NOT-DA-18-025: Notice of Intent to Publish a Funding Opportunity Announcement for Data Coordinating Center for the HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (UM1)

Notice of Intent to Publish a Funding Opportunity Announcement for Data Coordinating Center for the HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (UM1)

Notice Number: NOT-DA-18-025

Key Dates

Release Date:July 18, 2018
Estimated Publication Date of Funding Opportunity Announcement: September 17, 2018
First Estimated Application Due Date: December 04, 2018
Earliest Estimated Award Date: February 01, 2019
Earliest Estimated Start Date: February 01, 2019

Related Announcements
NOT-DA-18-026
RFA-DA-19-016
RFA-DA-19-017

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

The National Institute on Drug Abuse(NIDA), in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), intends to publish a Funding Opportunity Announcement (FOA) to solicit cooperative agreement applications and ultimately fund up to three research sites and one data coordinating center to participate in the: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (HEALing Communities Study).

The HEALing Communities Study will test the immediate impact of implementing an integrated set of evidence-based interventions across healthcare, behavioral health, justice, and other community-based settings to prevent and treat opioid misuse and Opioid Use Disorders (OUD) within highly affected communities. Highly affected communities of interest could include counties, neighborhoods, or some other justifiable geographic areas, within states that are burdened with higher than average rates of overdose mortality and opioid-related morbidity, and other complications.

The integrated set of evidence-based prevention and treatment interventions should be designed to achieve the following goals: reduce overdose fatalities, and events; decrease the incidence of OUD; and increase the number of individuals receiving medication-assisted treatment, retained in treatment beyond 6 months, and receiving recovery support services compared to baseline.

As background, on June 18, 2018, NIH held a planning meeting with scientific experts and stakeholders to discuss questions related to the design and outcomes for the HEALing Communities Study. A summary of meeting proceedings is available at: https://www.drugabuse.gov/drugs-abuse/opioids/nih-heal-initiative. To solicit additional input on the study from interested stakeholders a Request for Information (RFI) was developed. The RFI can be found at: https://grants.nih.gov/grants/guide/notice-files/NOT-DA-18-023.html.

Data coordinating center applications are expected to establish a multi-disciplinary team to support study coordination and communication; manage data, analyses, and modeling; and conduct health economics research.

This study will be part of the of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award. NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement. See 45 CFR 75.306 for additional details.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and appropriate projects.

The FOA is expected to be published in September 2018, with an expected application due date in December 2018.

This FOA is expected to utilize the UM1 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with a wide range of expertise to consider applying for this FOA. The areas of research encouraged in this initiative are such topics as: collaboration, coordination, and communication for large complex multi-site research; epidemiology and modeling; public health, healthcare, behavioral healthcare, and justice data systems; data management, collection, cleaning, harmonization, integration, storage, analysis, and sharing; cluster trial design, modeling, and analysis; systems and implementation science; community-based participatory research, and health economics.

Objectives and Scope

Overarching research questions include:

1) What evidence-based integrated prevention and treatment system of care is needed to reduce overdose fatalities by at least 40% and improve other related individual, public health, process, and structural outcomes?

2) What factors (structural, organizational, community, and policy-level) contribute to successfully implementing and sustaining an integrated evidence-based prevention and treatment system?

3) What analytic tools, resources, and strategies are most useful in helping communities respond rapidly and most effectively to the opioid crisis?

4) What are the incremental costs and cost effectiveness of a coordinated integrated evidence-based prevention and treatment system compared to standard care in the community with respect to reducing overdose fatalities by at least 40%?

The primary objective and outcome of this program is to support the design and conduct of a multi-site cooperative study that measurably reduces overdose fatalities by at least 40% compared to baseline.

Research Strategy: The HEALing Communities Study coordinating center applications must consist of the functional and structural units clearly marked in sub-sections A-E (required) and F (optional) described below.

Sub-section A: Overall Research Plan (required). Describe the overall approach to achieving the programmatic goals of the HEALing Communities Study. This includes using innovative technology-driven tools to: a) provide logistical support for collaboration(s) and communications between NIH and federal partners including SAMHSA, and the HEALing Communities Study steering committee and research sites; b) provide data management, modeling, and analysis support; c) conduct health economics research to determine the cost, cost effectiveness, and economic models related to the study.

Sub-section B: Coordination and Communication (required). Describe the plan to support cross-site collaboration(s) and work using a secure internet-based infrastructure for document sharing and management; support in-person and web-based meetings; develop and maintain a public facing website for dissemination of study related materials and findings. This section should also include plans to develop metrics with research centers and NIH (using the Results Based Accountability Framework) and provide dashboards and reports related to study progress.

Sub-section C: Data Management (required). Describe the plans for providing scientific, technical, regulatory, ethical, and logistical support for data collection, integration, harmonization, management, quality control, modeling, and analyses.

Sub-section D: Health Economics Research Focus (required). Describe aims, approach, study design, measures, datasets and de novo data collection, analysis plan, etc. for research addressing the incremental cost, cost effectiveness, and potential economic modeling of coordinated integrated evidence-based prevention and treatment system compared to standard care in the community with respect to reducing overdose fatalities by at least 40%.

Sub-section E: Data Coordinating Center Overview, Management, and Operations subsection (required): Each application must propose plans for data coordinating center leadership, coordination, administration, and operations. An organizational chart explaining overall structure of the data coordinating center must be included. This section should also include: a) overall programmatic structure to effectively promote collaborations and communications with the research centers and their community partners the NIH, and other key stakeholders; b) administrative organization with roles, responsibilities, and clear lines of authority for personnel involved in the center; c) project management plans and processes for establishing, tracking, reviewing, and managing milestones and productivity; d) quality control to ensure rapid problem identification and resolution, prioritization of resources, high quality data and publications.

Sub-section F: Scientific Research Support Unit(s): (optional): This section includes any other SRS necessary to support the research agenda. A full description with strong justification will be needed.

Funding Information

Estimated Total FundingTBD
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.279

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Redonna K. Chandler, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1470
Email: [email protected]