Developing Digital Therapeutics for Substance Use Disorders

Developing Digital Therapeutics for Substance Use Disorders is sponsored by National Institutes of Health (NIH). Aims to accelerate the development of digital therapeutics for substance use disorders, including AI-powered platforms.

Expired PAR-24-064: Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional) 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 on Drug Abuse ( NIDA ) Funding Opportunity Title Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional) UG3 / UH3 Exploratory/Developmental Phased Award Cooperative Agreement Notices of Special Interest associated with this funding opportunity May 9, 2025 - Notice to Applicants That the Simplified Review Framework Will be Applied to All Relevant Applications for August/October 2025 Councils.

See Notice NOT-OD-25-116 . 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 04, 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 The purpose of this notice of funding opportunity (NOFO) is to accelerate the development of Digital Therapeutics (DTx) to treat Substance Use Disorders (SUDs).

Advances in technology offer unprecedented opportunities to develop clinical-grade mobile, web, or other software-based platforms designed to deliver treatments that are safe and effective for SUD. FDA authorization of DTx can play an important role in increasing the availability of treatments to patients with SUD.

The primary objective of this NOFO is to move DTx to their next step in the development process, with the ultimate goal of generating new, FDA authorized, disseminated treatments for SUDs. Applications may focus on the pre-clinical and/or clinical development and testing of new DTx or existing DTx developed for other indications. The UG3/UH3 Cooperative Agreement involves two phases.

The UG3 phase, for up to two years, is designed to support a project with specific milestones to be accomplished by the end of the period. The UH3 phase is to provide funding for up to three additional years following successful completion of the UG3. UG3 projects that meet their milestones will be administratively considered by the National Institute on Drug Abuse (NIDA) and prioritized for transition to the UH3 phase.

Investigators submitting to this NOFO must address both UG3 and UH3 phases. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date 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 24, 2025 per NOT-OD-25-113 (Originally November 20, 2026) 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 Substance Use Disorders (SUDs) continue to have a significant adverse impact in the United States, resulting in more than $700 billion annually in health care expenditures, lost earnings, and expenses. The prevalence of SUD is widespread, with approximately 21.

6 million individuals over the age of 12 experiencing substance use or dependence. There are safe and effective FDA approved medications for opioid and nicotine use disorders, but the long-term success rate is low. There are no FDA approved medications for other SUDs.

Behavioral therapies for SUDs, delivered directly between a therapist and patient, have shown efficacy but the substance use relapse rates are high. New device and digital technologies are being investigated, and these interventions have only recently started achieving FDA authorization.

Expanded development of safe and effective digital therapeutics for SUDs represents a new opportunity to address the high public health need for new SUD interventions. Digital therapeutics (DTx) are clinical-grade mobile, web, or other software-based platforms designed to deliver treatments for medical conditions or diseases.

These therapeutic interventions do not include wellness apps or telehealth which provides remote access to a clinician. Instead, DTx can deliver new behavioral interventions or those that have previously only been available for delivery through direct, face-to-face interactions with a clinician. DTx can provide therapeutic opportunities beyond those that are available under current standard of SUD care.

For example, the delivery of a behavioral intervention by DTx ensures it is provided in a highly reproducible manner. DTx are available 24 hours a day, whenever a patient might need support. Access is not affected by transportation challenges to a clinician, or by when a patient might have the time available to visit a clinician.

Privacy can be ensured by providing discreet and confidential care, avoiding the challenges of stigma around the potential for public exposure of receiving treatment. DTx can be highly scalable, increasing access at low cost. Over the last several years, the FDA has provided a pathway for authorization of DTx and there already has been approval of DTx for SUD.

However, more work is needed to expand on the types of treatments delivered, the technologies used for delivery, that target special populations or specific SUDS, or other aspects that can increase the efficacy and reach of treatment using DTx. The goal is to support research into the development and testing of DTx for stand-alone treatments or DTx integrated with FDA-approved SUD treatments.

Stand-alone DTx treatments may, for example, deliver behavioral interventions that are currently accessed via face-to-face interactions with a therapist. The treatment may be completely delivered by the DTx, or it may include reduced numbers of face-to-face interactions with a therapist. However, it is intended that no other intervention is included in a stand-alone treatment.

Approaches integrated with FDA-approved SUD treatments would support and enhance the effect of the treatments. Indications targeted by the interventions could include: prevention of the initiation of SUDs, increasing medication adherence, enhancing treatment retention, treatment of withdrawal, initiation of abstinence, or reduction of relapse.

Investigators are strongly encouraged to reach out to the appropriate FDA Center for Devices and Radiological Health (CDRH) office via the Pre-Submission process to discuss the proposed development pathway and clinical validation data requirements. Guidance on this process can be found here: Q Submission Process .

Questions for discussion in a Pre-Submission could include: whether a DTx would meet the definition of a medical device and require FDA oversight; the most appropriate regulatory pathway for a DTx if it does meet the definition of a medical device; whether a clinical trial investigating the safety and effectiveness of an investigational DTx would represent a significant risk study and require prior Investigational Device Exemption (IDE) approval.

Additional discussions can include clinical study design considerations (including feedback on the proposed patient population, study endpoints and assessments, statistical analysis plan, study comparator, and others) to support the safety and effectiveness of the DTx for a particular use indication. Sham comparators or validated active comparators should be included when appropriate.

If applicable, investigators should design studies to evaluate potential sex differences. Methods to evaluate subjects' compliance with the study treatments should be included when possible. Monitoring adherence to the treatment would be especially appropriate for DTx that are integrated with FDA-approved SUD interventions.

Applicants should consult with National Institute on Drug Abuse (NIDA) staff when developing plans for an application (see Agency Contacts, Section VII). This early contact will provide an opportunity to clarify NIDA policies and guidelines, identify whether the proposed project is consistent with NIDA program priorities, and discuss how to develop an appropriate project timeline, which is subject to peer review.

UG3/UH3 Phases of Research This notice of funding opportunity (NOFO) uses a phased innovation approach (UG3/UH3). The UG3 phase provides support for up to two years with specific milestones and go/no-go rules, determined by the investigator, to be accomplished by the end of the UG3 phase.

The milestones and go/no-go rules must be based on quantifiable measures and designed around what needs to be achieved to reach the next stage of development. Applicants must plan for both the UG3 and UH3 phase. At the completion of the UG3, the grant will undergo administrative review by NIDA staff to determine if the milestones are successfully met.

Following review, the application may then be awarded up to three additional years of support (UH3 phase). The focus of the UG3 phase should be on moving the intervention forward to the next stage of design and testing, providing milestones relevant to the FDA authorization pathway. The specific activities and milestones appropriate for the UG3 phase will depend on the type of intervention under study and its stage of development.

Grant applications should provide clear, measurable milestones and go/no-go rules to be accomplished at the end of the UG3.

Activities for the UG3 may include: Development of a finalized version of the DTx and validation in the study population; Evidence that the intervention effects efficacy related endpoints, such as craving, dependence, days of abstinence, etc; Evidence that the intervention effects behavioral endpoints as they relate to SUD, such as measures of working memory, impulsivity, risk-taking propensity, distress tolerance, self-regulation, stress reactivity, etc; Evidence that an adequate dose range/treatment duration for the DTx intervention(s) can be applied with acceptable safety, tolerability, adherence, etc; Evidence that when integrated with an FDA-approved treatment, there is enhanced adherence, retention, efficacy or effects on other measures relevant to the approved treatment; Completion of a proof-of-concept, feasibility clinical trial; Q-submission to obtain FDA feedback on the regulatory pathway; Completion of IDE-enabling studies; Approval of an IDE or confirmation that an IDE is not required Funding for the UH3 phase is contingent on successfully meeting the milestones in the UG3 phase (see Section VI.

Award Administration Information, 1. Award Notices for further information). The UH3 phase supports the next step in the development of the intervention and progression towards FDA authorization.

Applicants are expected to describe the entry and exit points of the proposed research in the development continuum. The application must provide quantifiable milestones to determine success of the UH3. Activities for the UH3 are contingent upon the milestones defined and accomplished in the UG3 and availability of funds.

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

Section II. Award Information Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement for this NOFO. Application Types Allowed The OER Glossary and the SF424 (R&R) 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 limited to $500,000 direct costs for each year of the UG3 phase, but are not limited for the UH3 phase. However, budgets need to reflect the actual needs of the proposed project.

The project period is limited up to two years for the UG3 phase and up to three years for the UH3 phase. 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 All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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 (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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

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

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

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

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

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; 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 SF424 (R&R) 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. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: [email protected] 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 SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Investigators should describe how the project addresses an important problem or a critical barrier to progress in the field.

Describe the scientific premise and indicate how scientific knowledge, technical capability, and/or clinical practice will be improved if the aims are achieved. Describe how successful completion of the aims may change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field.

A strong design to allow for the validation or rejection of the behavioral intervention or device being tested should be integral to the study. Indicate how the characteristics and rationale of the project make it ready for the proposed phase of testing.

Without duplicating information in the biosketches, descriptions must be provided showing the investigators can work as a team and have the necessary methodological and statistical expertise to evaluate the proposed outcomes. The environment should support timely subject recruitment and completion of both the UG3 and UH3 phases.

Investigators must provide information regarding the specific regulatory pathway (e.g., will the project require an IDE) and a clear and feasible plan to address all regulatory requirements (e.g., describe the plan for a Q-submission to discuss the regulatory requirements with the FDA and receive their feedback). If an IDE is required, describe the specific plans to submit and obtain the FDA approval.

Information regarding the regulatory pathway should be included, and where the studies fall along the pathway for submission to FDA for review and regulatory approval. Applications must include specific aims and research plans with environmental support for both the UG3 and UH3 phases. Required milestones and go/no-go rules for the UG3 phase must be clear, quantitative and achievable.

A successful UG3 phase must set the stage for the larger UH3 phase. Describe how the research strategy for the UG3 phase utilizes reliable, objective and valid measures to assess the proposed endpoints. The UH3 phase must provide a more focused study that will move the intervention forward.

For applications proposing clinical trials The scientific rationale and need for a clinical trial should be supported by preliminary data and information in the literature. Describe how the clinical trial is necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy.

If the trial focuses on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, describe how the trial will advance scientific understanding. Without duplicating information in the biosketches, address how the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines.

Describe the expertise in study coordination, data management and statistics. If the study involves a multicenter trial, describe how the organizational structure is appropriate and identify a core of potential center investigators and staffing for a coordinating center. The study should be appropriate to address primary and secondary outcome variable(s)/endpoints that are clear, informative and relevant to the hypothesis being tested.

Explain how the study is adequately powered and designed efficiently to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results. The study should be appropriate and well justified for the populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial.

Address differences, if applicable, in the intervention effect due to sex and race/ethnicity. Potential ethical issues should be adequately addressed and the process for obtaining informed consent or assent appropriate. The plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up should be appropriate to ensure robust data collection.

Ensure that the planned recruitment timelines are feasible and have an adequate plan to monitor accrual. Address the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria. Applications should discuss the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines.

The planned analyses and statistical approach should be appropriate for the proposed study design, methods used to assign participants, and deliver interventions. Include procedures for data management and quality control of data. Describe the methods for standardization of procedures for data management to assess the effect of the intervention and quality control.

Data analysis should be completed within the proposed period of the award. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1.

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. Overview Information 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 SF424 (R&R) 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 SF424 (R&R) 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. 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