technology Development Coordinating Center for the NIBIB Biomaterials Network. The Biomaterials Network is a new program being established to accelerate biomaterials-based technology development at the NIBIB by advancing iterative design, validation, and dissemination of biomaterials-based technologies. The Network will be composed of NIBIB Technology Development projects, a resource for translation, and a Coordinating Center. The Coordinating Center will be responsible for enhancing integration between components of the NIBIB Biomaterials Network program by facilitating opportunities for collaborations and accelerating translation of biomaterials-based platform technologies. Also, the Coordinating Center will disseminate program advances, develop resources and outreach strategies for engaging the broader biomedical research community, and manage an Opportunity Funds program to rapidly fund and support promising small-scale work that advances translational development of innovative NIBIB biomaterials-based platform technologies. In support of these activities, the Coordinating Center will develop an infrastructure for coordination of technology development funded by NIBIB through the Biomaterials Network that will include significant administrative, logistical, and technical management. The Coordinating Center will be expected to work collaboratively with NIBIB-funded technology development grantees and NIBIB staff, as well as interact with other investigators and programs with goals that align with the NIBIB Biomaterials Network program.

Background

The Biomaterials Network is a new framework with the aim to accelerate innovation, development, and early dissemination of biomaterials-based technologies. Advances in biomaterials-based technologies and methods have facilitated novel paradigms in biomedical intervention and research. However, novel classes of biomaterials require support to cross translational hurdles and barriers between the bench and the bedside.

The foundational goal of the program is to address the translational barriers faced by biomaterials-based technologies across the technology development spectrum by providing coordinated resources to aid in the development of novel approaches and the refinement of current technologies. The Biomaterials Network will include three major components:

• The technology development projects will include milestone-driven projects that explore novel biomaterials development towards biomedical relevance, as well as projects that establish novel biomaterials platforms for biomedical intervention. These efforts are platform and disease independent.
• The resource center for translation will provide expertise and resources to address barriers to technology dissemination and translation, including developing and convening a network of consultants to assess technologies at every stage of maturity, and providing clinical pathway and commercialization consultation.
• The Technology Development Coordinating Center will coordinate integration of the technology development efforts supported by the Biomaterials Network, including developing a Modeling and Simulation Core to assess modeling and simulation needs and form partnerships to enhance modeling and simulation, managing an opportunity fund to support technology development, and coordinate network projects as well as training and education programs for the Biomaterials Network.

Overall, this program aims to accomplish its goal by (1) facilitating the development of a broad array of biomaterials-based technologies with clinical and commercialization potential, (2) providing expertise and resources to lay the groundwork to overcome future barriers to implementation and commercialization, (3) creating a forum for interactions across supported technology development projects, and (4) enabling targeted collaborations across the NIH at early and advanced stages of technology development. With this goal in mind, the Biomaterials Network program consists of a growing set of interrelated efforts that enable novel and refined technologies to proceed through discovery and development, towards commercialization and clinical utilization. Through interactions with the network resources, NIBIB technology developers will have opportunities to engage with consultants that can assess and advise on the design and utility of their technology platforms. Technologies will be assessed at various points along the path to maturity. Also, technology developers gain an opportunity to improve their translational and entrepreneurial awareness through training and education programs.

NIBIB supports investigator-initiated biomaterials technology projects through several funding mechanisms, including NIH parent announcements. Opportunities can be limited for coordinated interactions among the diverse community of researchers that contribute to NIBIB biomaterials technology development, unless outlined through specific programs. Furthermore, biomaterials technologies supported by the NIBIB are being newly developed and continuously improved in response to scientific advances; however, they are not always widely promoted as resources that are disseminated and used by the broader biomedical research community. With establishment of the NIBIB Biomaterials Network Technology Development Coordinating Center, an infrastructure will be developed to address the need for closer interactions between these efforts. This will enable opportunities for collaboration among grantees, accelerated technology innovation, and improved dissemination of program advances and resources to the broader biomedical research community. Also, the Coordinating Center will support a Modeling and Simulation Core, to assist in promoting informed design using groundbreaking techniques across the spectrum of biomaterials-based technology development.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. Applicants are strongly encouraged to attend the Technical Assistance teleconference to ask for information on preparing a PEDP.

For the purpose of this NOFO, "the Biomaterials Network program" refers to activities for the program described above. The Center's responsibilities primarily will be for the Biomaterials Network program.

Objectives

NIBIB seeks to fund a Coordinating Center that will expand the support and coordination of technology development efforts funded by the NIBIB Biomaterials Network. Varied expertise is required, especially prior experience in coordinating large and complex multidisciplinary collaborative research efforts and appropriate expertise in the scientific areas covered by the Biomaterials Network program. The Coordinating Center’s objectives are to facilitate collaborations and accelerate translation of biomaterials-based technologies, to disseminate advances and develop outreach and community engagement approaches, and to provide opportunity funds for translational studies.

To meet these objectives the Coordinating Center is expected to:

• Lead efforts to coordinate, develop, and promote the translation of biomedically-relevant biomaterial-based technologies supported by the Biomaterials Network. This will involve the formation of working groups to address translational and technical issues identified among the Biomaterials Network Technology Development projects in consultation with NIBIB staff. Groups will be composed of Biomaterials Network program grantees. As part of these efforts, the Coordinating Center will be expected to work with working group members to develop and organize recommendations that can be shared with the broader biomedical research community.
• Lead efforts to promote a culture change in biomaterials development and informed design using computational methods. This will involve formation of a Modeling and Simulation Consulting Core within the Coordinating Center to assess needs for modeling and simulation studies to refine technology design and serve as a matchmaker to connect technology development projects with the appropriate modeling expertise. Additionally, the Core will form an associated working group and host a series of workshops or webinars.
• Manage and administer an Opportunity Funds program to support studies for innovative technology development projects in priority areas aligned with the goals of the Biomaterials Network program. Funds for this program will be provided as part of the Coordinating Center in years 2-5 and disbursed to successful applicants as approved by NIBIB. The Coordinating Center will manage the solicitation of project proposals, review process, selection of projects recommended for funding, and disbursement of funds through subawards issued to individual investigators. Also, the Coordinating Center will be responsible for regularly monitoring and reporting on awardee progress, expenditures, and management of the Opportunity Funds program to the NIBIB.
• Be responsible for mediating outreach to existing programs supported by the NIH and programs that are not NIH-supported that support translational technology development relevant to the interests of the Biomaterials Network program. The focus should be on developing interactions to facilitate sharing of lessons learned, best practices, and existing standards that can be leveraged to enhance development and translation of biomaterials-based technologies.
• As needed, establish working groups around other topics of interest to the field of biomaterials technology development identified by program grantees in consultation with NIBIB staff.
• Be responsible for establishing a publicly accessible website for the Biomaterials Network program to share information, such as supported technologies, resources, partnerships, and program advances.
• Be responsible for the development of informational resources focused on technology transfer. This will be relevant to all with interests in commercializing biomaterials-based technologies and clinical utilization, especially for researchers at institutions with limited internal resources or experience in supporting the technology transfer process. The goal of these efforts is to provide resources that range from information about the fundamentals of intellectual property protections to identifying relevant applications and strategies for technology dissemination and adoption.
• In line with engagement of the community, develop outreach approaches and educational materials to engage program grantees and the broader biomedical research community. This may include activities, such as webinars and presentations on technologies that range from overviews of basic technology concepts to new innovations in biomaterials-based technologies. Materials developed should be wide-ranging to target a variety of researchers from trainees to established investigators.
• Organize one annual two-day investigator meeting per year for the Principal Investigators of the Biomaterials Network program. Attendance of these meetings by the respective program grantees is required. Annual meetings are expected to serve as venues to facilitate sharing of research findings, promote the exchange of ideas, and enable discussion of opportunities, challenges, and emerging needs in biomaterials technology development.

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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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 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.

• 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 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 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 SF424 (R&R) 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:

Luisa M. Russell, Ph. D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-5654

Email: [email protected]

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:

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

SF424(R&R) Senior/Key Person Profile

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

Senior/Key Personnel should demonstrate scientific, administrative, technical, and management expertise consistent with the objectives of the Coordinating Center. This should include experience in facilitating collaborations, coordination of large research efforts, website design and management, and management of selection and disbursement of subawards.

The PD(s)/PI(s) must designate a dedicated project manager to direct the day-to-day operations of the Coordinating Center. A PD/PI may serve as the project manager.

R&R Budget

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

• Budget requests should include support for the Biomaterials Network program’s annual meetings (approximately 100 participants) to cover costs for meeting facilities and logistics, participant meals, and travel and accommodations for 4-6 outside speakers.
• For all annual meetings, budgets should include costs for attendance by appropriate Coordinating Center members.
• Budget requests for years 2-5 must include $600,000 in year 2, $1.2M in year 3, $1.8M in year 4, and $2.1M in year 5 to execute subawards from the Opportunity Funds program. This should be detailed in the budget for these years under F. Other Direct Costs, as the single line item "Opportunity Funds".
• Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

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:

In the Research Strategy, applicants should propose plans, approaches, and potential alternative strategies for carrying out the activities of the Coordinating Center. The Research Strategy should consist of the following subsections. Details about what should be discussed in each section are described below.

1. Overview of the Coordinating Center

• Provide an overview of how the Coordinating Center will be structured to facilitate the Center’s objectives and enhance technology development efforts supported by NIBIB.
• This section should include a description of previous experience in facilitating collaborations and coordination of large, complex research efforts, appropriate expertise in technology development, as well as a description of the staffing and management structure for each objective without duplicating information in biosketches.
• Applicants should include their plans for collaborating with NIBIB-funded technology development grantees and NIBIB staff in the development of approaches and strategies relevant to meeting the Coordinating Center’s objectives.
• If there are any additional responsibilities that are not detailed in the NOFO but are considered necessary for operation of the Coordinating Center, applicants should note them in this section and describe potential approaches.

2. Plans and Approaches to Facilitate Collaborations and Accelerate Translation of Biomaterials-based Technologies

• Describe plans for organizing annual investigator meetings for the Biomaterials Network program. This should include descriptions of needed logistical and operational management.
• Propose plans for coordinating working groups as described in the Research Objectives. These should include strategies for consensus building, development of recommendations, and promotion of group outcomes, as well as approaches for facilitating interactions with investigators and groups outside the Biomaterials Network program.
• Propose a plan for the development and maintenance of the Modeling and Simulation Core Resource, as well as the associated working group(s). This should include strategies for consensus building, development of recommendations, and promotion of group outcomes, including approaches for facilitating interactions with investigators and groups both inside and outside the Biomaterials Network program.
• Provide strategies and approaches for enabling communication and coordination of program activities such as establishment of teleconferencing platforms and any needed communication platforms.
• Applicants are encouraged to propose and justify any other activities relevant to facilitating collaborations and coordinating scientifically focused discussion groups.

3. Plans and Approaches to Disseminate Advances, Develop Outreach Materials, and Engage the Community

• Provide a strategy for development and maintenance of the Biomaterials Network program website. Within this strategy, applicants should detail a plan for website design utilizing a portable software platform and plans for transferring this platform and any other resources generated by the Coordinating Center to the government (or another Center) at the completion of the Center’s project period.
• Propose and describe strategies for developing technology transfer informational resources outlined in the Research Objectives. For example, these may include webinars, web-based tutorials, in-person presentations, and specialized sessions at the annual meetings.
• Propose and describe strategies that include approaches for developing and promoting educational materials and other informational resources.
• Provide plans for outreach and community engagement. This should include an overview of target audience(s) and methods.
• Where applicable, propose and justify any other activities relevant to disseminating advances and developing outreach and community engagement approaches.

4. Plans and Approaches to Provide Opportunity Funds

• Propose and describe a management plan for the Opportunity Funds program that includes a description of the administrative structure; process for solicitation, review, and selection of projects; recommendation process for NIBIB review and approval; procedures for funds disbursement; and plans for monitoring and reporting progress.
• Applicants should describe plans for interacting with the institutions of awardees and for regularly reporting on awardee progress, expenditures, and management of the Opportunity Funds program.
• As needed, propose and justify any other activities relevant to management of the Opportunity Fund that are not detailed in this section.

5. Timeline

• Provide a detailed timeline (e.g., Gantt chart) of Coordinating Center activities and milestones to track progress towards the Center’s objectives. This should be organized by month and year.

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 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.

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.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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 particular announcement, note the following:

The emphasis and priority of this NOFO are the coordination of the NIBIB Biomaterials Network program and the interrelated efforts that comprise this program. As described in this NOFO the NIBIB Biomaterials Network Technology Development Coordinating Center is expected to organize and coordinate efforts that will enable all supported projects to accelerate technology development and progress in the field of biomaterials. Coordinating Center objectives are to be performed in collaboration with NIBIB staff. Accordingly, reviewers will evaluate the PI’s prior experience in managing large, complex research efforts and the potential for the Coordinating Center to provide capabilities in developing the infrastructure to support program coordination and assist in achieving program goals.

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 convened by the National Institute of Biomedical Imaging and Bioengineering, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned 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 National Advisory Council for Biomedical Imaging and Bioengineering. 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 including the PEDP.

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 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 Research Terms and Conditions
• 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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. 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.htmlandhttps://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 (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR 200 , and other DHHS, 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 the NIH as defined below.

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

• Determining research approaches, designing protocols, setting project milestones, and conducting research for carrying out the responsibilities of the Coordinating Center.
• Agreeing to accept close coordination, cooperation, and participation of NIBIB staff in the scientific and technical management of the Coordinating Center.
• Adhering to the NIBIB policies regarding intellectual property, data release, and other policies currently established and newly established during the funding period of the Coordinating Center.
• Collaborating with recipients of the NIBIB Biomaterials Network program.
• Coordinating, managing, and participating in annual program meetings.
• Leading and organizing working groups that support the discussion and exchange of ideas across the NIBIB Biomaterials Network program.
• Preparing and disseminating working group and program meeting minutes, as appropriate.
• Accepting and implementing common guidelines and procedures developed for the NIBIB Biomaterials Network program.
• Solicitation of project proposals and organization of scientific review for the Opportunity Funds program.
• Management and disbursement of Opportunity Funds through subawards to individual investigators at awarded institutions.
• Providing regular reports (reporting period to be determined in collaboration with NIBIB staff) on outreach and community engagement activities, Opportunity Funds management, and other Coordinating Center activities as determined by NIBIB staff. Any foreign collaborations included as part of working groups are the responsibility of the Coordinating Center to report to NIH. NIH reserves the right to ask individual research projects to report as well.
• Coordinating and collaborating with other NIBIB research programs, where opportunities are identified.
• Coordinating and collaborating with other research programs, within and outside the NIH, that engage in biomaterials technology development and other efforts in alignment with NIBIB’s Biomaterials Network program, where opportunities are identified.
• Data/software ownership and transition to another grantee:
  • A fundamental objective of this cooperative agreement is to ensure that the valuable data, products, and resources provided by the Coordinating Center remain available without interruption to the research community if recipient withdraws or otherwise can no longer manage the resource or the award is terminated by the NIH.
  • Consistent with 45 C.F.R. 75.322, the recipient will own the data generated and software developed by the awardee, and it will be able to continue to use these data and software upon expiration or termination of the award. NIH will have unrestricted cost-free access and use of the data, resources and software generated by the awardee, including the right to transfer said data and/or software to other NIH-funded and/or managed resource projects, at the NIH's sole reasonable discretion upon termination or expiration of this cooperative agreement.
  • Ownership of the data and software that may be hosted (but not created) by the Coordinating Center remains with the data and software providers.
  • Open-Source Technology: Capabilities and software built as part of Coordinating Center must be delivered under an open source model. Organizations may propose to use proprietary platforms, so long as the requirements for data transparency and interoperability are maintained.
  • 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 DHHS, PHS, and NIH policies.

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

NIH staff designated as project scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in the conduct of the Coordinating Center's activities. However, the role of NIBIB will be to facilitate and not to direct the activities of the Coordinating Center. Specifically, the project scientist will:

• Negotiate objectives, including timelines, with the Coordinating Center awardee as necessary.
• Help coordinate collaborative research efforts that involve multiple components of the NIBIB Biomaterials Network program.
• Assist the Coordinating Center with the development, if needed, of policies for dealing with situations that require coordinated action.
• Provide advice on the management and technical performance of the Coordinating Center.
• Assist in promoting informational resources and other materials developed in the course of the Coordinating Center's award to the broader biomedical research community.
• Serve on working groups of the Biomaterials Network program, as appropriate.
• Coordinate review and approval by NIBIB of recommended Opportunity Funds projects.
• Serve as a liaison to other NIH Institutes/Centers and with groups within and outside NIH that are similarly involved in biomaterials technology development.
• Periodically report progress to NIBIB Leadership.
• Additionally, an NIBIB Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned Program Director may also serve as the NIBIB Project Scientist.

Areas of Joint Responsibility include:

• The Coordinating Center PD(s)/PI(s) will be expected to work collaboratively with NIBIB-funded technology development grantees and NIBIB staff to develop and disseminate informational resources to the broader biomedical research community.
• Close interactions between the Coordinating Center and participating program investigators will be required, as well as significant involvement from NIH to coordinate NIBIB technology development programs. The Coordinating Center PD(s)/PI(s), the NIBIB Project Scientist, and the NIBIB Program Director are expected to attend annual program meetings.
• For the Biomaterials Network program, working groups are expected to be developed to discuss topics of interest determined by program investigators. As needed, NIBIB staff will work with the Coordinating Center PD(s)/PI(s) and personnel to create working groups focused on these topics. Working groups and other Coordinating Center activities may involve participants from other NIH programs or groups outside NIH. The Coordinating Center PD(s)/PI(s) will work collaboratively with the NIBIB Project Scientist to interact with other relevant NIH programs and groups outside NIH, as needed, to promote synergy among biomaterials technology development efforts.
• The NIBIB project scientist will also work with the Coordinating Center PD(s)/PI(s) to help define and prioritize research needs to be supported through the Opportunity Funds program.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the award recipient(s) 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 awardee. This special arbitration procedure in no way affects the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 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: [email protected] (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: [email protected]

Luisa M. Russell, Ph. D.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-5654
Email: [email protected]

Manana Sukhareva, Ph.D.
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]

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.