It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The National Institute on Drug Abuse (NIDA), in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA) is soliciting cooperative agreement applications with the intention of ultimately funding up to three research sites (see RFA-DA-19-016) and one data coordinating center (DCC) 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 or cities within states that are burdened with higher than average rates of overdose mortality and opioid-related morbidity, and other complications. Combined, all the communities participating in a single research site application must demonstrate having experienced at least 150 opioid related overdose fatalities (15% of these fatalities must be from rural communities) and a rate of 25 opioid related overdose fatalities per 100,000 persons or higher in the past year, based on the most recent complete year of data available. States within the top third for age-adjusted drug overdose death rates in 2016, (per the Centers for Disease Control and Prevention) are of special interest. The integrated set of evidence-based prevention and treatment interventions should be designed to achieve the following goals: reduce overdose fatalities (by 40% over a 3-year period), and events; decrease the incidence of OUD; and increase the number of individuals receiving medication for OUD, retained in treatment beyond 6 months, and receiving recovery support services, and the distribution of naloxone compared to baseline.
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.
Communities across the US are dealing with the catastrophic consequences of greater availability of opioids including prescription opioids and illicit opioids, such as heroin and illicitly manufactured fentanyl (and related analogs). Millions of Americans are struggling with inappropriate use of opioids, and OUD. The consequences of this crisis are grave with continued increases in overdose fatalities. In addition, rates of OUD and injection drug use, acute hepatitis C virus (HCV) infections, localized outbreaks of HIV, and other serious health conditions such as endocarditis and neonatal abstinence syndrome continue to rise.
One driver of the opioid crisis is the recognized gap between the number of individuals who could benefit from a prevention or treatment intervention to reduce opioid use and OUD and those engaged in care. Currently, a menu of evidence-based prevention and treatment interventions exist including school and community based primary prevention, prescription drug monitoring programs and other strategies to reduce inappropriate opioid prescribing, medications for addiction treatment, behavioral therapies, and recovery support services. Unfortunately, these evidence-based interventions have largely failed to penetrate community settings including addiction treatment, general medical care, social support services, schools, and the justice system. This failure is in part due to a lack of evidence-based approaches for assisting communities in the development and deployment of a data driven custom-designed response strategy to deliver comprehensive integrated evidence-based interventions.
NIDA, in partnership with SAMHSA, is soliciting applications for a Data Coordinating Center (DCC) to participate in the HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis. The objectives of this multi-site research cooperative are to support rigorous research to: 1) determine the health impact of implementing a data-driven multi-pronged approach to opioid misuse and OUD by enhancing the systematic delivery of evidence-based prevention and treatment interventions across multiple settings (required settings include healthcare, behavioral health, and justice); 2) identify facilitators and barriers to implementation and sustainability, including relevant payment policy strategies; 3) determine the incremental cost and cost-effectiveness of this multi-pronged approach; and 4) develop an evidenced based model for deploying effective data-driven multi-pronged approach(es) to reduce overdose deaths and prevent and treat opioid misuse and OUD in affected communities across the US.
Highly affected communities of interest could include counties, towns or cities (or a justified aggregate of counties, towns, or cities functioning as one community) within states burdened with higher than average rates of opioid-related overdose morbidity and mortality and other health consequences associated with opioid misuse. For this FOA there is a special interest in states ranking in the top third of age-adjusted drug overdose death rates in 2016, per the Centers for Disease Control and Prevention. For a particular application, all of the communities participating in the research must be located in the same state and 30% of them must be rural (https://www.ruralhealthinfo.org/am-i-rural/help). For this FOA, the minimum threshold for “highly affected" communities is having at least 150 opioid related overdose fatalities (15% of these fatalities must be from rural communities) and a rate of 25 opioid related overdose fatalities per 100,000 persons or higher, based on most recent complete year of data available. States within the top third for age-adjusted drug overdose death rates in 2016, (per the Centers for Disease Control and Prevention) are of special interest. For this FOA, opioids include prescription opioids and illicit opioids, such as heroin and illicitly made fentanyl (and related analogs). OUD refers to the clinical diagnosis defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
The DCC will execute an array of scientific and support activities for the HEALing Communities Cooperative within three broad areas: coordination and communication, data, and health economics research. DCC applications are asked to propose how they will perform these activities in a rigorous innovative way. DCC applications will be expected to include personnel with a wide range of expertise to support activities of the cooperative including documented expertise in: collaboration, coordination, and communication applicable to a large complex multi-site research project; epidemiology and modeling; public health, healthcare, behavioral healthcare, and justice data systems; data collection, confidentiality, cleaning, harmonization, integration, storage, analysis, and sharing; cluster trial design, modeling, and analysis; systems and implementation science; community-based participatory research; and health economics research and economic evaluation. The DCC will provide expertise and coordinate ethical, regulatory, and other required activities for research involving human subjects including a Central IRB.
The DCC will work with research sites to support the HEALing Communities Study. The DCC will conduct and facilitate cross-site analyses for required primary and secondary outcomes including: 1) determining the health impact of implementing a data-driven multi-pronged approach to opioid misuse and OUD by enhancing the systematic delivery of evidence-based prevention and treatment interventions across multiple settings (required settings include healthcare, behavioral health, and justice) with primary goal of reducing opioid overdose fatalities by at least 40% in three years across combined communities participating in the cooperative); 2) identifying facilitators and barriers to implementation and sustainability, including relevant payment policy strategies; 3) determining the incremental cost and cost-effectiveness of this multi-pronged approach. Secondary aims of interest in the study should be part of a linked pathway to reducing overdose fatalities. Required secondary outcomes include: reducing the number of overall overdose events; decreasing the misuse of opioids, decreasing incidence of OUD and progression in severity to OUD or injection drug use; increasing the number of individuals (and percentage of individuals with OUD) receiving medication (methadone, buprenorphine, or naltrexone) and behavioral treatment; increasing the number of individuals and percent of individuals receiving treatment that are retained in treatment beyond 6 months; increasing the number and percent of individuals participating in or completing treatment that are receiving recovery support services; and increasing access to naloxone.
In addition, the DCC will monitor and may conduct cross-site analyses for the required structural aims intended to decrease overdose fatalities and impact secondary outcomes. Data will be collected by research sites for the required structural aims including:
Research sites may propose additional aims and outcomes and conduct their own analyses. Other research site specific analyses may be conducted in coordination with the DCC.
Data for the cross-site primary and secondary research aims will come from up to 3 research sites partnered with at least 15 communities within a single state, at least 30% of which will be rural (https://www.ruralhealthinfo.org/am-i-rural/help). The communities must be highly burdened by mortality, morbidity, and other health and psychosocial complications related to opioid misuse and OUD. Each research site will be working in communities reporting a total of at least 150 opioid overdose fatalities across the combined study communities for the most recent year of available data, and at least 15% of the fatalities must have occurred in the rural communities. NIDA and SAMHSA anticipate reaching a total of 40-50 communities through all funded HEALing Communities Study research sites.
In addition if appropriate, applicants are encouraged to take advantage of NIDA's Clinical Trials Network https://www.drugabuse.gov/about-nida/organization/cctn/ctn) and the Clinical and Translational Science Award Program funded by the National Center for Advancing Translational Sciences (https://ncats.nih.gov/ctsa/about).
This multisite research cooperative will be part 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.
In addition, 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. A summary of responses received from the RFI can be found at https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/request-information-rfi-healing-communities-study.
A Notice of Intent to Publish a Funding Opportunity Announcement for a Data Coordinating Center the HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (UM1) can be found at: https://grants.nih.gov/grants/guide/notice-files/NOT-DA-18-025.html. Applicants are encouraged to participate in a future technical assistance webinar related to the FOA by registering at HEALingCommunitiesStudy@Leedmci.com. It is anticipated the webinar will take place between September 24-28, 2018.
Special Considerations: Applications with the following specifics will be considered non-responsive and will not be reviewed:
Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.
Data Harmonization for Substance Abuse 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 (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support 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 FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose clinical trials.
NIDA intends to commit up to $6.5M each year in FY 2019–2022 to fund one Data Coordinating Center, subject to availability of funds.
Application budgets need to reflect the actual needs of the proposed project.
The maximum project period is 4 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.
Contact PD/PI must contribute no less than 5 person months annually over the life of the award.
For grantees from a for-profit organization, this FOA does require cost sharing, as defined in the NIH Grants Policy Statement. More information on cost matching requirements is in Section IV.2 R&R or Modular Budget.
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. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov.
Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative, the letter may also be sent to:
Office of Extramural Policy and Review
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following additional requirements:
The Research Strategy must consist of the following sub-sections with the indicated page limits:
Sub-section A - Research Plan: required - 12 pages
Sub-section B - Coordination and Communication: required - 6 pages
Sub-section C - Data Management: required - 6 pages
Sub-section D - Health Economics Research: required - 6 pages
Sub-section E - Data Coordinating Center Overview, Management, and Operations: required - 6 pages
Sub-section F - Scientific Research Supports: optional - no more than 3 SRS- 6 pages each
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed. With the following additional instructions:
Facilities & Other Resources: For each research site, provide details about the infrastructure for the proposed research study and institutional support for the conduct of clinical research under U.S., DHHS, and NIH regulations and policies regarding human subjects.
Other Attachments: Provide the below listed additional materials with the specified names in support of the application. All the listed materials must be provided as a single PDF file, labelled as “Data Coordinating Center Organizational Data.”
1. Table of contents of the Attachment
2. Data Coordinating Center Organization: A diagram explaining the overall structure of the Data Coordinating Center and how the Subsections of the RFA fit within the overall program must be provided.
3. Coordination and Communication Plan: A table or diagram illustrating communication plan(s) with all NIDA funded HEALing Communities research sites and their partners, the NIH and SAMHSA, and other key players involved (refer to Sub-section B).
4. Data Tools and Resources: A table listing tools for data collection, sharing and reporting, data analysis software and platforms, tools for implementation and analyses of economic research, and resources for data storage and other applicable activities (refer to Sub-section C).
5. Management and Operations Overview: A Flow chart(s) illustrating the leadership, coordination, and operational processes for the Data Coordinating Center in relation to the three HEALing Communities Research Sites (refer to Sub-section E).
All instructions in the SF424 (R&R) Application Guide must be followed. In addition, the application must include the following information specific to this FOA:
-It is expected that all key personnel will devote substantial effort to the activities proposed in the Data Coordinating Center
All instructions in the SF424 (R&R) Application Guide must be followed. With the following additional instructions:
In the budget justification, provide budget breakout for activities under each sub-section of the research strategy. Budgetary requests for all activities should align with the major responsibilities and activities of the DCC in the broad areas of Collaboration and Communication, Data Related Activities and Cross-Site Data Analyses, and Economic Research. Include support for no less than 3 person-months per year and travel for the Steering Committee Chair for participation in web-based and face-to-face SC and other meetings. Include support to coordinate and participate in the following meetings: initial 3-day face-to-face kick off meeting, 2 face-to-face Steering Committee meetings in the Bethesda, MD area per project period; at least 2 one-two day meetings of the economic evaluation workgroup to facilitate the economics research; up to 3 two-day meetings per year to support subcommittees of the cooperative to develop specific components of the research. The DCC PD/PI must dedicate at least 5 person months for each year of the DCC funding period.
Cost Matching Requirement for For-profit Applicants
Cost matching or documented in-kind contributions is required for for-profit organizations responding to this FOA. The for-profit awardee is required to match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount (direct costs, as well as facilities and administrative costs), as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.
Federal funds may not be used as a source of matching funds. Generally, cost matching requirements may not be met from the following sources:
a) Costs borne by another Federal grant or sub award;
b) Costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds;
c) Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient);
(d) Program income; and
(e) Patient incentives.
The for-profit organization 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. Applicants must submit budgets that clearly document the total costs, the source and amount of matching funds, and how valuation was determined in the case of in-kind contributions, as well as the Federal and Institutional (non-Federal) components of the budget. 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.
Budget Justification: All for-profit applicants must document the matching (non-Federal) component and the federal (non-matching) component in the total project budget. That is, the requested budget plus the cost-matching budget must be detailed in tabular format to document the cost-matching (non-Federal) component and the federal (non-cost matching) component. The amount of matching is subject to adjustment based on total allowable costs incurred. All costs and contributions used to satisfy the matching requirement must be documented by the recipient, including how the value for in-kind contributions was determined, and are subject to audit. The cost matching requirement is not negotiable for for-profit organizations.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Provide a clear rationale for the overall approach to all activities undertaken by the Data Coordinating Center (DCC). The DCC will execute an array of support and scientific activities for the HEALing Communities Cooperative within three broad areas: coordination and communication, data, and health economics research. Specific aims should be included for each of these activities and be distinct and outline plans for effectively executing them. In addition, the DCC should demonstrate how they will interact with HEALing Communities Research Sites and their community partners, and assist them in their efforts to develop and implement evidence-based prevention and treatment response strategies. Aims also must focus on assisting the research sites in establishing and meeting the RFA-specific primary and secondary aims.
The ‘HEALing Communities Study Data Coordinating Center’ applications must include the following functional and structural units. These units referred to as ‘Sub-sections A-F’ must be clearly marked and include all information specifically requested for each of them.
Sub-section A – Overall Research Plan: required
Sub-section B - Coordination and Communication: required
Sub-section C - Data Management: required
Sub-section D - Health Economics Research: required
Sub-section E - Data Coordinating Center Overview, Management, and Operations: required
Sub-section F - Scientific Research Supports: optional
The HEALing Communities Study Data Coordinating Center (DCC) applications must consist of the functional and structural units clearly marked in sub-sections A-E (required) and F (optional) described below. Include a diagram of the overall structure of the DCC and how the subsections of the RFA fit within the overall program (See ‘Other Project Information’ for instructions about submitting a diagram of organizational structure labeled “Data Coordinating Center Organization”).
Sub-section A: Overall Research Plan (required). Describe the overall approach to achieving the
Overall aims: a) providing 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) providing data management, modeling, and analysis support; c) conducting 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 communication. At a minimum the DCC should include plans to support the following activities:
See ‘Other Project Information’ for instructions on submitting a table or diagram illustrating how the DCC will facilitate communication with all research sites and their partners, NIDA, SAMHSA, and other key players labeled “Coordination and Communication Plan”.
Sub-section C: Data Management (required). Describe the plans for providing scientific, technical, regulatory, ethical, IRB, and logistical support for data collection; confidentiality, integration; harmonization; management; quality control; modeling; analyses related to all cross-research site required primary and secondary aims, outcomes, and economic evaluations, and sharing. Plans should address the following specific data related activities of the DCC:
Sub-section D: Health Economics Research Focus (required).
The DCC is responsible for designing and conducting health economics research. The DCC should propose a scientifically rigorous economic evaluation to determine the incremental cost and cost effectiveness of a hypothetical coordinated integrated evidence-based prevention and treatment system compared to standard care in communities participating in the research with respect to reducing overdose fatalities by 40%. Study aims, approach, design, measures, datasets and de novo data collection, and analysis plan should be described. The DCC should also propose a simulation modeling, existing, adapted, or new, that can be used to add to the scientific yield of the study, and show how data from multiple sites with different protocols might be incorporated into the model to address additional questions. The DCC may also propose additional health economics studies that advance the overall scientific goals of the HEALing Communities Study.
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 (See ‘Other Project Information’ for instructions on providing this information in a diagram labeled as “Management and Operations Overview” including information related to meetings and teleconferences to facilitate communication).
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.
Letters of support:
Letters of support are required to demonstrate participation from key partners involved in the activities of Data Coordinating Center. Support letters demonstrating institutional commitment, and commitment from other organizations assisting with data platforms, tools and services must be included with the application.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
For-profit applicants must include a letter(s) of support confirming that the required secured cost matching (cash; in-kind commitments such as salary, consultant costs, equipment) is available and confirm that the essential personnel have the authority within the organization to allocate resources.
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. 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
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) 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 NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIDA Referral Office by email at NIDAReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this announcement, note the following:
In the evaluation of the HEALing Communities Study-Data Coordinating Center application, reviewers will emphasize the overall approach of the center in relation to the three broad areas of responsibility: 1) coordination and communication; 2) data activities; 3) health economics research. The DCC application should demonstrate a vision for: 1) facilitating collaboration and communication between research sites and their partners, NIDA, SAMHSA, and other important entities to support the goals of the research; 2) leading activities related to all aspects of developing and collecting data for common data elements and analyzing data related to cross-site primary and secondary study aims and making data available; 3) leading in the development and conduct of economic research.
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).
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.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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, services, or preventative interventions that drive this field?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA: Is there clear description of roles for all key personnel involved in the Data Coordinating Center? Are investigators experienced in coordinating complex state, community or population-level studies? Are investigators experienced with public and private datasets related to opioid morbidity, mortality, other consequences, and substance use prevention and treatment? Are investigators experienced with substance use and health economic evaluation research? Are the investigators experienced in state of the art quantitative and qualitative data analyses, modeling, and economic modeling?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA: Is there innovation in the approach to coordination and communication, data related activities, and the economic study? Is there innovation in the approach to data related activities including integration of existing datasets, capture of de novo data, development of data capture systems, sharing of data, quantitative and qualitive data analysis, data sharing? Does the research plan include novel strategies for capturing, monitoring, and displaying metrics data on performance from the research sites? Are there state of the art and novel web-based platforms or tools for collaboration, communication, and data management? Does the research plan include innovative approaches to conducting economic evaluations or modeling? Are there innovative approaches to communicating between research sites and with all their community-based partners? Are there innovative dissemination strategies or approaches for findings and best practices applicable for communities and community organizations dealing with the opioid crisis?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA: Is there a well-coordinated plan for establishing and maintaining: collaboration and communication, data related activities, and health economics research? Is there a clear communication plan and state of the art technology proposed to facilitate collaboration between research sites, their partners, the Steering Committee, NIDA, SAMHSA, and other important entities? Is there a federally compliant web-based data infrastructure tool that supports data deposition, sharing, transfer and analysis? Is there a thorough plan for cross-site data analyses? Is there a thorough approach to developing or considering appropriate statistical and analytical techniques suitable for analyzing complex data sets from the research sites? Is there a sound approach to health economic research? Are there plans to leverage existing data infrastructure, tools, systems and resources? Is there a clear vision or framework for working with research sites and other involved key players to coordinate all study-related activities? Are there plans to develop or assist in developing data-driven models for expanding the implementation of the tested response strategy? Is there a conceptually driven dissemination plan for study findings that include communities and community based organizations across the country dealing with the opioid crisis?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this FOA: Does the application describe existing infrastructure, tools, systems and resources that can be leveraged to collect data and how they will be used? Does the application demonstrate a track record of coordinating complex research programs involving state, academic, local and community-based organizations? Does the application list the infrastructure necessary to deliver data and project coordination activities for the large multi-site study? Does the application describe an environment with experience conducting or coordinating research related to drug abuse, opioid misuse, OUD, and overdose, and health economics?
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.
Are there clear timelines for facilitating development of common data elements, measures, case report forms, data quality standards, data capture tools and platforms, and other data collection activities lead by the DCC? Are there clear timelines for assisting the research sites with the collection of baseline data? Is the projected timeline for the economic evaluation research feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., practice-based research networks, electronic medical records, administrative and other databases, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the six 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 six 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.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
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.
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).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Specific to this FOA:
How likely is it that the plans for cost matching will be adequate?
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDA, in accordance with NIH peer review policy and procedures, 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:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA.. 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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Special award condition specific to this FOA: A grantee from a for-profit organization funded under this 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. See 45 CFR 75.306 for additional details. Matching funds must be non-Federal funds set aside for this project and are available from the source(s) identified in the application, as committed to by the recipient. Cost matching will be evaluated by the awarding office to ensure that this requirement is being met. Compliance with the matching requirement must be verified on an annual basis and must be documented in the annual and final FFR.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
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 (DHHS)
grant administration regulations at 45 CFR Part 75, 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 and SAMHSA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH and SAMHSA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume primary direction, responsibility, or a dominant role in the activities. Consistent with this concept the primary responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees, NIH, and SAMHSA as defined below.
The DCC will have primary responsibility for and agrees to:
The PD(s)/PI of the DCC receiving this award will:
NIH, SAMHSA, and other Federal Staff Staff Responsibilities: NIH and SAMHSA staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below:
Areas of Joint Responsibility include:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Grantee chosen without NIH staff voting, one NIH designee, and a third designee from CDC 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
A final Research Performance Progress Report (F-RPPR), invention statement, and the expenditure data portion of the Federal Financial Report, including Federal and non-Federal share for cost matching, are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred
method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information
(Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Redonna Chandler, PhD
National Institute on Drug Abuse (NIDA)
Gerald McLaughlin, PhD
National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA))
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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