NIMH Biobehavioral Research Awards for Innovative New Scientists (NIMH BRAINS) (R01 Clinical Trial Optional)

NIMH Biobehavioral Research Awards for Innovative New Scientists (NIMH BRAINS) (R01 Clinical Trial Optional) is sponsored by NIH. Supports early-stage investigators in launching innovative clinical, translational, or basic research programs in mental health disorders.

Expired RFA-MH-22-185: NIMH Biobehavioral Research Awards for Innovative New Scientists (NIMH BRAINS) (R01 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

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 ) Funding Opportunity Title NIMH Biobehavioral Research Awards for Innovative New Scientists (NIMH BRAINS) (R01 Clinical Trial Optional) R01 Research Project Grant March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No late applications will be accepted for this Funding Opportunity Announcement.

New Date May 24, 2025 per NOT-OD-25-113 (Originally June 21, 2025) 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 The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for recovery, prevention, and cure.

An essential element of this mission is the support and career promotion of the future generation of exceptionally talented and creative new scientists who will transform the understanding and treatment of mental illnesses.

To fulfill its mission of assuring a cadre of productive, highly innovative mental health investigators for the future, the NIMH needs to support programs to identify and inspire the best new investigators and facilitate their establishing high impact, independent research programs in areas relevant to the mission of the NIMH.

This award is intended to provide support for highly promising early stage investigators who may lack the preliminary data required for a traditional R01 and allow them to pursue their most innovative, creative, and potentially most impactful ideas at an earlier stage in their career.

In order to identify outstanding basic, translational and clinical investigators at the formative stages of their careers and assist them in launching innovative research programs with the potential to transform our understanding of the underlying mechanisms of mental illness and develop innovative treatments and prevention strategies, the NIMH has established this program of R01 research grants intended for Early Stage Investigators (ESI) according to NIH policy ( NOT-OD-17-101 ).

This program is designed specifically to support unusually creative investigators with highly innovative research ideas that may lack preliminary data necessary for a traditional R01. Accordingly, preliminary data are not required or expected but may be included to demonstrate feasibility. Competitive applications will balance the high risk of innovative methods and approaches with the potential for transformative gains to the field.

The program emphasizes both the potential of the Program Director/Principal Investigator (PD/PI) to be a future leader in the field and the innovation, creativity, and potential impact of the project. This program is expected to be highly competitive, and only a limited number of grants will be awarded per year.

Potential applicants are encouraged to consult the recent National Advisory Mental Health Council Genomics Workgroup report and research recommendations summary which describe NIMH priorities for genetics research on the etiology of mental disorders.

Additionally, applicants are encouraged to read two guide notices that clarify NIMH interests for stress-related research ( NOT-MH-18-058 ) and considerations regarding the use of animals in research relevant to mental illness ( NOT-MH-19-053 ). Project effort for mentored K-awardees: Mentored K awardees are encouraged to seek R01 or equivalent funding to support their research programs.

Therefore, the NIMH expects that such awardees may be particularly interested in seeking support through the BRAINS R01 program. Such PDs/PIs are encouraged to consult with their mentored K Program Official at NIH prior to submission to ensure that the large effort commitments of both awards are feasible for their individual circumstance.

However, since the BRAINS program requires a minimum of 6 person months per year, BRAINS K-Awardees should not apply unless they will be in the final two years of the K-Award at the time of a BRAINS award in light of NIH policy limiting reduction in minimum required percent effort for K recipients (see NIH Guide NOT-OD-09-036 ).

Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. See Section VIII. Other Information for award authorities and regulations.

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ). The application’s PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice.

Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

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. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIMH intends to commit $3,000,000 in each of fiscal years FY 2024, 2025, and 2026 to fund 6-8 awards. An applicant may request a budget for direct costs up to $500,000 per year.

The total project period for an application submitted in response to this FOA may not exceed five 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 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 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 not 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.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

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. Applicants must be designated Early Stage Investigators (ESI) by NIH as defined in the NIH Grants Policy Statement .

In addition, applicants must have faculty appointments which are tenure track or equivalent, generally at the level of Assistant Professor or equivalent, and have a research or health professional level degree (e.g., Ph. D. , M.

D. , or equivalent) at the time of application. If the applicant is at an institution/organization that does not have a tenure track, he or she must hold an equivalent appointment and must have demonstrated support from the institution.

Individuals must show that they have established research independence from a mentor, and have dedicated independent laboratory and research resources available to conduct the research proposed in the grant application.

If an ESI applicant loses their ESI status by virtue of successfully competing as a PD/PI for a substantial NIH independent research award prior to the award of a BRAINS award, they will lose their eligibility to receive the BRAINS award.

Potential applicants who anticipate developing or testing interventions that focus on measuring target engagement and mechanism of action are strongly advised to contact the Scientific/Research Contact for this FOA regarding the match between an application, current NIMH priorities, and the unique goals of this FOA.

If a PD/PI has submitted to a prior BRAINS FOA but was not successful in receiving funding, they may be eligible to apply again if they still have NIH ESI status and the application proposes a scientifically distinct project than the prior submission. Resubmissions or submission of the same project as a new application are not allowed under this RFA. 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, per 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ) Additionally, a resubmission or submission of the same project as a new application are not allowed under this RFA. 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 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: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. 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. All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed.

Other Attachments: Include a "Future Goals and Objectives" attachment (one page maximum) that briefly describes the career track and long-term research interests/objectives of the PD/PI with emphasis on how these interests/objectives relate to the mission of NIMH. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed.

Biographical Sketch: The "Personal Statement" section of the biographical sketch should clearly describe the applicant's scientific development from graduate school, the postdoctoral experience(s), through the present faculty position. Provide evidence to support your claim of innovation and creativity and describe the impact that your research has had on the field to date.

For example, describe experiences that demonstrate your inclination to challenge paradigms and take intellectual risks, develop unique collaborations, integrate diverse sources of information, or develop novel approaches when new challenges or opportunities arise. All instructions in the SF424 (R&R) Application Guide must be followed.

The PD/PI should budget sufficient travel costs to present results of the research at a variety of high-caliber technical meetings, at least one of which is devoted directly to mental health research and is widely attended by other NIMH grantees. A portion of the budget could include travel for external members of the advisory committee to meet yearly.

In addition, the PD/PI should budget for travel to the NIH campus in Bethesda, MD each year in years 3-5 to present a seminar or participate in a research symposium. Applicants are expected to devote at least 6 person months (50%) effort to the grant.

However, after three full years of funding for this grant, should the PD/PI be successful in obtaining funding through another R01 or similar award, the effort on the BRAINS award may be negotiated with the NIMH program staff down to no less than 3. 6 person months, (30%), if adequate progress has been made on the aims of the BRAINS award. In addition, the awardees' departments are encouraged to provide an additional 3-3.

6 person months (25-30%) release time from clinical, teaching, and administrative duties in order to allow the awardee to devote a larger amount of time to research efforts. For MPI applications, the effort requirements described above apply to each PI. 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. Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Research Strategy: In the Research Strategy applicants must address the following topics as they pertain to the research project proposed: The challenge: What is the hypothesis or problem that will be addressed?

If you are testing an unconventional, exceptionally novel hypothesis, how does it challenge the standard paradigm? If no paradigm exists, how will your project create one? Innovation: State clearly and concisely what makes your project unusually innovative.

Approach: Provide enough information so that reviewers can determine what you are proposing to do. If your methodology is standard, what is unconventional and exceptionally innovative about your approach? How does your approach differ from what other investigators have attempted to do?

If the approaches entail a high degree of risk, what will you do if these approaches are unsuccessful and how do the potential benefits/rewards outweigh the risks? If you are including collaborators on the project for aspects of the project that are not within your expertise, please describe their roles and how they will contribute to the success of the project and the research career advancement of the PD/PI.

This information should not overlap with information in the biosketches. The appropriateness to the BRAINS program: Why is the proposed research uniquely suited to the stated goals of the BRAINS initiative, rather than a conventional research grant application? Timeline: Provide a timeline for the proposed research that does not overlap the Study Timeline submitted on the Human Subjects-Clinical Trial Information form, if applicable.

Advisory Committee: The PD/PI is expected to include the establishment of a to-be-named external advisory committee.

It is very important that potential advisory board members not be contacted or identified in advance (i.e., in the application) to minimize conflicts during the review process and so that all individuals with appropriate scientific expertise remain eligible for consideration by NIMH review staff for the peer review panel that evaluates BRAINS applications.

If an application is selected for funding, NIMH will request the names of advisory committee members as part of the Just-in-Time process. The application should indicate the areas of scientific expertise and anticipated input, and any critical considerations in the selection of potential members. Advisory committee members cannot be collaborators or consultants on the proposed project.

The Advisory Committee is expected to meet at least annually to provide ongoing assessment of the progress of the research; to discuss future research goals, aims, and ideas; and to provide research career guidance to the awardee during the five years of the grant.

NIMH suggests an Advisory Committee structure such as the following: At least three scientists, two of whom are external to the Department, (one external to the University or Institution). One member should have research expertise similar to that of the PD/PI, and one should be an individual who is expert in human or clinical studies and who can provide input into the translation of the research.

A schedule for the Advisory committee meetings should be included in the timeline. During the project period, the PD/PI will be expected to describe the proceedings of the advisory committee in annual progress reports. Letters of Support: The Chair of the Department where the PD/PI holds the primary academic appointment must provide a letter describing any tangible research support that has been committed to the PD/PI.

This may include start up packages provided to the investigator, salary commitment, protected time for research, space and equipment allocations, core facilities that will be made available without charge-back, specialized training and mini-sabbatical experiences to promote career enhancement, etc. In addition, the letter should discuss the departmental commitment to protected research time for the applicant.

The department is encouraged to provide release time so that the applicant will be able to devote at least 6, and preferably up to 9 person months (75%) of his/her professional effort to research (See Section III - Eligible Individuals (PD/PI)). The strength of the institutional support will be considered a factor in the review of the application.

If a previous postdoctoral or research mentor remains in the same Institution as the PD/PI, a letter should be included in the application outlining the respective roles of the PD/PI and the research mentor in the design and conduct of the proposed research. The previous research mentor should also indicate how the proposed research program is expected to be independent from the research directions of his/her laboratory.

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. All applications, regardless of the amount of direct costs requested for any one year, should include plans to share data via the NIMH Data Archive .

Data Sharing Plan should incorporate expectations outlined in NOT-MH-19-033 Notice of Data Sharing Policy for the National Institute of Mental Health To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-19-033 ).

Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this FOA are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission.

The NDA web site provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page .

Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to NDA and review their data for accuracy after submission.

Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied.

The NDA Data Sharing Plan is available for review on the NDA website . NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary . 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.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement . 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII . All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form .

Failure to register in the Commons and to include