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

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

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

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 purpose of this Notice of Funding Opportunity (NOFO) is two-fold: 1) to encourage submission of applications to do more in-depth phenotyping on investigator-selected cohorts of embryonic lethal or subviable Knockout (KO) mouse strains generated by the International Mouse Phenotyping Consortium (IMPC) of which the NIH Knockout Mouse Phenotyping Program (KOMP) is a member; and, 2) to encourage submission of applications to use investigator-selected embryonic lethal, perinatal lethal, or subviable IMPC-generated KO mouse strains in hypothesis-driven research focused on placental defects, structural birth defects, and/or fertility issues. The KOMP2 Program is in its final phase (2022-2027) of production and primary phenotyping of KO strains, and it is anticipated that the number of available strains for analyses by the research community will increase substantially.

In-depth phenotyping and further research using embryonic lethal, perinatal lethal, and subviable KO mouse strains are of strategic importance for several reasons. Most obviously, these genes are critical to embryonic growth, differentiation, and organogenesis. Early lethals have defects in pre- and peri-implantation processes in embryonic or extra-embryonic tissues. Mid-gestational lethals have defects in organogenesis. Lethality in the fetal or immediate perinatal periods (late lethals) indicates failures in the transition to adult functioning organ systems. These mouse strains are extremely useful as models for a range of congenital human diseases, structural birth defects, infertility, and spontaneous miscarriage. Viable heterozygote alleles are likely to be widely represented in human disease because of their haploinsufficiency or dominant phenotypic effects. So, there is significant and complementary value in also phenotyping heterozygote mutants of these KO strains for clinical phenotypes.

Background

The mouse has long been an important mammalian model system for the study of gene function in human health and disease. Mouse mutants with phenotypes that mimic human traits have served as critical research tools in understanding the genetics underlying mammalian biology. Equally important, mouse mutants have been the tools used to begin to understand gene function and pathways as the science has moved from gene identification to mammalian functional genomics.

In 2006, the Trans-NIH Knockout Mouse Project (KOMP) was launched with the goal of generating KO mutations in 8,500 genes in C57BL/6 mouse lines by deleting all or most of the exons in target genes or producing knockout-first conditional ready alleles. Together with the European Conditional Mouse Mutagenesis Program (EUCOMM) and the North American Conditional Mouse Mutagenesis Program (NorCOMM), these efforts produced knock out embryonic stem cells for 18,000 protein coding genes, as well as live mouse lines, frozen embryos and sperm, and vectors which are available from public repositories under the auspices of the International Knockout Mouse Consortium (IKMC). The first phase of the KOMP program was completed in 2011.

In 2011 the KOMP program was expanded as the Knockout Mouse Phenotyping Program (KOMP2), funded as a joint trans-NIH and Common Fund program, with the goal of generating and phenotyping mice strains. Since its launch, KOMP2 integrated operations with other members of the International Mouse Phenotyping Consortium (IMPC). Adoption of CRISPR technology in 2014 greatly increased the efficiency of this program. The current (July 19, 2022) IMPC data release includes phenotype data for 8260 knockout genes.

The current phase of the KOMP2 program was funded in 2022 to extend the trans-NIH program for additional five years (2022-2027). The purpose is to support production of approximately 1,200 mutant mouse lines using CRISPR/Cas9 technology and perform a series of phenotyping assays; representing substantive contribution to completion of all high priority mouse:human orthologs.

Scope

A tiered triage approach to the phenotyping of embryonic lethal KO strains to facilitate flexibility in experimental design and economize on breeding strategies is in place. Primary tier screening begins with a careful evaluation of genotype ratios during breeding to generate adult cohorts for the adult phenotyping pipeline. A mid-gestation stage of E12.5 is the initial reference time point for a "first look" at strains deemed embryonic lethal or subviable and for assessment of developmental anomalies. Based on the E12.5 analysis, embryos are triaged for further analyses at either earlier or later time points (e.g., E9.5 or E14.5 in KOMP or E18.5 across other IMPC centers) as recommended by the Bloomsbury Report. The established phenotyping pipeline includes collection of robust, three-dimensional imaging datasets that are accessible and free to be mined through the IMPC data portal (http://www.mousephenotype.org/data/embryo). In addition to the embryonic lethal KO strains, it is important to note two other cohorts of interest: the estimated 15% of perinatal lethal KO strains and 10% of subviable KO strains. These represent cohorts for further study as these are likely to represent models of human structural birth defects as well.

Depending upon the data available from the embryonic lethal pipeline primary tier screening being performed by the IMPC centers, investigators may consider three options when applying for funding through this NOFO:

• Pursue non-hypothesis-driven, non-mechanistic secondary- and/or tertiary tier screening on a select cohort of IMPC-generated KO strains using various approaches. 1) Studies could focus upon the acquisition of more detailed morphological information with any of a variety of 3D imaging modalities (e.g., magnetic resonance, µCT, high resolution epifluorescence microscopy, OPT, and optical coherence tomography). It is impossible to dictate the "best" stage or modality for imaging to discover novel phenotypes as developmental processes vary by embryonic stage and the interests of the investigators should dictate these aspects. The IMPC will continue to play a leadership role in standardizing operating procedures for 3D imaging of embryos in the same manner that they have developed the common protocols for adult phenotyping. Potential applicants are encouraged to visit the IMPC website for updated information [http://www.mousephenotype.org/data/embryo]. 2) An optional approach for characterization of gene function would be to perform mRNA expression profiling using RNA sequencing (RNAseq) of embryonic tissues to measure global perturbations caused by the KO. Sequencing technologies are continuously evolving; therefore, it is conceivable that this could be applied to embryonic mouse screening, too. 3)Tertiary tier screening would involve more focused phenotyping of strains of interest to individual investigators. These types of analyses could include, but are not limited to, more detailed immunohistochemistry, laser capture micro-dissection, or the development of cell-based assays.
• Pursue a combination of non-hypothesis-driven, non-mechanistic secondary tier screening on a select cohort of IMPC-generated KO strains and hypothesis-driven aim(s) on selected strains. As the KOMP2 phenotyping effort continues (current phase, 2022-2027), it is clear that there will be a significant increase in phenotypic data available on embryonic lethal, perinatal lethal, and subviable KO strains. In an effort to encourage the further use of these data and strains, applications that make use of these IMPC-generated strains, further the phenotyping effort, and incorporate hypothesis-driven research aim(s) will be considered under this FOA. For these studies applicants can use a combination of IMPC and other resources to address their hypothesis.
• Pursue strictly hypothesis-driven research on a select cohort of KOMP-IMPC-generated embryonic lethal, perinatal lethal, and/or subviable KO strains. Applications that have hypothesis-driven aim(s) to study the underlying mechanisms resulting in embryonic lethality, and/or perinatal lethality and/or subviability will also be considered under this FOA. For these studies applicants can use a combination of IMPC and other resources to address their hypothesis.

Research Interests of Participating Institutes

The participating NIH Institutes have provided a brief outline of their interests as they relate to the goals of this NOFO. These mission statements are intended to indicate the breadth of the biomedical areas of interest.

NICHD

The NICHD is interested in the evaluation and use of embryonic lethal, perinatal lethal, and subviable KO strains exhibiting structural and other defects in embryonic development. This includes, but is not restricted to, defects affecting post-implantation development, gastrulation and organogenesis, especially those that affect multiple organ systems; limb, neural, cardio-vascular, musculoskeletal, urogenital, digestive, and respiratory. Additionally, understanding potential links between fertility status and any co-morbid conditions in the subviable KO strains would be of interest. Finally, evaluation and use of KO lines with defects in trophoblast development, allantois-chorion fusion, or other aspects of placental development or function are of interest. The focus should be on the determination of placental etiology resulting in embryonic lethality at the pathohistological and molecular levels as well as delineating the possible regulatory mechanism(s) affected by loss of gene function.

NIDCR

The NIDCR supports research into all areas of dental, oral, and craniofacial biology including but not limited to: aspects of craniofacial development such as neural crest migration and the regulation and disorders thereof; mineralized tissues; and, salivary gland development and function. Studies characterizing embryonic, perinatal, and adult phenotypes of KO mice relevant to dental, oral, and craniofacial biology are welcome.

ORWH

The Office of Research on Women’s Health (ORWH) is part of the NIH Office of the Director, and works in partnership with the 28 NIH Institutes, Centers, and Offices (ICOs) to ensure that women's health research is part of the NIH scientific framework and supported throughout the biomedical enterprise. ORWH uses a multidimensional framework to represent the intersection of factors that underlie patterns of disease and determinants of health outcomes in populations.

ORWH is interested in supporting biomedical research that considers sex and/or gender influences and includes adequate plans for collecting and reporting sex-specific data. There is a crucial need to address sex and/or gender influences in basic, translational, interdisciplinary, behavioral, clinical, and/or health services research relevant to women's health, and, where appropriate, include both sexes to better understand the influence of sex as a biological variable (SABV) on health and disease. Integrating the purposeful accounting for SABV in biomedical research, from the most basic to the clinical and applied efforts, will fill gaps in our knowledge, and will inform more effective and personalized approaches for women and men. For additional guidance, please review the 2024-2028 NIH-Wide Strategic Plan for the Health of Women (https://orwh.od.nih.gov/about/trans-nih-strategic-plan-womens-health-research).

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)

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 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 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:

Mahua Mukhopadhyay, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6886
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 or Modular Budget

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

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:

Applicants must clearly justify the approach they choose (non-hypothesis driven secondary screening, hypothesis-driven research, or a combination of the two) and how the chosen approach will utilize the KOMP2/IMPC resources.

Letters of Support: Applicants are encouraged to include a letter of support for deposition of phenotypic data to a public database.  Funds can be included in the requested budget to cover the cost.

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.

Applicants are required to comply with the instructions in the SF424 (R&R) Application Guide, with the following modifications:

• NICHD expects that biospecimens resulting from NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. Researchers can submit information about the location and availability of biospecimens to the DASH catalog, if applicable.
• NICHD expect that tools, workflows, and/or pipelines created or used with support from this NOFO will be shared with the wider scientific community in a timely manner that would enable other researchers to replicate and build on for future research efforts. Plans should align to open-source practices and other NIH Best Practices for Software Sharing (https://datascience.nih.gov/tools-and-analytics/best-practices-for-sharing-research-software-faq) as much as possible.
• The Resource Sharing Plan will be considered during peer review and by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Other Plan(s): 

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.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

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.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score. 

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

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 Center for Scientific Review (CSR), 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 national 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. 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 the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Not Applicable

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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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.

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: 301-480-7075

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

Mahua Mukhopadhyay, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6886
Email:[email protected]

Zubaida Saifudeen, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-3334
Email:[email protected]
 

Rajeev K Agarwal, PhD
ORWH - Office of Research on Women's Health
Phone: 301-451-7058
E-mail: [email protected]

Maqsood Wani
Center for Scientific Review
Telephone:  (301) 435-2270
Email:  [email protected]

Hong Cao
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6999
Email:[email protected]

Gabriel Hidalgo
National Institute of Dental and Craniofacial Research (NIDCR)
Phone: 301-827-4630
E-mail: [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.