Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title
HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) - Building Engagement, Assistance, Capacity, Outreach, and Networks (BEACON) Center (U2C Clinical Trial Not Allowed)
Activity Code

U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type
Reissue of RFA-DA-21-029
Related Notices
  • Check for any recent Notices of NIH Policy Changes that may impact application requirements.
  • January 23, 2026 - NIH Pause on New Submissions to the NIH Human Embryonic Stem Cell Registry and Request for Information on Reducing Reliance on Human Embryonic Stem Cells in NIH-Supported Research. See Notice, NOT-OD-26-031.
Funding Opportunity Number (FON)
RFA-DA-28-012
Companion Notice of Funding Opportunity
RFA-DA-28-011 , RM1 Research Project with Complex Structure
Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.279, 93.273, 93.213, 93.866, 93.853
Notice of Funding Opportunity Purpose

The National Institutes of Health (NIH) intends to renew the Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) research network. This renewed network will include several individual research projects supported by one central Coordination Center. The goal of the network is to test new and improved approaches for people who have both chronic pain (CP) and opioid use disorder (OUD). These approaches should lead to meaningful improvements in how health systems deliver care.

The network will be part of the NIH's Helping to End Addiction Long-term (HEAL®) Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and OUD and (2) enhance pain management.

This notice of funding opportunity (NOFO) seeks applications for a single Building Engagement, Assistance, Capacity, Outreach, and Networks (BEACON) Center. BEACON will provide overall network coordination support; research education activities to build capacity at the intersection of CP, OUD, and implementation science; conduct annual survey/qualitative activities to understand health services barriers and attitudes; and develop key resources for stakeholders that can inform/improve sustainability and scalability of evidence-based practices, including findings and resources from IMPOWR Phase I.

Funding Opportunity Goal(s)

To support basic, clinical, translational, and implementation research in the field of substance use. To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcome, including HIV/AIDS. 

Key Dates

Posted Date
October 06, 2026
Open Date (Earliest Submission Date)
December 26, 2026
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
January 26, 2027 Not Applicable Not Applicable July 2027 August 2027 December 2027

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.

Expiration Date
January 27, 2027
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

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/.

IMPOWR Background

Recent estimates suggest that roughly 60% of people with opioid use disorder (OUD) also have chronic pain (CP), which is associated with substantial illness and death nationwide. Evidence-based treatments exist for both conditions, including behavioral therapies, nonpharmacological treatments, neuromodulation modalities, and medications. Service delivery approaches such as the Collaborative Care Model have also demonstrated effectiveness, particularly for individuals with co-occurring mental illness. Despite the high rate of co-occurrence, evidence remains limited on integrated service delivery packages and multi-component interventions that coordinate these evidence-based elements.

The Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) program (FY21) funded 10 clinical trials to evaluate psychosocial interventions, optimize Medications for Opioid Use Disorder (MOUD) dosing strategies, and test innovative care delivery models, informed by collaboration with people living with OUD/CP (PWLE) and practitioners. The IMPOWR network also developed a harmonized dataset capturing key measures across substance use, pain, quality of life, and co-occurring mental health conditions to characterize factors affecting treatment engagement and retention. Since IMPOWR Phase I, regulatory changes have expanded reimbursement pathways, workforce capacity, and service delivery options nationwide. Additionally, observational data suggest GLP-1 agonists and neuromodulation modalities may hold promise for CP and OUD, underscoring the need for data-driven insights to optimize care in this evolving landscape.

Purpose and Scope of Activities for IMPOWR Phase II BEACON Center

This NOFO seeks applications for one Coordination Center: the Building Engagement, Assistance, Capacity, Outreach, and Networks (BEACON) Center. Review the companion notice for the IMPOWR Phase II Clinical Trials (RM1) (RFA-DA-28-011) to fully understand the mission of the IMPOWR research network. BEACON will establish: an Administrative Core for network logistics and systems, a Research Education Core for capacity building across career stages, a Survey and Qualitative Data Core for annual stakeholder surveys, and an Evidence to Clinical Impact Core for creating practical resources to overcome barriers in integrated pain and addiction treatment.

Network Structure and Participation

IMPOWR Phase II will include 6–8 clinical studies to speed adoption of evidence-based treatments in routine care. A single BEACON Coordination Center will provide network coordination and administrative support.

Investigators are expected to:

  • Join monthly Steering Committee or workgroup calls
  • Attend one annual in-person network meeting (plan for 3–5 staff attendees per Hub). BEACON hosts the first meeting; hosting rotates each subsequent year among awardee institutions.
  • Work together to choose common measures based on IMPOWR Phase I common data elements (CDEs) and set data sharing policies and processes
  • Share de-identified summary statistics and enrollment metrics with BEACON quarterly. BEACON will combine these data to support collaboration and network meta-analyses.

Pre-Application Consultation:

Potential applicants are strongly encouraged to consult with National Institute on Drug Abuse (NIDA) 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 intent of this NOFO. See Scientific/Program Contacts in Section VII.

Data Harmonization for Substance Use and Addiction via the PhenX Toolkit

NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit. Please see NOT-DA-12-008 for further details.

For further information on special considerations for NIDA applicants, please see the Resources section on the NIDA Grants and Funding page.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed
New

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

The NIH HEAL (Helping to End Addiction Long-term) Initiative intends to commit an estimated total of $2.5 million to fund one award in FY2027. Awards pursuant to this funding opportunity are contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications

Award Budget

Application budgets are limited to $1.50 million direct costs per year. Budgets must reflect the actual needs of the proposed project.

Award 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

1. Eligible Applicants

Eligible Organizations

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 Organization) 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 not allowed. 

Required Registrations

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

Program Directors/Principal Investigators (PD(s)/PI(s))

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

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 his/her 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- Definitions 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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) 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) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - 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.

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 6 Required 1 1
Administrative Core Admin Core 6 Required 1 1
Research Education Core Core 6 Required 1 1
Survey and Qualitative Data Core Core 6 Required 1 1
Evidence to Clinical Impact Core Core 6 Required 1 1

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type 'Overall'.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Follow standard instructions.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: The Specific Aims should describe the research infrastructure in BEACON to support and advance the IMPOWR network.

Research Strategy: Applicants should describe the overall structure to include:

1. Center Overview & Strengths

  • Describe the characteristics of the BEACON Center, explain why its the right fit, and what is expected for day-to-day operations
  • Highlight unique strengths, resources, and capabilities
  • Identify institutional resources and multidisciplinary team expertise

2. Core Structure & Coordination

  • Describe the cores and how they work together as one unified resource center
  • Show how cores support individual RM1 Research Centers, the full network, and stakeholders serving people with CP and OUD
  • Explain how cores are aligned, integrated, and managed together

3. Collaboration & Governance

  • Describe how team members work together within BEACON and across IMPOWR
  • Explain decision-making processes, roles, responsibilities, and conflict resolution
  • If cores are at different institutions, provide a clear plan for cross-site communication, shared workflows, and accountability

4. Network Integration & Work Plans

  • Explain how BEACON will support and connect with the IMPOWR network
  • Provide deliverables and timelines for the overall Center and each core
  • Explain how BEACON will track progress, key outputs, and advance network goals

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

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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Applications must comply with Data Management and Sharing (DMS) and Genomic Data policies, methods and standards for scientific data.

HEAL Initiative Expectations

All data from HEAL-funded projects must be shared through a HEAL-compliant data repository so the data can be accessed through the HEAL Data Ecosystem. The HEAL Initiative has additional requirements for awarded applications that must be addressed in the Data Management and Sharing Plan (refer to HEAL Data Sharing Requirements under Section VI.3 for details).

See guidance below for more information:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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 (Overall)

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

Administrative Core

When preparing your application, use Component Type 'Admin Core'

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant's Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Follow standard instructions.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Include travel funds for:

  • PD(s)/PI(s) and all Core Leads
  • Support staff needed to coordinate in-person meetings and take notes

Annual Network Meeting (Years 1-5)

  • Plan for one 2-day meeting each year with 75-100 people
  • BEACON will host the first meeting. Meeting location rotates between recipients each year.
  • Budget should include costs for venue space if host institution can't identify cost-neutral venue.
  • Efforts to coordinate hotel accommodations, meeting logistics, food. BEACON collaborates with the host institution each year to arrange these items.

Year 1 Kickoff Meeting (Rockville, MD)

  • NIH will identify a conference venue for the meeting
  • BEACON will coordinate: hotel accommodations, meeting logistics, food.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Specific Aims should identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy: The Administrative Core of the BEACON Center provides overarching resources and organizational structure and management of the Cores and Projects.

As part of this section, applicants should describe their plan for completing the following activities:

External Communications

  • Maintain public-facing website meeting accessibility standards (508 compliance, SEO) and implement improvements to enhance impact
  • Execute coordinated communication strategy across all audiences. Tasks include:
    • Track and promote conference presentations and publications from IMPOWR projects
    • Develop training resources for practitioners and stakeholders
    • Create social media strategies, press releases, and other communications as needed
    • Summarize findings and key resources from IMPOWR Phase I

Internal Network Support

  • Maintain internal collaboration website, updated listservs for all IMPOWR members, and file sharing/project management infrastructure
  • Track and report network activities and outputs (publications, meetings, findings) and facilitate dissemination within the network
  • Provide meeting support for Steering Committee and workgroups including note-taking, facilitation, and convening for all virtual and in-person meetings

In-Person Meeting Planning

  • Provide logistical and planning support for all in-person meetings, including securing meeting space when needed
  • Year 1: Plan two meetings with 75-100 people–kickoff meeting in Rockville, MD and first annual meeting hosted by BEACON
  • Years 2-5: Assist rotating host sites with hotel accommodations, meeting logistics, and food planning (site selection determined in Year 1)

Monitoring Network Outputs

  • Track and synthesize key outputs (publications, presentations) from all network studies
  • Coordinate with Evidence to Clinical Impact Core to create synthesis products such as publications, presentations, and webinars
  • Provide real-time metrics to NIDA on overall network outputs

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

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, with the following modification:

Other Plan(s):

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

  • Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide.

PHS Human Subjects and Clinical Trials Information (Admin Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Research Education Core

When preparing your application, use Component Type 'Core'

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

SF424 (R&R) Cover (Research Education Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant's Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Education Core)

Follow standard instructions.

Research & Related Other Project Information (Research Education Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities & Other Resources. Describe the resources available to support your program:

  • Educational environment and facilities
  • Laboratories and participating departments
  • Computer services and technology infrastructure
  • Any other relevant resources for program development and implementation
  • List all related sources of support for research training and education (use Current and Pending Support format)

Other Attachments. Provide an Advisory Committee Plan titled Advisory_Committee.pdf to include:

  • Composition and desired expertise of committee members (can draw from Network membership and proposed initial core members)
  • Roles and responsibilities
  • Meeting frequency
  • How the committee will evaluate overall program effectiveness
  • Names of proposed members already invited to participate

Project /Performance Site Location(s) (Research Education Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Education Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Education Core)

Budget forms appropriate for the specific component will be included in the application package.

  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

Budgets for the Research Education Core are limited to $350,000 in direct costs annually plus applicable F&A.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Education Core)

Specific Aims: The goal of the Research Education Core is to build capacity for researchers to engage productively at the intersection of pain and addiction medicine, and for practitioners to engage in, and apply the findings of, NIH-funded research. Training should support researchers at various levels interested in working in OUD and pain settings and facilitate engagement with the broader IMPOWR network. Specific Aims should outline a vision for achieving this goal, providing an overview of specific activities planned, targeted audience for training, priority content areas, and plan for evaluation of the success of the research education activities.

Proposed Research Education Program

  • Describe how your program is distinct from existing federally-funded research training and education programs at your institution
  • If training programs exist in the same department, clearly differentiate between existing programs and your proposed activities
  • Provide programmatic detail, timeline, objectives, and specific activities (courses, curricula, seminars, short-term research experiences)
  • Explain how objectives align with overall IMPOWR network goals
  • Create resources for dissemination to IMPOWR network and external stakeholders (e.g., virtual grand rounds via YouTube)
  • Describe participant engagement with IMPOWR
  • Key educational domains include, but are not limited to:
    • Applying implementation science tools and frameworks
    • Working across pain and addiction health settings, especially addressing data sharing and collaboration challenges
    • Designing, fielding, and analyzing pragmatic trials across siloed settings
    • Collaborative care management and care team service provision spanning addiction and pain medicine
    • Educating pain providers on addiction screening, treatment, and sustained engagement
    • Educating addiction providers on pain screening (including validated assessments), treatment modalities, and local service providers

Core Leads

  • Describe program administration arrangements
  • Provide evidence that PD/PI is actively engaged in research and/or teaching in clinical effectiveness and/or implementation research in addiction and/or pain settings
  • Demonstrate Core Lead(s) can organize, administer, monitor, and evaluate the program
  • For multiple Leads: describe complementary expertise, leadership approach, and governance structure
  • At least one Core Lead per Core must have experience leading similar programs and a track record of NIH funding

Program Faculty

  • Propose Core Faculty with research expertise in clinical and/or implementation research in addiction and pain settings
  • Utilize IMPOWR network expertise (PIs, researchers, partners from RM1 clinical trials)
  • Outline plan for engaging IMPOWR network investigators in the Research Education program

Program Participants

Describe who can participate, required qualifications and background, and targeted career levels. Audiences may include:

  • Research investigators to conduct rigorous studies in addiction/pain settings
  • Research staff in health organizations to run practical studies and evaluations
  • Individuals living with CP and OUD to enhance knowledge on research methodologies.

Plan for Instruction in the Responsible Conduct of Research.

Applications without RCR plan will not be reviewed. See NOT-OD-10-019 and NOT-OD-22-055. Address all NIH-required components:

  • Format: Face-to-face lectures, coursework, and/or real-time discussion groups (online-only is not acceptable)
  • Subject Matter: Breadth of topics (conflict of interest, authorship, data management, human subjects, animal use, laboratory safety, research misconduct, research ethics)
  • Faculty Participation: Role of program faculty in instruction
  • Duration: Number of contact hours appropriate for program duration
  • Frequency: Instruction during each career stage and at least once every four years

Evaluation Plan

  • Specify baseline metrics (participant numbers, educational levels, demographic characteristics)
  • Include measures to gauge short and long-term success in achieving objectives
  • Obtain participant feedback to identify weaknesses and improvement suggestions

Dissemination Plan

  • Provide specific plan to disseminate findings and materials nationally in conjunction with BEACON Center components
  • Address methods: web postings, presentations at scientific meetings, workshops, sharing course curricula
  • Specifically address how information will be leveraged in other BEACON Center components

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

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, with the following modification:

Other Plan(s):

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

  • Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Education Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Survey and Qualitative Data Core

When preparing your application, use Component Type 'Core'

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

SF424 (R&R) Cover (Survey and Qualitative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant's Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Survey and Qualitative Core)

Follow standard instructions.

Research & Related Other Project Information (Survey and Qualitative Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Survey and Qualitative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Survey and Qualitative Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Survey and Qualitative Core)

Budget forms appropriate for the specific component will be included in the application package.

Applicants should specify a budget appropriate to the project proposed in Year 1 of the project. Since all subsequent projects will be treated as delayed onset, in Years 2-5, the budget should reflect staffing and leadership for this core as well as funds required to execute future studies of similar scope and scale as described in the Research Strategy section for this Core.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Survey and Qualitative Core)

Specific Aims: Specific Aims should identify general objectives planned for this Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy: This core will conduct annual surveys of key stakeholders to understand the evolving climate for delivering CP/OUD services.

Plans must include:

Annual Survey Execution (minimum 1 nationally representative survey per year)

  • Pre-identify Year 1 survey topic, respondent audience, study design (including sampling and weighting), scientific rigor approach, and timeline for data collection and analysis
  • Justify public health significance of survey topic
  • Topics may address opinions and knowledge gaps regarding addiction/pain practices, workforce, workflow, clinical barriers, operational barriers, and other topics relevant to IMPOWR Phase II studies or emerging trends

Rapid Dissemination

  • Ensure rapid translation of survey insights and findings to relevant audiences
  • Collaborate with Evidence to Clinical Impact Core to inform resource development and prioritization
  • Make data rapidly available for collaborative analyses with IMPOWR researchers when appropriate

Network Input & Flexibility

  • Develop strategy for soliciting input from IMPOWR researchers and outside stakeholders on priority survey topics
  • Outline process for evaluating emerging research priorities annually
  • Develop additional surveys as needed post-award in consultation with NIH and IMPOWR Phase II researchers
  • Consider potential for multiple surveys per year to respond to urgent emerging clinical practice issues

Approval Process

All survey content must receive input from IMPOWR Project Scientist and NIH approval

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

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, with the following modification:

Other Plan(s):

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

  • Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide.

PHS Human Subjects and Clinical Trials Information (Survey and Qualitative Core)

When involving human subjects research, clinical research, an/or NIH-defined clinical trials 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 a 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.

Evidence to Clinical Impact Core

When preparing your application, use Component Type 'Core'

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

SF424 (R&R) Cover (Evidence to Clinical Impact Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant's Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Evidence to Clinical Impact Core)

Follow standard instructions.

Research & Related Other Project Information (Evidence to Clinical Impact Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Evidence to Clinical Impact Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Evidence to Clinical Impact Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Evidence to Clinical Impact Core)

Budget forms appropriate for the specific component will be included in the application package.

Applicants should specify a budget appropriate to the project proposed in Year 1 of the project. Since all subsequent projects will be treated as delayed onset, in Years 2-5, the budget should reflect staffing and leadership for this core as well as funds required to execute future studies of similar scope and scale as described in the Research Strategy section for this Core.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Evidence to Clinical Impact Core)

Specific Aims: This core will develop key resources that address barriers hindering integrated addiction and pain treatment. Identify general objectives and main benchmarks that indicate accomplishment of these objectives.

Research Strategy: State and local leaders make critical decisions affecting access, availability, cost, quality, and effectiveness of addiction and pain treatment services. This Core will enhance the impact of these decisions by providing timely, robust, and actionable health services research findings and resources informed by stakeholder engagement.

  • Target audiences include: state and local government organizations responsible for funding/monitoring/providing treatment services, Single State Agency leaders, local health/public health departments, and addiction services provider leaders (e.g., psychiatry department chairs, CEOs of community-based treatment programs).
  • Resource types may include: infographics for clinicians/patients, evidence-based treatment summaries for stakeholders, podcasts, webinars, cost-calculators, electronic tools for resource allocation or care planning, and other innovative dissemination channels.

Required activities include:

Resource Development

  • Describe at least one resource and its intended end user
  • Justify significance and impact from the stakeholder's perspective
  • Additional products planned as delayed onset in the outyears informed by the annual surveys, IMPOWR researchers, external stakeholders, and NIH input
  • Develop plan for soliciting ideas and input from network recipients and NIH representatives for additional resources in outyears. IMPOWR Project Scientist can prioritize content areas when resources are constrained

IMPOWR Phase I Dissemination

  • Disseminate findings from IMPOWR Phase I to relevant audiences using lay-audience language
  • Include actionable steps for health system leaders, stakeholders
  • Work with National Addiction and Health Data Archive Program (NAHDAP) to jointly disseminate the CDE dataset from IMPOWR Phase I and support secondary data use

Tracking & Reporting

  • Track dissemination and resource utilization
  • Include metrics in reporting to NIDA

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

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, with the following modification:

Other Plan(s):

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

  • Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide.

PHS Human Subjects and Clinical Trials Information (Evidence to Clinical Impact Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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) using ASSIST or other electronic submission systems. 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 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.

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.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 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. 

Mandatory Disclosure

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 NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Center address the needs of the research network that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?

Specific to this NOFO:

  • If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? 
  • How will successful completion of the aims change the concepts, methods, technologies, treatments, or services currently being employed by the field?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing integrated CP and OUD research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research network the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Specific to this NOFO: 

  • Does the research plan include novel or appropriate strategies for capturing, monitoring, and displaying metrics data on performance from the awarded research centers? 
  • Are there innovative approaches to communicating between RM1 Research Center and with all their relevant stakeholder partners? 
  • Are there innovative strategies or approaches for disseminating findings and best practices applicable for relevant PWLE and stakeholder partners? Are there innovative approaches for engaging with a range of stakeholders?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this NOFO: 

  • Does the application demonstrate a track record of collaborating with the relevant stakeholder partners and PWLE (with co-occurring CP and OUD)/patient organizations and is there information about the nature and extent of collaborations between the researchers and stakeholder/PWLE partners?
  • Does the application list the infrastructure necessary to deliver project coordination activities for a large multi-component network?

Additional Review Criteria - Overall

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Inclusion of Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. 

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals (as applicable), the committee will consider the progress made in the last funding period.

Revisions

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For networks involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Overall Impact - Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Cores collectively to support the coordination center. Criterion scores will not be provided for the Cores.

Review Criteria - Cores

Reviewers will consider each of the review criteria below in the determination of scientific merit.

Review Criteria - Administrative Core

  • To what extent are the proposed strategies and processes for the Administrative Core appropriate for scientific administration, fiscal administration, procurement, property and personnel management, planning, budgeting etc.?
  • How effective are the plans for maintaining an external-facing website, internal collaboration, and communication infrastructure; providing required logistical support; and executing progress monitoring across the IMPOWR network as outlined in the NOFO?
  • How will they establish and maintain effective communication and cooperation among the BEACON Center cores? Across the network as a whole?
  • To what extent will they be able to successfully recruit participants for the Research Education Core, both within and external to IMPOWR?

Review Criteria - Research Education Core

  • To what extent will the proposed Research Education Core result in an increase in the availability of well-trained researchers who can execute complex studies and reach a broad group of trainees?

Review Criteria - Survey and Qualitative Data Core

  • How comprehensive is the plan for executing the Survey and Qualitative Data Core and Evidence to Clinical Impact Core, especially as it related to outyear project planning?

Review Criteria - Evidence to Clinical Impact Core

  • To what extent does the Evidence to Clinical Impact Core generate resources that will meaningfully advance clinical care and training?
  • How comprehensive is the plan for disseminating and evaluating materials and trainings in the Evidence to Clinical Impact Core?
  • How effective is their plan to disseminate key findings from IMPOWR Phase I and the IMPOWR Common Data Element resource?

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.

Appeals 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 guidelines 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 their 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations must ensure that 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.

2. Administrative and National Policy Requirements

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

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.

Recipients of both Clinical Trial Required and Clinical Trial Optional awards subject to this term shall report standardized clinical trial activation and enrollment performance data for any interventional clinical trial supported under the award. These metrics are intended to assess trial startup efficiency, site activation, and post-activation performance and to support continuous quality improvement in clinical trial operations (see supplemental guidance). Recipients shall report required data annually at the time of Research Performance Progress Report (RPPR) submission on clinical trial activation and enrollment performance milestone dates as calendar dates; NIH will calculate standardized interval metrics from these dates.

Institutions are expected to maintain capabilities that support efficient clinical trial startup, participant enrollment, and performance monitoring, including streamlined workflows and systems for electronic tracking of milestones.  Recipients are encouraged to implement and evaluate approaches that improve trial efficiency and the participant experience. 

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.

In administering programs under this and all funding announcements, NIH prioritizes: 

  • Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
  • Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
  • NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 
Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) of the BEACON Center will be responsible for the scientific and technical direction of the project and agree to abide by the policies and guidance set up by the IMPOWR network. This includes:

  • Accepting the actions and recommendations approved by the Steering Committee
  • Serving as Core Director(s) responsible for integration and management of activities within the BEACON Center
  • Organizing day-to-day management, coordinating across all Cores
  • Serving as a member of the IMPOWR Steering Committee (SC)
  • Accepting close coordination, cooperation, and participation of NIH HEAL Initiative and other involved NIH Institutes, Centers, and Offices in project management as described below
  • Attending network meetings and participating in the cooperative nature of the consortium
  • Implementing the approved Data Management and Sharing Plan, which will be incorporated as an additional term of award
  • Sharing (making available) data both within the network and with the scientific community
  • Complying with institutional intellectual property policies and practices as approved in the award
  • Retaining custody of and having primary rights to data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies
  • Providing updates annually regarding meeting IMPOWR network metrics, with responsibility for problem-solving and corrective action throughout the award duration to ensure result-based accountability metrics are successfully met

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH Project Scientist(s):

  • Will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. This individual serves as a research peer to the PI team.
  • Will coordinate and facilitate the IMPOWR network
  • Will attend and participate as a voting member in all meetings of the SC on behalf of participating NIH Institutes, Centers, and Offices (one vote total for NIH, regardless of how many NIH staff participate)
  • Will serve as a liaison between the SC, the network, and other involved NIH Institutes, Centers, and Offices
  • Will serve on various IMPOWR workgroups, providing scientific advice and guidance on the direction of the network
  • Will assist the BEACON Center, workgroups, and other committees in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action
  • Will work closely with the PD(s)/PI(s) of the BEACON Center and the PIs of all IMPOWR network components to ensure proper conduct

NIH Program Official:

  • Will handle the normal stewardship of the award and will be named in the award notice
  • Will be responsible for the normal scientific and programmatic stewardship of the award
  • May elect to attend SC meetings, but not as a member of the committee
  • Will review the scientific progress of the individual award components

Results-Based Accountability:

  • A results-based accountability management approach will be utilized to ensure achievement of stated network goals/outcomes
  • Additional metrics will be added as a term and condition of the award throughout the duration of the project
  • If an outcome is not being met, the NIH Program Official will ask the PD/PI for a resolution plan and increased progress reporting to ensure compliance
  • If scientific progress is not met, the NIH Program Official may recommend withholding of support, suspension, or termination of an award for lack of scientific progress or failure to adhere to award conditions

Areas of Joint Responsibility include:

  • The SC is the primary governing body of the IMPOWR network. One representative from each RM1 Center and BEACON sit on the SC. Award recipients must participate in the SC. The SC reviews and approves the research agenda, develops and monitors policies and procedures guiding the research activities, and oversees communications. Award recipients agree to abide by the procedures and policies established by the SC. The NIH Project Scientist(s) will have one (1) vote on SC, regardless of how many NIH staff participate across the network.
  • The PD(s)/PI(s) provide, in concert with the NIDA staff, support necessary to ensure that sites and investigators, and NIH and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.
  • Award recipients and NIDA will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data.
  • All award recipients and NIDA will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care systems engaged in research and beyond.
  • The SC, will facilitate these joint activities and, in particular, development of research protocols, human subjects and other regulatory protocols, data harmonization, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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.
 

1. Study Registration and Metadata (within 1 year of award)

2. Data and Metadata Submission

Awardees must submit data, metadata, and code (if applicable) to a HEAL-compliant repository.

Before final data submission

Required data submissions may include:

  • Data files
  • Data dictionaries (variable level metadata)
  • Code (if applicable)

Data dictionaries can be submitted by:

Timeline for data sharing (NOT-OD-21-013)

  • Share data as soon as possible
  • No later than:
    • The time of publication, or
    • The end of the performance period (whichever comes first).

3. Additional Requirements for Human Subjects Research

Studies involving human participants must meet the following:

Use of Common Data Elements (CDEs)

HEAL funded studies focusing on pain research:

To gain access to the CDEs and questionnaires (NIH box account)

All other HEAL-funded studies are encouraged to use CDEs when applicable

  • NIDA strongly encourages the use of the Core and Specialty collections available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org).
  • See NOT-DA-12-008 for further details.

If proposing new questionnaires:

  • Consult with the program official and the HEAL CDE team
  • Provide justification for inclusion

For copyrighted questionaries

  • Obtain licenses before data collection
  • Provide licenses to the HEAL CDE team and the program officer

Informed consent

When possible:

Data Protection and Confidentiality

All HEAL data are protected under a Certificate of Confidentiality and entitled to the protections thereof.

Awardees and Institutions must:

  • Use data only for approved purposes
  • Follow all applicable federal and state laws
  • Follow informed consent requirements

Comply with NIH policies including:

  • NOT-OD-17-109
  • 42 U.S.C. 241(d)

Failure to adhere to this criterion may result in enforcement actions.

4. 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.

Application Submission Contacts

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).

Scientific/Research Contact(s)

Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse (NIDA)
Email: IMPOWR@nih.gov

National Center for Complementary and Integrative Health (NCCIH)
Division of Extramural Research (DER)
Email: NCCIHDERFunding@nih.gov
 

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

Division of Clinical Research
National Institute of Neurological Disorders and Stroke (NINDS)
NINDS_IMPOWR@ninds.nih.gov

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

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

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

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Grants Management Contact
Email: NIAAA-GMB@mail.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

National Institute on Aging (NIA) 
Email: NIA-NOFO-Grants@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.

Authority and Regulations

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.