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

BRAIN Initiative: Reagent Resources for Brain Cell Type-Specific Access to Broaden Distribution of Enabling Technologies for Neuroscience (U24 Clinical Trial Not Allowed) is sponsored by National Institute of Mental Health (NIMH), National Institutes of Health (NIH). This funding opportunity supports the establishment of facilities, particularly at minority-serving institutions, to develop and broadly distribute reagent resources for brain cell type-specific access, thereby advancing neuroscience research through innovative neurotechnologies.

Expired RFA-MH-21-180: 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) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information 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 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 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) U24 Resource-Related Research Projects Cooperative Agreements September 26, 2024 - This RFA has been reissued as RFA-MH-26-120 .

June 14, 2022 - Notice to Extend RFA-MH-21-180, 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).

See Notice NOT-MH-22-250 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients.

See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel.

See Notice NOT-OD-21-109 May 7, 2021 - Notice of Correction to Eligibility Information of RFA-MH-21-180. See Notice NOT-MH-21-280 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility . 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.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date(s) Renewal / Resubmission / Revision (as allowed) 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.

New Date - October 25, 2023 (Original 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. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description 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. 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."

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.

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.

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.

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

Section II. Award Information 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 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. Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial?

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. Application budgets are not limited but need to reflect the actual needs of the proposed project. 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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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. Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations 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.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3. Additional Information on Eligibility 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. 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