Time-Sensitive Evaluation of Policies Affecting Health Behaviors and Chronic Disease Risk (R01-Clinical Trial Not Allowed)

Time-Sensitive Evaluation of Policies Affecting Health Behaviors and Chronic Disease Risk (R01-Clinical Trial Not Allowed) is sponsored by NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAR-25-312: Time-Sensitive Evaluation of Policies Affecting Health Behaviors and Chronic Disease Risk (R01-Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) Funding Opportunity Title Time-Sensitive Evaluation of Policies Affecting Health Behaviors and Chronic Disease Risk (R01-Clinical Trial Not Allowed) R01 Research Project Grant May 21, 2025 - Notice of Change: Expiration of PAR-25-312: Time-Sensitive Evaluation of Policies Affecting Health Behaviors and Chronic Disease Risk (R01-Clinical Trial Not Allowed).

See Notice NOT-DK-26-328 . 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 See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) establishes an accelerated review/award process to support time-sensitive research to evaluate a new policy or program that is likely to influence diet, physical activity, sleep, and/or weight and thus has the potential to lower rates of chronic diseases, particularly in populations at risk for health disparities.

This NOFO is intended to support research where opportunities for empirical study are, by their very nature, only available through expedited review and funding. All applications submitted to this NOFO must demonstrate that the evaluation of the policy or program of interest offers an uncommon and scientifically-compelling research opportunity that will only be available if the research is initiated with minimum delay.

For these reasons, applications submitted to this time-sensitive NOFO are not eligible for re-submission. It is intended that eligible applications selected for funding will be awarded within 4 months of the application due date; however, administrative requirements and other unforeseen circumstances may delay issuance dates beyond that timeline.

Funding Opportunity Goal(s) NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 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.

New Date May 21, 2025 per NOT-DK-26-328 (Prior Date January 12, 2028). Any due dates beyond the new expiration date are no longer available. 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. 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 Unhealthy behaviors such as poor dietary intake, inadequate physical activity, excessive sedentary behavior, and lack of sleep are major contributors to many serious chronic diseases and conditions that are associated with increased morbidity and mortality, higher healthcare expenses, and reduced quality of life.

The prevalence of obesity and other chronic diseases that are associated with these unhealthy behaviors has dramatically increased in both children and adults in the United States over the past four decades with disproportionately larger increases observed in many populations that are affected by health disparities.

For NIH, populations that experience health disparities include racial and ethnic minority groups ( see OMB Directive 15) , people with lower socioeconomic status (SES), underserved rural communities, and people with disabilities. Factors that hamper healthy behaviors are more likely to affect these populations owing to larger social and structural influences such as discrimination, lack of access to healthcare, and economic inequality.

Adverse social and structural determinants are likewise strongly linked with food and nutrition insecurity, inadequate housing, lack of safe spaces for physical activity, and unfavorable environmental factors that influence sleep among others.

Across the United States, many localities, states, and the Federal government are taking action to address obesity and chronic disease rates through policies and programs that have the potential to improve health behaviors.

While helping people achieve and maintain healthy behaviors and potentially lowering the rates of chronic diseases are critical public health goals, there are many gaps in knowledge regarding the effectiveness of large-scale policies and programs that could help achieve these goals at the population level or within sub-populations, including populations at risk for health disparities.

Rigorous scientific evaluation of these policies and programs can help build an evidence base to better inform policy and public health approaches to prevent chronic diseases.

This notice of funding opportunity (NOFO) is intended to encourage and support research in which a unique and time sensitive opportunity has arisen to collect baseline data and then prospectively assess effectiveness of an imminent policy or program that is likely to influence diet, physical activity, sleep, and/or weight and thus has the potential to lower rates of chronic diseases, particularly in populations at risk for health disparities.

For the purposes of this NOFO: Policy is broadly defined to include both formal public policies at local, state, and Federal levels of government, and organizational-level policies, such as those implemented by large organizations, worksites, or school districts, that are expected to influence diet, physical activity, sedentary behavior, and/or sleep.

Examples include, but are not limited to, the development of supermarkets in underserved areas, calorie labeling requirements, taxes on foods and/or beverages, Food is Medicine programs, changes in health insurance/system reimbursement policies, after-school and summer programs, or modification of the built (or human-made) environments to encourage walking or cycling for transportation or leisure.

Program is defined as a set of activities initiated by governmental or other organizational bodies to enhance chronic disease prevention and control. Examples might include programs implemented at worksites, healthcare organizations, after-school or summer programs, or in a community that can be expected to improve behaviors such as energy intake, sleep, and activity levels.

This NOFO is not intended to support the initiation and delivery of new programs; rather, it is intended to support evaluation of the effectiveness of programs and/or policies that are being or will be implemented independent of NIH grant funding.

Applications submitted to this NOFO should demonstrate that measures or outcomes to be collected and evaluated will allow for meaningful and scientifically valid conclusions to be made about the effects of the policy or program on the target behaviors and chronic disease outcomes.

Examples of appropriate studies include, but are not limited to, the following: Introduction of food or beverage taxes/subsidies/price changes/other incentives; Infrastructure initiatives such as retailers or other public venues offering healthier food options in underserved areas; Changes to workplace food and/or physical activity environment; Polices expected to influence available dietary options and/or purchasing behaviors, such as calorie labeling in restaurants, produce prescriptions, meal delivery, menu or food product reformulation, and supermarket layout or pricing strategies; Modification of school system policies, including food, physical activity, or starting time; Significant changes in policy or practice in large healthcare organizations that are expected to improve weight outcomes, such as changes in reimbursement for services or pharmaceutical agents, incentives, or wide scale implementation of prevention or treatment services; Policies or programs designed to improve access to or quality of housing and the surrounding built or food environment; Modifications to the built environment to encourage active transportation or leisure physical activity, such as the implementation of bike lanes in urban areas, multi-use trails, subsidies for public transit, upgrades of sidewalks, or improved access to parks and recreation facilities.

There are several distinguishing features of time-sensitive obesity program and/or policy research evaluations: The research question must clearly offer a unique and scientifically compelling research opportunity that will only be possible if the evaluation research component is initiated with minimum delay, and The plan for collection of baseline and follow-up data must be feasible.

Primary outcomes under study must be assessed using objective measures or gold standard assessment methods.

Examples of acceptable primary outcomes include rigorously measured behavior change, such as 24-hour dietary recalls or purchasing behaviors, use of resources intended for physical activity, food or beverage purchasing data, energy intake with a focus on lowered calories or lower calorie substitutions, activity changes such as reduced sedentary behavior or increased physical activity, assessment of sleep with actigraphy, weight-related variables (e.g., BMI, body composition), and/or relevant chronic disease outcomes.

Other self-reported measures of dietary intake and physical activity can be included but should not be the primary outcome measure(s). Where possible or relevant, applications should include secondary outcomes that evaluate potential unintended consequences of a policy or program, degree of implementation, and an assessment of barriers and facilitators associated with implementation.

This includes measures that will help identify why the policy or program does or does not succeed. This NOFO strongly encourages effective scientific partnerships between researchers and public partners (e.g., community-based organizations, local governments, school districts, employers, etc.). Where appropriate, agreements must also be in place that allow for unrestricted publication of findings regardless of study outcomes.

The Program Director/Principal Investigator of the evaluation study application may not be the Director and/or initiator of the policy or program that will be evaluated. Given the possibility for changes in policy or program implementation that are beyond the control of the grantee, grant awards may be terminated early if these changes limit the possibility to collect meaningful outcome data.

Applications requesting research support for the evaluation or retrospective analysis of existing policies or programs that are not time-sensitive should not be submitted under this NOFO. Such applications will be returned to the investigators without review. The focus of this FOA is on research in humans, not animals.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) : NIDDK is interested in the evaluation of large-scale programs or policies expected to influence diet, physical activity, sleep, and/or weight with relevance to the development, progression and/or management of diseases and conditions within its mission , including diabetes, other endocrine and metabolic diseases; gastrointestinal, liver and pancreatic diseases; nutritional disorders; obesity; kidney diseases; and urologic conditions.

NIDDK encourages research teams that enhance the scientific process, including meaningful partnership with individuals who are living with NIDDK-relevant diseases/conditions as well as family and community members.

This includes applications with interdisciplinary research teams comprised of individuals with a breadth of lived experiences and biomedical scientific expertise deemed necessary to positively inform the study design, research conduct, and applicability of research findings for the populations of interest.

NIDDK has many research areas within its mission, but all research related to relevant diseases/conditions may not be appropriate for NIDDK. Applicants to this NOFO are strongly encouraged to contact NIDDK staff as soon as possible in the development of the application, so that NIDDK staff can help the applicant understand whether the proposed study is within the goals and mission of the Institute and is appropriate for this NOFO.

National Cancer Institute (NCI) : NCI is particularly interested in the evaluation of programs or policies that may affect diet, physical activity, sleep, and/or weight, and studies incorporating economic research on such programs and policies. Prospective applicants are strongly urged to contact the NCI Scientific/Research Contacts prior to preparation of such proposals.

Applications assigned to NICHD must address one or more NICHD priority populations.

These include: Infants, children and adolescents, including individuals transitioning from pediatric to adult health care providers Pregnant, peripartum, postpartum or lactating women Those of reproductive age in regard to gynecologic and reproductive health care Individuals of any age with intellectual and developmental disabilities Individuals of any age with physical disabilities Applications that are not responsive to this NOFO: The following types of applications are not responsive to this NOFO.

Applications not responsive to this NOFO will not be reviewed.

Applications that do not clearly describe the time-sensitivity of the project(s), Applications that do not propose objective measures for the primary outcome(s), Applications that are not specific to policies/programs that may affect dietary intake, physical activity, sedentary behavior, and/or sleep, Applications that independently propose initiation and/or delivery of new policies or programs, Applications exclusively proposing to conduct analyses of existing data, including data in the electronic medical record, Applications proposing to assess policies or programs implemented outside of the United States or US territories, Applications proposing research with animals, or Applications where the Program Director/Principal Investigator is the Director and/or initiator of the policy or program to be evaluated.

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.

Not Allowed: Only accepting applications that do not propose clinical trials. 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) 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 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: 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.

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.

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. 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.

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.

Use of Common Data Elements in NIH-funded Research Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.

Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.

NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (https://cde. nlm.

nih. gov/home ( https://cde. nlm.

nih. gov/home )) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.

Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. 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 in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. Factor 1.

Importance of the Research