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 FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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

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
Section II. Award Information
Section III. Eligibility Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) encourages applications to establish Biomedical Technology Optimization and Dissemination (BTOD) Centers in any of the basic or clinical research areas within the NIGMS mission. This program supports optimization of late-stage technologies that have demonstrated laboratory feasibility and dissemination of the optimized technologies to the broad biomedical research community. A BTOD Center may focus on a specific technology or it may integrate multiple technologies to create a transformative approach to solving a class of research problems.

Appropriate technologies for a BTOD Center may be drawn from the full range of NIGMS-supported research areas including, but not limited to, biomedical workforce training, bioanalytical chemistry, biostatistics, chemistry and chemical biology, data science, imaging tools and analysis, sepsis (clinical trials not allowed), and single cell technologies.

Background

The NIGMS technology research and development grant pipeline supports technology development from its earliest stages to broad dissemination of products to the research community. The Technology Development R21/R01 Program supports early-stage proof of concept and prototype development projects. The RM1 BTOD Centers program supports prototype optimization and later stage development, with an emphasis on demonstrating broad utility for biomedical research and disseminating technologies to the research community, including through commercialization.

Center Expectations

A BTOD Center refines/optimizes technologies that have demonstrated feasibility by applying them to a wide variety of biomedical problems and disseminates these technologies to the biomedical research community. A Center accomplishes this through synergistic interactions between technical and biomedical expertise and through intensive collaborations with other laboratories to test and refine the technologies in a variety of research settings. Ideally, a Center should be uniquely positioned to identify biomedical research problems that will benefit from access to and training in the tools derived from its emerging technologies. The intense synergy between technology development and community-driven biomedical problem-solving fundamentally distinguishes a BTOD Center from laboratories engaged in research projects that may have more narrowly defined, inwardly focused goals. In addition, large potential user bases should exist for the technologies being optimized by BTOD Centers. Specialized technologies that would only be useful for small communities of researchers are not appropriate for optimization through the BTOD program and applications that focus on such technologies will not be supported.

BTOD Center technologies must have demonstrated feasibility and utility for addressing biomedical questions but require improvements to serve a wide range of users. For example, in cases where a developed instrument, method, protocol, or platform is accessible to experts with a deep understanding of the theory and practices of a field, a Center could continue its development to enable use by a wider community of experts and non-experts alike. Likewise, a Center could make an instrument, method, protocol, or platform that is currently only applicable to a small set of scientific questions or challenges more generalizable and broadly useful. A BTOD Center accomplishes these goals by combining established methods, improving automation, hardening methodology or experimental pipelines, introducing robust platforms, and/or incorporating validated algorithms. It is the Center’s responsibility to identify and reach out to user communities that will benefit from its technologies to obtain input and allow them to contribute to the optimization process. Success of BTOD Center-supported technologies is ultimately measured by their adoption by the relevant biomedical research communities, which in many cases may require commercialization. An application that proposes to transition a previously-funded P41 Biomedical Technology Research and Resource (BTRR) to a BTOD Center should shift its focus to optimizing later-stage technologies for broad utility and dissemination of these technologies in a self-sustaining manner.

The objective of the BTOD program is for the technologies they optimize to rapidly become widely distributed and accessible. As such, a BTOD Center will be funded for no more than 15 years, with previous years of BTRR and/or BTDD Center funding included in this limit.

It is important to note that BTOD Centers engage with researchers with different biomedical questions or challenges in order to test and refine the Center's technologies. BTOD Centers, however, are not intended to serve as long-term community resources or user facilities. Instead, the goal of BTOD Centers is to harden the technologies to the point where they can be disseminated through training, commercialization, or, in cases of high-value, large-scale technologies, incorporation into national or regional user facilities. NIGMS supports the latter through the National and Regional Resources (R24) Program.

Center Structure

A BTOD Center optimizes technologies through collaborations between Technology Optimization Projects (TOPs) and Driving Biomedical Projects (DBPs). Working iteratively with DBPs, TOPs develop and improve technologies by addressing challenges in a range of biomedical research problems. Centers disseminate technology through Community Engagement (CE) activities that advertise and transfer the proposed technologies to the broad research community through activities such as training, commercialization, and publicity.

Technology Optimization Projects (TOPs): TOPs are the central focus of the BTOD Center application and serve as the foundation for all other Center activities. Centers select and organize TOPs based on scientific rationale.

Characteristics of TOPs

• State-of-the-art, late-stage technologies: Research teams bring critical, often unique technologies at the forefront of their fields that have been proven and used in their own and collaborators laboratories but are not sufficiently robust for broad use. Further optimization by the Center will facilitate broad adoption and utility in biomedical research.
• Synergy: TOPs may be multiple applications of a common underlying technology or complementary technologies supporting a common goal.
• Acceleration through Technology Partnership Projects (TPPs): TPPs may be included and conducted as a funding-neutral collaboration to accelerate technology optimization over a short duration, generally one to two years. Alternatively, TPPs may be supported through deploying Center funds as consortium subcontracts. TPPs should be described if they are anticipated at the time of application. TPPs may also be initiated at any time during the grant period at the discretion of the PD(s)/PI(s), consistent with NIH grant policy. BTOD Centers are encouraged to collaborate with industrial partners. In general, industrial partnerships should be funding neutral, characterized by in-kind contributions of effort and equipment.
• Not focused solely on data collection: Modest subprojects designed to generate data for use in technology development or testing may be included as a part of a TOP. Such projects do not substitute for DBPs and should be included only when data to test tools, devices, or software is not available elsewhere.

Driving Biomedical Projects (DBPs): Biomedical research tool development is most effective when pursued in the context of challenging scientific problems. A BTOD Center’s DBPs are biomedical research projects that the Center pursues in collaboration with outside investigators to serve as test beds for integration and refinement of its technologies. This collection of projects is an essential aspect of a BTOD Center's mission and should represent a significant investment of its time and effort.

Applicants should seek out a majority of DBPs outside of their home institutions. However, it is understood that in unusual instances there are significant technical and logistical obstacles associated with distant collaborations (e.g., access to patient populations, or the need for repeated, ready access to biological materials). In exceptional cases, a majority of DBPs may be local with sufficient justification. BTOD Centers should engage a range of collaborators posing different biomedical questions in a variety of institutional settings and with different levels of technical expertise. DBP engagement can be at a range of levels, from longer-term (e.g., 2-3 years), intensive projects, to shorter-term (e.g., weeks to months) smaller scale projects. BTOD Centers are encouraged to interact with DBPs across these levels in order to engage a variety of potential technology users and refine the technologies in different settings and with a variety of scientific problems.

Characteristics of DBPs

• Pose significant biomedical research problems and technical challenges: The iterative relationship between TOPs and DBPs should lead to Center technology optimization and advance both TOP and DBP goals. Specifically, DBPs should present opportunities to clearly demonstrate the broad utility of the Center's technologies and to harden the technologies for widespread use. These efforts should lead to joint publications that will help make the community aware of the technologies being optimized and disseminated by the BTOD Center.

* Purely technical collaborations focused on advancing some aspect(s) of a TOP are not considered DBPs but can be included as part of the relevant TOP, either as an ongoing element of that project, or as a TPP.

• Independently funded: DBPs should, in most cases, stem from ongoing biomedical research projects that have been peer reviewed. While a BTOD Center is expected to fund Center staff for work done in the Center, in most cases the collaborating DBP investigators should not receive financial support from the Center for the work that they do in their laboratory or for DBP investigators working at the Center performance site. In cases in which collaboration with a lower-resourced institution would increase the diversity of the research questions addressed by the technology and/or aid in dissemination of the technology to different settings or regions, BTOD Center funds may be used as a subcontract to enable this partnership.
• Broad in scientific scope, geographic, and institutional distribution: Centers are strongly encouraged to work with investigators in lesser-resourced institutions, including minority-serving institutions and in Institutional Development Award (IDeA) states. Centers should also develop collaborations with users with a range of experience levels - for instance, at primarily Undergraduate Institutions (PUIs) - to test and refine the technologies to ensure broad utility and adoption by the scientific community.
• Interact with multiple TOPs: Although each TOP must have a relationship with at least one DBP, it is preferred that each DBP drive more than one TOP and that each TOP interact with more than one DBP.
• Dynamic: DBPs should turn over during the project period and should be chosen based on both their potential for significant biomedical impact and their appropriateness as TOP test beds. Lack of successful DBP turnover will be considered a negative outcome for Center renewals.

Community Engagement (CE): Effective biomedical research community engagement is critical to disseminating the BTOD Center’s technology. The Center leadership should present a detailed plan to engage different segments of the biomedical research community and to provide broad accessibility for the eventual widespread and routine adoption of Center technologies. This plan may include engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based) and should include engagement with investigators and teams composed of researchers at different career stages and with individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031). The CE approaches need not be novel, and applicants are encouraged to look to other funded BTDD and BTOD Centers for methods.

*Applications that incorporate students, postdoctoral fellows, and other trainees in CE operations require an institutional letter describing how these activities are integral to the students' or trainees' overall training goals.

Characteristics of CE

• Sustainable Dissemination of Center technologies: The Center’s dissemination activities should have the long-term goal of enabling the broad research community to use the technologies independent of the Center itself. Activities can include but are not limited to the following:
  • publish articles, books, newsletters, annual reports, or special issues of technical journals, issue press releases, and present research results at meetings
  • conduct workshops and conferences, and produce web-based training modules and tutorials

*Acknowledgment of NIGMS grant support and citation of NIGMS grant number are required (see Attribution of NIH/NIGMS Support).

• Strong Center financial and personnel commitment: The Center should commit substantial financial and personnel resources to ensure broad dissemination of the technologies and methods developed beyond the Center’s primary research focus.
• Robust web presence: A Center should create and maintain a robust website that provides current information about its research focus and capabilities, for both researchers and the public. It should provide information about how to contact the Center to establish DBPs and promote user training activities.
• Broad user training: A Center should build technical competence in the broad expert and non-expert research communities to facilitate Center technology adoption in their own research. Examples of user training include:
  • consultation with Center staff on how the technologies could be used to address research questions or needs
  • on-site, hands-on laboratory experience, or off-site visits by Center personnel
  • seminars and lectures
  • workshops, short courses, or symposia offered independently or in conjunction with scientific meetings attended by the user community.

*Academic courses, research, and training activities that are not available to the biomedical research community external to the Center’s institution are not considered Community Engagement.

• Clear path toward commercialization: When applicable, a Center should engage in mechanisms to broadly disseminate the technologies through commercialization. Examples may include:
  • collaborate with vendors or dissemination through creation of new businesses, for example with assistance of small business (SBIR/STTR) grants
  • patent inventions and license technologies to industry
  • provide reagents, tools, and maintenance directly through commercial arrangements.

External Advisory Committee: Each BTOD Center must have an External Advisory Committee (EAC) that meets at least annually and prepares a written report of its recommendations. EAC members are appointed by the PD(s)/PI(s) to advise them on future Center directions, particularly in setting priorities for allocation of Center facilities. EAC membership should be rotated periodically. The committee chair should be knowledgeable of the Center's technologies and the science it serves but should not be a member of the Center staff or a major user of the Center. Other committee memberships should be distributed among scientists with knowledge of the Center’s technologies, experts in its application to biomedical research problems, and Center technology users. Inclusion of DBP collaborators on the EAC is not prohibited but should constitute a minority of members. Members should represent a diversity of perspectives and at least one member should be from a lesser-resourced institution, including minority-serving, IDeA state, or PUI.

Enhancing Diverse Perspectives

NIGMS recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from, research, and enhancing public trust. To support the best science, NIGMS encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Transdisciplinary research projects and collaborations
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Training and mentoring opportunities encouraging participation of individuals from diverse backgrounds, including those from groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see Section IV.2 SF424(R&R) Other Project Information. Other Attachments). For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/pedp-key-elements-and-examples.

Prior Consultation with Institutes and Centers (IC) Staff

Potential applicants are strongly encouraged to consult with NIGMS staff at least 12 weeks prior to the application due date about alignment of the proposed research strategy with the goals and mission of the Institute, whether it addresses one or more high priority NIGMS research areas, and its potential suitability for a BTOD Center. Institute staff will not evaluate the technical and scientific merit of the proposed program in advance; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. During the consultation phase, if the proposed research strategy does not include the necessary subcomponents, meet NIGMS programmatic needs, or is not appropriate as a BTOD Center for other reasons, applicants will be advised to consider other funding opportunities.

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 FOA.

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 his/her 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.

PD(s)/PI(s) must each provide a minimum of 3 person months effort to the Center project.

NIGMS PDs/PIs with a Maximizing Investigators' Research Award (MIRA) are eligible to apply, but must maintain 51% research effort toward their MIRA, and 3 person months effort toward the BTOD Center. While a MIRA can support a PD/PI's laboratory for early-stage technology development, a BTOD Center award can only support late-stage technology optimization and dissemination efforts.

2. Cost Sharing

This FOA 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 FOA. 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 funding opportunity announcement 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.

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 FOA.

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.
For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

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, with the following additional instructions:

Facilities and Other Resources: For projects with more than one performance site, provide any plans to mitigate adverse effects of geographic separation of Center activities.

Other Attachments:

1. Plan for Enhancing Diverse Perspectives (PEDP) (required, 1 page maximum): The application 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 are 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 should include a timeline and milestones for relevant components that will be considered as part of the review. This attachment should be titled, Plan for Enhancing Diverse Perspectives.

Examples of items that advance inclusivity in research and may be part of the PEDP 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 underrepresented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure to support career-enhancing research opportunities for 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, including those from underrepresented groups.
• 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 research participants or collection of tissue samples from diverse groups, including those from underrepresented groups.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/pedp-key-elements-and-examples.

For applications from a BTRR or BTDD Center to transition to a BTOD Center, the following attachments are required:

2. EAC Report: Include the most recent version as an attachment in this section, as appropriate. This attachment should be titled, "EAC Report"

3. Directly Supported Publications: Provide the title and complete reference for all publications, manuscripts accepted for publication, patents, and other referenceable materials that have resulted from the Center. All publications directly resulting from Center-funded efforts should explicitly acknowledge the Center support and be included in the publication list. This attachment should be titled, "Directly Supported Publications".

4. Indirectly Supported Publications: List the publications indirectly resulting from Center efforts. This attachment should be titled, Indirectly Supported Publications".

SF424(R&R) Senior/Key Person Profile

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

Include leads of TOPs and CE as key personnel.

Biographical Sketch: PD(s)/PI(s) and other key personnel should describe their suitability for their roles in the Center, training, experience, and accomplishments in collaborative basic research, technology development, and its dissemination.

R&R Budget

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

The budget should include a detailed justification for key personnel. The budget justification should include a table of all personnel and the level of effort for each project with which they are involved. Total effort for each person cannot exceed 100%.

The PD/PI is required to dedicate a minimum of 3 person months effort to this program. For multi-PD/PI applications, each PD/PI is required to dedicate a minimum of 3 person months effort. Subsection leads for TOPs and CE should be identified and provide a minimum of 1 person month effort to the project. Describe specific duties in the Budget Justification. If effort proposed is greater than support requested, then this should be noted.

Equipment may be requested. A justification should be supplied for the equipment requested for the Center and organized by project usage (indicate which TOP will utilize the equipment). Price quotes should be included for equipment costing more than $25,000. The budget justification section should include an evaluation of alternative instruments or manufacturers along with a discussion of the proposed procurement plan.

Funds may be requested in the Consultant Costs category of the budget for support of External Advisory Committee (EAC) member travel expenses for the annual EAC meeting.

PEDP Implementation Costs: Budget request may include allowable costs (as outlined in the Grants Policy Statement) associated with PEDP implementation.

Other than BTOD Center staff salary support, no support may be requested for DBP conducted outside of the BTOD Center (i.e., laboratory work undertaken by any personnel associated with the collaborating laboratories cannot be supported through the BTOD Center grant).

If a charge back system that results in program income is planned, include a description in the budget justification describing the rationale and any planned uses for the income. Note that special administrative requirements applying to program income must be observed. See the NIH Grants Policy Statement Section 8.3.2.

No funds may be requested to support travel or accommodations for training course registrants.

Trainee stipends are not an allowable cost and may not be requested.

R&R Subaward Budget

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

Support for Technology Partnership Projects can be requested by including a consortium subcontract to the collaborating investigator’s institution for personnel, materials, and travel for this work. The performance site for the work may be at the collaborating institution or at the BTOD Center performance site(s). The request should not span the entire 5-year project period for these dynamic, short-lived collaborations.

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:

Specific Aims: Describe the overall aims of the proposed Center. Note that the first page of each TOP Research Strategy subsection is reserved for Specific Aims for the respective TOP.

Research Strategy: The Research Strategy must consist of the following subsections, in the order listed below, uploaded as a single PDF attachment:

• Overview
• Administration and Management
• Technology Optimization Projects (TOPs)
• Driving Biomedical Projects (DBPs)
• Community Engagement (CE)

Note: A project may not be supported beyond a combined total of 15 years as a BTRR, BTDD, or BTOD Center. Applicants submitting for the final project period should be aware that BTOD Center funding will not be extended past the end of the final project period, and should propose a Research Strategy and a sustainable technology dissemination plan for the final five-year project period that takes this into account.

Overview

Provide an overview and describe the long-term goals of the proposed BTOD Center. Provide the current state of the art in the field and the project objectives, which should be a significant advance beyond the state of the art. Describe competing/similar existing technologies and centers and point out unique features of the proposed Center. Provide justification for the need for the proposed technology optimization and dissemination projects and explain how the technology will broadly enable new avenues of research.

Describe the TOPs and Technology Partnership Projects (TPPs), if any, highlighting the synergy and complementarity among them.

Describe plans to ensure geographic and institutional distribution of Center DBP and TPP collaborators and broad geographic reach of technology dissemination. Describe how the Center will address the research community's needs in general, and the DBPs, in particular, in terms of currently available technologies and resources.

Describe the primary CE strategies and explain how they will position the BTOD Center to bring its technologies into sustainable broad use independent of the Center. Describe any circumstances that factor into the CE plans with justification of the proposed approaches.

Describe how elements of PEDP intersect with Center TOPs, DBPs, and CE.

Annotated Timeline: Include an annotated timeline/graphic that depicts how the proposed TOPs, TPPs, and DBPs relate to one another as a work-flow and the target dates for availability of technologies.

New Center: Include information on factors and events contributing to the decision to create the BTOD Center.

BTRR or BTDD Center transition:

• Include a brief summary of progress in the current project period.
• Include progress in technology development and optimization.
• Include relevant metrics for any research products (publications, software, videos, tutorials, etc.), both those demonstrating impact through dissemination alone and through collaborative interactions.
• Highlight both commercial and non-commercial dissemination of mature technologies and tools (reagents, instruments, methods, software).

Administration and Management

Include the following sections, with headings: Organizational Structure and Staff Responsibilities, Center Operating Procedures, External Advisory Committee (EAC), Technology Dissemination Plan, and Resiliency Plan.

Organizational Structure and Staff Responsibilities: Describe the BTOD Center organizational structure. Indicate the relationship of the Center to the applicant institution's administrative structure. Describe how the PD(s)/PI(s) and the proposed Center staff will be organized with respect to the Center components: each of the TOPs, CE, and Administration and Management functions. If students or trainees are involved in BTOD Center operations, documentation that these activities are integral to their overall training goals is required in an institutional letter of support (See Letters of Support below).

Describe how the PD(s)/PI(s) will provide leadership and direction to the key Center components, including directing and coordinating the TOP leaders, overseeing DBP progress and turnover, and overseeing all CE activities, including ensuring proper access to Center resources. Highlight strategies described in PEDP that will be applied to these activities.

If multiple PD(s)/PI(s) are proposed, describe in general the structural and procedural elements that will ensure their integration and prevent fragmentation of the Center, demonstrating how it is not simply a collection of individual projects with a common technological theme. Refer to the multi-PI (MPI) leadership plan, where details may be fully elaborated.

Center Operating Procedures: Describe operating procedures and policies planned for the Center. Include criteria and mechanisms to review and approve requests for collaboration with the Center through DBPs, to provide feedback to both successful and unsuccessful applicants, and to schedule interactions once approved. Refer to relevant elements in the PEDP. Include a description of how the Center will educate and monitor users in the requirements to acknowledge Center support in any resulting publications, and about all NIH data sharing policies.

External Advisory Committee (EAC): Describe the EAC's role in advising on instrument purchases, evaluating the progress of TPPs and current DBPs, reviewing new DBPs for merit and appropriateness, monitoring adherence to approaches and aims of the PEDP, allocating instrument time, and on proposed plans for the BTOD Center renewal (if appropriate).

• For existing and proposed Centers with an established EAC, include names of current committee members and a brief description of their qualifications.
• If an EAC has not been established, describe the scientific disciplines of anticipated committee members that will be represented on the EAC and how a variety of expertise, institutions and regions will be established. Do not name in the application, contact, or appoint potential EAC members prior to completion of the grant submission, review, and funding process.
• Additional advisory committees are allowed. Describe the function and meeting schedule for any local executive committee or other local committee appointed as an adjunct to the EAC to deal with specialized topics.

Technology Dissemination Plan: Describe plans for achieving wide-spread access to and adoption of Center-developed technologies and related resources beyond the life of the BTOD Center. Include metrics for determining success of these plans. Delineate the plans as activities in the proposed project period that will work toward ensuring dissemination, and those envisioned to occur at a later date, e.g., through commercialization. Note that a successful Center is not expected to continue to exist beyond the 15 year maximum funding term because the technologies will have been fully established and disseminated.

Resiliency Plan: Describe the plans for continuing the Center's operations in the event that the PD(s)/PI(s) or other key personnel cannot fulfill their assigned roles.

Technology Optimization Projects (TOPs)

Provide this subsection for each TOP, with a maximum of three TOPs. Name the TOPs sequentially as TOP# followed by a short descriptive title. For a BTRR or BTDD Center applying to transition to a BTOD Center, please denote TOPs that are new to this application with bold font.

Each TOP description should begin on a new page with "TOP#: a short descriptive title" as a heading. List the DBPs associated with the TOP, by number and title, immediately after the TOP heading. List the lead investigator(s) who will be primarily responsible for the TOP. Describe the TOP goals. Present the Research Strategy in sufficient detail for critical evaluation of the potential impact of the technology, the quality of the technology optimization, and the role of the project in the overall Center. Describe why the TOP is at the cutting edge of the technological field and how optimization will meet the goal of increasing the technology’s impact on biomedical research. Provide evidence that the technology has been developed to the point of established feasibility and successful application to a biomedical aim or problem and that optimization, expansion and broad dissemination are now warranted. Address the background and rationale for the TOP, its significance, and methods. Describe how the technology improves upon any alternative technologies that address the same research needs.

Describe plans for technology optimization to realistically enable broad dissemination. As appropriate, relate TOP optimization plans to dissemination plans. Present alternative approaches to solving technological problems in the event that the main conceptual thrust(s) should prove infeasible. Include plans for prototype and method validation, and reagent and biological authentication, that ensure the technologies can achieve the intended biological aims.

Include the following under the specific subheadings in the TOP subsection:

• Technology Partnership Projects: If one or more TPPs are proposed, explain plans for the TPP and provide supporting evidence that they are dynamic, short-term collaborations that will enable the Center to adopt and incorporate emerging capabilities in rapidly evolving fields.
• Technology Integration: Describe the relationship of this TOP to the overall technology optimization program of the BTOD Center. Discuss the complementarity between this TOP and the other proposed TOPs.
• DBP/TOP Interactions: Describe how the TOP is responsive to the emerging needs of the biomedical research community. Describe how each associated DBP will serve as a test bed for the TOP. Describe how each DBP, led by an expert or non-expert user, is enabled by the TOP.

Driving Biomedical Projects (DBPs)

All applications must provide the following (suggested page limits provided as guidance): table of proposed DBPs (1 page), summary of DBPs (1 page), and descriptions of a maximum of 10 DBPs (1 page per DBP including references).

Table of Proposed DBPs: Provide a 1-page table of up to 10 DBPs. Format the table to include the following columns:

1. DBP#; (existing BTRRs and BTDD Centers should indicate new DBPs in bold) and title of the project
2. TOPs with which the DBP interacts
3. Name(s) of the primary collaborating investigator(s) for the DBP
4. Collaborating Investigator(s)' Institution(s)
5. External funding source and status (end date) of the project, including NIH grant number, where applicable
6. Human subject and/or vertebrate animal involvement in the project
7. For BTRR or BTDD Center transitions: number of publications that have resulted from the continuing DBP

Summary of DBPs: Provide a 1-page summary of all DBPs with a succinct description of the overall goals. Provide a description of criteria used for including new DBPs and rotating existing DBPs out of the BTOD Center during the award period. Include plans with references to PEDP, as appropriate, to enhance diversity among DBP projects in terms of science, geography, institution types and user experience levels.

Descriptions of a maximum of 10 DBPs (1 page per DBP including references). Begin each on a new page with the following information:

• DBP#, title of the project, primary collaborating investigator(s) and institution(s)
• Description: Describe the overarching goal of the DBP and its research aims/activities that are relevant to the BTOD Center application. Describe how the DBP will provide a context for demonstration, integration, and refinement of Center technologies. Describe the potential impact of the proposed technology optimization on the DBP, and when appropriate, provide challenges to this DBP and how the TOP(s) will address them.
• Progress report: Include a progress report for continuing DBPs.

Community Engagement (CE)

Describe overarching plans for active engagement with the research community, providing a rationale for each activity. List the lead investigator(s) who will be primarily responsible for CE and their roles in the proposed activities.

Current BTRRs or BTDD Centers: Compare the Dissemination Efforts for the proposed center to those for the current resource or center. For current BTRRs, the proposed CE plans should place a greater emphasis on technology dissemination. Applications from current BTDD Centers should detail new CE activities. A progress report of Community Engagement activities from the previous project period should be included in this section.

Describe strategies for engaging the community to promote dissemination and adoption of the Center's technologies. Describe plans for obtaining feedback from the research community on how the technology could be further optimized to make it more useful for different research areas and in different settings. If applicable, provide plans to mitigate any obstacles to dissemination, promotion, and adoption of developed technologies. For example, if replication of a technology outside the Center is not feasible, state how this might be overcome to make the technology portable through TPPs and industrial partnerships to ensure widespread access.

Provide details for the following activities under the appropriate heading:

Technology Training for the User Community: Describe plans for providing training to the scientific community in the technical capabilities and accomplishments of the BTOD Center technologies and how these tools can be applied to their research problems. The PEDP should be referred to and incorporated into these plans. Describe how successful user training activities will enable researchers to fully utilize the technologies and resources developed by the BTOD Center. User training should be well thought out, accessible, and effective, but does not need to be innovative.

Examples of appropriate approaches to user training include hands-on laboratory experiences such as visits to the BTOD Center laboratories by researchers from other laboratories or reciprocal visits by Center personnel; training core facility managers at other institutions; seminars and lectures; short courses or symposia offered independently or in conjunction with society meetings attended by the user community; workshops on relevant topics that bring together researchers in multiple areas from academic institutions, hospitals, and industry for discussions on the use of BTOD Center technologies in biomedical research.

If the Center will provide on-site user training and collaborative work, describe plans to make workspace available for visiting scientists. Do not include academic courses that are offered as part of the Center’s institution's curriculum that are not available to those outside the institution. Individuals who will benefit from user training may not be paid a salary in conjunction with the training, nor may the training experience be a requirement for receipt of an academic degree. Do not include formal pedagogy training activities of students and post-doctoral fellows involved in the BTOD Center, as those educational activities are not considered relevant to the BTOD Center's user training element, which is focused on the external research community.

Technology Dissemination: Provide plans to disseminate the BTOD Center's technologies to both experts and non-experts at a variety of institution types and geographic regions. Approaches can include, but are not limited to, distributing and supporting software products; transferring technologies to other laboratories directly; and patenting inventions and licensing technologies to industry, including partnerships with small businesses and support from the SBIR and STTR programs.

Provide plans for measuring the success of dissemination efforts, including plans for tracking the demand for and utilization of resources provided directly by the BTOD Center. These plans may include measures of the PEDP progress benchmarks.

In Centers that are developing software, emphasis should be placed on producing portable, well-documented, efficiently-coded, user-friendly software, making it readily available to the user community and providing user support. NIGMS encourages sharing of source code. Although software is not required to be open source, if the software will be distributed using a restrictive license, then written justification is required in the application.

Use of Common Data Elements in NIH-funded Research: NIH encourages the use of the FAIR (Findable, Accessible, Interoperable, and Reusable) principles and common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subjects research to facilitate broader and more effective use of data and advance research across studies. Applicants should refer to the NIH Common Data Element (CDE) Resource Portal", which assists investigators in identifying NIH-supported CDEs and provides guidance and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.

Website: Describe plans to provide a robust web presence for a newly formed Center, or describe the current web presence for an existing center and how it will be kept up to date. Information on the website should include:

• The Center’s research focus and capabilities
• A section of plain language information for the general public about the technologies being optimized and how they will benefit biomedical research
• Contact information
• How to apply for DBPs
• How Center collaborators should cite the BTOD Center grant
• A section on current newsworthy items directed to the general public
• An image gallery that features data and results generated by the technologies, as applicable.
• Links to online tutorials
• Availability of software, reagents, and other resources that are accessible to both expert and non-expert users, as applicable.
• Acknowledgement of NIGMS grant support for the BTOD Center

Letters of Support: Provide a table of contents for Letters of Support. Include the names of signatories and their institutions. Letters expressing institutional support should be presented first. Letters of support from investigators specifically collaborating with Center investigators on any TOP, DBP, or other projects described specifically in the application should be included next. The purpose of collaborative letters of support is to describe the nature of the collaborative relationship, including its scope, and any special circumstances (e.g., materials or technology transfer, or intellectual property agreements). If students or trainees are involved in BTOD Center operations, institutional letters documenting that these activities are integral to their overall training goals must be included. Do not include letters of support from users whose interactions are limited to activities described in the CE component.

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.

• Blank application forms for user requests to access Center CE activities may be included in the appendix (e.g., for training, collaboration, or dissemination of resources).

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 FOA 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 NIGMS. Applications that are incomplete or non-compliant will not be reviewed. Applications must include a PEDP submitted as an Other Attachment on the SF424(R&R) Other Project Information form. 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.

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

For this particular announcement, note the following:

The objectives of the BTOD FOA are to optimize technologies that are in late stages of development and to sustainably disseminate these optimized technologies for use by the biomedical research community. The late stage technologies described in the Technology Optimization Projects (TOPS) should have the potential for broad utility in biomedical research. Optimization through iterative interactions with the Driving Biomedical Projects (DBPs) should bring the technologies to a stage at which they can be readily used by both experts and non-experts. Sustainable dissemination of the optimized technologies to enable independent use by the research community, which is carried out through Community Engagement strategies, should eliminate the need for the BTOD Center. Therefore, Center support, including previous support of BTRRs and BTOD Centers that transition to BTOD Centers, is limited to a total of 15 years.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the center 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 center 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 center that by its nature is not innovative may be essential to advance a field.

As applicable for the center 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 center 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 the Center for Scientific Review, 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. 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, consistent with applicable law:

• Scientific and technical merit of the proposed center, as determined by scientific peer review;
• Availability of funds;
• Relevance of the proposed center to program priorities ;
• Portfolio balance;
• Geographic and institutional distribution.

NIGMS will give priority to areas of technology development not already supported in current NIGMS-funded Centers.

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

Institutional Review Board or Independent Ethics Committee Approval: 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 FOA.

• 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.

Not Applicable

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 reporting plan tailored to evaluate the progress in technology optimization and dissemination is required in the RPPR. Report data on an annual basis to track optimization, demand, utilization, training, and dissemination of Center technologies under TOPs, DBPs, and CEs. Sample data may include the following.

• Research publications enabled directly and indirectly by the Center technologies;
• Other successes such as patents, grant awards, license transfers, or spin-off companies;
• Breadth and geographical reach of DBPs and trainees;
• Other outcomes from Community Engagement activities.

The report of recommendations prepared by the EAC must be included under G.1 of the annual RPPR.

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 FOAs 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.

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the BTOD program, employing representative measures identified below. In assessing the effectiveness of technology development investments, NIGMS may use information from progress reports and public databases, PDs/PIs, and from participants themselves. Where necessary, PDs/PIs and participants may be appropriately contacted after completion of the grant period for updates on participants subsequent outcomes. The overall program evaluation will be based on metrics that include, but are not limited to, the following:

• Aggregate types of materials, tools, and technologies provided by the Center;
• Grant awards enabled by the Center materials, tools, and technologies;
• Dissemination of Center materials, tools, and technologies through commercial agreements, licensing, and direct transfer to research laboratories;
• Training activities for outside users: their diversity and geographical reach;
• Patent applications;
• Publications from Center technologies or enabled by Center technologies.

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]

[email protected]

Vinod Charles, Ph.D.
Center for Scientific Review (CSR)
Email: [email protected]

Angela Urdaneta
National Institute of General Medical Sciences (NIGMS)
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.