National Center for Complementary and Integrative Health (NCCIH) NOFO for multi-site feasibility studies of mind and body interventions on whole person health restoration (Forecast)

National Center for Complementary and Integrative Health (NCCIH) NOFO for multi-site feasibility studies of mind and body interventions on whole person health restoration (Forecast) is sponsored by National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH). National Center for Complementary and Integrative Health (NCCIH) NOFO for multi-site feasibility studies of mind and body interventions on whole person health restoration (Forecast) is sponsored by National Center for Complementary and Integrative Health (NCCIH), National Instit…

PAR-25-267: NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 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 Center for Complementary and Integrative Health ( NCCIH ) Funding Opportunity Title NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs.

See Notice NOT-OD-26-029 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 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II Resource-Related Research Project (Cooperative Agreements) See Section III.

3. Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose This notice of funding opportunity (NOFO) invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority.

Applications submitted under this NOFO are expected to propose a multisite feasibility clinical trial that will provide new information that is scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIH’s mission.

NCCIH expects that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R01) research is scientifically necessary to design or plan the subsequent fully powered, full-scale clinical trial.

Under this R01, the data collected should be used to fill gaps in scientific knowledge, including, but not limited to the following: assessing whether the intervention can be delivered with fidelity across sites; demonstrating feasibility of recruitment, accrual, and randomization of participants across sites; demonstrating participant adherence to the intervention, as well as retention of participants throughout the study across sites; refining and assessing the feasibility of protocolized multimodal interventions, and/or demonstrating feasibility of data collection across sites in preparation for a future fully powered, multisite efficacy or effectiveness trial.

The need for multisite feasibility trials is expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trial(s) or the published literature. The data collected should be used to fill gaps in scientific knowledge and be necessary to develop a competitive fully powered multisite clinical trial that has the potential to make a significant impact on public health.

Prior to submitting to this NOFO, applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact person for the science area of the planned application. Funding Opportunity Goal(s) The National Center for Complementary and Integrative Health (NCCIH) provides funding for research into complementary and integrative health approaches.

Research constituting a rigorous evidence base for complementary health approaches will be developed through a range of research strategies including basic and translational research, and clinical investigation. Open Date (Earliest Submission 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.

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 National Center for Complementary and Integrative Health (NCCIH) is committed to the rigorous investigation of promising complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions).

These mind and body interventions are widely used by the public, and they are increasingly recognized as a nonpharmacologic approach to symptom management (e.g., chronic pain, mild depression, anxiety). These approaches can be used by individuals to help prevent, treat, or self-manage various conditions, and they can be complementary to conventional health care.

There is a need for research to evaluate mind and body approaches as they are used and delivered to determine whether they are safe and efficacious or effective for given conditions or disorders. For clinical trials to address this need, they must be well-designed and test hypotheses that will guide decisions about the inclusion of these interventions or approaches in health care.

To move through the clinical trial process, investigators need to rely on and cite published literature or conduct a series of early-phase clinical trials to gather the multiple types of information to design subsequent large and rigorous efficacy or effectiveness studies.

Although the scientific literature may provide the rationale for conducting an efficacy or effectiveness trial, investigators may lack critical information about key elements needed to plan and conduct such a trial.

Some key aspects that may need further investigation to plan the future clinical trial could include refining or adapting the intervention to specific populations, modalities, or settings; assessing the feasibility, acceptability, and adherence to protocolized multi-component interventions; finalizing the intervention delivery method, and determining appropriate outcome(s), or recruitment strategies.

Early phase clinical trials supported under this notice of funding opportunity (NOFO) can fill this information gap, thereby improving study design and feasibility.

That is, multi-site feasibility trials can provide valuable information regarding whether the intervention can be delivered with fidelity by multiple providers across multiple sites; determine feasibility of recruitment, randomization, and retention strategies; and test methods for consistent data collection including follow-up data to minimize missing data.

NCCIH has an oversight process to provide stewardship and maintain excellence, integrity, and rigor in our supported clinical studies ( https://www. nccih. nih.

gov/grants/toolbox ). Investigators are encouraged to review the NCCIH Clinical Terms of Award for Human Subjects Research ( https://www. nccih.

nih. gov/research/nccih-clinical-terms-of-award-for-human-subjects-research ) to learn more about NCCIH's requirements. Prior to submitting an application, NCCIH strongly encourages consultation with the NCCIH Scientific/Research contacts relevant to the area of science for which they are planning to develop an application.

Early contact provides an opportunity for NCCIH staff to discuss the scope and goals, and to provide information and guidance.

Research Objectives of the Mind and Body Multi-Site Feasibility Clinical Trial (R01) This NOFO invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority.

Applications submitted under this NOFO are expected to propose a multi-site feasibility clinical trial that will facilitate the design and execution of a future fully powered multi-site clinical trial (see examples below).

To justify the need for a multi-site feasibility clinical trial, applicants must provide their own preliminary data or cite extant published data from a single site feasibility trial (see preliminary data requirements below). If previous multi-site feasibility trials have been published, are completed, or underway, then further feasibility research is not needed.

Applications proposing such iterative or duplicative studies will be considered of low programmatic relevance. The application should address any remaining gaps in knowledge that are needed before conducting a fully powered, multi-site efficacy, effectiveness, pragmatic trial, or dissemination and implementation trial. Investigators should consult the NCCIH website ( https://www.

nccih. nih. gov/grants/pilot-studies-common-uses-and-misuses ) for more information on the uses and misuses of feasibility studies.

For this NOFO, multi-site feasibility clinical trials are defined as trials that enroll research participants from at least two sites that are geographically distinct and nonoverlapping with respect to the population of patients engaging with services and are likely to recruit a variety of participants.

Demonstrating the ability to deliver an intervention with fidelity across sites is critical to demonstrating the ability to perform a fully powered multi-site efficacy or effectiveness clinical trial. Multiple sites are necessary in efficacy and effectiveness trials to increase the generalizability of the findings, by increasing the size and complexity of eligible participants to enhance recruitment efforts.

Appropriate goals for multi-site feasibility clinical trials proposed in response to this NOFO include but are not limited to: Demonstrate feasibility of recruitment rate, randomization, and retention of participants across multiple sites. Assess whether the intervention can be delivered with fidelity across sites, and/or assess whether minor intervention adaptation is useful to enhance adherence, outcome selection, and/or fidelity.

Demonstrate acceptability and/or adherence to a protocolized multi-component intervention across sites. Demonstrate feasibility in measuring outcomes within designated time frames, training interventionists, and delivering the intervention with fidelity across sites. Demonstrate participant adherence to the intervention throughout the study across sites.

Demonstrate consistent collection of clinical data including follow-up data across sites. Assess feasibility of strategies for integrating a mind and body approach into multiple health care systems to inform the execution of future pragmatic or implementation research trials. Determine appropriate control/comparison condition for future large-scale study.

Investigators should propose a randomized controlled trial design with at least one intervention arm and one comparator arm. There should be strong rationale for the comparator condition (e.g., time and attention control, usual care, standard of care, sham condition, and/or active comparator(s)) based on the research question you plan to address in the future powered trial.

Due to lack of rigor and potential expectancy effects, NCCIH will not support studies proposing a waitlist comparator condition.

Pilot or feasibility studies are carried out in preparation for future large scale, adequately powered studies and therefore, should address key issues of process (e.g., recruitment, retention, feasibility, adherence, and/or fidelity) and/or outcomes assessment (e.g., feasibility of the method, frequency, burden, and duration of data collection procedures).

Given the limited sample sizes that can be supported under this R01 grant mechanism, proposing to conduct fully powered tests of clinical outcomes (i.e., efficacy) or underpowered tests of outcomes (i.e., "preliminary efficacy") or attempting to utilize the highly variable point estimate of an effect size for future power calculations would not be appropriate and are noted as nonresponsive below.

As pilot and feasibility studies are not designed (or powered) to address efficacy or effectiveness of an approach or intervention, statistical methods should be mainly descriptive. Applicants should use quantitative benchmarks corresponding to each assessment category in determining trial feasibility.

Scientific and/or statistical justification should be provided to demonstrate how the sample size is sufficient to make a feasibility/acceptability determination in accordance with proposed benchmarks. Sample sizes used in pilot studies are not formally powered for testing prespecified hypotheses as conventionally expected for confirmatory studies.

Sample sizes for subsequent fully powered studies should be based on an achievable, clinically meaningful improvement due to the intervention in the research population with appropriate power calculations. Investigators should consult the NCCIH website ( https://www. nccih.

nih. gov/grants/pilot-studies-common-uses-and-misuses ) for more information on the uses and misuses of feasibility studies.

Group-Based Interventions In some cases, investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms, and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator.

Investigators should provide a strong rationale for the choice among trial design options. The selection of study design should be guided by decisions about how best to deliver the intervention and by concerns regarding contamination and logistics. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions.

Additional information is available at https://researchmethodsresources. nih. gov/ .

There are often questions about whether feasibility trials should include mechanistic aims to evaluate how interventions work. Trials submitted under this NOFO should not include aims to assess the impact/efficacy of an intervention on a mechanism of action or evaluate mediation effects.

Mechanistic measures may be included in multi-site feasibility trials for the purpose of determining if collecting the mechanistic measure is feasible, which can inform whether mediation or moderation aims should be included in a future, large-scale efficacy or effectiveness trial. Applications would need to justify why the mechanistic outcome(s) should be included in the future efficacy or effectiveness trial.

The inclusion of mechanistic measures should not introduce significant burden for participants or utilize a significant portion of the budget. NCCIH has other funding mechanisms to support basic, mechanistic and translational research ( NOT-AT-21-006 ).

Preliminary Data About the Intervention: This NOFO is appropriate when there is a clear and compelling rationale, a rigorous empirical basis, and a scientific premise to conduct a multi-site feasibility trial.

The following preliminary data from previous studies (preferred from published literature, or the team’s previous research) on a similar intervention, patient population and age group as proposed in the current application are required: Demonstration that an intervention similar to the one proposed in the trial is well tolerated (does not produce frequent severe adverse events) in pilot human studies.

Pilot single-site feasibility data on a similar intervention in a clinical population similar to the one that will be studied in the proposed trial (e.g., a proposed study to examine vinyasa yoga in adults with anxiety may cite pilot work on hatha yoga in a population of adults with depression and anxiety) Demonstrated adherence (e.g., cite a pilot study of similar duration with sufficient adherence).

Demonstrated retention of participants for a similar study duration (e.g., cite a pilot study that retained a sufficient percentage of participants at the primary outcome time point). Information to justify how the intervention is delivered (e.g., duration of individual intervention, frequency of delivery, and timeline of intervention delivery to achieve clinical benefit) in the study.

For example, the intervention could be delivered as a single 30-minute session once a week for 8 weeks, or as self-paced 5-minute modules over 10 weeks. Preliminary data should demonstrate that the selected doses are feasible and likely to have the greatest impact on clinical outcome and minimize the risk of adverse events.

Preliminary Data about the Research Team: In addition, all the following information demonstrating the research team’s collective experience conducting clinical trials is required: Delivered a similar intervention via the same delivery mode in a clinical trial with fidelity. Successfully recruited, randomized, and retained similar participants. Successfully randomized participants to similar intervention and control conditions.

Achieved adherence to a similar intervention study protocol by research staff. Retained participants for a similar study duration. Completed collection of follow-up data with consistency and minimal missing data.

Published results from previous completed trials. For applications studying the feasibility or acceptability of including a natural product as part of a multi-component intervention, the application must provide published data that the formulation of the natural product proposed has demonstrated efficacy for the condition being studied from at least one fully powered placebo-controlled trial.

Investigators should propose a realistic timeline for the startup and completion of the clinical trial and provide contingency plans to proactively confront potential delays or disturbances to the planned trial.

NCCIH Priorities for Clinical Trials of Mind and Body Interventions The complementary or integrative approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) should include one or more of the following: Physical approaches such as spinal manipulation or mobilization, massage, tai chi, qi gong, yoga, acupuncture; or Psychological approaches such as hypnosis, guided imagery, breathing exercises, progressive relaxation, meditation, biofeedback, mindfulness techniques, music or other art-based therapies Multi-component interventions such a naturopathic medicine, traditional Chinese medicine, Ayurvedic medicine, chiropractic care, or a combination of two or more of the specific complementary health approaches (e.g., massage and biofeedback, or natural product and mindfulness); or integrated approaches to care in which a complementary health approach is used in combination with standard care (e.g., mindfulness or yoga as augmentation to conventional medications); or Multilevel intervention level (patient, caregivers of patient, clinicians, and health care system) where at least one level of intervention includes a mind and body intervention.

In addition, proposed projects could include an outcome measure(s) that relates to at least one of the following high-priority topic areas: Promotion of health behaviors, health restoration, emotional well-being, or resilience; Prevention or treatment of symptoms such as sleep disorders or disturbances, depression, anxiety, chronic stress, post-traumatic stress (disorder), obesity, and acute and chronic pain conditions; Whole person health outcomes including multisystem or multilevel outcomes; Minority health and reduction of disparities in areas such as pain, obesity, mental and emotional behavioral health, and maternal health; Social and structural determinants of health ( https://www.

ninr. nih.

gov/researchandfunding/nih-sdohrcc ); Enhancement of adherence to medications or prescribed behavioral approaches (e.g., physical activity and healthy eating); Reduction or deprescribing of inappropriate use of medications or other substances (e.g., drugs of abuse or medications that are contraindicated in specific patient populations); or Reduction in risk for/incidence of HIV, or comorbidities, coinfections and complications from HIV ( https://abs2.

od. nih. gov/Docs/NIH_StrategicPlan_FY2021-2025.

pdf ) When evidence justifies, NCCIH encourages applications to conduct studies in a way that assesses the impact of integrating interventions into relevant settings (e.g., health care systems, schools, Federally Qualified Health Centers, military or veteran health care delivery organizations, community organizations, justice systems, or homeless shelters).

All National Institutes of Health (NIH)-funded research must adhere to the Code of Federal Regulations, which outlines specific requirements to enhance protections for pregnant women, human fetuses, and neonates; children; and prisoners ( https://grants. nih. gov/policy/humansubjects/policies-and-regulations/vulnerable-populations.

htm ). The Inclusion Across the Lifespan policy requires that that individuals of all ages, including children (i.e., individuals under the age of 18) and older adults, must be included in all human subjects research, conducted or supported by NIH, unless there are scientific or ethical reasons not to include them ( https://grants. nih.

gov/grants/guide/notice-files/NOT-OD-18-116. html ). Applications proposing research topics not identified above as high programmatic priority can be submitted but may be considered of lesser or lower programmatic priority, could reduce the likelihood of funding.

Applications proposing research studies using an intervention and patient population that are the same as or very similar to those used in studies already in progress, conducted, or published by other groups are likely to be lower programmatic priority as well.

Types of Clinical Trials Not Responsive to this NOFO: Applications proposing the following activities will be deemed nonresponsive: Studies proposing to analyze data from a feasibility trial to assess efficacy/effectiveness of an intervention or estimate effect size ( Pilot Studies: Common Uses and Misuses ).

Trials that do not include an aim to assess the multi-site feasibility, acceptability, fidelity, and/or adherence to the intervention. Studies to assess the initial feasibility of a mind and body complementary or integrative health approach (i.e., feasibility should have already been demonstrated in at least a single site), or those proposing substantial adaptations to an existing intervention. Fully remotely delivered clinical trials.

Studies that do not include a mind-body intervention. Studies that propose a waitlist control. Studies that are geographically limited (e.g., recruiting from one city or region).

Trials that propose to assess feasibility of interventions for the treatment or prevention of cancer. (Investigators interventions for the treatment or prevention of cancer. (Investigators interested in cancer treatment or prevention trials should contact the National Cancer Institute.)

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 The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project. However, it is strongly recommended that applicants not request a budget of more than $350,000 in direct costs per year.

The scope of the project should determine the project period, but it is strongly recommended that applicants do not request a project period of more than 3 years. The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

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

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

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

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

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

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

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

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

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

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

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

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

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

3. 7. 4 Submission of Resubmission Application .

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

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

4 Similar, Essentially Identical, or Identical Applications ). Applications with Foreign components are encouraged to read NCCIH International Health Research page . Foreign components can include foreign collaborators or consultants, but should not include foreign sites outside of the U.S. or Canada, according to NCCIH’s policy.

Section IV. Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.

gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this NOFO.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. Biographical Sketches: Document the PD/PI’s experience in leading clinical trials and expertise in the content area of the trial (e.g., intervention, study population, research methods).

Even feasibility clinical trials will require a multidisciplinary team (e.g., clinician, biostatistician, data manager, study coordinator), and the application should reflect their hands-on involvement in the design and implementation of the study protocol.

Applicants are encouraged to provide strong evidence of the study team’s qualifications and ability to conduct the proposed as well as future research, experience as investigative team members, and previous investigative experience in related clinical trials.

We strongly encourage that all clinical trials include a biostatistician as part of the key personnel, and the application should reflect their hands-on involvement in the design and implementation of the study protocol. Applicants are encouraged to provide strong evidence of the study team’s qualifications and ability to conduct the proposed as well as future research and previous investigative experience in related clinical trials.

All instructions in the How to Apply- Application Guide must be followed. The budget for the first year of the grant should reflect the time needed for trial startup. Applicants are strongly encouraged to request no more than $350,000 direct costs per year for up to 3 years of support.

The request of a longer project period or higher per-year costs must be extremely well justified, specifying why the costs exceed those of a typical multi-site feasibility trial. The budget for the number of participants included in the trial should be based on the number of participants needed to demonstrate feasibility outcomes, not on the power for assessing efficacy on a clinical outcome, which will not be supported by this