Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for Alcohol, Tobacco, and Other Drugs (ATOD) Use and Misuse in Adult Populations that Experience Health Disparities (R01, Clinical Trial Required)

Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for Alcohol, Tobacco, and Other Drugs (ATOD) Use and Misuse in Adult Populations that Experience Health Disparities (R01, Clinical Trial Required) is sponsored by National Institutes of Health (NIH). Seeks applications to test innovative approaches to implementing SBIRT/P for ATOD use and misuse in adult populations experiencing health disparities.

PAR-26-001: Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities (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 Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute on Drug Abuse ( NIDA ) National Institute on Minority Health and Health Disparities ( NIMHD ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

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

Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities (R01, Clinical Trial Required) R01 Research Project Grant January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs. See Notice NOT-OD-26-029 .

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) 93. 273, 93. 313, 93.

279, 93. 121, 93. 307, 93.

399 Funding Opportunity Purpose The Office of Disease Prevention (ODP) and participating National Institutes of Health (NIH) Institutes, Centers, and Offices (ICOs) are issuing this NOFO seeking applications to test innovative approaches to implementing SBIRT/P for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult NIH designated populations that experience health disparities.

SBIRT/P, (a term used for purposes of this funding announcement), involves screening individuals for risk of ATOD use and misuse, briefly intervening with a conversation about harmful substance use, and referring individuals for treatment or preventive services, as needed.

Proposed research should include prospective tests of SBIRT/P and should leverage collaborations with healthcare and community partners Specific research interests of participating NIH ICOs are detailed within. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

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 purpose of this NOFO is to support research projects that test innovative approaches to implementing Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities.

SBIRT, involves screening individuals for risk of ATOD use and misuse, briefly intervening with a conversation about harmful substance use, and referring individuals for treatment, as needed. The addition of preventive interventions to SBIRT is a novel approach to the delivery of early intervention and treatment services for adults at risk for ATOD use and misuse.

The acronym SBIRT/P will be used to include the prevention of ATOD use and misuse by those who are at risk of developing these disorders.

The ADVANCE (ADvancing preVentive intervention reseArch in populatioNs that experienCe health disparitiEs) program was created to develop and test new interventions and new strategies to disseminate existing interventions that address the leading risk factors for death and disability in populations that experience health disparities in response to a portfolio performed in the NIH Office of Disease Prevention (ODP).

The portfolio analysis of NIH-funded grants and cooperative agreements between fiscal years 2012-2017 showed that only 8. 5% of all prevention research projects focused on preventing the leading risk factors or causes of death and disability. Additionally, an analysis that examined prevention research projects between 2016-2019 revealed that only 3.

6% of the NIH-funded projects included a randomized intervention to address a leading risk factor for death and disability in populations that experience health disparities. The Global Burden of Disease Project identified ATOD use and misuse in the top 10 leading risk factors for death and disability.

Therefore, effective screening, treatments, and increased uptake of preventive interventions related to ATOD use and misuse risk factors are needed to improve population health and reduce disparities in morbidity and mortality. Currently, screening, brief intervention, and referral to treatment (SBIRT) is recognized as an effective strategy to reduce ATOD use and misuse in adults.

However, implementation of SBIRT in healthcare settings remains low, and much less is known about how screening and brief intervention can be used to also refer to prevention interventions, i.e., to prevent the onset of ATOD use and misuse or prevent escalation from misuse to disorder.

Additionally, less work has been done on ways to effectively implement and scale SBIRT/P across various systems and settings and address barriers to effective referral to treatment or preventive interventions. This is especially true in populations that experience health disparities.

Research Objectives and Scope This NOFO encourages research to develop and prospectively test implementation strategies that overcome known barriers to SBIRT/P for ATOD use and misuse in adult NIH-designated populations that experience health disparities .

Projects are strongly encouraged to include robust engagement with relevant healthcare and community partners (e.g., consumer advocacy groups, social service agencies, employers, and faith-based organizations, etc.) to enhance the acceptability, feasibility, and sustainability of SBIRT/P for ATOD use and misuse in adult populations that experience health disparities.

It is expected that projects will examine and/or modify organizational and system contexts that improve the accessibility, utilization, efficiency, effectiveness, and quality of SBIRT/P. The proposed SBIRT/P intervention or implementation should improve health outcomes in populations that experience health disparities at the individual, interpersonal, organizational, or community level, or in combination.

Examples of potential topic areas or approaches with HD populations include, but are not limited to, the following:Reconceptualization or adaptation of SBIRT/P to improve implementation and sustainability in different settings or populations, including examination of cost-effectiveness or the impact of different reimbursement models on health outcomes.

Interventions testing strategies to implement or scale-up SBIRT/P in non-traditional settings (e.g., college campuses, churches, workplaces, social service agencies, justice settings) and provide appropriate linkages to services, as needed.

Interventions that involve partnerships with community organizations to address barriers to follow-up or engagement in treatment or prevention services after referral, such as food or housing insecurity, lack of transportation or childcare, limited English proficiency, stigma, etc. SBIRT/P interventions for multiple substances (such as concurrent alcohol misuse in combination with tobacco use).

Interventions that address ATOD in addition to other risk factors (co-morbidities), such as high fasting glucose, mental health issues, high systolic blood pressure, low physical activity, etc. Organizational interventions to ensure effective access to and delivery of SBIRT/P interventions. Non-responsive Applications Projects that do not focus on NIH-designated populations that experience health disparities .

Projects that do not prospectively test SBIRT/P to address ATOD use or misuse. Specific Areas of Research Interest National Cancer Institute (NCI) The co-use of alcohol, tobacco, and/or other drugs (ATOD) is associated with increased frequency of use, difficulty with quitting or maintaining abstinence of the substances used, and worse health status/outcomes.

The risk of cancer is better characterized for some patterns of co-use (e.g., tobacco and alcohol) than others and more research is needed. NCI is particularly interested in understanding the patterns of ATOD across the cancer control continuum, and Screening, Brief Intervention, and Referral to Treatment or Prevention (SBIRT/P) offers an important opportunity to conduct this research.

Specific areas of interest include, but are not limited to: Examining ways to prevent, reduce, and/or treat polysubstance use at individual or community levels. Conducting interventions that can address polysubstance use through community engagement, communication, and/or policy approaches. Examining how the intersection of identities and social determinants impact health disparities associated with polysubstance use outcomes.

Examining how approaches that address one substance may fail to adequately address the interplay and influence across other substances. Improved assessment of substance use behaviors to better understand the attendant disease risks, including morbidity and mortality from cancers.

National Institute on Alcohol Abuse and Alcoholism (NIAAA) There is research evidence that SBIRT is an effective strategy to screen for and reduce negative consequences associated with alcohol misuse and alcohol use disorder for individuals at all stages of life (youth, mid-age and older adults, pregnant women, etc.). The U.S. Preventive Services Task Force recommends that primary care clinicians screen all adults for alcohol use.

Additional research is needed to improve implementation and sustainability of alcohol Screening, Brief Intervention, Referral to Treatment or Prevention (SBIRT/P) in health disparity populations and ensure that the referral to treatment or prevention portion of SBIRT/P is implemented.

NIAAA seeks studies that evaluate effective models and new strategies that improve implementation and sustainability of alcohol SBIRT/P in these populations. Partnerships and leveraging resources with health, community, and other organizations that implement SBIRT/P are highly encouraged.

Areas of interest include, but are not limited to: Increasing adoption, sustainability, and implementation effectiveness of SBIRT/P in preventing and reducing alcohol misuse, AUD, and related outcomes. Improving implementation of SBIRT/P in the U.S. racial and ethnic population groups in which its implementation remains limited.

Testing feasibility and effectiveness of integrated protocols for SBIRT/P for alcohol and co-occurring conditions, e.g., cannabis (marijuana) and other drug use, PTSD, and other mental health problems. Evaluating new technologies for improving adoption, implementation, and sustainability of SBIRT/P, including in rural, remote, and under-resourced communities.

Establishing effectiveness of alcohol SBIRT/P in non-traditional settings outside of primary care, such as juvenile justice, community settings, and religious institutions. Evaluating SBIRT/P large-scale implementation to determine its impact at the individual, community, and population levels, cost-effectiveness, and sustainability.

National Institute on Drug Abuse (NIDA) The United States Preventive Services Task Force (USPSTF) recommends screening adults 18 years or older for unhealthy drug use, including pregnant and postpartum women.

There is a need for research to better understand the factors that support implementation, sustainability, and scaling of screening for substance use risk, substance misuse, and substance use disorder and referral to prevention and treatment services.

Areas of interest include, but are not limited to, research to: Test models for healthcare (including primary care, emergency departments, urgent care, school/college health centers) and other community settings (e.g., systems workplace, community, recreational, social services, criminal justice) to support screening and brief prevention and treatment interventions for substance use risk, substance misuse, and substance use disorder, as well as linkage to prevention and treatment services, especially among those who experience health disparities and have traditionally been excluded from research in healthcare systems and other settings.

Test models and strategies for integrating screening and referral or linkage to prevention and treatment services into systems/practices (e.g., policies, algorithms, decision tools, reminders), and test strategies for sustainability. Test policies and systems reforms to establish infrastructure to support the implementation and sustainability of prevention interventions.

Test the implementation factors, including the cross-sector partnerships, stakeholder decision-making factors, workforce supports, and community infrastructure needed to successfully implement screening and linkage to prevention and treatment services. Test innovative and new technologies to enhance implementation of screening and linkage to prevention and treatment services in multiple settings.

National Institute of Dental and Craniofacial Research ( NIDCR ) Alcohol, tobacco, and other drug (ATOD) use has adverse effects on dental, oral, and craniofacial (DOC) health; ATOD use may suggest a maladaptive coping behavior for DOC disorders.

Moreover, ATOD consumption during pregnancy can have negative health impacts on the pregnant woman as well as affect children’s dental, oral, and craniofacial tissues through altered maternal physiology. NIDCR’s interests include ATOD screening among women given that there are sex differences in triggers for ATOD use and metabolization and DOC conditions and diseases for which women are expressly susceptible.

Equally encouraged are projects designed to improve treatment outcomes for DOC diseases and conditions in which women experience disparate treatment outcomes.

Screening, Brief Intervention, and Referral to Treatment or Prevention approaches are particularly well-suited to dental settings, where ATOD screening already may be standard of care, and where oral health professionals may be positioned to deliver brief, clinically-relevant interventions, and subsequently facilitate referrals to treatment or prevention services.

NIDCR’s Clinical Trials Program typically supports clinical trials through a phased funding mechanism, with a robust planning phase, followed by a clinical trial phase if planning is successful.

To accommodate the R01 funding mechanism of this announcement, NIDCR will consider only clinical trial applications that propose early intervention development research, consistent with Stage 1 or Stage 2 in the NIH Stage Model of Behavioral Intervention Development and/or the refinement of casual hypotheses for intervention research.

Such a project would propose to develop or adapt an SBIRT/P intervention for use in the dental setting and/or that incorporates dental, oral, or craniofacial health in the approach. Additionally, to allow for completion of the clinical trial during the time allowed in the R01 funding mechanism, NIDCR will consider only applications that focus on short-term outcomes (i.e., no more than 6 months past intervention delivery).

Investigators seeking to conduct intervention research at a later stage in the intervention development pipeline are encouraged to apply through NIDCR’s Behavioral and Social Intervention Clinical Trial Planning and Implementation ( PAR-21-317 ) funding announcement.

National Institute of Minority Health and Health Disparities (NIMHD) Areas of specific interest to NIMHD include but are not limited to interventions that: Measurably reduce or eliminate existing disparities in who receives SBIRT/P within healthcare settings that serve variety of populations. Combine SBIRT/P with other brief screening or preventive services (e.g., cancer screening, diabetes screening, HIV testing, vaccination).

Address social and structural barriers to promote effective referral to and engagement in ATOD treatment or prevention services. Offer SBIRT/P in community-based settings (e.g., schools, workplaces, faith-based organizations, community centers) and facilitate linkage to ATOD treatment or prevention services.

Use innovative technologies to increase access to SBIRT/P and follow-up care in rural or other settings with limited resources or referral options. Office of Disease Prevention (ODP) The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention.

In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP is interested in providing co-funding support for research that has strong implications for disease and injury prevention and that include innovative and appropriate research design, measurement, and analysis methods.

Information on resources for designing studies using the best available methods is available at: https://researchmethodsresources. nih. gov/ .

For this NOFO, ODP is interested in interventions that involve more than one service sector (e.g., health, education, transportation, labor, etc.), to promote Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) by addressing social determinants of health for populations that experience health disparities. ODP does not award grants.

Please contact one of the IC program contacts listed for questions related to funding. Office of Research on Women's Health (ORWH) For this NOFO, ORWH is interested in research projects that address the impact of social determinants of health.

Interdisciplinary interventions focused on overcoming barriers related to the multiple domains of sex (for example, roles and norms, relations, power dynamics) that influence access to and receipt of SBIRT/P in populations of women historically understudied, underrepresented and underreported (U3) in health research are of particular interest.

ORWH encourages intersectional approaches to research questions, study design, data collection, and evaluation. Projects considering community-based collaborations are highly encouraged. 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 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. The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3. 7. 4 Submission of Resubmission Application .

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

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

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Research Strategy : All the following are required: Identify the health disparities (HD) population(s) that will be the focus of the intervention and describe the disparities they experience related SBIRT/P.

Explain how the proposed intervention addresses disparities or barriers in SBIRT/P (e.g., barriers to effective referral, type of brief intervention ) in populations that experience HD. Describe the potential for the intervention to be sustainable or scalable after the project is completed.

Identify and describe the roles responsibilities of healthcare and community partners ( e.g., consumer advocacy groups, social service agencies, employers, and faith-based organizations, etc.) . Provide a data analytic plan that specifies how multi-level factors, intervention effects and interactions, or outcomes will be handled, as appropriate.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply- Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide. 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7. 9.

1 Selected Items of Cost. 7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide .

Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Section III.

Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance.

For assistance with application submission, contact the