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

A. Overview

The Chemical Countermeasures Research Program (CCRP) was established in 2006 by the National Institute of Allergy and Infectious Diseases (NIAID/NIH) to promote the discovery and/or advancement of medical countermeasures (MCMs) to treat and/or prevent serious morbidities and mortality during or after mass casualty, high consequence, public health events involving the release of highly toxic chemicals. In support of these goals, the CCRP seeks to promote basic research to identify mechanisms of toxic effects and application of the fundamental information gained to support the identification and early-stage development of MCMs. To learn more, see “Supporting Fundamental Chemical Toxicology Research to Inform Medical Countermeasure Developments: The National Institutes of Health Chemical Countermeasures Research Program (https://doi.org/10.1021/acs.chemrestox.0c00086)" published in Chemical Research in Toxicology.

Objectives:

Almost 200 Chemicals of Concern (CoC) have been identified by the U.S. Department of Homeland Security (DHS) as high consequence public health threats. There is an urgent unmet need to gain a clear understanding of the physiological mechanisms involved in the initiation and downstream events of injury from acute exposure to these chemicals. 

CoCs are organized within toxidromes established by the U.S. Government. Toxidromes group chemicals based on their primary modes of toxicity. One benefit of this approach is that a single MCM may be effective against multiple different CoCs. To find out whether your toxicant is of interest to the CCRP, please contact the scientific program contact listed in this NOFO. 

This NOFO is intended to encourage health scientists to pursue studies using diverse animal models, organoid tissues, ex vivo studies using human or animal tissues, in vitro cell culture systems, and/or in silico models.

This NOFO intends to support fundamental research that will characterize the acute and/or long-term pathophysiological effects, such as cellular, biochemical, and molecular mediators/pathways, after CoC exposure to pulmonary and/or ocular toxicants. Projects seeking to understand the impact on diverse comorbidity factors such as age, sex, pregnancy, and/or pre-existing disease conditions, are encouraged. 

Specific topics of research interest include, but are not limited to, the following:

Pulmonary Toxicant Research Topics of Interest: CoCs of pulmonary interest include, but are not limited to, those that induce pulmonary edema, pneumonitis, and fibrosis, such as chlorine, phosgene, sulfur mustard, nitrogen mustard, and oleum.

Given the above, pulmonary applications are encouraged to consider the following aspects:

• Studies proposing to use in vitro models should include at minimum one cell culture model with at least two different cell types relevant to the target organ, and two or more toxicants and multiple time points post exposure. Applications using only immortalized/transformed cell lines or only one toxicant will be considered not responsive.
• Applications using animal models should use at least two different species or strains and both sexes, or collaborative cross strains or knock out models and both sexes, and a minimum of two toxicants as well as multiple time points post exposure to gain comparative understanding of the toxic effects. Applications using only one sex or one species/strain or one toxicant are not responsive.
• Studies investigating the role of susceptibility in the manifestation of toxic effects should use neonate, adult, old/aged animals of both sexes and assays performed at multiple time points post exposure and a minimum of two toxicants. Applications using only one sex or one susceptibility condition or one toxicant will be considered not responsive.
• Studies proposing to use high throughput screening approaches such as organoid tissue systems should use more than two toxicants and multiple time points post exposure that will facilitate cross comparison analysis for identifying common molecular targets.
• Applications that use a combination of in vitro, ex vivo or in vivo studies should use a minimum of two toxicants and both sexes with data generated at multiple time points post exposure. Applications using only one sex or one toxicant or one time point are considered not responsive.
• Applications using in silico and computational predictive modeling approaches for acute lung injury mechanisms are also encouraged.
• Studies to investigate delayed effects of acute toxicant exposure are encouraged to include acute response studies in two species/strains and both sexes, and to provide a strong justification for selection of one strain or one sex for investigations focused on delayed responses. The delayed response studies should include a time point of at the least 45 days.

Applications investigating chronic/repetitive exposures are not responsive to this NOFO.

Ocular Toxicant Research Topics of Interest: The eyes are usually the first and most frequent route of toxic exposure, making them especially vulnerable to chemically induced injuries. Compared to both the lungs and skin, ocular chemical injury typically manifests earlier and at lower toxicant concentrations. Dissecting and counteracting the eye’s vulnerability to chemical injury requires traction in at least four domains: (1) Responses to corneal toxicity (acute and chronic); (2) Models of corneal toxic injury; (3) Mechanisms of corneal pathologies and wound healing, and (4) Therapies for corneal pathology. To learn more, see "Ocular Surface – Merging Challenges and Opportunities (https://doi.org/10.1167/tvst.9.12.3)" and "Considerations in Developing Medical Countermeasures Against Chemical Ocular Toxicity (https://doi.org/10.1016/j.toxlet.2020.09.004)."

Given the above, ocular applications are encouraged to consider the following aspects:

• Chemical injury to the eye can result in a cascade of pathology: Pain, photophobia, corneal epithelial defects, keratitis, endothelial cell loss, edema, inflammatory response, conjunctivitis, tear disruption, neovascularization, corneal scarring, opacity, and blindness. Projects that propose to investigate more than one angle of this response/pathology are particularly responsive to this NOFO.
• The three-layer plan of the mammalian cornea raises the need to examine chemical toxicity across the epithelial, stromal, and/or endothelial layers (i.e., continuum of the injury and recovery process).
• The tear film is important to the function of the ocular surface and highlights the importance of an integrative investigation of ocular responses to chemical injury.
• Early/acute effects tend to resolve following chemical injury but then rebound as late/chronic effects. Shedding light on this delayed response is a particularly valuable objective of this NOFO.
• Proposed therapies against ocular chemical injury include anti-inflammatory, anti-fibrotic, anti-neovascular, and antioxidant agents but frequently result in incomplete or transient efficacy. Therefore, discovery of biologically active tools or probes to address the natural history of chemical ocular injuries is advocated under this NOFO.
• Replication of findings in more than one animal model raises confidence in the rigor of the obtained results.
• Inclusion of in vitro and/or in silico technologies to minimize the number of animal subjects.

The above are illustrative examples and do not exclude other meritorious ideas or approaches.

A. Special Biosafety Certification

Many of the CoCs are extremely hazardous to humans. All applications must include a letter from appropriate institutional biosafety officials indicating that studies are deemed safe for research personnel and the environment (See letters of support in Section IV). Special biosafety certifications may be required to conduct research with some CoCs (e.g., chemical warfare agents sulfur mustard and Lewisite). Therefore, applicants are encouraged to collaborate with laboratories and contract research facilities that are already certified to work with these CoCs, when applicable. Applicants are strongly encouraged to contact the Scientific/Research Contacts listed in this NOFO for further information if the research proposal uses restricted chemical agent(s).

B. Applications Not Responsive to NOFO

The following applications will be considered non-responsive to the NOFO and will be not be reviewed. 

• Applications that propose to study chemicals that are not on the DHS CoC list. Only projects that include CoCs will be supported by this NOFO. As such, applicants are strongly encouraged to contact the Scientific/Research contacts provided in this NOFO to confirm that the proposed toxicant(s) is of interest to the program. 
• Projects addressing health outcomes due to prolonged or persistent environmental/occupational chemical exposure.
• Efficacy studies, e.g., creation and validation of candidate MCMs.

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

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 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.

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.

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.

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 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(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:

Leroy Worth Jr, PhD
Telephone: 984-287-3340
Email:worth@niehs.nih.gov

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.

Specific to this NOFO (Significance): How will completion of the objectives generate tools and/or proof-of-principle data necessary to facilitate the development of competitive research applications for further support? How will results from the proposed study advance the scientific foundation of chemical toxicity and inform discovery of potential targets for exploring medical countermeasures that could reduce mortality and morbidity?

Specific to this NOFO (Approach): How reasonable is the timeline for the work proposed? Are explanations and assumptions for power analyses, statistical analysis methods and data inclusion or exclusion criteria satisfactory, with detailed procedures of how blinding and randomization will be conducted?

Specific to this NOFO (Environment): How thorough are special biosafety precautions for working with highly toxic chemicals? Have all proposed studies been deemed safe for research personnel and the environment by the appropriate institutional biosafety review official? If working with restricted chemical agents, are all institutional approvals in place? Were the formal letters of collaboration for all proposed collaborative arrangements (and estimated budget) provided with the application adequate, especially those utilizing restricted chemical agents?

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 or Modular Budget

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

The proposed budget should include travel support for the PD/PI to attend the Annual CounterACT Network Research Symposium for each of the proposed project years, in addition to other anticipated travel associated with the research. We strongly encourage post-doctoral, pre-doctoral, and junior investigators to attend these meetings and budgets should be planned accordingly.

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:

Research Strategy:

An R01 application should have a strong biological basis for the intended approach and the proposed studies must exhibit methodological rigor. A well-structured application should include rational experimental approaches that can yield clear understanding of pathophysiological mechanisms for later identification of targets and countermeasures development. Applicants to the program are urged to consider the rationale for the chosen model(s) and endpoints, adequacy of controls, justification of sample size, statistical methods, blinding procedures, strategies for randomization, and robustness and reproducibility of results. These criteria should also be addressed when describing supporting data (if presented) and in the design of the proposed studies within the Research Strategy section (as appropriate).

Letters of Support:

Many of the CoCs are extremely hazardous to humans. All applicants must include a letter from appropriate institutional biosafety officials indicating that studies are deemed safe for research personnel and the environment. This must be addressed in the application, including a description of adequate protection and safeguards if required. Specialized biosafety certifications may be required to conduct research with some restricted CoCs (e.g., chemical warfare agents sulfur mustard and Lewisite). Therefore, applicants must include a letter from appropriate Department of Defense (DoD) officials if utilizing such restricted agents. A formal letter of support (and estimated budget, if applicable) must also be provided for all proposed collaborative, consultative, and/or contractual arrangements. This is especially needed for those contracted partnerships specifically for the utilization of restricted chemicals.

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 for responsiveness by the NIEHS, NEI and NIAID (NIH). Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify NIEHS by email at worth@niehs.nih.gov when the application has been submitted. Please include the NOFO 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 announcement, note the following:

• The Research Project (R01) award supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or bio-behavioral research. An R01 application need not have extensive background material or preliminary information. Accordingly, the R01 is an award made to support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing the investigator's specific interest and competencies.   
• Reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.
• Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for applications submitted in response to this NOFO; however, they may be included if available.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project 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 project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project 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.

Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate Advisory Council or Board. The following will be considered in making funding decisions:

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

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: Generaland 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.

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: GrantsInfo@nih.gov (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: support@grants.gov

Srikanth Nadadur, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3296
Email: nadadurs@niehs.nih.gov 

Dave Yeung, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7237
Email: dy70v@nih.gov     

Houmam H Araj, PhD
National Eye Institute (NEI)
Phone: (301) 435-8166
E-mail: ha50c@nih.gov

Leroy Worth Jr, PhD
Scientific Review Officer (NIEHS)
Telephone: 984-287-3340
Email: worth@niehs.nih.gov

Jenny Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: jenny.greer@nih.gov

Tamia Powell
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2982
Email: tamia.powell@nih.gov

Karen Robinson Smith
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: kyr@nei.nih.gov

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.