BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R01 Clinical Trial Optional)

BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH) BRAIN Initiative. This Notice of Funding Opportunity (NOFO) from the NIH BRAIN Initiative supports efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative.

Expired RFA-MH-25-170: BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (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 ) 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: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (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 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity Exploratory/Developmental Grants See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) 93. 242, 93. 853, 93.

279, 93. 273, 93. 173, 93.

867, 93. 866, 93. 865, 93.

286, 93. 213 Funding Opportunity Purpose Guided by the goals established in BRAIN 2025: A Scientific Vision and reinforced by the Advisory Council to the Director Working Group on BRAIN 2.

0 Neuroethics Subgroup , this Notice of Funding Opportunity (NOFO) from the NIH Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative is intended to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative.

This NOFO encourages research project grant applications from multi-disciplinary teams focused on key ethical issues associated with BRAIN Initiative supported research areas. Efforts supported under this NOFO are intended to be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.

For small projects that are primarily exploratory in nature or designed to generate pilot data in preparation for a larger study, applicants should consider RFA-MH-25-171 , the BRAIN Initiative Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science Exploratory/ Developmental Research (R21) NOFO.

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

New Date May 24, 2025 per NOT-OD-25-113 (Originally October 10, 2026) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of 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. Notice of 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 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 NOFOs . The BRAIN Initiative requires a high level of coordination and sharing between investigators. It is expected that BRAIN Initiative recipients 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 . One of the defined themes in the BRAIN 2025 report is: “ Considers ethical implications of neuroscience research . ” Although ethical issues that are common to other areas of biomedical science also impact brain research, there are special ethical considerations unique to brain research.

Considering that the brain gives rise to consciousness, our innermost thoughts, and our most basic human needs, it comes as no surprise that mechanistic studies of the brain have revealed novel social and ethical questions.

With respect to research supported by the BRAIN Initiative, there are important ethical issues in areas such as brain imaging and modulation, data privacy, informed consent, and many other areas germane to the BRAIN Initiative that warrant focused attention. It is clear that these critical issues must be considered thoughtfully and with an empirical research framework.

Specifically, BRAIN 2025 describes the importance of “Support for data-driven research to inform ethical issues arising from BRAIN Initiative research, ideally with integrated activities between ethicists and neuroscientists.

” In addition, feedback solicited through a BRAIN Neuroethics Request for Information underscores that the broader public and scientists alike endorse that scientific advances and technology development are well-served by thoughtful consideration of potential ethical issues. This NOFO seeks to provide opportunities to directly consider the integration of ethical issues with BRAIN-supported scientific advances.

Specifically, this NOFO seeks to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements in research and development supported by the BRAIN Initiative.

The goal is that efforts supported under this initiative will be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative. The Advisory Council to the Director Working Group on BRAIN 2.

0 Neuroethics Subgroup identified several broad areas for the BRAIN Initiative to consider as suggested next steps: Enhance integration of neuroscience and neuroethics Provide additional tools and resources for neuroscientists to recognize neuroethics issues and opportunities for neuroethics research Assess the development and use of innovative animal and neural-circuit model systems Establish guidelines for the neuroscience data ecosystem that address data capture, storage, sharing, and translation to humans and society Initiate conversations and collaborations to address neuroscience applications beyond biomedical and clinical contexts In addition to these broad areas, several specific neuroethics topics remain central to the cutting-edge research supported through the BRAIN Initiative.

These topics include, but are not limited to: Research Participant Engagement, Special Populations, and Social Implications The ethical implications of access to and use of emerging neurotechnologies and their relationship to informed consent (participant perspective on the consent process, consent with special populations, changes in consent capacity associated with disease progression) Studies focused on the advances in neural recording and/or neuromodulation specifically for use in pediatric populations Public, researcher, and research participant attitudes and decision-making about monitoring or modulating brain function for purposes of improving our understanding of human brain function and/or reducing illness and disability due to brain diseases and disorders Considerations of the ethical implications of health disparities in the BRAIN Initiative, with additional consideration to cultural differences, treatment/access barriers, and efforts to enhance inclusion in the research enterprise Research on risk/benefit analyses and informed consent practices in human neuroscience research with neural devices, and long-term obligations to patient populations Studies that empirically consider different perspectives on the distinction between invasive versus non-invasive brain imaging and/or neuromodulation; particularly as those views are similar or different between groups such as participants, researchers, physicians, families, and the broader public view Ethical issues associated with predictive/diagnostic research related to brain disorders Data collection/storage/sharing and model systems Cybersecurity/privacy considerations, such as effective security and safeguards for human brain data and wireless transmissions to/from neural devices; gaps/provisions needed in existing regulatory models Studies that probe the ethical implications/considerations of both collecting large volumes of brain data and the sharing of such for broader scientific purposes Studies that explore the evolving richness of collected human neural data and considerations such as data ownership, access, de-identification and re-use practices, privacy, and unintended uses Studies that consider the ethical implications of evolving neuromodulation and neuroimaging technologies, specifically as they pertain to the infrastructure of these technologies (e.g., activation and monitoring of devices, long-term maintenance, data security, intended and unintended use of these new technologies) Research efforts to link neural data with behavioral data to better understand and/or diagnose brain diseases and disorders Ethical issues unique to research that leverages opportunities with human brain tissue Protection of Human Subjects : 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.

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.

Applications Not Responsive to this NOFO Applications proposing the study of specific disease mechanisms, or existing disease therapeutics and treatments, or focused on bioethical issues that are not central to or derived from the cutting-edge research supported by the BRAIN Initiative will be considered non-responsive to this NOFO and will not be reviewed.

Studies for the investigation of bioethics issues associated with specific diseases and disorders, or the mechanisms of such diseases should be directed to the appropriate NIH Institutes. 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 financial assistance 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 NOFO. 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 NIH BRAIN and partner components intend to commit an estimated total of $3M in fiscal years 2025, 2026, 2027 to fund up to 8 new awards, each year, contingent upon annual appropriations. Application budgets are limited to $300,000 in direct costs in any project year and need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum project period is 4 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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- including the NIH Intramural Program 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 (Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

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

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

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; 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 their 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. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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 How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO. 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. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. Applications must provide clear evidence that the proposed research team is comprised of highly skilled investigators in all areas of interdisciplinary science needed to advance the proposed research.

Where appropriate, applicants are strongly encouraged to propose embedding ethicists into BRAIN Initiative-supported research projects. All instructions in the SF424 (R&R) Application Guide must be followed. 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.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Research Strategy: All applications must include the following information: Research supported through this NOFO should focus on novel, transformative approaches that thoughtfully consider the integration of ethical considerations with evolving advancements in BRAIN Initiative research.

Applicants should make a compelling case as to why a specific ethical topic is particularly fertile for exploration at this point in time and how it relates to advancements in the type of research that the BRAIN Initiative supports. Applicants should describe how the proposed research will revolutionize how we think about ethics and/or integration of ethical considerations as research is planned and conducted.

Sufficient details should be provided regarding the methodological approach and discussion of how this line of research will be beneficial to brain research as well as the broader public. Finally, consideration regarding additional research that might stem from the proposed project should be described.

Current State-of-the-Art Statement: Applicants should clearly state the specific goals of their application to include defining the current state of the science/technology as a benchmark against which the proposed research will be measured.

Critically, applicants should provide an assessment of how their application will advance beyond the state-of-the-art, with an emphasis on the current specific ethical issues they expect to understand/improve, and how the proposed studies will enable and guide transformative advances in brain science.

Preliminary Data: While preliminary data are not required for this NOFO, if such data are included it should be limited and appropriately supportive of the proposed research. High-risk projects with limited preliminary results are welcome if they have the potential for suitable high impact.

A sound rationale should be provided as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful. Project Timeline and Milestones : A timeline must be included as part of the Research Strategy and should include a distinct final section, entitled “Milestones”, that briefly proposes operationally-defined indicators of progress at critical junctures.

These junctions include the translation from pilot research, if needed, to the translational efforts to systematically integrate advancements in ethical research into brain research. These milestones should be tailored to the unique scope of each project and written concretely enough to evaluate exactly what will be achieved during the course of the project.

This should include the specific proof-of-concept test(s), if applicable, that will indicate how the proposed approaches will be tested and validated along with alternative strategies should an effort fail to perform as expected. The application should describe the potential implications of how the proposed research might extend beyond the purview of BRAIN Initiative supported research.

Investigators should describe how results will be used to inform future phases of research and development, and how our current ethics standards will be transformed by the findings from the proposed research. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The data sharing expectations for BRAIN Initiative awards require that the data is deposited to relevant data archives developed by the BRAIN Initiative. Applicants can refer to NOT-MH-19-010 , for more information about BRAIN Initiative data sharing information.

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.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 2.

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. 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 Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications . 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 How to Apply – 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 Section 7.

9. 1 Selected Items of Cost . 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 field of the Senior/Key Person Profile form .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

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

Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. 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 co-investigators in accord with the Terms and Conditions provided in this NOFO. 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. Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Section V.

Application Review Information 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. While preliminary data are not required for