Newborn Screening Implementation Program

Newborn Screening Implementation Program is sponsored by National Institute of Child Health and Human Development (NICHD). Supports research and implementation projects aimed at improving newborn screening practices and outcomes.

PAR-25-265: Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R01 - Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Funding Opportunity Title Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R01 - Clinical Trial Optional) R01 Research Project Grant March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity Exploratory/Developmental Grants See Section III. 3.

Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This NOFO encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for conditions for which newborn screening has already been implemented, as well as for potentially fatal or disabling genetic conditions that could benefit in the near future from the early detection made possible by newborn screening.

This research is especially critical given that accurate screening tests and demonstrable benefits of early intervention are often prerequisites for new conditions to be added to newborn screening panels. Funding Opportunity Goal(s) To conduct and support research, clinical trials, and studies with people that explore health processes.

NICHD researchers examine growth and development, biologic and reproductive functions, behavior patterns, and population dynamics to protect and maintain the health of all people. To examine the impact of disabilities, diseases, and defects on the lives of individuals. With this information, the NICHD hopes to restore, increase, and maximize the capabilities of people affected by disease and injury.

To sponsor training programs for scientists, doctors, and researchers to ensure that NICHD research can continue. By training these professionals in the latest research methods and technologies, the NICHD will be able to conduct its research and make health research progress until all children, adults, families, and populations enjoy good health.

The mission of the NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description This NOFO encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for conditions for which newborn screening has already been implemented, as well as for potentially fatal or disabling genetic conditions that could benefit in the near future from the early detection made possible by newborn screening.

This research is especially critical given that accurate screening tests and demonstrable benefits of early intervention are often prerequisites for new conditions to be added to newborn screening panels. The R01 activity code supports long-term projects, or projects designed to increase knowledge in a well-established area.

Projects that are exploratory or novel, break new ground, extend previous discoveries toward new directions or applications, or generate pilot data in preparation for a larger study are well-suited for the companion R21 Exploratory/Developmental Research Grant NOFO, PAR-25-266.

Screening newborns at birth for potentially fatal or disabling conditions provides a window of opportunity for early treatment – often while the child is still asymptomatic – which can have a profound impact on ultimate disease trajectory and severity. If left undiagnosed and untreated, many of these disorders can cause irreversible neurological damage; physical, intellectual, and developmental disabilities; or even death.

Since newborn screening programs began in the 1960s, over 150 million infants have been screened for genetic and congenital disorders. Newborns are now screened in all 50 states, though the panel of tests varies between states.

To date, the Health and Human Services (HHS) Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has approved a list of 38 core and 26 secondary disorders, called the Recommended Uniform Screening Panel (RUSP) , that are recommended for inclusion in state universal newborn screening programs.

Established through the Newborn Screening Saves Lives Act of 2007, the Hunter Kelly Newborn Screening Research Program allows NICHD to fund an array of newborn screening research that focuses on identifying, developing, and testing new newborn screening technologies in order to improve existing tests and develop new tests, as well as developing and testing innovative interventions and treatments for conditions that could be detected through newborn screening but are not yet treatable.

The Newborn Screening Saves Lives Reauthorization Act of 2014 (Public Law 113-240) authorized the HHS Secretary to expand the Hunter Kelly Newborn Screening Research Program to provide research and data on newborn conditions under review by the ACHDNC for addition to the RUSP and authorizes the NIH to conduct pilot studies on conditions recommended by the ACHDNC to ensure that screenings are ready for implementation by state health agencies.

Expanded knowledge of the genetic and molecular basis for various conditions, as well as technological innovation, can potentially increase the ability to screen for many disorders. Unfortunately, the development of effective treatments often lags behind the development of new screening technologies, which limits the benefits of screening for some disorders.

For other disorders, effective treatments do exist, but reliable screening tests are lacking. This NOFO encourages projects that could fill these research gaps to improve screening and outcomes in conditions for which newborn screening is already implemented, or to facilitate screening in conditions not yet included on state panels.

Specific Areas of Research Interest Investigators with diverse scientific interests are invited to apply their expertise in basic, behavioral, translational, and/or clinical research to understand or develop innovative screening approaches and/or therapeutic interventions for disorders that are either currently included in newborn screening panels or those which might be included in the near future.

Potential research topics include, but are not limited to, those listed below: Development, optimization, and validation of new screening technologies, assays, and paradigms, especially those that leverage technology platforms that are currently in use, or could be easily adopted, by state newborn screening laboratories. Development of new, higher-tier screening assays with the potential to reduce false positive rates.

Adaptation and validation of existing newborn screening technologies to be more easily deployed in low-resource settings, such as low- and middle-income countries. Use of artificial intelligence and/or computational modeling to improve screening algorithms. Basic investigations to optimize current treatment regimens or to develop new therapeutic interventions.

Comparative effectiveness studies that examine treatments or interventions. Tests of feasibility for the use of other sample types (e.g., urine, saliva, stool) for use in newborn screening. Preclinical testing for safety, toxicity, and efficacy in animal models or other benchmarks required for moving candidate therapies into Phase I clinical trials.

Clinical trials of treatments or interventions that use validated health outcome markers as study endpoints. Identification of genetic and environmental factors that determine risk or modify disease onset, symptoms, progression, or outcome, as well as how race, ethnicity, sex, and comorbid medical conditions influence screening test accuracy and/or treatment outcomes.

Clinical studies, including genotype-phenotype analyses, that will provide a foundation for the treatment or management of screenable conditions. Research on health systems outcomes and/or access to care or services for infants with genetic disorders who are or could be identified through newborn screening, especially those in medically underserved communities.

Embedded studies that explore the ethical, legal, and social implications (ELSI) of novel screening technologies or therapeutic approaches. Examples of potential ELSI research questions can be found in Goldenberg et al. Genet Med 2019 Mar;21(3):525-33 ( https://pubmed.

ncbi. nlm. nih.

gov/30100612/ ). NICHD is interested in applications addressing conditions for which newborn screening has already been implemented, as well as for potentially fatal or disabling genetic conditions that could benefit in the near future from the early detection made possible by newborn screening.

These include, but are not limited to: metabolic disorders, lysosomal disorders, hemoglobinopathies, congenital immunodeficiency syndromes, neuromuscular disorders, congenital heart disease, congenital endocrine disorders, chromosomal aneuploidies, and syndromes related to intellectual disabilities.

Applicants are strongly encouraged to contact Scientific/Research staff prior to submitting an application that includes a clinical trial or interventional study in humans.

NICHD Expectations for Data Sharing: The NIH Policy for Data Management and Sharing (Policy) expects researchers maximize the sharing of scientific data and data be accessible as soon as possible and no later than the time of an associated publication or the end of the award period, whichever comes first. NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (DMS Plan).

The DMS Plan is expected to address the Elements as described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan ( NOT-OD-21-014 ) The DMS Plan will be reviewed and approved by NIH Program Staff prior to award. Awardees will be required to comply with their approved DMS Plan and any approved updates.

For human data, NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. Information about DASH may be obtained at https://dash. nichd.

nih. gov/ . For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP and the Sequence Read Archive, in line with the NIH Genomic Data Sharing Policy .

If use of DASH is not feasible, NICHD expects awardees to share data through other equivalent broad-sharing data repositories. For applications that aim to analyze existing data, DMS Plans should describe where and how other researchers can access that data to enable reproducibility and reuse. Additional information on the Data Management and Sharing Policy is available on the NICHD Office of Data Science and Sharing website .

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period.

The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Research Strategy: Applications must be relevant to one or more conditions that are either already part of existing newborn screening panels or that would benefit from the presymptomatic detection and early intervention benefits provided by newborn screening.

For this PAR, innovation is not limited to the development of new therapies, screening tools, and/or technologies; it can also come from the novel application of existing therapies, screening tools, and/or technologies to conditions that are not currently part of newborn screening panels.

Applications must clearly explain how the proposed project provides innovation through the development of new therapies, tools, and/or technologies, or the novel application of existing therapies, tools, and/or technologies.

Applications focusing on screening approaches are encouraged to describe implications or strategies for scaling up the proposed methods or findings to newborn screening settings or supporting newborn screening panels run by state health agencies. Where possible, new screening assays should focus on multiplexed technology development that allows simultaneous screening for multiple disorders.

Projects that focus on screening technology development should address each of the following components (where applicable): Ability to detect meaningful differences across various populations Outcomes that are interpretable and relevant to the domains being measured Benefits of either screening or treatment For applications proposing pilot tests of screening technologies or approaches , describe efforts to recruit diverse, underrepresented groups and how they might be used to understand the epidemiology of the condition(s) (e.g., alleles or pseudogenes more prevalent in certain ancestry groups) and/or the performance of the screening assay across populations.

Applications focusing on preclinical studies in animal or cellular models should focus on gaps that would need to be addressed in order to develop a screening approach or therapy for a condition that is, or could be, part of newborn screening panels.

For applications focusing on therapeutics , clearly explain how the project will facilitate development of therapeutic interventions for conditions for which newborn screening has already been implemented, as well as for potentially fatal or disabling genetic conditions that could benefit in the near future from the early detection made possible by newborn screening.

Interventions may be intended to be used as a single treatment, as an adjuvant to existing therapies, or as a combination therapy. When applicable, clearly specify the validated primary and major secondary endpoints to be measured with a clear differentiation of the importance of various endpoints.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

All 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.

Section 2 - Study Population Characteristics If the research involves a clinical trial, a Milestone Plan must be included.

The Milestone Plan must include a timeline for the following general milestones, as applicable: Completion of regulatory approvals; Enrollment of the first participant; The anticipated time frame for enrollment of 25%, 50%, 75% and 100% of the projected recruitment for all study participants, including women, minorities and children (as appropriate); The anticipated time frame for completion of data collection; The anticipated time frame for completion of primary endpoint and secondary endpoint data analyses and completion of final study report; and Detailed protocol-specific performance milestones and timeline; these milestones may be negotiated at the time of the award, if appropriate.

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

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 2.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies).

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications . Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E. O.

12372) This initiative is not subject to intergovernmental review. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.

9. 1 Selected Items of Cost. 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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 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 consider Factors 1, 2 and 3 in the determination of scientific merit, and