Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)

Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional) is sponsored by National Institutes of Health. Accelerates development of devices to treat substance use disorders, aiming for FDA approval of new device-based treatments.

Expired PAR-25-023: Device Based Treatments 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 Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional) UG3 / UH3 Exploratory/Developmental Phased Award Cooperative Agreement November 24, 2025 - Notice to Expire PAR-25-023, "Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)".

See Notice NOT-DA-25-042 . 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 The purpose of this notice of funding opportunity (NOFO) is to accelerate the development of devices to treat Substance Use Disorders (SUDs). The continuing advances in technologies offer unprecedented opportunities to develop neuromodulatory or neurophysiological devices that are safe and effective SUD treatments.

The objective is to move devices to their next step in the FDA approval process, with the ultimate goal of generating new, FDA approved device-based treatments for SUDs. Applications may focus on the pre-clinical and/or clinical development and testing of new devices or existing devices approved for other indications. Applications may evaluate the mechanism of action of a device.

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 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 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 November 24, 2025 per issuance of NOT-DA-25-042 .

(Original Expiration Date: August 14, 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 substantial adverse impact in the United States, resulting in costs of more than $700 billion annually due to health care expenditures, lost earnings, and expenses associated with crime and accidents. There are effective pharmacological and behavioral treatments, but the long-term success rate is low and not all individuals are responsive.

Furthermore, approved treatments are not available for cannabis, methamphetamine, cocaine use and polysubstance use disorders. The development of safe and effective therapeutic devices for SUDs represents an opportunity to address the significant public health need for new SUD interventions.

With the approval of neuromodulatory devices for treatment of mental health disorders such as depression and obsessive compulsive disorder, interest has rapidly grown around applying these and related technologies to SUDs. Studies examining the effects of neuromodulation on nicotine, alcohol, cocaine, and other SUDs have reported some therapeutic effects. Further work, however, is needed to strengthen and build upon these results.

High priority areas of research include understanding the relationship between changes in brain circuitry and behavioral responses, what SUD behavioral activities are responsive, how long does the altered behavioral response last, how can devices be used together with FDA approved treatments, and are subsequent treatments needed to maintain the behavioral response.

This notice of funding opportunity (NOFO) seeks to support research into neuromodulatory technologies to treat SUDs. These technologies include, but are not limited to, transcranial magnetic stimulation, transcranial direct current stimulation, vagal stimulation, deep-brain stimulation, focused ultrasound, and others.

Also of interest are technologies that may not directly modify neuronal function but report on or alter neurophysiology that affect outcomes. This NOFO strongly encourages the testing of device-based interventions previously approved/marketed for non-SUD disorders, as well as new interventions in active development. Understanding how these new treatment modalities work is of primary importance to this NOFO.

In neuromodulatory technologies, for example, there are multiple coil types which can result in different breadths and depths of biologic effect.

For studies that seek to understand how the neuromodulatory and neurophysiological interventions function, early stage endpoints should incorporate objective measures that examine both the delivered dosage/treatment duration and the proposed mechanism of action of the intervention, and should determine if the intervention target has been modulated.

Areas of interest to this NOFO include understanding the effect of the intervention on circuit-based targets, as well as to characterizing the breadth and stability of the behavioral effect. The questions may include, but are not limited to: Does the intervention preferentially and reproducibly engage/modulate a circuit-based target in a dose/stimulus-dependent manner?

If circuit-based target engagement is verified, is there a measurable clinical benefit as detected through functional domains or clinical measures? What is the relationship between changes in brain circuitry and behavioral responses? What types of SUD behavioral activities are responsive to the intervention?

How long does the altered behavioral response last? Are subsequent treatments needed to maintain the behavioral response? Are there potential side effects and safety issues associated with the doses?

All aspects of dose delivered by a device should be thoroughly defined.

This includes, when applicable, The spatial distribution of dose delivered by electromagnetic devices, using anatomically-accurate computational head models to simulate the distribution of electromagnetic field in the brain; The temporal characteristics, including pulse shape, pulse direction, frequency, train duration, inter-train interval, and other aspects where appropriate; The contextual aspects of when and how the dose is administered, including specification of brain state at time of administration, engagement in cognitive/behavioral therapies, social context of device delivery, and others.

Studies are strongly encouraged, when appropriate, to include evaluation of circuit-directed target engagement, using on-line (e.g., TMS/fMRI interleaving, EEG, PET) or off-line (e.g., PET, fMRI/rsfcMRI, MRS) approaches, depending on the nature of the spatial anatomical and/or neural oscillatory targets. Careful attention should be paid to the time-course of action.

For rapidly acting interventions, where changes in circuit-based targets occur acutely during administration, it may be most appropriate to use pharmacodynamic outcome measures (e.g. neurocognitive task performance, craving). Sham/placebo stimulus comparators should be included when appropriate.

If a sham is used, demonstration must be provided not only of adequate masking procedures but also lack of biological action that would exert CNS effects. If applicable, investigators should design studies to evaluate potential sex differences. When appropriate, methods to evaluate subjects' compliance with the study treatments should be included, such as when integrative pharmacologic or behavioral approaches are used.

For studies that include device development, applications are required to include a go/no-go decision tree regulatory pathway with clear milestones. Prospective applicants are encouraged to discuss the development plan with the appropriate regulatory authorities at the FDA.

For studies requiring an Investigational Device Exemption (IDE), applicants are expected to provide confirmation of an existing IDE, or describe the status of any such pending regulatory submissions. If an IDE application is not submitted by the time of the grant application submission, the applicant is expected to describe the plan and timeline for submitting the request and obtaining the IDE prior to the initiation of a grant award.

If the device is exempt from the IDE, the grant application is expected to include the justification and documentation for why the device would be exempt. Applicants are strongly encouraged to 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 NOFO uses a phased innovation approach (UG3/UH3).

In the UG3 phase, milestones must be designed around the next stage of device or treatment development. The UG3 phase provides support for up to two years with specific milestones determined by the investigator and expected to be accomplished by the end of the UG3 phase. At that time, the grant will undergo administrative review by NIDA staff to determine if the milestones are successfully accomplished.

If they are, then the application may be awarded for up to three additional years of support (UH3 phase). Milestones and UG3/UH3 Transition: Applicants must plan for both the UG3 and UH3 phase. The UG3 section must include a description of an entry point and the milestone(s) that will be reached at the end of the phase.

The milestones must include quantifiable metrics to determine success of the UG3. To successfully transition to the UH3 phase, the project must reach the milestones outlined in the application. Additional milestone(s) may be negotiated before or after funding decisions are made.

The UG3 phase must provide an entry and exit point (milestone) for the device and treatment in the FDA approval pathway. The focus should be on moving forward to the next stage of testing and validation. 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 must provide clear, measurable milestones to be accomplished at the end of the UG3 .

Generally, these activities and milestones may include: Objective measures of the circuit-based target, including selectivity, and mechanism of action Evidence that the measure(s) of target engagement can be reliably and validly manipulated in a dose-dependent fashion Demonstration of adequate target engagement with established dose selection or stimulus range Evidence that the intervention effects efficacy related endpoints, such as craving, dependence, or days of abstinence Evidence that the intervention effects behavioral related endpoints, such as measures of working memory, impulsivity, risk-taking propensity, distress tolerance, self-regulation, or stress reactivity Evidence that an adequate dose range/treatment duration for the intervention(s) can be applied with acceptable safety and tolerability Completion of initial safety studies Q-submission to obtain FDA feedback on regulatory pathway Completion of pre-clinical and clinical IDE-enabling studies Completion of a proof-of-concept, feasibility clinical trial 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.

Applicants must provide the entry and exit points of the proposed research in the development continuum. The application is required to provide quantifiable milestones to determine success of the UH3.

Activities for the UH3 may include: Demonstration of the relationship between target engagement and functional outcomes, preferentially using dose-ranging studies; Demonstration of the relationship between changes in the circuit-based target and biomarkers/measures of brain function, domains of functions, and symptom/functional measures; Development of target engagement, brain function and symptom/functional measures.

Endpoints may include measures of abstinence and decreased use, as well behavioral measures such as craving and dependence; Demonstration of the efficacy of the intervention based on generally accepted measures, such as abstinence; If a behavioral treatment is used integratively, demonstration of its effect on the outcome measure Applications Not Responsive to this NOFO The following types of studies are not responsive to this NOFO and will not be reviewed: Any application without quantifiable milestones Applications that do not propose the inclusion of a device to treat SUDs either, alone or in combination with alcohol use disorder.

Applications that only involve alcohol use disorder 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 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 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 to two years for the UG3 phase and 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 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 .

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 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. 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 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: 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 neural target or device being tested must 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 are required to show the investigators can work as a team and have the necessary methodological and statistical expertise to evaluate the proposed outcomes. The environment are required to support timely subject recruitment and completion of both the UG3 and UH3 phases. Go/no-go milestones for the UG3 phase must be clear, quantitative and achievable.

A successful UG3 phase should set the stage for the larger UH3 phase. Describe how the research strategy for the UG3 phase utilizes reliable, objective and valid measures of target engagement to definitively test the intervention's ability to modulate the target. The application is required to demonstrate how the UH3 phase plans to include a more focused study that will move the intervention forward.

For applications proposing clinical trials The scientific rationale and need for a clinical trial must 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. 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. 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-definedclinical 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.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement , and procedures for foreign institutions 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. 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. Investigators should 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. 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.

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