Part 1. Overview Information

Key Dates

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.

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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. 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.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background: HEAL Initiative 

The NIH Helping to End Addiction Long-term (HEAL) Initiative: This notice of funding opportunity (NOFO) encourages applications in support of the NIH's HEAL initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for overdose, opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal.nih.gov/.

Purpose

The goal of this initiative is to address the opioid/stimulant crisis and/or overdose events by supporting action-oriented research that accelerates the translation of addiction epidemiology, prevention, treatment, and recovery research to practice. Research may include the intersection of substance misuse, addiction and pain, however, applications that focus solely on reducing opioid prescribing or that are purely descriptive will not be considered responsive to this NOFO.

This NOFO seeks phased awards, which are most appropriate for projects that require 1-2 years for preparatory work during the R61 phase, leading to a larger scale R33 phase, which may focus on large-scale data collection and/or intervention or implementation trials. Preparatory work in the R61 phase should establish the feasibility of or justification for executing the R33 phase. Phased awards do not require pilot or feasibility data at the time of submission. Projects must meet relevant milestones outlined in the R61 phase of the project to transition to the R33 phase. Transition to the R33 phase is not guaranteed even if all milestones are met.

Research Objectives

Studies should target novel individual, provider, organizational, community, and/or system-level factors relevant to the opioid/stimulant and overdose crises. Studies may take place across a variety of settings including but not limited to: substance use disorder (SUD) treatment, general and specialty healthcare, criminal justice, social and human services, educational settings, pain clinics, pharmacies, victim service, workplaces, and community settings. Nontraditional service delivery settings are also of interest when they could potentially broaden the reach of evidence-based services.

Intervention studies are not required. Applications are encouraged to use a range of methods and approaches, including multidisciplinary and innovative methods as appropriate to the study questions.

For intervention, infrastructure, or services studies, applications should consider acceptability, feasibility, scalability, and sustainability. Projects are strongly encouraged to engage relevant end users in study conceptualization, design, execution, and interpretation. End user is broadly defined and may include people who experience addiction, youth, families, community members, practitioners, intervention implementers, organizational leaders, prospective funders/payers, and others. Applications that provide a conceptual and/or pragmatic framework and clear vision for how the research can be sustained beyond the life of the grant will be prioritized.

Priority Topics

Specific high priority topics of interest include, but are not limited to:

• Research resulting in improved methods that enhance meaningful and representative real-time data capture and use to improve public health approaches to reducing substance use, misuse, addiction, and overdose.
• Research to develop and test strategies to prevent the initiation of substance use, or progression to SUDs. This may include phased studies to support the rapid translation of epidemiological findings to substance use and addiction preventive interventions. Of priority is translational research improving the ability to identify and characterize malleable individual, familial, behavioral, developmental, and environmental factors (within the population or precise subgroups) that, if targeted by intervention, could prevent initiation of substance use or progression to misuse or use disorder.
• Research on strategies to implement and sustain evidence-based prevention services, that are embedded within or across existing systems and settings (e.g., healthcare, child welfare, justice, education). This might include research on facilitating the delivery of prevention services by adapting programs to setting or target population, using non-clinical providers, and leveraging existing resources within the system or setting (e.g., data or funding sources). Additional service delivery-related questions could include implementation, sustainability and scalability, workforce challenges, and economic implications (e.g., cost benefits/offsets and cost-effectiveness).
• Research to address provider-level challenges in the uptake of effective interventions across diverse care delivery settings (e.g., primary care, mental health, emergency care). This may include efforts to enhance recruiting, training, and retaining clinicians and other providers and reducing barriers to delivering evidence-based treatment and recovery interventions (e.g., contingency management); efforts to better understand task shifting and other strategies to enhance the efficiency or quality of services; care models that integrate peers or other lay interventionist (e.g., family) approaches.  
• Research to enhance our understanding of recovery processes, including understanding mechanisms of recovery, natural recovery trajectories, and influences of services on recovery pathways; whole person approaches that account for dynamic physical, psychological, social, and environmental influences on recovery outcomes; approaches to understanding the role of concerned significant others including dyadic intervention approaches; and testing interventions to support self-management of substance use symptoms, relapse prevention, and treatment re-engagement.
• Research on interventions and strategies to better support efficient transitions across care settings or levels of care intensity, for example inpatient to outpatient treatment setting transitions, jail to community settings, hospitalizations and subsequent care, with the goal of increasing retention through a full cascade of care.

Community-Engaged Research Methods in HEAL Research Studies 
People with lived/living experience (e.g., patients, people in recovery, caregivers, families, community leaders) have important insights that can improve meaningful outcomes and uptake of research findings across the continuum of research from basic through implementation studies. The NIH HEAL Initiative strongly encourages the use of community-engaged research methods (e.g., the promotion of bi-directional communication between the researchers and the relevant community throughout the research project). Community-engaged research methods will vary with the focus and approach used in each project but should at minimum ensure that researchers are connecting with people with lived/living experience to incorporate their input throughout the conception, implementation, and dissemination of the research.

See this resource for more information on community-engaged research methods:  https://heal.nih.gov/resources/engagement

Phases of the Award & Milestones

This funding opportunity uses a R61/R33 Exploratory/Developmental Phased Award mechanism. Support will be provided for up to a total of 6 years, which includes initial support of up to 2 years for the R61 phase, followed by up to 5 years of support for the R33 phase, upon successfully meeting R61 milestones.

Applicants are not required to provide preliminary data for this NOFO. The R61 phase is a planning or exploratory phase that can be for up to two years and will support activities that demonstrate feasibility or establish pivotal data infrastructure justification in support of the R33 phase. Activities during the R61 phase may include: (1) collecting feasibility or pilot data for a clinical trial; (2) stakeholder engagement to ensure buy-in, sustainability, scalability, or other needed components before launching a larger study; (3) testing hypotheses for which preliminary data is not otherwise available; (4) demonstrating ability to access key datasets or build critical infrastructure; (5) primary data collection, secondary analysis of existing data sets (qualitative and/or qualitative); (6) conducting policy analysis/impact studies to establish targets for an intervention; or (7) focus groups or cognitive testing to improve methodology or prepare for larger scale data collection.

Applications must include specific, concrete milestones to be accomplished by the end of the R61 phase (see Section IV, Timeline and Milestone Plan). Milestones should represent findings or successful completion of activities from the R61 phase that would justify transition to the R33 phase of the project. For example, milestones might be related to demonstrating the feasibility of the approach taken in the R33 phase by including metrics for a successful pilot of an intervention or recruitment approach, timelines for data access, acquisition or management, or establishing Memoranda of Understanding with key stakeholders. Applications that propose R33 effectiveness or adaptation clinical trials must include successful piloting of the intervention as a R61 milestone.

For transition to the R33 phase, recipients must submit the transition package 75 days prior to the anticipated start date of the R33 phase. The transition package should include the R61 progress report describing in detail the progress towards the R61 milestones and a description of how research proposed for the R33 phase will be supported by the completion of the R61 phase milestones. These materials will be evaluated by NIH program staff to determine if the milestones were met.

Transition to the R33 phases requires administrative review by NIH staff and is not guaranteed. Approval of the transition to the R33 phase will be based on the original R61/R33 peer review recommendations, successful completion of transition milestones, any proposed changes to the R33 research based on R61 findings, program priorities, and availability of funds. It is not expected that all applications will continue to the R33 phase even if all milestones are met. 

Pre-Application Consultation

Potential applicants are strongly encouraged to consult with appropriate NIH Program staff early in the application development process. This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope of the project relative to the HEAL initiative mission and intent of this NOFO.

Non-responsive Applications

The following applications will be considered non-responsive and will not be reviewed:

• Applications that do not include research related to substance use epidemiology, prevention, or treatment and recovery research or that focus solely on alcohol or tobacco use disorder.
• Applications focused solely on testing new treatment interventions.
• Applications that focus solely on reducing opioid prescribing without addressing/measuring an opioid related harm.
• Applications proposing an R33 effectiveness clinical trial that do not include a R61 milestone to collect pilot data.

Special Considerations

National Institute on Drug Abuse (NIDA) applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

There are also opportunities to harmonize data within the broader NIH HEAL Initiative. Applicants selected for funding should expect to have a conversation with NIH program staff early in their project regarding high priority areas for potential harmonization.  

NIH HEAL Requirements: The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative award recipients will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual NIH HEAL Investigators Meeting, as well as other activities.

Clinical Trial Accrual:  This NOFO will support applications that include a series of milestones for completion of the clinical trial and provide contingency plans to proactively confront potential delays or disturbances in attaining the milestones. Continuation of the award is conditional upon satisfactory progress, availability of funds, and scientific priorities of the HEAL Initiative. If, at any time, recruitment falls significantly below the projected milestones for recruitment, NIH will consider ending support and negotiating an orderly phase-out of the award. NIH retains the option of periodic external peer review of progress. NIH program staff will closely monitor progress at all stages for milestones, accrual, and safety. Please refer to the HEAL Policy for the Enrollment of Participants in Clinical Trials for additional information.

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

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

1. Eligible Applicants

Higher Education Institutions - Includes all types

• 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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• 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
• Regional Organizations

Foreign Organizations/International Collaborations

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.

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

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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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.

2. Cost Sharing

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

Number of Applications

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

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.

SF424(R&R) Cover

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.

Timeline & Milestone Plan (Required - 2 page maximum)

Applicants must include an Other Attachment entitled Timeline and Milestone Plan, clearly specifying proposed milestones and when those milestones are expected to be achieved. Milestones should be specific, quantifiable, and scientifically justified; they should establish the feasibility or empirical basis for pursuing the R33 phase of the study. Milestones must not simply be a restatement of the specific aims for the R61 phase, they should signify the completion of major elements necessary to support the larger scale research project in the second phase of the award. For applications where there is no preliminary data or where new partnerships are proposed, applicants should be especially attentive to proposing milestones that will help establish the feasibility of their proposed R33 project. The application should include contingency plans to proactively confront potential delays in meeting the milestones.

Examples of potential milestones for the R61 phase include, but are not limited to:

• Data to be used in the epidemiological study, including how those data represent the population of focus and the targeted outcomes or mechanisms of interest.
• A report of an epidemiological analysis of risk factors or target consequences to be addressed in a trial.
• A summary of planned implementation strategies, including staff selection, staff training, supervision, and fidelity measures.
• Evidence of having established research partners the community and/or system of relevance, and a plan for collaborating over the course of the research project.
• Developed and piloted study elements including measures, the study design, adaptation or refinement of the intervention or delivery strategies, intervention manuals, and/or engagement and implementation strategies (e.g., fidelity monitoring, training).
• For prevention or recovery support efficacy studies, a final plan for recruiting, consenting, and retaining participants, describing where recruitment will occur, how many participants are likely to be recruited, and the process for obtaining consent. For effectiveness or adaptation intervention studies, the R61 phase must include piloting the intervention to be tested in the R33 phase.
• Tests of data collection and data management systems and processes, including the piloting of survey instruments, cognitive testing, and harmonizing datasets.
• Data safety and operational oversight plans; regulatory approvals (e.g., IRB, Tribal review, Data and Safety Monitoring Plan [DSMP]) and other essential documents and procedures for safeguarding data and protecting participants.
• Updated data sharing protocols and/or plans for data archival, and a timeline for releasing the first set of data or publication of results.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R Budget

All instructions in the How to Apply- Application Guide must be followed.

R&R Subaward Budget

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.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: In the single page attachment allowed for the specific aims, applicants must provide clearly marked headers for R61 Specific Aims and R33 Specific Aims with brief descriptions of the aims specific to each phase of the study.

Research Strategy:

The Research Strategy should be organized in a manner that will facilitate peer review. The body of the application should present an overview of the state of the science, relevance of the proposed activities, and consideration of long-term sustainability and scalability of the proposed efforts.

The research strategy must clearly specify how the proposed project will create a significant public health impact by addressing effectiveness, services, or implementation questions relevant to other treatment of and/or recovery from opioid use or stimulant use disorder in the targeted population and/or setting.

The following criteria should be addressed:

Significance: The R61 and R33 should coherently address a single set of research questions and goals, with the R61 phase establishing feasibility and necessary data to support transition to the R33 phase. Given this tight integration, only one Significance section is needed.

Innovation: The Innovation section should explain how the proposed project, if successful, would lead to innovations that could help accelerate the translation of research findings to practice that would address the overdose crisis. Given the tight integration of the R61/R33 phases, only one Innovation section is needed

Approach: The application should contain separate Approach sections for the R61 and R33 phases, as described below. It is not necessary to repeat any information or details in the R33 section that are described in the R61 section. Applications must also include a Timeline & Milestone plan as an attachment as described in the SF424(R&R) Other Project Information. The approach sections may reference this attachment and should limit what is repeated from this attachment, except where necessary for clarity.

The approach section must address the following elements in the phase most appropriate to the proposed study:

• For all studies, approach to engaging relevant practitioners and/or community stakeholders as partners and/or considerations relevant to the perspectives of end-users (i.e., patients, service recipients, payers) of the interventions or infrastructure being studied, where relevant.
• For epidemiological studies, considerations relevant to the impact these data would have on translating findings into prevention, services, and/or recovery;
• For studies of interventions, considerations relevant to the sustainability of the proposed intervention;
• For studies of interventions or infrastructure, considerations relevant to the potential scalability of the proposed intervention or infrastructure;

Preliminary data are not required nor is it required that teams have worked together previously. The phased award approach allows for earlier stage high risk/high reward projects. However, applications without preliminary data should have a strong scientific premise and establish a strong rationale for how solving the challenges outlined in the application would improve outcomes relevant to overdoses and/or opioid-related morbidity and mortality. NOTE: For early-stage research involving new partnerships or where preliminary data is needed to support the premise of the larger study, these aspects of feasibility must be explicitly included as milestones for the R61 phase.

R61 (Phase 1) Approach:

The R61 phase of the award may be up to 2 years long. The R61 Approach section of the application must include an overview of milestones that are expected to be achieved by the end of the R61 phase. Milestones should be specific, quantifiable, and scientifically justified; they should establish the feasibility or empirical basis for pursuing the R33 phase of the study. Milestones must not simply be a restatement of the specific aims for the R61 phase. Specific details regarding timelines and other specifics should be included in the Timeline & Milestone Plan in SF424(R&R) Other Project Information. 

Examples of Milestones for the R61 Phase:

• Fully executed Memorandum of Understandings (MOUs), letters of support, and data sharing agreements, as relevant to the goals of the study, from partnering departments, agencies or stakeholders.
• Demonstration of active engagement and partnership with key entities and stakeholders (e.g., formation of trans-department or trans-agency change teams).
• If preliminary data was not included in original application, preliminary data demonstrating feasibility of R33 phase must be included. For applications where there is no preliminary data or where new partnerships are proposed, applicants should be especially attentive to proposing milestones that will help establish the feasibility of their proposed R33 project.
• Applications proposing a R33 effectiveness or adaptation trial must propose milestones that pilot and demonstrate feasibility during the R61 phase.

R33 (Phase 2) Approach

Although the Research Strategy for the R33 Phase is expected to be broad and flexible due to the planning/exploratory nature of the R61 Phase, the research strategy for the R33 phase of the award should be described in sufficient detail for reviewers to evaluate the merit of this component of the application, based on anticipated results.

The R33 phase may be revised based on activities and data collected during the R61 planning phase. In the event of approval to move into the R33 phase, the PD/PI and NIH staff will negotiate proposed changes.

Applications that propose a clinical trial in the R33 phase should include relevant information for the proposed clinical trial in the clinical trial attachment.

Note: The R33 phase of the proposed research may be up to 5 years, although applicants are encouraged to streamline the project period to complete the research as efficiently as possible. Applicants proposing R33 phases that exceed 4 years must provide a very strong justification.

Letters of Support: Include letters of support/agreement for any collaborative arrangements, subcontracts or consultants. For activities to be conducted at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the institutional officials, must be submitted with the application.

Applicants should include relevant letters of support from community or Tribal partners, and stakeholders as appropriate for the project. Where relationships with relevant systems or stakeholders do not exist or are not yet fully formalized, applicants should include formalizing these relationships as a milestone for the R61 phase.

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.

 Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

HEAL Data Sharing Requirements:

Data and metadata generated by HEAL Initiative-funded projects must be submitted to study-appropriate, HEAL-compliant, data repositories to ensure the data is accessible via the HEAL Initiative Data Ecosystem. Guidance is available at (https://www.healdatafair.org/resources/guidance/selection) and follow requirements of the selected repository.

All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy. HEAL award recipients must follow all requirements and timelines developed through the HEAL Initiative Data Ecosystem, as described in HEAL's compliance guidance:
 

1. Within one year of award,

• Register your study with the HEAL platform (https://heal.github.io/platform-documentation/study-registration/). This process will connect the Platform to information about your study and data, including variable level metadata and any data dictionaries, and identify the selected repository. HEAL requests initial submission within one year of award, with annual updates, and to be updated in accordance with any release of study data.
• Submit study-level metadata Some of the required study-level metadata will be auto-populated as part of the registration process.

2. Submit data and metadata (and code, if applicable) to HEAL-Compliant repository

• At the completion of the study and/or when prepared to make the final data deposits in the repositor(ies) of choice, ensure your study registration is complete.
• Submit data dictionaries/variable level metadata to the HEAL data ecosystem, if applicable (e.g., studies collecting structured data, including clinical data).
  • Submit data dictionaries /variable level metadata through repository curation processes, if applicable at your choice repository
  • Use HEAL Data Ecosystem utility tools to create a HEAL-compliant data dictionary, and then submit to the HEAL Platform (https://github.com/HEAL/platform-documentation/blob/main/docs/vlmd/vlmd_submission.md); OR send to the HEAL Data Stewardship Group (HEALStewards@RENCI.org)
• The NIH HEAL Initiative expects data sharing timelines to align with timeline requirements stated in the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013). Scientific data should be made accessible as soon as possible, and no later than at the time of an associated publication, or the end of performance period, whichever comes first.

3. Additional Requirements for HEAL Initiative studies involving human subjects.

These studies must meet the following additional requirements:

• HEAL Initiative trials that are required to register in clinicaltrials.gov should reference support from and inclusion in the HEAL Initiative by including the standardized terms "the HEAL Initiative (https://heal.nih.gov/)" in the Study Description Section.
• All new HEAL pain studies conducting research involving human participants are required to use core questionnaires required by the HEAL Common Data Elements (CDE) Program. In addition to the core questionnaires, studies are encouraged to select supplemental questionnaires from the repository of measures used by other HEAL studies, which is housed in an NIH Box account. To gain access to this Box account, please email heal_cde@hsc.utah.edu. The program has created the CDE files containing standardized variable names, responses, coding, and other information for all of these questionnaires. The program has also formatted the case-report forms (CRFs) in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C § 794 (d); https://www.govinfo.gov/content/pkg/USCODE-2011-title29/html/USCODE-2011-title29-chap16-subchapV-sec794d.htm) which "require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities."
  • Studies that wish to use questionnaires not already included in the HEAL CDE Repository should consult with their program official and the HEAL CDE team. New questionnaires will be considered for inclusion in the repository on a case-by-case basis and only when appropriate justification is provided.
  • HEAL Initiative studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program.
• To the extent possible, all other (non-pain) HEAL studies conducting research involving human subjects are expected to use questionnaires by the HEAL CDE Program if applicable and relevant to their research.
  • Studies involving human participants, regardless of the research focus area, are expected to report CDE usage through appropriate channels.
• To the extent possible, HEAL awardees are expected to integrate broad data sharing consent language into their informed consent forms.

Additional details, resources, and tools to assist with data related activities can be found at https://www.healdatafair.org/.

All data collected as part of the NIH HEAL Initiative are so collected under a Certificate of Confidentiality and entitled to the protections thereof. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution's NIH funding, including NOT-OD-17-109 and 42 U.S.C. 241(d). Failure to adhere to this criterion may result in enforcement actions.

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.

Delayed Onset Study

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.

6. Funding Restrictions

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.

Applications must be submitted electronically following the instructions described in the  How to Apply – Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the  How to Apply – Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

Applications will be assigned on the basis of established PHS referral guideline to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

Not Applicable

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

HEAL Data Sharing Requirements

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy. HEAL award recipients must follow all requirements and timelines developed through the HEAL Initiative Data Ecosystem, as described in HEAL's compliance guidance (See "Already Funded" section: https://heal.nih.gov/data/complying-heal-data-sharing-policy): 
 

1. Within one year of award,

• Register your study with the HEAL platform (https://heal.github.io/platform-documentation/study-registration/). This process will connect the Platform to information about your study and data, including variable level metadata and any data dictionaries, and identify the selected repository. HEAL requests initial submission within one year of award, with annual updates, and to be updated in accordance with any release of study data.
• Submit study-level metadata Some of the required study-level metadata will be auto-populated as part of the registration process.

2. Submit data and metadata (and code, if applicable) to HEAL-Compliant repository

• At the completion of the study and/or when prepared to make the final data deposits in the repositor(ies) of choice, ensure your study registration is complete.
• Submit data dictionaries/variable level metadata to the HEAL data ecosystem, if applicable (e.g., studies collecting structured data, including clinical data).
  • Submit data dictionaries /variable level metadata through repository curation processes, if applicable at your choice repository
  • Use HEAL Data Ecosystem utility tools to create a HEAL-compliant data dictionary, and then submit to the HEAL Platform (https://github.com/HEAL/platform-documentation/blob/main/docs/vlmd/vlmd_submission.md); OR send to the HEAL Data Stewardship Group (HEALStewards@RENCI.org)
• The NIH HEAL Initiative expects data sharing timelines to align with timeline requirements stated in the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013). Scientific data should be made accessible as soon as possible, and no later than at the time of an associated publication, or the end of performance period, whichever comes first.

3. Additional Requirements for HEAL Initiative studies involving human subjects.

These studies must meet the following additional requirements:

• HEAL Initiative trials that are required to register in clinicaltrials.gov should reference support from and inclusion in the HEAL Initiative by including the standardized terms "the HEAL Initiative (https://heal.nih.gov/)" in the Study Description Section.
• All new HEAL pain studies conducting research involving human participants are required to use core questionnaires required by the HEAL Common Data Elements (CDE) Program. In addition to the core questionnaires, studies are encouraged to select supplemental questionnaires from the repository of measures used by other HEAL studies, which is housed in an NIH Box account. To gain access to this Box account, please email heal_cde@hsc.utah.edu. The program has created the CDE files containing standardized variable names, responses, coding, and other information for all of these questionnaires. The program has also formatted the case-report forms (CRFs) in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C § 794 (d); https://www.govinfo.gov/content/pkg/USCODE-2011-title29/html/USCODE-2011-title29-chap16-subchapV-sec794d.htm) which "require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities."
  • Studies that wish to use questionnaires not already included in the HEAL CDE Repository should consult with their program official and the HEAL CDE team. New questionnaires will be considered for inclusion in the repository on a case-by-case basis and only when appropriate justification is provided.
  • HEAL Initiative studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program.
• To the extent possible, all other (non-pain) HEAL studies conducting research involving human subjects are expected to use questionnaires by the HEAL Common Data Elements (CDE) Program if applicable and relevant to their research.
  • Studies involving human participants, regardless of the research focus area, are expected to report CDE usage through appropriate channels.
  • To the extent possible, HEAL awardees are expected to integrate broad data sharing consent language into their informed consent forms.

Additional details, resources, and tools to assist with data related activities can be found at https://www.healdatafair.org/.

All data collected as part of the NIH HEAL Initiative are so collected under a Certificate of Confidentiality and entitled to the protections thereof. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution's NIH funding, including NOT-OD-17-109 and 42 U.S.C. 241(d). Failure to adhere to this criterion may result in enforcement actions.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

Prior to publication, HEAL expects investigators to alert their program officers of upcoming manuscripts to ensure coordination of communication and outreach efforts. Award recipients and their collaborators are required to acknowledge HEAL Initiative support by referencing in the acknowledgment sections of any relevant publication: "This research was supported by the National Institutes of Health through the NIH HEAL Initiative (https://heal.nih.gov/)" under award number, [include specific grant/contract/award number; for NIH grant number(s) use full format for the grant number, which includes application type, activity code, institute code, serial number, support year, and other suffixes as defined in Deciphering NIH Application/Grant Numbers. Example: 5R01GM987654-03S]."

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

National Institute on Drug Abuse (NIDA)
Email: NIDA-26-063@nih.gov

National Institute on Aging (NIA)
NIA-NOFO-Scientific@nih.gov

National Center for Complementary and Integrative Health (NCCIH) Program Officer
Email: NCCIHDERFunding@nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Division of Neuroscience and Behavior
Email: NIAAA-HEAL@mail.nih.gov

Center for Scientific Review (CSR)
Email: NOFOreviewcontact@csr.nih.gov

Chief Grants Management Officer
National Institute of Drug Abuse (NIDA)
Email: nidagmbemail@nida.nih.gov

National Institute on Aging (NIA)
NIA-NOFO-Grants@nih.gov

National Center for Complementary and Integrative Health (NCCIH) Grants Management Officer
Email: NCCIHDERFunding@nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA) Grants Management Branch
Email: NIAAAGMB@mail.nih.gov

 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.