Note the purpose is to clarify the application process for applicants and grantees and is not intended to replace the detailed information in the program announcement.
What are the main goals of the BRAIN U24 program?
BRAIN U24 program provides support to projects aiming to broadly disseminate developed and validated tools and resources that are highly relevant to specific goals of the BRAIN Initiative, and to integrate them into neuroscience research practice. Proposed techniques, resources or approaches must be at a stage wherein the potential value for research is well established, through publications or other demonstration methods. Projects should be highly relevant to specific goals of the BRAIN Initiative and must include dissemination of an existing resource and may engage in one or more of the following types of activities:
- Production and distribution of reagents (e.g., viral vectors or transgenic lines) using quality control manufacturing processes
- Minor improvements to increase the scale/efficiency of resource production and delivery
- Services providing customized instrumentation based on end user needs / minor adaptations to meet the needs of a user community.
- Provision of state-of-art components, devices, or integrated systems (e.g., for assaying neural activity and/or connectivity) either distributed to end users or operated as specialized core facilities with user engagement
- Resources focused on enabling the translation of neurotechnologies for human use
- Maintenance, minor enhancements, and distribution of open-source computational models and software packages
- User facilities that enable scientists from outside institutions to utilize specialized tools or techniques
- User training on the usage of new technologies or techniques
What are some examples of non-responsive applications?
The following types of activities are not responsive to this FOA:
- Projects focused on developing novel and unproven technologies and which lack clear indication that the resource is well established and validated, through publications or other demonstration methods.
- Projects focused solely on development of a specific technology or software. Applicants considering such efforts are encouraged to explore alternative funding mechanisms. Use of existing technologies to develop new reagents, such as genetic lines or constructs, may be appropriate for this FOA, but clear value to the intended user group must be demonstrated in the application.
- Projects where dissemination is not planned to occur by early year 2.
- Projects that support clinical trials or provide patient services. Applicants considering such efforts are encouraged to explore alternative funding mechanisms.
- Projects proposing repositories of brain and related bio-specimens.
- Projects which propose to develop or disseminate data standards that are needed to describe experimental protocols being created by or used in the BRAIN Initiative will not be responsive this RFA. Such applications should consider RFA-MH-20-128 instead.
What do you mean by broad dissemination?
While the overall number of users will vary from project to project, users should span many unique labs and institutions and represent diverse perspectives. The user base should not be confined to a homogenous user group nor concentrated in a geographic region. See https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp for further information regarding the definition of diverse perspectives within the BRAIN initiative and information of interest to NIH. This is applicable both for technologies with smaller, niche user bases and those with large user bases.
What do you mean by developed and validated tools/resources?
The resource should be at point where it is validated, through publications or other demonstration methods and where the investigator can make a strong case this is ready for broad dissemination and not further development and beta testing. Projects where substantial development activities are needed such that dissemination is not planned to occur by early year 2 are considered nonresponsive to the FOA.
What are the main features of this U24 mechanism?
This U24 is a milestone-driven cooperative agreement. Investigators are required to propose quantitative millstones for each year of requested support in their applications. When an application is suggested for funding, the NIH staff and investigators negotiate milestones prior to award. Milestones will then be included in the notice of award and would be used to assess the success of the project. Investigators are required to meet all milestones and provide milestone completion report in their annual progress report submitted to the NIH.
What are milestones?
Milestones should describe the goal of the work and not just a statement that the work will be completed. The milestone should indicate the desired outcome of a study and not simply that the study was conducted, e.g., “workshop attendance with 40 users representing 20 unique institutions”, NOT “workshop completed in year 1”. The milestones must provide objective and quantitative outcomes by which to justify advancing the project, and should be objective measures, recognizable as appropriate endpoints by reviewers knowledgeable in the specific scientific area. These should include the rationale for your choices for quantitative values for the success criteria. Applicants may consider this template in developing their milestone plan.
What is a cooperative agreement?
A cooperative agreement is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. It requires a level of involvement from NIH staff that is higher than for a typical research project (R) grant. After award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. In many cases these are milestone-driven and in order to receive subsequent years of funding, milestones in the notice of award must be met which demonstrate the resource continues to have clear value to the BRAIN community. Funding may be discontinued if it is determined this is not the case.
What is a Scientific Steering Group (SSG)?
Upon receiving the award, investigators are required to form a Scientific Steering Group, typically consisting of 3-5 external members. Scientific Steering Group should be diverse, including across geography, career stage, and expertise. Expertise of the panel should reflect user perspective, technical areas related to the resource, and/or dissemination experience.
Investigators are required to have at least two meeting with the SSG per year. SSG should provide guidance and feedback to the investigators. Milestone completion, and/or any changes to the milestones should be approved by the SSG.
Applicants do not need to name specific SSG members in their application; however, information on the proposed number of members, their scientific expertise, committee operations and frequency of meetings should be included
Am I eligible to apply if my resource was not developed using BRAIN initiative/NIH funds? Is my user base limited to BRAIN funded investigators?
Applications are not limited to existing BRAIN Initiative investigators or to technologies previously developed using BRAIN Initiative or NIH funds, nor must the end user community be limited to investigators with BRAIN Initiative funding.
What has been funded in the past?
You can find a list of funded U24 projects here.
What is meant by a sustainability plan?
Grantees are expected, during their award period, to seek additional resources to maintain their operations after NIH funding and should include plans for other sources of support for program sustainability, including descriptions of all institutional support, financial and collaborative arrangements, and/or agreements for payment for services. Sustainability activities may include the use of user fees as cost offsets.
What should I do if I am interested in submitting an application?
It is expected that you email the BRAIN U24 program officer, Dr. Natalie Trzcinski, with your Specific Aims at least one month prior to the due date.
When may I submit an application?
The application due dates are listed below:
February 15, 2022; October 14, 2022; June 14, 2023; February 14, 2024; October 11, 2024.
All applications are due by 5:00 PM local time of applicant organization.
Where might I find a sample milestone document?
A sample milestone document can be found here.
Who may I contact if I have questions about my application?
If you have questions prior to submission or after summary statement release, please contact Dr. Natalie Trzcinski.
For questions about the review process after submission and before summary statement release, please contact email@example.com
I have questions about the PEDP- where can I find guidance?
See https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp for further information, including a wealth of resources and FAQs.
Do I need permission to exceed $500,000 in direct cost?
No, prior approval is not needed for applications which exceed $500,000 in direct cost
How many letters of support can I include in my application?
No more than 10 letters from planned or potential end users may be submitted. It is encouraged that these letters demonstrate the applicant has considered diverse perspectives from the end user community. Applications may also include institutional letters which describe financial and collaborative arrangements, and/or agreements for payment for services, or letters which describe third party or strategic partner’s interest. The Letters of Support attachment of the application should include a cover page listing the name, institution, and proposed role for each individual providing a letter of support.
Can I include budget for project manager in my application?
Yes. Projects may include budget for project manager.
Are renewals allowed?
Yes, one renewal is allowed.
What information should I include in a renewal application?
Renewal applications should include a progress report which includes a detailed account of experiences in dissemination and engagement highlighting outreach to users with diverse perspectives during the previous funding period, including successful and unsuccessful strategies. Information should be included on how the program's past experiences inform the current plan. Any non-public demographic information collected should be aggregated and anonymized.
PIs proposing a renewal may consider aggregating user institution type using:
research-intensive, i.e., those with an average of NIH research project grant (RPG) funding greater than or equal to $7.5 million total costs per year over the past 3 fiscal years, and research-active, i.e., those with an average of RPG funding less than $7.5 million total costs per year over the past 3 fiscal years (RPG data are available through NIH RePORTER)”
PIs may consider aggregating user career stage using:
- Early career: 0-14 years since terminal degree
- Mid career: 15-29 years since terminal degree
- Late career: 30+ years since terminal degree
See https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp for further information of interest to NIH.
Renewal applicants are expected to have sought additional resources to maintain their operations after NIH funding and should include plans for other sources of support for program sustainability, including descriptions of all institutional support, financial and collaborative arrangements, and/or agreements for payment for services. Appropriate documentation should be included in the application. Provide other relevant information about the applicant’s approach for self-sustaining infrastructure and operations, and why NIH support in particular is needed to disseminate this resource.