BRAIN Initiative: Reagent Resources for Brain Cell Type-Specific Access and Manipulation to Broaden Distribution of Enabling Technologies for Neuroscience (U24 Clinical Trial Not Allowed)

Department of Health and Human Services

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

National Eye Institute (NEI)

National Institute on
Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute on Drug Abuse (NIDA)

National Institute of Neurological Disorders and
Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

Funding Opportunity Title

BRAIN Initiative: Reagent Resources for Brain Cell Type-Specific Access and Manipulation to Broaden Distribution of Enabling Technologies for Neuroscience (U24 Clinical Trial Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Funding Opportunity Announcement (FOA) Number

RFA-MH-21-180

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.242, 93.279, 93.865, 93.273, 93.286, 93.867, 93.866, 93.213, 93.173, 93.853

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) from the NIH Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative is intended to support the establishment of facilities at minority-serving institutions (MSIs) and Institutional Development Award (IDeA)-eligible institutions for scaled production and distribution of brain cell type-specific access and manipulation reagents. Reagents will be initially developed in pilot resource projects for brain cell type-specific access and manipulation across vertebrate species from the BRAIN Initiative Armamentarium project. Awardees under this FOA will work with the other Armamentarium awardees to manufacture and distribute the resources for use throughout the neuroscience community. It is envisioned that the awardees will work both with the Armamentarium community as well as with the neuroscience research community to optimize the new reagents. The types of reagents to be produced and distributed could include but are not limited to viral vectors, nucleic acid constructs, and nanoparticles designed for selective access to and manipulation of brain cell types. Such reagents will enable neuroscientists to probe circuit function with high precision in experimental animals and ex vivo human tissue and cells. Facilities are needed to contribute to the production and distribution of BRAIN Initiative Armamentarium project reagents broadly to neuroscience users.

Posted Date

April 08, 2021

Open Date (Earliest Submission Date)

October 23, 2021

Letter of Intent Due Date(s)

30 days prior to the application due date(s)

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 23, 2021 November 23, 2021 Not Applicable March 2022 May 2022 June 2022
July 12, 2022 July 12, 2022 Not Applicable November 2022 January 2023 February 2023

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

No late applications will be accepted for this Funding Opportunity Announcement.

Expiration Date

July 13, 2022

Required Application Instructions

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.
  4. Table of Contents

Section I. Funding Opportunity Description

Background

Since 2014, the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space. It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders.

As one of several federal agencies involved in the BRAIN Initiative, NIH’s contributions to the BRAIN initiative were initially guided by “BRAIN 2025: A Scientific Vision,” a strategic plan that detailed seven high-priority research areas. This plan was updated and enhanced in 2019 by: “The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures” and “The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society.” This and other BRAIN Initiative Funding Opportunity Announcements (FOAs) are based on this vision and issued with input from Advisory Councils of the 10 NIH Institutes and Centers supporting the BRAIN Initiative, as assisted by the NIH BRAIN Multi-Council Working Group.

The NIH BRAIN Initiative 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, the NIH BRAIN Initiative encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

  • Transdisciplinary research projects and collaborations among neuroscientists and researchers from fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics. 
  • 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.
  • Participation of individuals from diverse backgrounds, including groups traditionally 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.

The NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business FOAs.

The BRAIN Initiative requires a high level of coordination and sharing between investigators. It is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities such as the annual PI meeting. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.

This FOA is related to the transformative project, “A Cell Type-Specific Armamentarium for Understanding Brain Function and Dysfunction,” described in “The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures” report of the Advisory Committee to the NIH Director BRAIN Initiative Working Group 2.0.

Broad Distribution of Enabling Technologies for Brain Cell Type-Specific Access and Manipulation

Recent progress in experimental neuroscience has been driven by new methods and technologies. These have in turn inspired new discoveries and hypotheses. Among new technologies are reagents to access and manipulate specific brain cell types in experimental animals and human ex vivo tissue and cells (e.g., adeno-associated viral (AAV) vectors, lentiviral (LV) vectors, rabies viral vectors, nanoparticles, improved transgenic engineering methods, molecular sensors of neural activity, optogenetic and chemogenetic effector proteins, gene editors). These molecular and genetic tools enable the dissection of neural circuit function through the precise delivery of mapping, monitoring, and manipulation reagents. Novel reagents have enabled the description of neural activity with sub-second timing and across thousands of individual neurons in behaving animals. A dynamic and detailed picture of the brain in relation to behaviors has started to emerge.

Increasing numbers of brain cell types are being defined based on comprehensive transcriptomic, epigenomic, and anatomical profiling. The BRAIN Initiative has supported this effort through the BRAIN Initiative Cell Census Network, which began in 2014. By 2020, this program defined, for example, at least 55 distinct cell types in regions of the mouse primary motor cortex. These neuronal cell types can be related in hierarchical classes defined by neurotransmitter identity, cortical layer position, or projection pattern. Many more cell types will continue to be delineated in the cortex and subcortical regions and across several species.

The BRAIN Initiative Armamentarium project intends to leverage this brain cell type information to create molecular or genetic access reagents to deliver mapping, monitoring, and manipulation payloads to distinct circuit components. The Armamentarium project is conceptually aimed at enabling unique access to each molecularly defined brain neural cell type that could exhibit a distinct cellular, circuit, or behavioral function. A pilot phase of the Armamentarium project, supported through  RFA-MH-20-556, will start the effort with demonstration projects to design, create, and validate reagents for unique access to defined neural cell types found in limited brain regions or networks of vertebrates. In addition, the pilot phase will also include cataloguing of the reagents for users in a brain atlas that is registered to cell types based on molecular, anatomical, or other properties. Moreover, the pilot phase awardees will produce and distribute reagents to neuroscience researchers. This FOA is intended to augment the reagent production and distribution efforts of the Armamentarium project.

As progress in experimental neuroscience has been driven by new methods, broader distribution of these enabling technologies could increase their impact on the study of the brain. Specialized reagent production infrastructure will be needed. The expansion of research infrastructure has been considered by the NIH as a means to promote diversity in the biomedical research workforce. The 2012 Draft Report of the Advisory Committee to the NIH Director Working Group on Diversity in the Biomedical Research Workforce recommended that “NIH should undertake a bold, well-funded, multi-year, incentive-based, competitive grant process to support infrastructure development in those comparatively under-resourced institutions with a documented track record of producing and supporting under-represented minority scientists as well as stimulating creative partnerships among these institutions and, where appropriate, including more resource-rich institutions.”

Likewise, the NIH has supported, through the National Institute of General Medical Sciences (NIGMS), the Institutional Development Award (IDeA) program to increase the geographic distribution of NIH funding for biomedical research. A strategy of the program is to “provide support for institutional research infrastructure enhancement” (“National Institute of General Medical Sciences 5-Year Strategic Plan,” March 2015).

Consistent with the above text, the goals of this FOA are to broaden distribution of specific enabling technologies for neuroscience; promote Armamentarium project reagent production infrastructure at minority-serving institutions (MSIs) and institutions in IDeA-eligible states; and increase the participation of under-represented groups in neuroscience research in terms of race, ethnicity, and US geographical location.

Resource Objectives

Reagent resources supported under this FOA must include three main functions. First, the resources will interface with the pilot Armamentarium project investigators (awardees of RFA-MH-20-556), who will design, validate, catalogue, and produce brain cell type-selective reagents. Second, the resources will conduct scaled-up production of the designed and validated reagents. Third, the resources will disseminate reagents to neuroscience research users. Reagent resources are sought to enable access to brain cell types in vertebrate species that are of significant interest to neuroscience researchers. Such resources are envisioned to support especially investigation of brain cell types and/or species with previously limited access.

Resource Scope

Interfacing with Armamentarium Project Investigators

Applicants must propose plans to partner with at least one pilot Armamentarium project. Plans must be described to receive validated reagent designs, reagent templates, and/or seed reagents from the partner(s) that were made under RFA-MH-20-556. A significant proportion of the pilot reagent designs, templates, and/or seed reagents from the partner(s) must be received. Plans must also be described for interfacing with the partner(s), for example, to improve the reagents, optimize the scaling up of reagent production, and/or further catalogue the reagents. The reagent types for production will depend on the nature and progress of the pilot Armamentarium projects. The types of reagents to be produced could include but are not limited to viral vectors, nucleic acid constructs, and nanoparticles designed for selective access to and manipulation of brain cell types. NIH will facilitate additional collaborations with the awardees under RFA-MH-20-556 as appropriate through a research consortium (see further below).

Scaled-up Reagent Production

Applicants must propose plans to scale up production of a significant proportion of the pilot reagents from the partner(s). The plans must detail strategies for scaled-up reagent production at an MSI or IDeA-eligible institution. Quality control metrics for reagents must be described, and quality assurance for the production processes must be delineated. Applicants must describe plans for the characterization, formulation, evaluation, and validation of the efficacy, reproducibility, stability, activity, and unique characteristics of produced reagents. Reagents for in vivo use must be proposed to be highly purified and produced in a manner safe and appropriate for use in animals and/or human ex vivo tissue and cells. Storage, inventory management, and domestic and international distribution approaches must be outlined.

Disseminating Reagents to Neuroscience Research Users

Applicants must propose plans to catalogue scaled-up product inventory for dissemination to users in the neuroscience community generally, including those at MSIs, institutions in IDeA-elgible states, and elsewhere. Such catalogues must be made widely accessible and kept updated. Plans to manage reagent delivery to users must be described. Efforts to assess the ongoing user demand for various reagents as well as to receive and incorporate constructive user feedback must be outlined. Applicants are required to propose creation of a website to achieve the above user interface objectives.

Successful applicants will be responsible for management and oversight of large-scale production and distribution activities including, but not limited to, material transfer and licensing agreements, webhosting, and recovery of production and distribution costs. Applicants are expected to include project management effort and personnel for proposed facilities for the production and dissemination of reagents.

Applicants are strongly encouraged to consult the Scientific/Research Contact(s) listed below to discuss the alignment of their proposed work with the FOA goals. A Technical Assistance teleconference will be held for potential applicants on Tuesday, July 13, 2021, from 1:00-2:00 PM ET. NIH staff will be available to answer questions related to this FOA. To obtain participant information, please contact by email the NIMH Scientific/Research Contact(s) listed below at least 24 hours prior to the call and specify the FOA number in the subject line or in the body of the email.

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

Other Objectives

Successful applicants will become part of a research consortium (see further below) encompassing other awardees from this FOA and awardees from the Armamentarium project. The NIH expects the consortium to operate as a cooperative network to promote collaboration and coordination, and to achieve the program’s overall goals. This will include regular meetings and other coordinated activities within the consortium as well as in the BRAIN Initiative more broadly.

Applications may propose to incorporate technology development and optimization, but these efforts should be integrated into a larger reagent production, use, and distribution project. For example, technology development and optimization could be incorporated to augment or improve existing methods for scaled-up reagent production based on feedback from reagent users.

Applicants must propose data sharing plans that are consistent with the Data Sharing Policy for the BRAIN Initiative.

Applications must include proposed milestones and a proposed timeline, both of which will be evaluated as part of the review process, but final versions of each will be agreed upon at the time of award. If justified, future year milestones may be revised based on data and information obtained in the current year. The milestones and timeline should include the timing and quantity of dissemination of reagents to the neuroscience community.

Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.  

Responsive Areas of Research

Examples of responsive activities include, but are not limited to:

  • Scaled-up production of adeno-associated viral (AAV) or lentiviral (LV) vectors containing transcriptional regulatory elements that enable selective or specific expression of neural activity monitoring or manipulation payloads in molecularly defined brain cell types that could have functional relevance.
  • Dissemination of cell type access and manipulation reagents for brains of vertebrate animals and/or human ex vivo brain tissue or cells to identify, characterize, and/or alter potentially disease-relevant neural cells or circuits.
  • Distribution of reagents related to scalable use of somatic cell, CRISPR gene editing to knock in monitoring or manipulation constructs to a collection of gene loci that contain cis regulatory elements that drive expression in specific brain cell types.
  • Large-scale production of AAV capsid variants to selectively transduce brain neural cell types.
  • Widescale dissemination of lipid nanoparticles containing surface proteins that mediate selective transduction of brain neural cell types with genetic constructs.
  • Manufacturing of LV vectors pseudotyped with antibody or nanobody proteins to mediate selective transduction of brain neural cell types targeting cell surface antigens.
  • Scaled-up production of transgenic mouse, rat, zebrafish, or other vertebrate responder lines containing widely used reporter, monitoring, or manipulation constructs that can be combined with molecular access driver reagents to be expressed in specific brain neural cell types.
  • Scaled dissemination of transgenic or genome engineered animals having knock in reporter, monitoring, or manipulation constructs passed through the germline and targeted to gene loci for brain cell type-specific expression in a manner that very substantially reduces the time, cost, and breeding required by current methods in experimental vertebrate organisms.
  • Large-scale production of combinations of molecular access reagents that intersectionally refine expression or delivery of monitoring and manipulation constructs to brain cell types with greater specificity.
  • Creation and maintenance of website-based catalogues of produced access reagents for users, showing inventory levels, efficacy, reproducibility, stability, activity, and unique characteristics of reagents; providing data on ongoing demand; and enabling receipt and incorporation of constructive user feedback.
  • Scaled distribution of a collection of systemically administered viral or non-viral reagents that efficiently cross the blood brain barrier and direct construct expression to molecularly defined brain cell types and that detarget peripheral organs.
  • Distribution of reagent use protocols that define parameters and methods for brain cell type-selective reagent use administered systemically or intracranially to minimize undesirable, perturbative effects of vectors or payloads.
  • Large-scale brain cell type-selective reagent manufacturing and dissemination platforms that ensure quality control, quality assurance, and adequate supply for neuroscience community users, including assessment of the quality of reagents.
  • Scaled production of collections of viral or non-viral vectors that enable neuronal projection mapping of or transsynaptic tracing initiated from defined brain cell types.
  • Widescale distribution of RNA-based reagents to target brain cell types based on nucleic acid complementarity, protein-RNA interaction, or nanoparticle delivery.
  • Integration of data on reagent performance, improvement of reagents, and provision of feedback to reagent designers.
  • Organization of reagent inventories and management of domestic and international deliveries to users.

Non-responsive Areas of Research 

The following research areas are considered outside the scope of this FOA, and such applications will be considered non-responsive and will not be reviewed:

  • Applications that fail to propose to address all three main functions of a resource where: (1) the resource will interface with the pilot Armamentarium project investigators (awardees of RFA-MH-20-556), who will design, validate, catalogue, and produce brain cell type-selective reagents; (2) the resource will conduct scaled-up production of the designed and validated reagents; (3) the resource will disseminate reagents to neuroscience research users.
  • Applications primarily focused on the pursuit of a biological mechanism or a hypothesis through basic research that does not result in the generation of a scaled-up reagent production and distribution resource.
  • Studies primarily focused on technology development that do not propose a scaled-up reagent production and distribution resource. Note: Applications for technology development may be submitted to other BRAIN Initiative FOAs (including RFA-MH-19-135, RFA-MH-19-136, RFA-MH-21-140, RFA-MH-20-135, and subsequent reissues).

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

Resubmission

Revision

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

Funds Available and Anticipated Number of Awards

Issuing IC and partner components intend to commit an estimated total of $2,000,000 per year to fund 2 to 4 awards.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 3 years.

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

Eligible Organizations

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

Enhancing Diversity

The overarching goal of this program is to enhance diversity among BRAIN Initiative research area institutions through research infrastructure support at institutions:

  • That have a historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation (NSF; see http://www.nsf.gov/statistics/wmpd; i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities), or

  • That have a documented record of: (1) recruiting, training and/or educating, and graduating underrepresented students as defined by the NSF (see above), which has resulted in increasing the institution’s contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers, or
  • From IDeA-eligible states and jurisdictions (those with historically low NIH grant funding success rates); see https://www.nigms.nih.gov/Research/DRCB/IDeA) for a current list.

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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.

  • Dun and Bradstreet Universal Numbering System (DUNS) – All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • 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.

  • eRA Commons – Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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.  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 NOT-OD-11-101).

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.

Letter of Intent

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

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

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Email: nimhpeerreview@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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.

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:

Other Attachments:

Plan for Enhancing Diverse Perspectives (PEDP)

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

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

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

SF424(R&R) Senior/Key Person Profile

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

Applicants may include project management personnel for the proposed facilities for the production and dissemination of reagents as Senior/Key Person(s).

R&R Budget

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

PEDP implementation costs:

Applicants should include as aspects of annual budgets the following costs:

  • Annual costs for product development, characterization, and testing to maintain a minimal inventory of reagents. Costs should include the purification, formulation, vialing, characterization, evaluation, quality control, quality assurance and/or other related activities.
  • Costs for project management and website/catalogue development and maintenance.
  • Costs for attendance at the anticipated annual in-person meeting for the consortium of awardees of this FOA and RFA-MH-20-556.

Do not budget for:

  • Production costs to manufacture reagents beyond the minimal inventory for distribution to requesting users. Neuroscience research users requesting reagents will pay for production costs.
  • Shipment and delivery of reagents. Neuroscience research users requesting reagents will pay for shipping costs.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy

Applicants must include as part of the research strategy:

1. Plans for the resource to interface with the pilot Armamentarium project investigators (awardees of RFA-MH-20-556), who will design, validate, catalogue, and produce brain cell type-selective reagents. This must include plans to:

  • Partner with at least one pilot Armamentarium project.
  • Receive validated reagent designs, reagent templates, and/or seed reagents from the partner(s) that were made under RFA-MH-20-556. A significant proportion of the pilot reagent designs, templates, and/or seed reagents from the partner(s) must be planned to be received.
  • Interface with the partner(s), for example, to improve the reagents, optimize the scaling up of reagent production, and/or further catalogue the reagents.

2. Plans for the resource to conduct scaled-up production of the designed and validated reagents. This must include plans to:

  • Scale up reagent production at an MSI or IDeA-eligible institution of a significant proportion of the pilot reagents from the partner(s).
  • Control the quality of reagents and assure the quality of production processes.
  • Characterize, formulate, evaluate, and validate the efficacy, reproducibility, stability, activity, and unique characteristics of produced reagents.
  • Highly purify and produce reagents in a manner safe and appropriate for use in animals and/or human ex vivo tissue and cells.
  • Store reagents, manage inventory, and distribute reagents domestically and internationally.

3. Plans for the resource to disseminate reagents to neuroscience research users. This must include plans to:

  • Catalogue scaled-up product inventory for dissemination to users in the neuroscience community. Such catalogues must be planned to be made widely accessible and kept updated.
  • Manage reagent delivery to users.
  • Assess the ongoing user demand for various reagents as well as to receive and incorporate constructive user feedback.
  • Create a website to achieve the above user interface objectives.
  • Manage and oversee large-scale production and distribution activities including, but not limited to, material transfer and licensing agreements, webhosting, and recovery of production and distribution costs.
  • Conduct project management for proposed facilities for the production and dissemination of reagents.

Applicants must include as part of the research strategy proposed milestones and a proposed timeline for achieving the three above elements.

Applicants should describe plans for Program Income, if any, including the expected charges to the neuroscience research community for distributing reagents.

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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.

Appendix:

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

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.

6. Funding Restrictions

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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

Because this FOA specifically seeks applications to scale up the generation of brain cell type-specific reagents, the NIH expects that some applications may propose mature and well-established approaches that may not be innovative per se to produce robust high-quality reagents for broad use by the research community. In their evaluation of Innovation, reviewers will be asked to weigh the potential of the applications to develop novel approaches and/or to integrate existing approaches in novel ways.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Resource address the needs of the research projects that it will serve? Is the scope of activities proposed for the Resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research projects?

How likely is the reagent resource to be significant for accessing brain cell types in circuits that are of interest to neuroscience researchers? To what extent will the reagent resource likely provide access to brain cell types in species with previously limited access? To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Resource? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing cell type-selective reagent research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Resource is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Resource? Does the applicant have experience overseeing selection and management of subawards, if needed?

To what extent have the investigators, collaborators, or other researchers demonstrated experience and expertise in scalable production and dissemination of reagent resources? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Innovation

Does the application propose novel organizational concepts, management strategies, or methods in coordinating the research projects the Resource will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or methods proposed?

How well does the application integrate existing approaches in novel ways? Will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

How well does the application describe feasible and effective plans to: (1) interface with the pilot Armamentarium project investigators (awardees of RFA-MH-20-556), who will design, validate, catalogue, and produce brain cell type-selective reagents; (2) conduct scaled-up production of the designed and validated reagents; and (3) disseminate reagents to neuroscience research users?

  • To what extent will the applicant receive validated reagent designs, reagent templates, and/or seed reagents from the partner(s) that were made under RFA-MH-20-556?
  • To what extent will the applicant interface with partners to improve the reagents, optimize the scaling up of reagent production, and/or further catalogue the reagents?
  • To what extent will the applicants scale up production at an MSI or IDeA-eligible institution of a significant proportion of the pilot reagents from the partner(s)?
  • How well will the applicant quality control reagents and quality assure the production processes? To what extent will the applicant characterize, formulate, evaluate, and validate the efficacy, reproducibility, stability, activity, and unique characteristics of produced reagents?
  • How well will the applicant purify and produce in a manner safe and appropriate for use in animals and/or human ex vivo tissue and cells for reagents? How well will the applicant store reagents, manage inventory, and distribute reagents domestically and internationally?
  • To what extent will the applicant catalogue scaled-up product inventory for dissemination to users in the neuroscience community?
  • How well will the applicant manage reagent delivery to users?
  • To what extent will the applicant assess the ongoing user demand for various reagents as well as receive and incorporate constructive user feedback?
  • To what extent will the applicant website succeed in facilitating reagent user interface?
  • How well will the applicant manage and oversee large-scale production and distribution activities including, but not limited to, material transfer and licensing agreements, webhosting, and recovery of production and distribution costs?
  • How well will the applicant conduct project management for proposed facilities for the production and dissemination of reagents?

How well does the Data Sharing Plan provide a summary of the shared data, a description fo the data standards, a plan for the data archiving, and a timeline for data submission to the archive and sharing data with the research community?

Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

Will the institutional environment in which the Resource will operate contribute to the probability of success in facilitating the research projects it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Resource proposed? Will the Resource benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

To what extent will the environment enable scalable production and dissemination of reagent resources? To what extent will the environment promote brain cell type-selective reagent production infrastructure at an MSI and/or IDeA-eligible institution? To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Milestones and Timeline

Are the Proposed Milestones and Timeline described in sufficient detail and are they appropriate for the project? Is the timeline reasonable? Are the milestones feasible, well developed, and quantifiable with regard to the specific aims? Do the milestones and timeline describe well and reasonably the timing and quantity of dissemination of reagents to the neuroscience community?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms and (2) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For Resources involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

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

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

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

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

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities including the PEDP.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the
eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. 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 awardee 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. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.

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 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and NIH grant administration policies.

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

The PD(s)/PI(s) will have the primary responsibilities as described below:

  • Produce and deliver reagents to the neuroscience research community.
  • Determine and coordinate the reagent resource approaches and procedures, conduct experiments, and analyze and interpret reagent resource data generated under this award.
  • Meet or exceed the timeline stated in their application.
  • Agree to participate as a voting member in a Consortium Steering Group composed of other awardees from this FOA and RFA-MH-20-556, NIH staff, and an external expert group.
  • Share technologies, reagents, and data with consortium members.
  • Ensure that results are published in a timely manner.
  • Coordinate with other consortium members the publication of research results, dissemination of reagent resources, and dissemination of data.
  • Submit reagents and data for quality assessment and/or validation in any manner specified by the Steering Group or the NIH Project Scientist.
  • Submit semi-annual milestone reports to the NIH with completeness that include experimental design with rigor, including assumptions for the design of the experiments, the results of the investigations, interpretations of the results, and for concluding whether milestones have been met or not.
  • Provide updates at least annually on implementation of the PEDP.
  • Accept and implement any other common guidelines and procedures approved by the Steering Group.
  • Attend Steering Group meetings. It is likely that there will be one in-person meeting per year and that other meetings will be held by telephone or using internet assisted meeting software.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

  • A Program Officer will be assigned to this award. The Program Officer will be responsible for normal scientific and programmatic stewardship and guidance.
  • Prior to award, the Program Officer will negotiate final milestones with the PD/PIs that will be incorporated in the Notice of Award.
  • A group of NIH program staff from the ICs that make up the NIH BRAIN Initiative will form a Project Team for this award.
  • The Project Team will include the Program Officer for these BRAIN Initiative awards.
  • The Project Team will review annual progress reports and other documents from the awardees and will advise the Program Officer about their view of the progress being made by the awardee as well as about progress being made by others in the field.
  • One or more extramural NIH program staff member will be assigned as Project Scientist for this award. The same person may serve as a Project Scientist for multiple BRAIN Initiative awards.
  • The Project Scientist(s) will interact scientifically with the PDs/PIs of the cooperative agreement and other named key personnel as a partner in the resource activities.
  • The Program Officer and the Project Scientist(s) will be members of the Steering Group.

Areas of Joint Responsibility include:

  • The purpose of the Steering Group is to transfer information among the awardees of this FOA and RFA-MH-20-556 and between the awardees and the BRAIN Initiative more broadly in order to achieve the goals outlined in the BRAIN 2025 and BRAIN 2.0 reports.
  • The Steering Group will be comprised of the PDs/PIs of the awards of this FOA and RFA-MH-20-556, the Project Scientist(s), the Program Officer, and a group of external experts.
  • The PDs/PIs and Program Officer will invite a group of external experts to attend Steering Group meetings. The external expert group will be composed of three to five scientists who are not awardees of this FOA or RFA-MH-20-556, represent the broad research community, and have relevant expertise. The group may be enlarged permanently or on an ad hoc basis as needed.
  • A chair of the Steering Group, who is an awardee of this FOA or RFA-MH-20-556, will be designated by the Steering Group on a rotating basis as needed.
  • It is expected that most of the decisions on the activities of the Steering Group will be reached by consensus. If a vote is needed, each awardee will have one vote and the Project Scientist(s) collectively will have one vote.
  • The Project Scientist may assist in research planning, may present experimental findings from an award from published sources or from relevant award projects, may participate in the design of experiments agreed to by the group, may participate in the analysis of results, may help ensure that duplication is avoided, and will interact scientifically with the Steering Group.
  • The Program Officer and the external expert group members will attend Steering Group meetings as non-voting participants.
  • In all cases, the role of NIH staff will be to assist and facilitate, but not to direct activities.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. These three members include: a designee of the Steering Group chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee’s right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 1.

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000.  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 Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

Peer Review Contact(s)

Financial/Grants Management Contact(s)

Section VIII. Other Information

Authority and Regulations

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.

You may also like...

Leave a Reply

Your email address will not be published. Required fields are marked *