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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

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:

• changing prescribing patterns to reduce the supply of prescription opioids
• increasing the number of specialty treatment programs that provide medications for OUD
• increasing the number of providers (doctors, nurses, nurse practitioners, physician assistants, pharmacists) prescribing and/or monitoring medications for OUD
• increasing the number of providers (physicians, nurse practitioners, physician assistants) with a DATA 2000 waiver to prescribe buprenorphine in the office-based setting
• increasing the availability of naloxone across a community to reduce fatal overdoses
• creating programs that can readily link individuals to treatment following an opioid overdose
• increasing the use of screening to identify opioid misuse and brief intervention(s) to address misuse within healthcare and other settings
• increasing evidence-based school and community-based opioid prevention services
• increasing number of formal linkages between the justice system and healthcare and behavioral health

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 [email protected]. 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:

• Applications with study aims that are not consistent with the areas of research identified in this FOA
• Applications not addressing the scope of activities outlined below in subsections Coordination and Communication and Data Management
• Applications not including a plan for conducting health economic evaluations as described below under subsection Health Economics Research
• Applications not providing a PD/PI committing a minimum of 5 person months annually over the life of the grant award

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.

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

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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)

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)
• 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

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

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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:

• 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 NOT-OD-11-101).

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to: [email protected].

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:

Specific Aims:

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:

• Providing operational and logistical support for the activities and meetings of the cooperative, including working groups. Plans should include coordinating logistics associated with in-person meetings of the Steering Committee (SC). This includes working with the NIDA program official (PO) to coordinate dates and locations; communicating with all relevant parties about logistics; maintaining participant lists; securing room blocks at area hotels for meeting participants (note: research sites are responsible for their own travel expenses); developing meeting materials in collaboration with the SC; compiling meeting minutes, and coordination of any post-meeting follow-up. The DCC will be responsible for travel expenses and level of effort (up to 3-person months per year) for the SC chairperson. For planning purposes, the DCC should assume 2 two-day SC meetings will be held per year at NIDA or other NIH offices in Bethesda, Maryland.
• Providing technical or logistical support for meetings of subcommittees and workgroups to be formed by the cooperative, including face to face meetings and providing conference call lines and webinar support. For planning purposes assume 3 two-day meetings per year to be held either in Bethesda, Maryland, or one of the research sites. Research sites are responsible for staff travel to these meetings.
• Developing and maintaining a public project website, and plain documents, to facilitate dissemination of plain-language study protocols, progress reports and research findings to multiple audiences, including communities and community-based organizations seeking information about how to address mortality, morbidity, and other consequences of opioid misuse and OUD.
• Working with NIDA, SAMHSA, and the SC to establish metrics, collect metrics data, and develop and maintain web-based metric dashboards to monitor individual research sites, DCC, and study progress. Metrics will be developed using the using the 4DX framework. Metrics will be monitored on a weekly basis with monthly reports for NIH and HHS.
• Maintaining a state of the art secure web-based project collaboration and document management system that meets applicable federal requirements to facilitate: a) communication between awardees and their partners, staff at NIDA and SAMHSA, and other key stakeholders; b) document sharing and storage, and c) dissemination of relevant data collection forms, research findings, timelines, and other documents.
• Maintaining up-to-date versions of the policies and procedures developed by the SC and making them readily available to the cooperative.
• Supporting the SC in the development and execution of a dissemination and publication plan for study protocols, findings, best practices, tools etc. Support a publications committee convened by the SC responsible for a) policies and procedures related to presentations, reports, publications, and manuscripts b) reviewing and approving presentations, reports, publications, and manuscripts related to integrated data. Track the progress of presentations, reports, publications, and manuscripts related to integrated data.
• Developing, with the SC, a conceptually driven dissemination plan for communications materials with study description, findings, lessons learned, etc. These materials would be appropriate for a wide range of stakeholders at the federal, state, local, and community level including, at a minimum, healthcare, behavioral health, and justice settings.
• Assisting research sites in the development of materials to use with communities and community-based organizations to provide information related to the study, study progress, and 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:

• Providing scientific, technical, and regulatory expertise and coordinating activities across the research sites to ensure compliance with all government policies and requirements related to the conduct of clinical research and the protection of human subjects. This includes but is not limited to contracting or convening a Central IRB (with the expertise and membership to approve drug abuse research and research that may involve subjects in the justice system and therefore classified as "prisoner" research) and monitoring the approval of IRB submissions, providing expertise on human subjects protections with regard to the use of any personally identifiable health data that may be collected as part of the study, coordinating activities across the research sites to ensure harmonization with regard to confidentiality and consent when necessary to participate in the research or provide access to personal health data, etc.
• With SC and other research sites, developing and implementing common data elements, instruments, case report forms, and approaches to data collection and integration to address cross-site research questions. Activities may include improving the quality of data already collected in community-based settings or de novo collection of data. This will include baseline and follow-up data for the primary outcome of testing the integrated set of evidence-based prevention and treatment interventions to reduce overdose fatalities by at least 40% across communities and required secondary outcomes: reducing number of 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. Also included are required structural outcomes: changing prescribing patterns to reduce the supply of prescription opioids; increasing the number of specialty treatment programs that provide medications for OUD; increasing the number of providers (doctors, nurses, nurse practitioners, physician assistants, pharmacists) prescribing and/or monitoring medications for OUD; increasing the number of providers (physicians, nurse practitioners, physician assistants) with a DATA 2000 waiver to prescribe buprenorphine in the office-based setting; increasing the availability of naloxone across a community to reduce fatal overdoses; creating programs that can readily link individuals to treatment following an opioid overdose; increasing the use of screening to identify opioid misuse and brief intervention(s) to address misuse within healthcare and other settings; increasing evidence-based school and community-based opioid prevention services; increasing number of formal linkages between the justice system and healthcare and behavioral health.
• Leading the development of policies and procedures, including data use agreements, related to data collection, use, sharing, and analyses for the cooperative.
• Providing a federally compliant online infrastructure to support the submission/transmission of research data, including clinical data.
• Monitoring data quality and performing systematic checks for data completeness and comparability.
• Compiling integrated datasets, develop codebooks, and data file documentation.
• Supporting requests from NIDA, SAMHSA, and other research sites for analytic data files.
• Developing data sharing and data use agreements to support harmonization and data use among research sites and the eventual creation of public use datafiles.
• Preparing de-identified public use data files and documents for submission into a NIDA supported repository (and/or restricted use data files, depending on the sensitivity of the data needed to be shared).
• Providing consultation to research sites on accessing and integrating existing federal, state, and community data sets related to the research - especially the required primary outcome of opioid related overdose fatalities and other required secondary outcomes. This might include but is not limited to: surveillance data collected by state and local health departments, medical examiners/coroners, law enforcement, courts, and mental health/substance abuse agencies; program data from service provider organizations; insurance and claims data from public or private insurers; public data regarding providers and agencies; census and other population-based surveys. The DCC is expected to continuously improve and expand the use of such data systems for the study to assure comparability of data across sites and allow for full integration of data from multiple sites, each of which will vary in data capacity.
• Conducting cross-site data analyses, including modeling and examining change over time, using the integrated datasets related to research questions. Performing descriptive data analyses to characterize cross-site research communities, the nature and extent of mortality and morbidity associated with the opioid epidemic, etc. Performing data analyses of baseline data for required primary and secondary study outcomes. Performing interim and final analyses of follow-up data for required primary and secondary study outcomes, using a variety of state-of-the-art statistical approaches.
• Utilizing statistical and analytical techniques, as well as, knowledge of different imputation techniques for large integrated datasets as appropriate.
• Utilizing qualitative or mixed methods approaches to advance the aims of the study.
• Maintaining expertise on state-of-the-art and emerging study designs and methodologies relevant to the research questions addressed by the cooperative to facilitate analysis and interpretation of data.
• Working with the research sites to accelerate the development for all aspects of baseline data collection across all the communities participating in the cooperative. Ensure baseline data is collected using standardized forms and procedures; human subject and consent issues addressed as need to ensure all members of the cooperative have access; and data are processed into analysis-ready files. The DCC will provide analyses of pilot and/or baseline data to inform deliberations of the SC about appropriateness and validity of measures and the development of research. The research sites are responsible for collecting the data; the DCC is responsible for ensuring consistency of measures and methods across sites; creation and distribution of survey forms or data entry screens; merging, cleaning, and analysis of the cross-site baseline data file. Timely completion of this activity is essential to support the research.
• Describing plans for collecting metrics data to monitor study activities and research site performance.
• A table listing tools for data collection, sharing and reporting, data analysis software and platforms, tools for implementing and analyzing economic data, and resources for data storage and other applicable activities must be provided program (See Other Project Information for instructions about submitting a table labeled Data Tools and Resources ).

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Regardless of the amount of direct costs requested for any one year, all applications are expected to include a Data Sharing Plan detailing how data will be made publicly available, as appropriate and consistent with achieving the goals of the program.

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.

Appendix:

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.

Important reminders:

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 [email protected] 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.

Study Timeline

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.

Not Applicable.

Not Applicable.

Not Applicable.

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.

Not Applicable.

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:

• 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.
• Will receive a written critique.

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:

• 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.
• Data Coordinating Center infrastructure and prior experience of the PD/PI in coordinating complex research programs.

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 DCC will work with research sites, the NIDA PO, and SC to meet the communication, collaboration, data, and economic evaluation needs of the collaborative.
• The DCC awardee(s) agrees to accept coordination, cooperation, and participation of NIDA, SAMHSA, and other federal staff in those aspects of scientific and technical management of the research and to work cooperatively with other awardees to pursue common methods, protocols, and data elements and collection as appropriate.
• The DCC will promote and support the use of state of the art technology to facilitate the work of the cooperative and dissemination of findings including but not limited to: public project website to facilitate dissemination of plain-language study protocols, progress reports and research findings to multiple audiences; and a secure web-based project collaboration and document management system, public use files, etc.
• The DCC will provide integrative, organizational, logistical, and communication support for all activities of the cooperative including tracking, scheduling, and facilitating work of the SC, other committees, task forces, work groups, and advisory panels related to the project including preparing meeting materials, concise meeting minutes for distribution, and action items. In addition, the DCC will provide support for the development of research protocols, tracking of protocol approval, maintaining most recent version of protocols, and execution of protocols.
• The DCC will plan, organize, and execute a kick off planning meeting of approximately 3 days and thereafter biannual 2-day meetings per project period year in Bethesda, Maryland. They will cover travel expenses of DCC staff coordinating and participating in the meetings.
• The DCC will provide representation to the SC and will support any other committees, task forces, and advisory panels related to the project, as needed and will participate in regularly scheduled conference calls with the awarding agencies. Project budgets should include travel for participation in these activities.
• Awardees shall participate in the SC and abide by decisions of the SC and the policies and procedures adopted by the SC.
• The DCC is responsible for coordinating, leading, and tracking activities related to the development and implementation of common data elements, instruments, approaches to data collection, for baseline, and follow-up data collection across all research sites for the cross-study primary and secondary aims. The DCC is responsible for cross-site analyses for the required primary and secondary study aims.
• The DCC will provide expertise and leadership in addressing issues of broad scientific applicability such as informed consent, data sharing standards, cluster trial design methods, collection and integration of administrative or other data from multiple sources (details under Objectives and Scope section above), data analysis, economic research, dissemination of findings including development of best practices.
• The DCC will provide salary and travel support for the Chair of the SC. Salary support is not less than 3 person-months/year unless given prior approval by the NIDA Program Official (PO).
• The DCC will develop research plans for economics research in conjunction with research centers and submit them for approval by the SC and review of the NIDA program official. Depending on the interventions chosen by each site, there may be one overall economic evaluation and one for each site. The DCC will take lead responsibility for implementation of selected economic research plans as determined by the SC.
• The DCC will work with research sites to determine data, data collection processes, and instruments needed to conduct the evaluation. The DCC will provide research sites with expertise and technical assistance, to compliment expertise at the research sites, during the collection of data for economics-focused analyses. Research sites will collect economic-related data and submit it to the DCC. The DCC will conduct research in partnership with communities and their partnering organizations; assure quality of data; assure that research findings are communicated to research partners, NIDA, and SAMHSA; assure that the economic evaluation(s) are conducted in accordance with approved protocols.
• The DCC is responsible for analyzing these data and developing a publication plan in collaboration with the SC; delivering one or more high-quality peer-reviewed journal articles; making the aggregated data file available to the cooperative, NIDA, and SAMHSA for further analysis if requested; and delivering a de-identified public-use data file. The DCC will convene and run a working group for the economic research with membership from research sites, NIDA, and SAMHSA, and potentially outside experts approved by the SC. This working group may require occasional face-to-face meetings. For planning purposes, the DCC should anticipate 2 one day in-person meetings per year. These meetings could take place during or around the time of biannual SC meetings.
• A PD/PI on a UM1 awarded under this RFA will be expected to maintain significant effort commitment not less than that stated in the application (5 person-months).
• The DCC is responsible for working with research sites, NIDA, and SAMHSA to develop, implement, collect metrics data and provide dashboards related to research site and DCC performance on study activities in the 4DX framework (see "The 4 Disciplines of Execution" for more information). Awardees agree to submit metrics data in a timely fashion. The DCC will ensure metrics dashboards are updated on a weekly basis and NIDA receives a report on a monthly basis.
• Awardees will submit semi-annual progress reports to the NIDA program official. Funding is contingent on progress reported in these reports and monthly metrics, including collaborative contributions.

The PD(s)/PI of the DCC receiving this award will:

• Obtain prior written approval of the NIDA Grants Management Specialist in consultation with the NIDA Program Officer for a change in any of the key personnel identified in the Notice of Award.
• Own the rights in any tangible work products for which they made significant contributions created under the terms of the cooperative agreement. Work products may include such things as research reports, papers, research, findings, training curricula, data sets, books, patient tools, and other materials. All such products shall be made accessible to the public under NIH s Public Access Policy https://publicaccess.nih.gov/ and are subject to Government rights of access, as appropriate, in accordance with NIH’s legal directives and authorities.
• Meet milestones established in Milestone Study Plan for coordination and economic research activities submitted at the time of funding. Failure to achieve minimally acceptable milestones may result in the withholding future support and/or negotiating an orderly close-out of this study.

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:

• NIDA will name a program official (PO) responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIDA PO will not participate in the research, publications, or be a member of the SC and will be responsible for the oversight of each award under the cooperative agreement. The PO carries primary responsibility for: (1) review and approval of the progress of the research plans in relation to their stated objectives, and (2) making recommendations regarding continuance of the program. The NIDA PO will be responsible for monitoring the conduct of the research and overseeing the DCC. The PO will have access to all study metrics, reports, and dashboards to ensure study progress in addition to progress reports. The NIDA PO will work collaboratively with the NIDA Grants Management Specialist to assure high quality business management of the program, including the most effective use of Federal financial assistance provided through this cooperative agreement. The PO will receive all required progress reports to determine that satisfactory progress is being made.
• NIDA and SAMHSA will designate project scientists (PS) to collaborate with awardees in DCC activities related to coordination and communication, data, and economics research. The PSs will collaborate with the DCC in an array of activities related to the economic research and provide input into the economic research design(s), data analysis, and dissemination of findings according to policies governing the cooperative. The NIDA and SAMHSA PSs serve as a resource for specific information on NIDA and SAMHSA s programmatic intentions and priorities, and will help foster collaborations to increase the value of the research to these participants. They will participate in the development of instrumentation, study plans, quality control, and coordination of economics research, but will not participate in activities that directly involve assessment, testing, or treatment of human subjects, or collection of economics data.
• The NIH, as primary funder and administrator reserves the right to phase out or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting, and will do so with the consultation of other federal partners. NIH support of this study is contingent upon adequate study progress based on the Grantee’s Milestone Plan submitted at the time of funding.
• The cooperative will enable cross-institute and cross-agency collaboration of several types. NIDA and SAMHSA will convene representatives from Federal agencies that provide resources, assistance, expertise, data collection tools and platforms, etc. directly to the research or indirectly to communities and community-based organizations participating in the research. NIDA and SAMHSA will convene meetings of this panel to ensure Federal agencies are informed of the activities and progress of the cooperative and to provide a venue for receiving their input on research conducted by the cooperative. In addition, members of the panel may be asked for feedback by the SC. The NIDA and SAMHSA PSs will serve on the Federal panel.

Areas of Joint Responsibility include:

• SC: The SC is the primary governing body of the Cooperative. Awardees 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. Awardees agree to abide by the procedures and policies established by the SC.
• Economic Study Plan Development and Implementation: Economic study plans are mutually acceptable to the research sites and their community partners, the SC, and NIDA program official. Communication throughout all stages of study development and implementation is essential. The NIDA and SAMHSA PSs will contribute to the economic study plan design as appropriate. The NIDA PO will review the scientific rationale, programmatic relevance, priority, design, statistical requirements, and implementation of proposed economic studies.
• Data Management, Analysis, and Access: Data generated are the property of the awardee. Research sites must provide economic-related research data to the DCC in a timely fashion in accordance with the policies and procedures established in study protocols and by the SC. In addition, the DCC and all research sites must provide NIDA and SAMHSA with access to all data generated under this award, subject to rules specified in any Certificates of Confidentiality obtained by awardees. Data must be shared upon request with the SC and subcommittees reporting to the SC when appropriate. As governed by any Certificates of Confidentiality, data may also be available for external monitoring if required by NIDA's agreements with other Federal agencies.
• As the Cooperative is intended to be a national resource, the DCC must be prepared to share their data under provisions that safeguard the privacy and confidentiality of respondents. Thus, the DCC proposal should include explicit indications of how they will make their data available for broad use and on what timetable. The DCC will provide for data sharing consistent with its data sharing plan, as approved by NIDA.
• The PD(s)/PI(s) provide, in concert with the NIDA and SAMHSA 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.
• Awardees, NIDA, and SAMHSA will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care provider organization patients, health care providers and other institutions.
• All awardees, NIDA, and SAMHSA 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, with the support of the DCC, 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 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.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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)

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Contact Center Telephone: 800-518-4726
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Redonna Chandler, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1919
Email: [email protected]

Gerald McLaughlin, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5819
Email: [email protected]

Pam Fleming
National Institute on Drug Abuse (NIDA))
Telephone: 301-480-1159
Email: [email protected]

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.