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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The Gabriella Miller Kids First Pediatric Research Program (Kids First) was established by The Gabriella Miller Kids First Research Act, or Kids First (https://www.congress.gov/bill/113th-congress/house-bill/2019/text), for an initial 10 years, from 2015-2024. The program was reauthorized as Kids First 2.0 by the 118th Congress for an additional five years, and the program was transferred from The Common Fund to the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI). DPCPSI and Common Fund have agreed that Common Fund will continue to administer Kids First on behalf of DPCPSI.  

The overall goal of the Kids First program is to help researchers uncover new insights into the underlying biology of childhood cancer and congenital anomalies, including the discovery of shared genetic pathways between these disorders, to understand the underlying mechanisms of disease. This understanding would lead to novel and more refined prevention tools, diagnostics, and ultimately more targeted therapies and interventions. Kids First is an NIH-wide effort to enable researchers, clinicians, and patients to work together to accelerate collaborative research and promote data sharing to advance new discoveries for children affected with cancer and congenital anomalies. The Kids First Data Resource Center (DRC) hosts genomic and phenotypic data of high value to the pediatric research community, facilitates data sharing and data analysis in the cloud across diverse conditions, and promotes interoperability to accelerate collaborative research and promote new discoveries.  

The Kids First program has previously utilized the X01 mechanism (PAR-15-259, PAR-16-150, PAR-17-063, PAR-18-583, PAR-19-104, PAR-19-390, PAR-21-040, PAR-22-054, PAR-23-035, and PAR-24-082) to solicit proposals for the generation of genomic and epigenomic data from samples collected from childhood cancer and congenital anomalies cohorts. Future calls will be published to continue identifying childhood cancer and congenital anomalies projects each year of the Genomic Data Generation Center  award(s), pending availability of funds. 

This NOFO invites applications for Kids First genomic data generation  center(s) to produce high quality raw and derived genomic (e.g., whole-genome sequences, long-read sequences), transcriptomic (e.g., RNA sequence and expression data), and epigenomic (e.g., genome-wide methylation profiling, chromatin accessibility assays) data, from pediatric disease cohorts and their specimens to contribute to the Kids First Data Resource for sharing with the research community. 

Goals

The goals of this NOFO are as follows:

• Generation of high quality genomic, transcriptomic, and epigenomic data from childhood cancer and congenital anomalies cohorts selected by the Kids First Program. Kids First is also interested in considering other additional technologies, such as clinical-grade sequencing, as these technologies advance and costs decrease.
• Submission of individual-level genomic, transcriptomic, epigenomic sequences, derived data, and metadata to the Kids First Data Resource Center (DRC), and to any other databases that may be designated by the Kids First Program, as well as providing the same data to the project/sample Program Directors/Principal Investigators (PDs/PIs), as needed.
• Coordination with project/sample PDs/PIs who will submit samples as well as coordination with the Kids First DRC to fulfill program goals. 

The NOFO expects high quality genomic, transcriptomic, epigenomic sequences and derived data to be generated from the largest number of cases and samples possible with available funds. It is anticipated that throughput and costs will improve over the course of the award while data quality is maintained or enhanced, so the number of cases and diversity of conditions that can be sequenced and analyzed per dollar spent are expected to increase. 

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 - Includes all types

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

• 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

Foreign Organizations/Foreign Collaborations

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 not 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. 

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

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.

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:

Applicants should address the following aspects. Relevant previous experience should be described succinctly.

A) Sample Management and Data Production 

Sample coordination and processing 
Centers are expected to provide shipping instructions to project/sample investigator  teams, including reminders to use subject and sample IDs that are two-steps removed from personal information per dbGaP requirements. Coordination should include receipt, QC, verification, tracking, and storage of de-identified nucleic acids. Protocols for isolating DNA from tumor tissue (frozen or paraffin embedded) and blood specimens, and DNA quality and yield, should be described. While project/sample teams are expected to extract nucleic acids prior to shipping to the genomic data generation center, center staff may be asked to suggest protocols and provide guidance for technically challenging tissue types (e.g., paraffin embedded tumor tissue) and, in some instances, to carry out these extractions.

Genomic, transcriptomic, and epigenomic sequences and derived data generation
This NOFO anticipates that the following types of cohorts will be sequenced and analyzed: 1) congenital anomalies in family structures such as "trios"(proband, mother, father) or in multiplex/multigenerational pedigrees; 2) childhood cancers in families with or without tumor, such as "quads" (normal from proband, tumor from proband, mother, father). The Kids First program will also accept project/sample  applications that include sequencing of affected somatic tissue from congenital anomalies cohorts as well as "tumor trios" for childhood cancer cohorts (normal from proband and tumor samples from multiple time points: pre-treatment, post-treatment, relapse, and/or metastasis), when justified. In addition, the sample/project PDs/PIs may propose other types of cohorts to be sequenced and analyzed by the funded center(s). 

Genomic data generation center applicants should propose plans for 1) appropriate whole-genome sequence and transcriptome coverages for these types of cohorts and samples, 2) methods for identifying germline or somatic genomic variants from the sequence data, and 3) methods for epigenomic profiling of tumors and/or affected tissue. Types of genomic variants to be identified should include SNVs, indels, and structural variants. 

Applicants should propose timelines from having samples in house through delivering the sequence data and VCF files to project/sample PDs/PIs and the Kids First DRC. The flexibility of the data generation, data processing, and variant calling pipeline to accommodate possible fluctuation of sample availabilities should be described as well (e.g., processing and submitting data in batches). Including a table of data types generated, costs, and typical timelines from intake to data generation would be helpful.Applicants should describe the facilities, data generation platform(s), and analytical pipelines that will be used for the proposed activities. Activities should include genomic (e.g. whole-genome, long-read sequencing), transcriptomic (e.g., RNA sequencing) and epigenomic (e.g., genome-wide methylation profiling, chromatin accessibility assays) data generation. Protocols for 1) generation of libraries or raw data, 2) sequence or equivalent data generation, 3) storage and transfer of BAM, CRAM, or equivalent files, 4) generation, storage, and transfer of Variant Call Format (VCF) or equivalent files, and 5) quality metrics, should be described. Describe clinical-grade sequencing services if available. Applicants should provide documentation of IT security that will ensure protection of sensitive genomic data.

Applicants may propose additional technologies that they are able to provide, especially innovations that would be of interest to childhood cancer or congenital anomalies cohorts.
 
After the delivery of genomic, transcriptomic, epigenomic sequences, derived data, and metadata, the next step may be custom analysis and/or validation of variants for a subset of cases by the center(s) or between the centers and the project/sample PIs, if both parties are interested in pursuing such collaborations. With NIH approval, the funded center(s) may spend a small portion of the total budget(s) for this type of scientific collaboration (see the instruction for R&R Budget). Applicants interested in pursuing such collaboration should describe the methods that will be applied and products that will be delivered. 
 
Finally, to demonstrate the readiness for performing all of the above activities, applicants should describe relevant examples of previous success.

B) Computational and bioinformatics capacity.

Computational and bioinformatics capacity to support sample processing, data (genomic, transcriptomic, and epigenomic) generation, processing, and QC, variant calling and validation, data storage, and data transfer to project/samples PIs and the Kids First DRC or other NIH-designated repositories, should be included. Genomic data generation centers should describe their plans and timelines for hosting data files generated for the program; in general, it is expected the centers will store data for at least one year after data generation completes.  Applicants should provide documentation of IT security that will ensure protection of sensitive genomic data.

C) Costs

Applicants should provide the following itemized costs.

• Per sample cost for each data type 
  Applicants should estimate the per-sample cost for each type of data production and analysis (e.g. whole-genome, long-read sequencing, RNA sequencing, genome-wide methylation profiling, chromatin accessibility assays) per sample. Describe cost structure of clinical-grade sequencing, if available. These estimates should factor in, but are not limited to, the following items:

Sample intake and processing 
Library preparation 
Data production (e.g. standard short-read whole genome sequencing, long-read sequencing, RNA sequencing, ATAC sequencing, Methylation profiling) 
Data storage and retention 

Generation of VCF or other derived files 
Quality Control 
Experimental failures 
Equipment 
Computational and bioinformatics costs 
Labor 
Indirect costs

Describe whether the cost estimates vary for different sample sources (e.g., blood, saliva, frozen tumor, paraffin embedded tumor). Separately, provide estimates for DNA/RNA isolations.

• Total number of samples to sequence and analyze. 
  The applicant should estimate a minimum number of samples for which the proposed center can generate a complete set of genomic, transcriptomic, epigenomic and derived data, with annual breakdowns that factor in a cost reduction plan. For the sake of the application, assume equal number of samples in each of the two cohort types. For reference, the Kids First Program so far has identified approximately 6,000-10,000 samples per year.  
• Cost reduction. 
  Plans for decreasing all of the above costs over the years of this award while improving efficiency and quality should be proposed.
• Complementary sequencing approaches. 
  Plans for using complementary sequencing approaches not discussed above (e.g., whole exome sequencing) can be proposed with a rationale that considers unit costs, scale up costs, data quality, and added scientific value for specific sample and variant types.

D) Management Plan

A management plan for the proposed center should be included. The plan should describe the organization, reporting, and communication structure within the proposed center including the roles of key center members and decision-making processes. The plan must assure adequate personnel for 1) the generation and delivery of genomic, transcriptomic, epigenomic and derived data to project/sample investigators and the DRC; and 2) coordination with NIH Kids First Program staff. Overall, the plan should discuss how the proposed organization and management structure will likely lead to success in attaining the goals of the center and the Kids First program.

E) Coordination and Communication with the Kids First Data Resource Center

A major function of the Kids First Data Resource Center (DRC) is to serve as a Data Coordinating Center to track, ingest, process, harmonize, store, and distribute data generated by Kids First sequencing centers. Therefore, sequencing centers are expected to coordinate and communicate with the DRC on activities that include, but are not limited to:

• Sample-Level Data Tracking. 
  The DRC is tasked with tracking and reporting sample-level status reports for the Kids First program. Genomic data generation centers are expected to communicate sample-level status updates to the DRC including: date of shipment receipt, QC results (including details about samples that fail QC), updates on when sequencing starts and completes, and notifications when data is available.
• Data Transfer and Delivery. 
  Kids First genomic data generation centers are responsible for submitting genomic, transcriptomic, epigenomic, and derived data to the Kids First DRC, which is serving as the controlled-access public database for this program and is responsible for distributing Kids First data to the research community. Additionally, data generation centers are responsible for delivering data to the project/sample PDs/PIs, which can be facilitated by and coordinated with the Kids First DRC.
• File Formats and Analytical Pipelines. 
  For whole genome data, data generation centers are expected to provide to the DRC, at minimum, 1) individual-level sequence read files aligned to the most recent reference genome (e.g., BAM or CRAM aligned to GRCh38) and/or raw unaligned data files with associated metadata (e.g., FASTQ), and 2) individual-level variant data (e.g., VCF). Data generation centers should describe what file formats they intend to provide for whole genome sequence as well as RNA sequence, genome-wide methylation, and chromatin accessibility profiles. Decisions regarding formats and analysis pipelines of sequence and variant data will be finalized in discussions with the NIH.

Although this list is not exhaustive, such activities require close coordination between data generation centers and the DRC. Therefore, data generation center applications should include a plan for how they will communicate and coordinate with the DRC to fulfill the expectations described above. 

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): 

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

• A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive 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 grantdisclosures@oig.hhs.gov. 

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 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 CSR, in accordance with NIH peer review policies and practices, 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.

Requests for reconsideration 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 Child Health and Human Development (NACHHD) Council. 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.

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.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

Recipients of both Clinical Trial Required and Clinical Trial Optional awards subject to this term shall report standardized clinical trial activation and enrollment performance data for any interventional clinical trial supported under the award. These metrics are intended to assess trial startup efficiency, site activation, and post-activation performance and to support continuous quality improvement in clinical trial operations (see supplemental guidance). Recipients shall report required data annually at the time of Research Performance Progress Report (RPPR) submission on clinical trial activation and enrollment performance milestone dates as calendar dates; NIH will calculate standardized interval metrics from these dates.

Institutions are expected to maintain capabilities that support efficient clinical trial startup, participant enrollment, and performance monitoring, including streamlined workflows and systems for electronic tracking of milestones.  Recipients are encouraged to implement and evaluate approaches that improve trial efficiency and the participant experience. 

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

• Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
• Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
• NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, 45 CFR 75 (for indirect cost provisions), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Maintaining primary responsibility for planning, directing, and executing the proposed scientific activities.
• Overseeing all aspects of data generation, including discussing requirements for sample submission, such as quality-control, quality-assurance, technologies available, and shipping deadlines with project/sample cohort PD/PIs, and consideration of other additional technologies (such as clinical-grade sequencing). 
• Submitting individual-level genomic, transcriptomic, epigenomic sequences, derived data, and metadata to the Kids First Data Resource Center (DRC), and to any other databases that may be designated by the Kids First Program, as well as providing the same data to the project/sample PDs/PIs, as needed.
• If requested by the project/sample PD/PI, the Data Generation Center may provide expert advice and help in analyzing genomic data.  This advice may reduce the number of samples that can be assayed. 
• Participating in presentations and training sessions that may be organized and developed by the Kids First Training and Outreach Core.
• Participating in the Kids First Working Group (see joint responsibilities) to provide Kids First governance and establish initiative-wide procedures and policies.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Software sustainability and transition to another grant recipient

• A fundamental objective of this cooperative agreement is to ensure that the valuable data, tools, and resources managed and created by the Genomic Data Generation Center remain available without interruption to the research community in cases where the award is terminated by the NIH or if the recipient withdraws or otherwise can no longer manage the resources. NIH has the right to transfer said resources to other NIH-funded and/or managed resource projects, at the NIH's sole discretion.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Serving as liaisons between the recipients, the NIH Kids First Working Group, and the larger scientific community in helping the Kids First Program to achieve its goals. Serving on subcommittees of the Kids First Working Group, as appropriate.
• Discussing proposed cohorts with recipients and making recommendations around cohort allocation of resources. 
• Participating in discussions about additional technologies, as relevant, and helping develop pilot projects that may be used to consider new technologies or new innovations.
• Coordinating the efforts of the Kids First program with others engaged in similar and related activities.
• Periodically report progress to the Director of NIH.
• Assist in promoting the availability of the Data Resource developed by the Kids First Program to the scientific community at large.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The PDs/PIs of the Kids First Genomic Data Generation Center, the PDs/PIs of the Data Resource Center (DRC), the PDs/PIs of the Training and Outreach Core (TOC), and NIH members will work together to constitute the Kids First Working Group. Each Working Group member will have one vote; the NIH collectively will have one vote on the Working Group.

The NIH Kids First Working Group is responsible for governing the Kids First Program, with oversight from Institute and Center Director co-Chairs. 

The Kids First Working Group may be asked to:

• Establish milestones under this NOFO.
• Help develop uniform procedures and policies necessary to meet Kids First goals.
• Provide input on issues that arise and brainstorm solutions.
• Provide information to the Program Consultants, who will be appointed by the NIH. The Program Consultants will evaluate the progress of the Kids First Program and the Program's recipients, and provide advice to the NIH about scientific direction.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Working Group chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Gabriella Miller Kids First Program
kidsfirst@od.nih.gov 

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date)"

Gabriella Miller Kids First Program
kidsfirst@od.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.