Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional) is a National Institutes of Health funding opportunity inviting Research Project Grant applications proposing to study the ethical, legal, and social implications of human genetic and genomic research.

Applications may use single or mixed methods including empirical qualitative and quantitative approaches, conceptual analyses, legal analyses, and normative analyses. Applied research addressing ELSI issues in genetics and genomics is also considered. Multiple NIH institutes participate, including NHGRI, NIMH, NCI, and others.

Direct community engagement is encouraged but not required.

PAR-25-371: Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional) 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. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Human Genome Research Institute ( NHGRI ) National Eye Institute ( NEI ) National Institute of Allergy and Infectious Diseases ( NIAID ) 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 Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Institute on Minority Health and Health Disparities ( NIMHD ) National Cancer Institute ( NCI ) Tribal Health Research Office ( THRO ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional) R01 Research Project Grant April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

November 13, 2023 - Notice of Pre-Application Webinar for Ethical, Legal and Social Implications (ELSI) Research: PAR-23-293 (R01 Clinical Trial Optional), PAR-23-294 (R21 Clinical Trial Optional) and PAR-23-295 (R03 Clinical Trial Optional). See Notice NOT-HG-24-010 . 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. 172, 93. 313, 93.

853, 93. 307, 93. 113, 93.

310, 93. 279, 93. 865, 93.

173, 93. 855, 93. 399, 93.

867, 93. 242 Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) invites Research Project Grant (R01) applications that propose to study the ethical, legal and social implications (ELSI) of human genetic or genomic research. Applications may propose studies using either single or mixed methods.

Approaches may include but are not limited to empirical qualitative and quantitative methods, and conceptual, legal, and normative analyses. Applied research designed to address ELSI issues in genetics and genomics will also be considered responsive. Direct engagement with communities and other interested groups is encouraged, but not required.

Funding Opportunity Goal(s) NHGRI supports the development of resources and technologies that will accelerate genome research and its application to human health and genomic medicine. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research.

NHGRI also supports the training and career development of investigators and the dissemination of genome information to the public and to health professionals. Open Date (Earliest Submission Date) 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.

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.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. 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 The 2020 NHGRI Strategic Vision notes that “genomics has become increasingly woven into the fabric of biomedical research, medical practice, and society” and points to the continued importance of focusing on ethical, legal, and social implications (ELSI) research.

As biomedical investigators are applying genomic knowledge and tools to study an expanding range of diseases and traits in a wide array of settings, novel ELSI questions continue to emerge. Innovations in gene editing, gene therapy, polygenic risk scores, and genomic testing across various life stages continue.

However, the use of new genomic technologies and information is not always preceded by confirmation of their validity, reliability or utility across populations. Sufficient evidence may be lacking to determine whether new innovations are transferrable across health care settings or valid in populations whose genomic data were not used in their discovery.

Professional norms, systemic practices, and societal forces may affect the uptake of genomic medicine across communities. Translating genomic research and data into benefits for the public presents another set of challenges. The relative dearth of genomic data collected from populations who remain understudied in biomedical research and underserved in the healthcare system can limit genomic utility and innovation.

Potential deficits may be exacerbated by the application of artificial intelligence and machine learning approaches to genomic data analysis. These methods will not produce accurate results if the data upon which they are trained are incomplete. Efforts to help ensure that the human genome reference sequence and population-based genomic datasets better represent existing human genomic variations are underway.

However, evaluating and addressing the availability and quality of genomic information for all Americans is an ongoing challenge. Genomic information can have profound implications for how people understand themselves as individuals, and in relationship or contrast to others. There are many examples where the value and predictive nature of genomic information was overstated and misappropriated to the detriment to society.

Examples include research suggesting that complex phenotypes such as hypertension, diabetes, and depression can be meaningfully explained by genomic factors without accounting for other non-genetic risk factors. These oversimplified attributions of individual and group differences to genetic causes alone threatens the integrity of genomic science and research.

Overall, ongoing advancement and change in the conduct of genomic research and the translation of genomic science may require key stakeholders to revisit, revise, and reiterate the norms and responsibilities that guide the field. New ELSI questions continue to arise about genomics while other questions endure, resurface, or are transformed.

Yet, at the forefront of genomics remains an incredible array of opportunities to improve the health and wellbeing of all people. The purpose of this NOFO is to solicit applications for research projects that identify, examine, and address the ELSI of advances in genomics for individuals, families, communities, groups, institutions, and society.

To address the broad scope and reach of genomics and corresponding ELSI issues, applications are invited from investigators representing a wide range of academic disciplines, including, but not limited to, bioethics, the humanities (e.g., history, religion, philosophy, literature), behavioral and social sciences (e.g., psychology, sociology, anthropology, political science, economics, communication science), law, genetic and genomic science, genetic counseling, clinical medicine, health services and implementation science research, health outcomes, health communications, public health, and data science.

Applications are encouraged from multidisciplinary investigator teams who represent a broad range of disciplines, experiences, and perspectives. Applications may propose studies using either single or mixed methods. Approaches may include, but are not limited to, conceptual, legal, and normative analyses, and empirical qualitative and quantitative methods.

Applied research conducted to address real-world ELSI issues facing genomics or to facilitate the uptake of ELSI findings may also be proposed. NIH encourages applicants to consider the use of variables provided in the PhenX Toolkit which provides recommended standard measures for use in biomedical research. These measures have been selected by domain experts using a consensus process.

The Toolkit provides protocols for collecting data, and tools to help investigators incorporate protocols into their studies. Using protocols from the PhenX Toolkit facilitates cross-study analysis, potentially increasing the reproducibility and scientific impact of individual studies. .

Community and Stakeholder Involvement There are a variety of communities and stakeholders whose knowledge, perspectives and experiences can inform and improve the field of genomics. Community or stakeholder involvement in any and all phases of a research project is not required but is allowed.

For the purposes of this NOFO, the term “community” refers to "a group or groups of people affiliated by geographic proximity, special interest, or similar situations" ( Centers for Disease Control and Prevention, 2011 ). The term “stakeholders” refers to “individuals, organizations or communities that have a direct interest in the process and outcomes of a project, research or policy endeavor” ( Deverka et al. 2012 ).

Community and stakeholder involvement may include a range of methods or approaches that vary in level and intensity including, but not limited to, establishment of advisory boards or panels, stakeholder-driven research, community-oriented research, or community-based participatory research.

Areas of Research Interest Participating NIH Institutes, Centers, and Offices (ICOs) listed at the top of this announcement have specified research areas of interest, outlined on the ELSI: Participating NIH ICOs webpage . Prospective applicants are strongly encouraged to review these resources and contact the scientific/research contacts listed in Section VII of this NOFO prior to initiating plans for application submission.

Related Notices of Funding Opportunity For small projects that are primarily exploratory in nature or designed to generate pilot data in preparation for a larger study, applicants should consider PAR-25-269, the ELSI Exploratory/ Developmental Research (R21) NOFO, which provides a total of up to $275,000 in direct costs over three years.

For very small projects, such as those involving single investigators, focused conceptual or analytical studies, or secondary data analyses, applicants may wish to consider PAR-25-270, the ELSI Small Research Grant (R03) NOFO, which provides a total of up to $50,000 in direct costs a year for two years. Note that not all Institutes and Offices participating in this R01 NOFO participate in the R21 and R03 NOFOs.

Recipients must comply with the NIH Data Management and Sharing Policy ( NOT-OD-21-013 ) and NIH Genomic Data Sharing Policy ( NOT-OD-14-124 ). NIH recognizes Tribal sovereignty and the rights associated with Tribal sovereignty around data collection, data management and sharing of data and has published a supplemental Notice regarding the DMS Plan for AI/AN populations, NOT-OD-22-214 .

NHGRI supports broad appropriate data sharing with timely data release through widely accessible data repositories. Please follow the NIH guidance on writing a Data Management and Sharing (DMS) Plan . Applications directed to NHGRI should ensure the Plan is in alignment with NHGRI’s data sharing expectations, which are summarized at genome.

gov/data-sharing . Applicants are strongly encouraged to contact NIH Scientific/Research Staff at the relevant participating ICO(s) listed at the end of this NOFO, prior to developing an application to discuss whether their application is responsive. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations. 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 How to Apply 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 The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets are not limited but need to reflect the actual needs of the proposed project. Budgets should include costs required to implement the proposed Data Management and Sharing Plan and the proposed Resource Sharing Plan The scope of the proposed project should determine the project period.

The maximum project period is 5 years, but given how quickly the field changes, it is expected that some projects will be no more than 4 years in duration. Longer project periods should be well justified. Additional consideration for longer projects may be given to new or early stage investigators or projects proposing significant stakeholder or community involvement.

All applicants are strongly encouraged to discuss project length with Scientific/Research Staff prior to submission. 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 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 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 How to Apply- 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 the 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 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 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 How to Apply-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. 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 How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. Budgets should include any funds required to support sharing of scientific data under this NOFO.

NIH provides guidance on allowable costs for data management and sharing here .

For projects generating genomic data derived from research participants, investigators should also consider costs associated with complying with the NIH and NHGRI GDS Policy expectations (e.g., obtaining samples with explicit informed consent for future research use and broad data sharing, implementing processes to seek new consent from study participants, etc.).

Applications that include community members or stakeholders as research team members or advisors should describe their research roles in the budget justification and describe budgetary support to enable their successful involvement in the project. All instructions in the How to Apply-Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Research Strategy: NIH encourages applicants to consider the use of variables provided in the PhenX Toolkit which provides recommended standard measures for use in biomedical research. These measures have been selected by domain experts using a consensus process.

The Toolkit provides protocols for collecting data, and tools to help investigators incorporate protocols into their studies. Using protocols from the PhenX Toolkit facilitates cross-study analysis, potentially increasing the rigor, reproducibility, and scientific impact of individual studies.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide. All applications, regardless of the amount of direct costs requested for any one year, must develop a Resource Sharing Plan consistent with the goals of the proposal.

The Resource Sharing plan should summarize whether and how research findings and products (e.g., publications, meeting reports, software, websites, research tools) will be made available to relevant communities and stakeholders.

Applicants should include a proposed timeline for implementing the Resource Sharing Plan, name the platform(s) or mechanism(s) that will be used to make research findings and products publicly accessible, and indicate who will be responsible for implementation. Applicants sharing software are encouraged to use software licenses that allow for unrestricted redistribution and modification of the software.

Additionally, NHGRI encourages investigators to consider disseminating research findings and products via publicly accessible platforms such as the Center for ELSI Resources and Analysis.

All instructions in the How to Apply-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. Please follow the NIH guidance on writing a Data Management and Sharing (DMS) Plan here , and ensure the Plan is in alignment with the NHGRI’s data sharing expectations explained below. Additional information can be found at genome.

gov/data-sharing .

Per NOT-HG-21-022 , NHGRI expects applications awarded under this NOFO to share comprehensive metadata and phenotypic, clinical, and environmental exposure data associated with the study; use standardized data collection protocols and survey instruments for capturing data, as appropriate; and use standardized notation for metadata (e.g. controlled vocabularies or ontologies) to enable the harmonization of datasets for secondary research analyses.

To ensure that maximal scientific benefit is derived from this significant public investment, this funding opportunity aims to advance and accelerate research by supporting rapid sharing of the resulting data with the broad scientific community.

All resulting scientific data should be submitted to an established repository as described in the Data Management and Sharing Policy guidance and NHGRI’s guidance on where to submit scientific data . Where human biological samples will be studied, they are expected to have been obtained using a documented informed consent process that allows for future research use and broad data sharing ( NOT-HG-20-011 ).

If new human biospecimens will be collected, or if clinical application is included in the application, the consent process should be described at a high level in the Research Plan and detailed in the Human Subjects Section.

NHGRI strongly encourages studies that propose to derive genomic data from human specimens and cell lines to obtain participant consent either for general research use through controlled access or for unrestricted access. Similarly, consent language should avoid both restrictions on the types of users who may access the data and restrictions that add additional requirements to the access request process.

NHGRI acknowledges that this will not always be possible or appropriate. In addition, individual participants who do not consent to future research use or broad sharing of their data (i.e., submission of their data to a publicly accessible data repository) may still participate in the primary study if consistent with study design. Additional guidance on informed consent can be found in the NHGRI Informed Consent Resource .

Applicants are encouraged to get feedback from the communities in which the research will be performed regarding plans for how individual level data resulting from the research projects will be shared with the scientific community for research purposes.

Feedback and recommendations for data access, protection of participant and patient privacy and confidentiality, and management of health information should be integrated into the project’s Data Management and Sharing Plan . Note that any project receiving NIH funding that collects or uses identifiable, sensitive information is automatically issued a Certificate of Confidentiality ( CoC ).

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide. No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply- 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 How to Apply- 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 How to Apply - 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 How to Apply - 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, NIH Applications that are incomplete or non-compliant will not be reviewed. Requests of $500,000 or more for direct