Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required) is sponsored by NIH. Supports the development of innovative psychosocial interventions for mental disorders through a phased award mechanism.

PAR-25-182: Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) Funding Opportunity Title Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required) R61 / R33 Exploratory/Developmental Phased Award Notices of Special Interest associated with this funding opportunity May 20, 2026 - Notice of Change to Key Dates for PAR-25-182 - Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required).

See Notice NOT-MH-26-030 . 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 Research Project (Cooperative Agreements) Exploratory/Developmental Grants Phase II Exploratory/Developmental Grants Phase II Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this NOFO is to encourage pilot research developing and testing innovative psychosocial intervention approaches in which the target and/or intervention strategy is novel.

Consistent with NIMH’s experimental therapeutics approach, this NOFO is intended to speed the translation of emergent research on mechanisms and processes underlying mental disorders into promising novel psychosocial preventative or therapeutic interventions.

Targets may include, but are not limited to, potentially modifiable behavioral, cognitive, affective, and/or interpersonal factors or processes, neural circuits or neural activity subserving specific behaviors or cognitive processes, and/or other neurobiological mechanisms.

Novel psychosocial interventions may be standalone interventions or novel augmentations to efficacious interventions for which there is an empirical rationale by which the augmentation (and corresponding target) is expected to substantially enhance outcomes.

Support will be provided for up to two years (R61 phase) for preliminary milestone-driven testing of a novel intervention's impact on a target process or mechanism associated with mental disorder risk, causation, or maintenance (target engagement). Up to 3 years of additional support (R33 phase) will be provided for studies with findings that meet the "go/no-go" milestones embedded in the R61 phase.

The R33 phase is intended to support the replication of target engagement and to test whether engaging the intervention target/mechanism mediates changes in clinical outcomes. Ultimately, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support "go/no-go" decisions about further development and/or testing of the intervention.

Applicants pursuing other stages of the clinical trial pipeline should consider one of the companion NOFOs listed above. Funding Opportunity Goal(s) The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

Open Date (Earliest Submission Date) Dates in bold and italics reflect changes per NOT-MH-26-030 Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

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

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

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

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

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

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

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

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure.

The purpose of this notice of funding opportunity (NOFO) is to encourage Phased Innovation (R61/R33) grant applications that focus on psychosocial intervention development consistent with the NIMH emphasis on the experimental therapeutic approach for the treatment and prevention of mental disorders in adults and children.

In this approach, clinical trials should be designed so that even negative results will provide information to guide further intervention development efforts .

The focus of this NOFO is on the early phases of intervention development, during which emergent research on mechanisms and processes underlying mental disorders is translated into clinical hypotheses and novel interventions are tested in a clinical population or population at-risk.

This NOFO supports the development and testing of innovative psychosocial intervention approaches where the target and/or the intervention strategy is novel .

Targets may include but are not limited to, potentially modifiable behavioral, cognitive, affective, and/or interpersonal factors or processes, neural circuits or neural activity subserving specific behaviors or cognitive processes, and/or other neurobiological mechanisms associated with risk for, causation of, or maintenance of a mental disorder.

Eligible intervention strategies might include in-person or technology-assisted delivery (e.g. digital therapeutics), provided the target and/or the intervention strategy is novel. Digital technologies that meet the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act, may be accepted under this NOFO.

It is important to note that such digital technologies with the intended use of treating or preventing mental illness are FDA-regulated, even if they are non-significant risk (NSR).

In the case of technology-assisted delivery, if optimization of the technological aspects of the delivery is the focus of study, this would be more appropriate for PAR-25-184 “Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required).

” This NOFO supports the development and testing of novel psychosocial interventions, as defined above, as monotherapies or as augmentations to a standard treatment (which may be psychosocial, pharmacological, neuromodulation, biologic, or other somatic modality).

Studies must include an examination of a defined intervention target/mechanism based on empirical evidence of disease processes or mechanisms that confer risk, causation, or maintenance of a disorder, and a clear hypothesis about how an intervention directed at changing the target/mechanism can lead to clinical benefit in persons with or at risk for mental disorders.

This NOFO provides support for up to two years (R61 phase) for milestone-driven testing, refinement, replication, and/or validation of the intervention's impact on an empirically-supported, measurable intervention target/mechanism of disorder (i.e., the intervention's capacity for target engagement), and the possibility (contingent on meeting R61 "go/no-go" milestones) of up to 3 additional years of support (R33 phase) for studies to confirm target engagement in a larger sample, assess the relationship between target engagement and changes in measures of clinical benefit, and examine preliminary signal of efficacy.

Results from the R33 phase should provide evidence to determine whether further development of the intervention is warranted, and if it is, to inform the design of a subsequent confirmatory efficacy trial. This NOFO encourages highly innovative projects, with the recognition that such projects may entail a greater failure rate (e.g., failure to reach pre-specified milestones for continued development).

NIMH values this early, efficient, and objective testing of an intervention's ability to alter a well-defined and objectively measured target/mechanism to help inform decisions about which interventions should be further developed.

This NOFO uses a phased innovation approach (R61/R33) to manage the risk of obtaining inconclusive or negative results in innovative therapeutic trials by requiring a demonstration of the intervention's effect on a target/mechanism that is associated with risk, causation, or maintenance of symptom expression or related impairment before moving into the R33 phase of the award.

Studies testing multimodal interventions (e.g., a novel psychosocial intervention designed to augment an established drug- or device-based intervention) are acceptable under this NOFO if the psychosocial intervention being tested is novel. Applicants should include a description of the combination of therapies, and how the combination parameters will be assessed.

Studies should detail how effects of the combined therapies on target engagement are positively synergistic (versus negative or net-neutral) or fill a gap left by the monotherapies, and use contextually appropriate comparison conditions (e.g., comparing the effects of the combined therapies relative to each monotherapy) when research methods allow for them.

For all combination therapies, applicants should follow all other guidance/requirements of the NOFO including defining measures of target engagement and describing how they will test various doses/combinations.

The rationale for the selection of doses/combinations being assessed should be well-supported by empirical evidence (i.e., preliminary data, clinical and/or preclinical studies, or existing evidence from the literature), a conceptual model, or rationale. For multimodal interventions in pediatric populations, a novel intervention should be paired with a previously established intervention.

For drugs and devices, an established intervention is defined through FDA approval/clearance of the intervention, for a specific indication, age range and dosing. NIMH Priorities for Developing and Pilot-testing Interventions NIMH requires applicants follow an experimental therapeutic approach to develop and test interventions .

Clinical trials following this approach are expected to address whether the intervention engages the target/mechanism presumed to underlie the intervention effects (target engagement). The term "target" refers to a factor that an intervention intends to modify, based on a hypothesis that modification of that factor will result in improvement of symptoms, behavior, or functional outcomes, or lower risk for the onset of mental disorders.

Targets/mechanisms can range from molecular, neural or neurophysiological systems to cognitive, behavioral, or emotional processes, to interpersonal/social group processes or contextual factors depending on the nature of the intervention and appropriate analyses. A target may be a disease mechanism, a factor related to a disease mechanism, or a factor that confers significant risk.

An appropriate target is an intervening variable that has either been demonstrated to be associated with risk for a mental disorder, with a clinical symptom or functional deficit, or is hypothesized (based on empirical evidence) to impact the biological or psychological pathway through which a clinical or functional benefit would be expected to occur.

Thus, it is hypothesized that change in the target will mediate the intervention's clinical or functional impact. While exposure to broad, societal/environmental circumstances might be used to identify at-risk populations, NIMH will not accept applications that propose to directly target or intervene on broad, societal adverse exposures, such as strategies to reduce poverty or violence.

"Target engagement" refers to verification that the intervention has had the predicted effect on the target/mechanism. In the experimental therapeutic approach, once target engagement is demonstrated, measures of target engagement are then related to clinical outcomes to begin to test the hypothesis that modification of the target/mechanism is sufficient to alter the clinical outcome under study.

Valid and reliable measures of change in the target/mechanism will provide useful information about the potential for further development of the intervention, whether or not target engagement is achieved. In the assessment of target engagement, NIMH encourages the use of measures that are as direct and objective as is feasible in the clinical research setting.

NIMH encourages hypotheses and measures of potential mechanisms across molecular, biological, cognitive, psychological, social, affective, and/or behavioral domains of analysis that might account for change in the target and clinical outcome. The type of measure(s) will depend on the conceptual model, the nature of the target/mechanism, and the availability of valid, reliable measures of change in the target/mechanism.

Measures might include self-reports, lab-based neurocognitive tasks, experimental psychopathological or other behavioral measures, psychophysiological measures, neuroimaging or other brain-based measures, sensor-based or other observational measures of interpersonal processes or contextual/environmental factors, or valid proxy measures as alternatives.

Specifically encouraged are empirically validated measures of the construct that extend beyond self-report and other subjective measures, where possible. Tests of multiple targets/mechanisms are allowed when appropriate. Each proposed novel target/mechanism must be supported by an empirically-supported rationale, a testable hypothesis, and valid and reliable measures of change.

Applications to evaluate more than one target should define their go/no-go criteria clearly, define milestones accordingly, and justify the decision to make proceeding to the R33 phase contingent on the specified effect of the treatment on them. Applicants are strongly encouraged to review the information on the NIMH website focused on clinical trials . The clinical endpoint or outcome will vary according to the type of intervention.

In the case of preventive interventions, the proximal target might involve a risk factor that has been associated with the etiology or onset of a psychological disorder. Accordingly, the intervention's efficacy might be evaluated in terms of whether or not the intervention, mediated by changes in the target, resulted in decreased rates of or delayed onset of the psychological disorder/condition (i.e., the clinical endpoint).

Alternative conceptualizations might propose proximal targets/mechanisms that are intervening variables purported to be instrumental in reducing the risk state itself (i.e., with the clinical endpoint defined in terms of a reduction of risk). The primary purpose of this NOFO is to support the development of novel intervention approaches that involve novel strategies and/or novel targets.

Novel intervention approaches must be theoretically supported and hypothesis-driven with an emphasis on why the novel approach is expected to substantially improve outcomes via engagement of the target/mechanism.

NIMH is particularly interested in the development of novel interventions that focus on operationally-defined, empirically-supported functional domains or symptom(s) of mental disorders as opposed to broad diagnostic categories in which not all subjects may share the same underlying disease process.

For example, NIMH Research Domain Criteria (RDoC) constructs may inform mechanism-based hypotheses and the selection of interventions, outcome measures and clinical subjects. Intervention targets related to RDoC constructs are of interest for this NOFO, but other, non-RDoC constructs may be suitable as well, especially if they maximize the probability that subjects share the same mechanism of disorder.

However, applications that involve using a new assessment method or new level of analysis to better understand established mechanisms of an established intervention should submit mechanistic clinical trial applications under the parent R01 announcement; (see Support for Clinical Trials for more information about NIMH’s use of parent announcements for mechanistic trials).

While the principal purpose of this NOFO is to support the development of novel strategies, adaptations of efficacious interventions may be supported under specific conditions.

Adaptations of existing interventions might be supported if they are based on empirical evidence suggesting that efficacy or specificity of the intervention could be substantially improved for a defined subpopulation of patients (e.g., non-responders) by engaging a novel target/mechanism (e.g., by engaging a target that has not previously been known to be critical or considered feasible to address in that subpopulation or disorder).

However, applications that involve testing modifications of existing intervention approaches, for the purposes of extending the approach to new settings, for improving intervention adherence or engagement, or for intervening on provider-, system-, community-, or societal-/structural- level factors, are referred to NIMH NOFOs for effectiveness research (see NIMH Support for Clinical Trials).

NIMH also encourages the use of these effectiveness NOFOs for applications for refinement and testing of approaches that are primarily comprised of research-informed strategies that may not have been extensively tested in the proposed combination and for cases where there is strong pilot data and the goal is to conduct further testing in a community practice setting.

It is important to note that while this NOFO will support pilot testing of novel technology-assisted intervention approaches where the focus is on the psychosocial intervention being delivered, it is not intended to support the translation of existing efficacious treatments into technology-based applications (e.g., mHealth).

The R61 phase must include a test of whether an objective measure can be used to assess intervention effects on the target/mechanism (i.e., target engagement). Other specific activities and milestones appropriate for the R61 phase will depend on the type of intervention under study and its stage of development.

Generally, R61 activities and milestones include 1) operational definition and specification of objective measures of the target/mechanism, including establishing that the proposed measures are sensitive to intervention-induced change; 2) optimization of the intervention protocol to alter the target and standardize the intervention, 3) demonstration of target engagement with the proposed treatment parameters (such as intensity, duration, frequency, i.e., "dose"); 4) demonstration that the intervention, with the proposed treatment parameters, can be administered in the select human population with adequate safety, tolerability, and acceptability; 5) initial manual or protocol development along with development of fidelity scales; and 6) demonstration of feasibility of recruitment and retention.

These activities may or may not necessitate the inclusion of a control condition(s) or tests of a range of doses of the intervention. These methodological choices depend on the specific features of the research protocol such as the nature of the intervention and the target, participant characteristics, preliminary data, or other factors.

Applicants should provide rigorous justification for their decision-making regarding the proposed experimental protocol. Applications using only the R61 mechanism or only the R33 mechanism will not be accepted under this NOFO.

Applicants who already have sufficient preliminary data to progress to the R33 phase should apply directly to PAR-25-181 "Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33)". Funding for the R33 phase is contingent on successfully meeting the milestones in the R61 phase (see Section VI. Award Administration Information, 1.

Award Notices for further information). The purpose of the R33 phase is to replicate target engagement demonstrated in the R61 study and to determine whether engaging the target affects clinical outcome(s) of interest.

Studies in the R33 phase should not be powered as definitive tests of clinical efficacy, but rather should determine the magnitude of the relationship between changes in the targeted mechanism(s) and changes in clinical and/or functional outcomes in a clinical or at-risk population.

In addition to the primary aim of linking target engagement and clinical benefit, secondary aims in the R33 phase may include 1) intervention refinement and standardization (e.g., further manual or protocol development along with fidelity scales); 2) further testing of the feasibility, safety, and acceptability of the intervention; 3) preliminary testing of the association between a change in the target/mechanism and clinical benefit; 4) evaluating the feasibility of recruitment, randomization (if appropriate), retention, assessments, and reporting of adverse events; and 5) developing measures of functional target engagement and of clinical benefit feasible for use in larger efficacy and effectiveness trials.

The specific activities appropriate for the R33 phase will depend on the type of intervention under study, and the stage of the study proposed. The dosage/delivery parameters (e.g., number, frequency, and duration of sessions) of the intervention in the R33 phase should be justified using outcomes from the R61 phase, other empirical data, and the conceptual model.

The results of the R33 phase should inform a decision about whether the intervention shows the potential for improving clinical outcomes, including evidence of safety, acceptability, and feasibility, and a preliminary signal of efficacy, and regarding the strength of the association between target engagement and clinical benefit. The study should also inform the design of a subsequent confirmatory efficacy trial if indicated.

The number of trial sites should be limited to minimize variability of the data. Areas of interest include, but are not limited to: Studies that are highly innovative and address an unmet therapeutic need, or otherwise have the potential for substantially improving outcomes for people with or at risk for mental disorders.

Innovation is reflected in the choice of a novel target/mechanism or a novel approach to altering a known target/mechanism. Studies based on a strong conceptual rationale, including empirical support, for choice of the target/mechanism and potential for the intervention to have an impact on that target/mechanism. Studies that propose a rigorous test of target engagement and strong go/no-go milestones in the R61 phase.

The research strategy should utilize reliable, valid measures of change in the target/mechanism and specify the key parameters of the intervention and clinical trial approach that will be used, including how the intervention protocol will be optimized for purposes of target engagement.

Studies that reconfirm target engagement in the R33 phase, as well as gather data needed to determine whether the intervention has good potential for further intervention development (feasibility, acceptability and preliminary signal of efficacy), and information needed to design a well-informed confirmatory efficacy trial. Studies that refine and pilot test the experimental protocol, methods, and measures during the R33 phase.

The study should utilize measures of treatment fidelity and psychometrically-sound outcome measures that capture changes in the disorder, functional domain, or symptom(s) within the context of a trial. In the R33 phase, examine whether intervention-induced changes in the target/mechanism are associated with changes in measures of clinical benefit, as predicted by the conceptual framework.

Studies that evaluate whether the intervention has therapeutic potential (feasibility, acceptability, and preliminary signal of efficacy), as well as other information needed to conduct a confirmatory efficacy (e.g., variability and sensitivity of measures, randomization methods) in a patient population contingent upon meeting go/no-go milestones in the R33 phase.

Applications Not Responsive to this NOFO Studies that are not responsive to this NOFO and will not be reviewed include the following: Applications whose scope of work does not include the measurement of intervention target/mechanism, the choice of which is supported by empirical evidence of its potential role in the disorder or symptoms in question, and of its potential to address an unmet therapeutic need.

Applications whose scope of work does not address the intervention's ability to alter the target/mechanism in the R61 phase and replicate that test in the R33 phase. Applications whose scope of work includes interventions that target or intervene on broad, societal adverse exposures, such as strategies to reduce poverty or violence. Applications whose scope of work includes nonhuman animal studies.

Applications whose scope of work includes examining novel pharmacological compounds, other biologics (e.g., nutraceuticals), or neuromodulatory devices. Applications whose scope of work is limited to the translation of existing interventions onto technology-based platforms (e.g., mHealth). Applications whose scope of work is focused on the use of an FDA-cleared device outside its intended use (e.g. using MRI to deliver neurofeedback).

Applications that involve adding a new level of analysis to assess or better understand known mechanisms of an established intervention (e.g., a study that adds brain-based assessments such as neuroimaging or psychophysiological measures to evaluate neurobiological underpinnings/correlates that are associated with changes in cognitive/affective processes commonly targeted by CBT).

Applicants are strongly encouraged to consult with NIMH staff when developing plans for an application (see Agency Contacts, Section VII ). This early contact will provide an opportunity to clarify NIMH policies and guidelines and discuss whether the proposed project is consistent with NIMH program priorities.

PD(s)/PI(s)s submitting applications consistent with the experimental therapeutic approach, but whose scope does not fall within that of the current NOFO are encouraged to contact Scientific/Research contacts or go to NIMH's Clinical Trials for Researchers page for further information.

Effective prevention and treatment of mental disorders have the potential to reduce morbidity and mortality associated with intentional injury (i.e., suicide attempts and deaths). Lack of attention to the assessment of these outcomes has limited our understanding regarding the degree to which effective mental health interventions might offer prophylaxis.

Accordingly, where feasible and appropriate, applicants are strongly encouraged to include assessment of suicidal behavior in clinical trials in response to this NOFO using strategies that can facilitate integration and sharing of data (e.g., see NOT-MH-23-100 and https://www. phenxtoolkit. org/ for example constructs and corresponding assessment strategies).

Applicants are encouraged to leverage existing resources and infrastructure such as those provided by institutions with Clinical and Translational Science Awards (CTSAs ) and/or other existing consortia/networks to promote efficient cross-disciplinary collaborations. The NIMH is committed to enhancing the reliability of NIMH-supported research through rigorous study design and reporting ( NOT-MH-14-004 ).

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH- 19-027 ) and Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers) . The application's Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice.

Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly.

Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIMH intends to commit a total of $27,000,000 million for FY 2026 to fund this NOFO and the companion NOFOs listed in Part 1. Overview Information.

Future year amounts will depend on annual appropriations. 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 period of the combined R61 and R33 phases is 5 years, with up to 2 years for the R61 phase and up to 3 years for the R33 phase. Applications with a project period less than 5 years are encouraged where feasible. 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. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards .

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

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