Part 1. Overview Information

Key Dates

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.

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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
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

Purpose:

The RIVER program is intended to invest in people rather than projects; rewarding individuals from the NIEHS grant recipient community who demonstrate a broad vision and potential for continuing their impactful environmental health research and who are most likely to benefit from a program emphasizing flexibility and sustained support.

Overview:

RIVER is intended to support investigators who demonstrate the potential to conduct outstanding, innovative, and transformative research and articulate a clear and compelling vision for revolutionary research to advance the environmental health sciences. For this reason, eligibility is limited. Please refer to Section III. Eligibility Information for specific details.

Key features and benefits of the program fall into two large categories: (1) freedom from traditional focused specific aims and a structured research plan which will enable investigators to pursue new directions in their research as they arise throughout the funding period, and (2) the ability to devote increased effort to research, mentoring, and scientific service due to reduced time spent writing and managing multiple grant applications and awards. These features are intended to facilitate ambitious, creative research strategies by providing a flexible and stable funding environment within a given scientific domain with broadly stated 'goals' rather than specific aims and by integrating emerging techniques that might be employed to address them rather than providing specific experimental details. 

RIVER is intended to support the majority of an individual's independent research program; as such, the R35 award will require a relinquishment and consolidation of projects funded by the NIEHS at the time the R35 is issued and dedication of at least 6 person months (i.e., the equivalent of 50% effort on a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) of the PD/PI's total effort to the project throughout the R35 award. NIEHS scientific program and grants management staff will review this information in relation to Other Support prior to award to ensure sufficient level of effort is dedicated to the project and to ensure no commitment overlap. Commitment overlap occurs when an individual's dedicated time exceeds 100% (i.e., 12 person months), whether salary is requested in the application.

Some types of grant awards will be excluded from consolidation, including:

• NIEHS-funded:
  • Multi-PD/PI research projects;
  • Clinical/Interventional Trials;
  • Grants supporting research resources;
  • Program project or center grants;
  • Contracts;
  • Cooperative agreements;
  • Grants supporting training/career development (Institutional or individual);
  • SBIR/STTR grants;
  • Conference grants;
• Research projects that are administered by the NIEHS but funded by other ICs or Agencies.

The NIEHS will not consider funding future individual or multiple PD/PI research grant applications from current R35 awardees until the final year of their award; however, the RIVER does not eliminate the eligibility of the PD/PI for the following separate sources of NIEHS funding:

• Grants supporting research resources;
• Program project or center grants;
• Contracts;
• Cooperative agreements;
• Grants supporting training/career development (Institutional or individual);
• SBIR/STTR grants;
• Conference grants;
• R35-eligible supplements (R35 awardees should check R35 eligibility on funding opportunities for supplements).

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

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

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

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 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.

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. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted. Applications that do not meet eligibility requirements will be deemed non-responsive and will not be reviewed.

Eligibility is determined by NIEHS after the receipt of applications on the intended application due date. Eligibility to apply to this NOFO is limited to those individual PD/PIs who meet one of the following criteria:

• Is currently PD/PI on at least one single-PD/PI (i.e., not Multi-PD/PI) NIEHS-supported R01-equivalent (defined here as R01, DP1, DP2, DP5, or U01) award that has been supported by NIEHS for 4 years (i.e. active at the time of application and in Fiscal years 2022, 2023, and 2024 including up to 1 year of no-cost extension within this period), OR
• Was PD/PI on at least one single-PD/PI (i.e., not Multi-PD/PI) NIEHS-supported R01-equivalent (defined here as R01, DP1, DP2, DP5, or U01) that was active in FY2024 and supported by NIEHS for 4 years during Fiscal years 2021, 2022, and 2023 including up to 1 year of no-cost extension within this period, OR
• Was PD/PI on at least one single-PD/PI (i.e., not Multi-PD/PI) NIEHS-supported R01-equivalent (defined here as R01, DP1, DP2, DP5, or U01) that was active in FY2023 and supported by NIEHS for 4 years during Fiscal years 2020, 2021, and 2022 including up to 1 year of no-cost extension within this period.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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 How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Leroy Worth Jr., PhD
National Institute of Environmental Health Sciences
Telephone: 984-287-3340
Fax: 301-480-3722
Email: [email protected]

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

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.

SF424(R&R) Cover

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.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

PD/PIs are required to devote at least 6 person months (i.e., the equivalent of 50% effort on a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) of their effort throughout the R35 award. This requirement pertains to total support and includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes or gifts are not included.

R&R Subaward Budget

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.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: Do not use. Specific Aims are not required and must not be submitted.

Research Strategy: The Research Strategy is expected to evolve over the duration of a RIVER award; therefore, a detailed experimental plan is not expected and should not be included. The Research Strategy should focus on general scientific themes and approaches to be taken to address broad but critical questions within the area of study/and or related to the goals of your research program.

The Research Strategy should contain the following sections:

1. Background:

• Provide a brief background of the area(s) of environmental health science research proposed and key scientific questions or challenges which will be addressed within the broadly stated goals.
• Describe the potential for the identified area(s) of research to be groundbreaking, paradigm-shifting, or transformative and the future impact on the environmental health sciences.
• Discuss the potential ways results from this work may impact human health and describe how the R35 project might evolve through different phases of the environmental health translational research process (https://ehp.niehs.nih.gov/doi/10.1289/ehp3657). Depending on the field of study, provide details on how the research will enable advancement of therapeutic targets, develop new or enhance existing strategies and approaches to protect human health, inform policy, lead to improvements in clinical protocols, or enable population-wide intervention/prevention efforts.

 2. Evidence of transformative impact: 

• In the context of the proposed area which is the focus of your R35 application, describe how you will leverage your contributions of novel ideas, key scientific accomplishments, expertise, high impact productivity, scientific service, or cross disciplinary collaborations in the proposed future research program. This discussion should highlight the impact of research funded by NIEHS, including groundbreaking findings from previous support and how your proposed goals will build on this body of knowledge to lead to revolutionary, innovative, and visionary discoveries. If the planned research diverges significantly from past work and the current NIEHS funded projects which will be consolidated into the R35, explain the rationale for the changes and describe your ability to undertake this new direction.
• Expanding beyond information covered in the Biosketch, discuss how you will continue to maintain a trajectory of creative, groundbreaking, paradigm-shifting, or transformative research and to conduct rigorous, reproducible, and transparent research in your proposed research program.

3. Overview of the future research program:

• Through broadly defined goals, describe the research vision for your research program for the requested support period. Discuss the reasons and likelihood that the proposed research program will continue to be important and generate significant/timely new discoveries.
• In general terms, discuss strategies and potential outcomes including any key innovative or unique methods which will be applied in your research program. Experimental details and extensive preliminary data are not required but information may be included if it is critical in assessing overall feasibility of the initial research approach. This includes justification for work utilizing either human subjects or vertebrate animals where projections based on previous (e.g., R01) research efforts are appropriate to describe the launch point for initial investigations in the R35. Include a discussion of rigor and reproducibility and the authentication of biological and chemical resources.
• Describe how the research program could evolve as the work is being performed and how the risks and challenges will be addressed. This description should set up the temporality of the program. In general, more detail is expected at earlier time points in the research strategy.
• Describe how results from the proposed research program will lead to significant advancement and/or paradigm shifts in your field regarding practice of existing methods, development of novel technologies or therapeutic targets, policy change, or changes in public health practice.

4. Suitability of the RIVER Program:

• Explain how sustained funding, level of effort, and a flexible research approach that this mechanism enables is necessary to complete the proposed work and to achieve the realization of your research vision.

5. Mentoring, Diversity & Inclusion, and Service:

• Describe your commitment and dedication to mentorship and training in environmental health science research.
• Describe ongoing and planned outreach and mentoring activities, to promote workforce diversity in your research program NOT-OD-20-031. 
• Describe planned activities during the grant period designed to develop or enhance skills of talented scientists from a wide variety of demographic groups, which may include individuals from underrepresented groups, and any actions planned to promote inclusive and equitable scientific biomedical research environments.
• Describe significant contributions of service to the research community (e.g. study section service) or community partners  to ensure equity and to support rapid research translation to improve practice and public health.

Please note that consistent with NIH practice and applicable law, funded programs may not use the race, ethnicity, or sex of prospective program participants or faculty as an eligibility or selection criteria. The race, ethnicity, or sex of candidates will not be considered by NIH in the application review process or when making funding decisions.

Letters of Support (required):

Because of the highly selective nature of the RIVER Program, all applications must include only one of each of two types of letters:

1. Letter of Recommendation (limit of 1): Applications must include, under Letters of Support, one Letter of Recommendation for the candidate being proposed for the RIVER Award. The Letter of Recommendation should come from a peer of the PD/PI and discuss the outstanding contributions of the candidate to the environmental health sciences and the unique qualities of this individual which make them an ideal candidate for a sustained and flexible research program. In two pages or less, the peer Letter of Recommendation should describe:

• A statement of the PD/PI's demonstrated outstanding contributions to the environmental health sciences including novel ideas, key scientific accomplishments, experience, high impact productivity, scientific service, or evidence of cross disciplinary collaborations, which are commensurate with their career stage and the potential for the PD/PI's research productivity and influence to continue at the same high caliber level; and
• A discussion of the unique qualities of the applicant which support the need for a flexible research opportunity.

2. Letter of Support (limit of 1): In addition, RIVER applications require a separate Letter of Support from the candidate's institution which should be signed by the person at the institution who has the responsibility to evaluate and endorse the outstanding potential contributions of the candidate to the environmental health sciences (e.g. Department Chair, Dean, etc.) and with the authority to commit the institution to all the requirements of the application and award. The institutional Letter of Support should indicate:

• The PD/PI's commitment of at least 6 person months (i.e., the equivalent of 50% effort on a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment of their effort throughout the R35 award (see Sections I and III.1 for further explanation);
• A statement identifying the NIEHS R01-equivalent (defined here as R01, DP1, DP2, DP5, or U01) award(s) that render the PD/PI eligible for the RIVER;
• A willingness to support the consolidation of other support from the NIEHS into the R35 award (see exceptions in Part 2, Section I);
• An agreement not to submit additional individual or multiple PD/PI research grant applications listing this individual as PD/PI to the NIEHS until the final year of the R35 award (see exceptions in Part 2, Section I); and
• A clear and continuing substantial institutional commitment to the PD/PI beyond the normal level extended by the Institution to faculty for the duration of the award.

Letters of Commitment (optional):

Applicants may also submit Letters of Commitment as appropriate to demonstrate the commitment of institutions and collaborators and to identify specific contributions or resources that will be provided to support the program (e.g., staff time, facility space, supplies, equipment, etc.). These additional letters are not required and there is no limit on the number submitted; however, applicants should only submit those that are truly relevant to the research program. Letters of Commitment should not be used to circumvent the limitations on the required letters and should not contain endorsements of the candidate's reputation, expertise, or the proposed research program. Letters of Commitment should be clearly labeled as such to distinguish them from both the Letter of Recommendation and Letter of Support.

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.

Other Plan(s): 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 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.

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.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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.

6. Funding Restrictions

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.

Important reminders:

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 and responsiveness by the National Institute of Environmental Health Sciences, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The research strategy is expected to evolve over the eight-year award period; therefore, applicants should describe general scientific themes and approaches to be taken to address broad but critical questions within the area of study and/or related to the goals of the applicant's research program. Experimental details and extensive preliminary data should not be included unless they are necessary to assess the feasibility of new avenues of research. Reviewers should evaluate whether the scope of research proposed is sufficiently comprehensive, forward-thinking, and innovative for the R35 mechanism.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

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

Specific to this NOFO: What is the justification for the need for a sustained and flexible research program to address a critical challenge in the environmental health sciences that cannot be achieved through other traditional research mechanisms? What evidence has the PD/PI provided that demonstrates creativity, innovation, and adaptability in their research career as relevant for their specific field that indicates that this individual is likely to thrive in a research program which is not bound by specific goals and methodological details? What evidence has the PD/PI provided that demonstrates a record of professional service to the research community and successful mentoring that could be expanded upon due to reduced time spent managing multiple grant applications and awards? How has the applicant's institution demonstrated appropriate support for fostering a sustained and flexible research program in the Environmental Health Sciences, assuring that the investigator will be able to dedicate appropriate resources to the RIVER program? 

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

2. Review and Selection Process

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

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

It is anticipated that the RIVER program will be evaluated on a continuing basis by the NIEHS, to assess the impact of the program on the portfolio of the NIEHS, and on the progression of the supported PD/PIs' careers. Metrics to be used include, but are not limited to: publications, including numbers, impact factors, citations of publications; academic promotion of the PD/PIs; invited talks at national/international symposia; students and postdoctoral fellows trained in the PD/PI's laboratory; honors and awards received by the PD/PI; committee service of the PD/PI; and subsequent grant support awarded. The Program Analysis Branch within the Division of Extramural Research and Training will determine program evaluation. PD/PIs who have received support under a RIVER grant will be requested to provide information for the evaluation during the period of the award.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Jennifer B. Collins
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3247
Email: [email protected]

Kimberly Gray, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3262
Email: [email protected]

Frederick L. Tyson, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3334
Email: [email protected]

Leroy Worth Jr., PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3340
Email: [email protected]

Camilo Asuncion
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-4521
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.