It is critical that applicants follow the Multi-Project (M) 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

Overview

Opioid use disorder (OUD) and opioid misuse consequences exist at the intersection of health and justice systems. Illicit opioids, including fentanyl and heroin, accounted for more than 60% of opioid-related overdose deaths in 2016. The intersection of justice and community-based health systems is a critical target for addressing the opioid crisis. At this nexus of public safety and public health, collaboration is essential to increasing access to and retention in evidence-based services for opioid misuse and OUD. Successfully targeting this nexus can reduce negative impacts on families and communities associated with the opioid crisis.

Through the NIDA Justice Community Opioid Innovation Network (JCOIN), NIH will establish a network of research investigators to rapidly conduct studies on quality care for opioid misuse and OUD in justice populations by facilitating partnerships between local and state justice systems and community-based treatment providers. Specifically, this work will include (1) conducting studies on the effectiveness and adoption of new medications, prevention and treatment interventions, and technologies in justice system settings; (2) conducting ongoing research on dynamic changes in policy and practice; (3) leveraging existing data sources and developing innovative research methods to address the opioid crisis; (4) fostering partnerships to ensure effective dissemination of lessons learned to the justice system and community-based provider stakeholders; and (5) conducting research on the most effective strategies for disseminating lessons learned to ensure scalable, sustainable solutions. These efforts are expected to offer novel insights into addressing gaps in the continuum of care for justice-involved populations in the United States.

This funding opportunity is intended to solicit a single Coordination and Translation Center to be part of NIDA’s Justice Community Opioid Innovation Network (JCOIN).

HEAL Initiative

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

Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed on 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.

Network Structure and Objectives

The Justice Community Opioid Innovation Network (JCOIN) is intended to facilitate transdisciplinary collaborations that can create actionable, translatable insights for the justice system and community-based organizations that work with justice-involved populations who use illicit opioids or who are at high risk of misusing prescription opioids.

To accomplish this objective, NIDA intends to establish a national consortium of investigators examining promising interventions and other approaches that can improve the capacity of justice systems to effectively respond to the opioid epidemic.

The structure of the network shall consist of (1) Clinical Research Centers, (2) a single, central Coordination and Translation Center, and (3) a single, central Advanced Analytics and Methodology Resource Center. A Steering Committee will include (a) a representative from each Clinical Research Center, (b) one representative from the Coordination and Translation Center, (c) one representative from the Advanced Analytics and Methodology Resource Center, and (d) a NIDA Project Scientist. Senior leaders from justice- and community-based settings named as key personnel in Clinical Research Center applications will also play a role in the Steering Committee. NIDA will appoint one Steering Committee Chairperson with expertise in justice and substance use disorders to coordinate the activities of the Steering Committee (described below). NIDA will have an active role in the activities of the network, including the development and approval of research protocols through the involvement of one or more appointed Project Scientists and Program Officials.

A. Clinical Research Centers: Clinical Research Centers will conduct clinical research and clinical trials, including implementation, effectiveness, and hybrid implementation-effectiveness studies. The goal of studies proposed by Clinical Research Centers should be to improve public health and public safety outcomes for justice-involved individuals who use or are at risk for using opioids. Public health outcomes are inclusive of illicit opioid use, opioid misuse, opioid-related overdoses and mortality among justice-involved populations. An opioid use disorder cascade or behavioral health cascade framework should be used to guide outcome selection. A behavioral health cascade framework includes screening for opioid use, referral to treatment, treatment engagement and retention in behavioral and pharmacological treatments for OUD. Relevant implementation outcomes such as penetration, scalability, and sustainability should also be considered. Additional information about this component can be found at: [RFA-DA-19-025]

B. Coordination and Translation Center: A single Coordination and Translation Center will manage logistics, stakeholder engagement, and dissemination of findings and products from the JCOIN network. This will include establishing infrastructure to support research education and rapid response and pilot research.

C. Methodology and Advanced Analytics Resource Center: A single Methodology and Advanced Analytics Resource Center will provide data infrastructure support across the cooperative and will conduct foundational research to support the work of the clinical sites, including modeling studies, national surveys, and/or systematic collection and analysis of relevant policies and laws. Additional information about this component can be found at: [RFA-DA-19-023]

Justice Setting Definition

For the purposes of this FOA, justice setting is broadly defined and is inclusive of prisons, jails, drug courts and other problem-solving courts (e.g., Driving While Impaired (DWI), family courts, veterans courts), policing and police diversion programs, transitions to secure settings from communities, transitions from secure settings to communities (i.e., re-entry), probation and parole, child welfare (particularly when there is concurrent involvement in other parts of the justice system), and juvenile justice. A key area of interest is models to bring medications for opioid use disorder (MOUD) to justice settings and to link justice-involved patients with community-based treatment services and other healthcare support upon release from secure settings (i.e., jails, prisons, detention centers).

Community-Based Services Definition

For the purposes of this FOA, a community-based service provider is inclusive of any setting where a justice-involved patient may engage with medical or behavioral health services that address illicit opioid use, opioid misuse, or related treatment and other service needs. This includes, but is not limited to behavioral health service providers, HIV service providers, Federally Qualified Health Centers (FQHCs), integrated primary care and behavioral health settings, office-based opioid agonist treatment providers, needle exchange sites, housing providers, opioid treatment programs, etc.

Coordination and Translation Center: Scope of Activities and Purpose

It is imperative that applicants for the Coordination and Translation Center carefully review the companion JCOIN FOAs for the Clinical Research Centers (UG1) (RFA-DA-19-025) and Methodology and Advanced Analytics Resource Center (U2C) (RFA-DA-19-023) to understand the full mission of JCOIN.

The JCOIN Coordination and Translation Center (CTC) is expected to provide coordination, infrastructure and other supports for the network. These supports include support in the day-to-day operations and coordination of the network; providing infrastructure for rapid response and pilot trials; providing research education infrastructure; disseminating research from the cooperative to a wide variety of external stakeholders; engaging external stakeholders and facilitating bidirectional communication between external stakeholders and network investigators; and conducting hypothesis-driven implementation research to support effective translation of network outputs.

The CTC will provide services and resources to the network via the following five cores. Cores may be located at different locations as long as there is a strong plan for communication and collaboration. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to the JCOIN by working together with individual Clinical Research Networks and the Methodology and Advanced Analytics Resource Center:

Administrative Core: The Administrative Core will provide overall infrastructure support to the cooperative as a whole. This includes: establishing an external-facing website and communications infrastructure; establishing internal collaboration and communication infrastructure and logistical support; and responsibility for monitoring progress across studies within the network and, in collaboration with the Methodology and Advanced Analytics Resource Center, will provide monthly reporting on progress to NIDA.

Rapid Response & Pilot Research Core: Policies and practices are rapidly changing and many opportunities for generating insights into the effectiveness of emerging policies and practices go uncaptured. The Rapid Response & Pilot Research Core will provide infrastructure support to research on newly emerging policies and practices as well as piloting new, promising approaches.

Dissemination and Stakeholder Engagement Core: The purpose of the Dissemination and Stakeholder Engagement Core is to translate network findings into resources of interest to external stakeholders. To achieve this goal, this Core is responsible for facilitating bidirectional communication and translation between network investigators and external stakeholders. External stakeholder groups include practitioners and policy makers at local, state, and federal levels across a range of justice settings and community-based service settings that work with justice-involved populations. This Core also has responsibility for engaging communities not formally involved in JCOIN and identifying strategies for assisting those communities in applying insights that emerge from research supported by the JCOIN network.

Research Education Core: The goal of the Research Education Core is to provide opportunities for research and engagement with the network. Training should support post-doctoral trainees interested in working in justice settings.

Implementation and Translation Research Project Core: The goal of the Implementation and Translation Research Project Core is to support one or more hypothesis-driven research projects that generate evidence regarding the most effective dissemination and implementation research approaches. This supports the overall goal of JCOIN to facilitate the effective translation of scientific insights into routine practice.

Collectively, these activities are expected to help ensure maximum public health impact of the collective activities of the JCOIN network.

Special Considerations:

Applications with the following specifics will be considered non-responsive and will not be reviewed:

• Applications that do not emphasize responding to prevention and/or treatment of illicit opioid use or opioid misuse in justice settings.

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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active 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.

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).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core	12
Rapid Rsps Core (use for Rapid Response and Pilot Research Core)	6
Dissem Core (use for Dissemination and Stakeholder Engagement Core)	6
Impl Project (use for Implementation and Translation Research Project Core)	12
Research Education (use for Research Education Core)	12

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: Required; Min 1, Max 1
• Administrative Core: Required; Min 1, Max 1
• Rapid Response and Pilot Research Core: Required; Min 1, Max 1
• Dissemination and Stakeholder Engagement Core: Required; Min 1, Max 1
• Implementation and Translation Research Project Core: Required; Min 1, Max 1
• Research Education Core: Required; Min 1, Max 1

When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

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

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

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

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

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.

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

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

Specific Aims: Specific aims should comprehensively address the goals of this FOA, which are to design and implement research infrastructure that will enable the Coordination Center to support and advance the work of the overall JCOIN network.

Research Strategy: Applicants should describe the overall structure of their proposed Coordination and Translation Center (CTC). This should include unique advantages or capabilities of the proposed center and how it will interact with the broader JCOIN network. In the Overall section, applicants should address how the various cores will be coordinated to establish the research resource.

The CTC should be viewed as interrelated Cores that provide support to individual Clinical Research Centers, to the network as a whole, and to the greater community of justice and community-based stakeholders engaged in working with justice-involved populations.

Because each Core should be strong individually and complementary to the other Cores and the network, it is important to describe the synergy across Cores. Provide justification in the application that key personnel will collaborate effectively. Describe the organizational structure of the CTC including the Cores. Explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goals of the JCOIN, and how combined resources create capabilities that are more than the sum of the parts.

If Cores will be located at different locations, provide a strong plan for communication and collaboration. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to JCOIN.

Describe work-flow plans and timelines.

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

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.

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.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Steering Committee Meetings: Budgets should include funds for travel for the PD(s)/PI(s), including each Core Lead, and as many support staff as needed to coordinate all in-person Steering Committee meetings. For planning purposes, assume that three (3) Steering Committee meetings will be held in year 1 in Rockville, MD. In subsequent years, two (2) Steering Committee meetings to be held in Rockville, MD annually. All Steering Committee meetings are expected to last 2 days, with the exception of a kickoff meeting to be held in late fall 2019, which is expected to last 3 days. The Coordination and Translation Center is responsible for identifying space to convene these in-person meetings. Whenever possible, NIDA staff will work with the Coordination and Translation Center to identify federal space that can be used for free. Coordination and Translation Center applicants should include plans, however, for when federal spaces cannot be identified to meet the requirements of the Steering Committee.

Steering Committee Chair Support: The budget for the Administrative Core should include a line item for travel and salary support for a Steering Committee (SC) Chair, to be named by NIDA at a later time. The SC Chair will lead all SC meetings. For budgeting purposes assume the equivalent of 2 months effort annually at a senior investigator level salary. Budget for the Steering Committee Chair should also include reimbursement for travel expenses to all in-person Steering Committee Meetings. Budget does not need to consider indirect costs specific to the SC Chair's institution.

Cost Matching Requirement for For-profit Applicants

Cost matching or documented in-kind contributions are 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.

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

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

Specific Aims: Specific Aims should comprehensively address the goals of the Coordination and Translation Center, which is to provide general infrastructure support to JCOIN. Specific Aims should identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives.

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

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

Establishing External-Facing Website and Communications Infrastructure:

• Developing and maintaining website infrastructure for public audiences, ensuring it maintains the highest standards of usability and accessibility (e.g., attend to 508 compliance, Search Engine Optimization).
• Designing and implementing a coordinated communication strategy for across audiences and functions, including dissemination of research findings to academic audiences, practitioners, and the general public. Examples of activities include, but are not limited to: (a) assisting with tracking and submitting research findings to academic research conferences; (b) developing training and sessions aimed at practitioner and policy-maker audiences (e.g., judges, drug courts, jail administrators, treatment providers, state and local policy makers), (c) developing social media communication strategies, (d) developing press releases, and other communication strategies and approaches as needed.

Providing Internal Collaboration and Communication Infrastructure and Logistical Support:

• Developing and maintaining a network-only website for internal collaboration
• Providing file sharing, project management, and communications infrastructure for the network as a whole
• Tracking and reporting internal network activities and outputs, including publications, subcommittee meetings, etc., and facilitating dissemination of updates and emerging findings within the Network
• Support all Steering Committee and related subgroups through logistical support inclusive of, but not limited to note taking, meeting facilitation, convening, and other support services for all in-person and virtual Steering Committee and trans-network Workgroup meetings.
• Support the Steering Committee through close collaboration with a Steering Committee Chair, to be named by NIDA.
• Providing logistical support and meeting planning support for all in-person Steering Committee meetings. For planning purposes, assume that three (3) Steering Committee meetings will be in year 1 in Rockville, MD. In subsequent years, two (2) Steering Committee meetings to be held in Rockville, MD annually. All Steering Committee meetings are expected to last 2 days, with the exception of a kickoff meeting to be held in late fall 2019, which is expected to last 3 days.

Executing Progress Monitoring and Reporting to NIDA:

• Establishing and coordinating a working group to ensure seamless coordination with the Methodology and Advanced Analytics Resource Center to provide monthly, data-driven reporting of network activities to NIDA.
• Reporting to NIDA is inclusive of, but not limited to, progress toward recruitment, retention, data quality benchmarks, and participation of network investigators and centers in overall network activities.
• Applicants should identify a relevant framework (e.g., Results Based Accountability, Four Disciplines of Execution) they will use to guide the tracking and reporting of progress and milestone achievement across the network.

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

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.

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.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

When preparing your application in ASSIST, use Component Type Rapid Rsps Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

Application guide states that Project Narrative is required. However it is only required for the Overall component

List all performance sites that apply to the specific component.

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

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

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

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

Budget Limits for the Rapid Response and Pilot Research Core

The following budget guidelines must be followed for the Rapid Response and Pilot Research Core:

• Awards through the Rapid Response and Pilot Research Core may be issued by the U2C as fixed price subawards. These awards will may not exceed $110,000 in total costs and may not be longer than 24 months in duration.
• No more than $375,000 in total costs will be made available annually for the awards through the Pilot Research Core.

Cost Matching Requirement for For-profit Applicants

Cost matching or documented in-kind contributions are 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.

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

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

Specific Aims: Describe the overall goals of the Rapid Response and Pilot Research Core and how it will contribute to the overall objectives of the JCOIN network.

Research Strategy:

The Rapid Response & Pilot Research Core is intended to provide rapid, flexible infrastructure to support research on newly emerging policies and practices. In addition, the Rapid Response & Pilot Research Core is intended to support pilot projects, which may be used for collection of data on new, promising interventions; to take advantage of novel research opportunities; to capture implementation data on newly emerging policies or programs; or support for new, early stage, or independent investigators. Projects funded through this core may take advantage of policy changes; newly emerging practices; or may include developmental pilots, feasibility studies, or other pilot work broadly defined as foundation work for further research. Pilot projects may not be used to supplement or prolong ongoing research and should not be used as bridge funds when other research support is no longer available.

The research strategy section for the Rapid Response & Pilot Research Core should provide a detailed plan for how the Coordination and Translation Center will structure this program to ensure capacity to provide flexible infrastructure across the JCOIN network to support emergent research opportunities. A key emphasis for the Rapid Response and Pilot Research Core should be on novel opportunities to capture time-sensitive data on emerging changes in systems.

Details in the plan should include:

• Provide a detailed plan for parameters of award program, including policies, procedures, priority areas, approach to engaging all components of JCOIN, etc.
• Describe plan for convening an advisory committee to oversee process. The advisory committee should include stakeholders both within and outside JCOIN as well as NIDA staff.
• Describe process for providing rapid, rigorous review, selection, and oversight of proposals.
• Describe how the process will be communicated to potential applicants.
• Timeline and workflow for application process. Applications must be received multiple times per year, with funding awarded within 3 months of application submission.
• Provide a plan for encouraging and supporting applications for pilot awards that support novel collaborations between justice settings not currently part of the JCOIN network and JCOIN investigators. This may include providing a platform for matchmaking between JCOIN investigators and potential research sites without formal partnerships with experienced justice investigators.

Please note the following guidelines that must be incorporated into all plans for the Rapid Response and Pilot Research Core:

• All awards must observe regulations and policies that would apply if the award was made directly by NIH, including, but not limited to, clinical trials registration, IRB approval, OHRP approval, public access compliance for manuscripts, etc.
• Awards through the Rapid Response and Pilot Research Core may not exceed $100,000 in direct costs per award and may not be longer than 24 months in duration.
• Individual investigators may not receive pilot funds from more than 2 awards total through this mechanism during the entire course of the JCOIN award.
• Process for applications and all awards made via this activity must be made publicly available via the public-facing JCOIN website.
• All publications resulting from these awards must acknowledge funding from NIDA via the JCOIN Coordinating Center Rapid Response & Pilot Research Core. All publications must also be included in the annual progress report submitted by the Coordination and Translation Center.
• All awarded applications must provide a reporting of the outcomes of their pilot funds to the Coordination and Translation Center within 3 months of the completion of their study. This information must be made available within 1 month of receipt on the public-facing JCOIN website.
• NIDA must be made aware of and provide input on all awards to be made through the Rapid Response and Pilot Research Core.
• No more than $350,000 in direct costs made be made available annually as awards through the Pilot Research Core.

The following guidelines should also be observed in structuring how the Rapid Response and Pilot Research Core will interact with other components of the CTC and the broader JCOIN network:

• All applications should involve one or more JCOIN investigators. JCOIN investigators may sponsor applications from investigators not otherwise affiliated with the network.
• Modeling studies may be funded through this Core, but must take advantage of infrastructure and resources available through the Methodology and Advanced Analytics Center.
• Participants in the Research Education Training Core are not eligible for pilot funds until the completion of their training activities. That is, Rapid Response & Pilot Research funds should not be used to support the research activities specified in the Research Education Core. After successful completion of Research Education training, participants may be eligible for funding through the Rapid Response and Pilot Research Core if sponsored by a JCOIN investigator.

The Research Strategy for the Rapid Response and Pilot Research Core should not specify any planned projects. All projects are expected to emerge across the JCOIN network after the award has been made. All studies should be treated as delayed onset studies.

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

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.

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.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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. Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

When preparing your application in ASSIST, use Component Type Dissem Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

Application guide states that Project Narrative is required. However, it is only required for the Overall component.

List all performance sites that apply to the specific component.

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

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

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

Although members of external advisory groups should not be pre-specified, budgets may include placeholders for payment of members of these groups. Use the instructions in the announcement in conjunction with the application guide to prepare your application. If instructions conflict, follow the FOA.

Cost Matching Requirement for For-profit Applicants

Cost matching or documented in-kind contributions are 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.

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

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

Specific Aims: Identify general objectives planned for the development and functioning of the Dissemination and Stakeholder Engagement Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy:

External Stakeholders are inclusive of, but not limited to, leadership and front-line practitioners at local, state, and federal levels in organizations that represent individuals or groups that (a) directly engage with justice-involved populations in justice or community-based settings; (b) make policies or provide guidance on interactions with justice-involved populations; or (c) provide funding to support research or practice improvements that affect justice-involved populations. External stakeholders also include groups that represent families of individuals who are justice involved as well as individuals with a history of justice involvement. External stakeholders may also include leadership and participants in other justice-focused initiatives that engage multiple communities and stakeholders.

The research strategy section should provide details on the planned approach in the following four areas as detailed below: (1) Stakeholder Engagement in Network Leadership; (2) Outreach and Training for Stakeholders; (3) Rapid Translation of Research Findings for Stakeholder Audiences; and (4) Identifying and Engaging Potential Sites for Future JCOIN Network Activities.

Stakeholder Engagement in Network Leadership

Research plan should outline approach to conducting activities to ensure engagement of key stakeholders at federal, state, and local levels with JCOIN network leadership. Specifically, this should include recruitment of members to (1) an External Advisory Board, with representatives from justice and community-based organizations, and (2) a Federal Partner and Funder Advisory Board, consisting of members from relevant federal agencies and external funders of similar work.

Applicants should not pre-specify members of these stakeholder groups; rather, they should outline a plan for how they will approach identifying relevant stakeholders, establishing relationships with these groups, and convening relevant external stakeholders to engage with JCOIN in synergistic ways. Applicants are strongly encouraged to include perspectives of individuals who have a history of justice-involvement and their families. A description of the approach to engaging this group of stakeholders should also be included.

Other activities that should be specified with regard to stakeholder engagement with JCOIN include:

• Outlining a plan for facilitating active engagement and coordination of stakeholders from justice and community-based service agencies named as Key Personnel in awarded Clinical Research Center applications. Plan should emphasize ensuring these stakeholders have opportunities to provide meaningful and broad input on network development and direction.
• Facilitating bidirectional communication between external stakeholders and JCOIN network investigators with an explicit goal of enhancing capacity of network investigators to be responsive to emergent priorities and areas of interest in policy and practice.

Outreach and Training for Stakeholders

Research plan should outline approach to identifying training and supervision needs in key stakeholder communities and leverage JCOIN findings and materials to create and disseminate training materials regularly. Targets for training should include both justice system stakeholders (e.g., judges, probation officers, attorneys) and community-based treatment providers (e.g., addiction psychiatrists, social workers, behavioral health providers).

Trainings should be conducted in person, leveraging existing meetings that engage justice and treatment professionals, as well as disseminated via comprehensive, easy to use, engaging online platforms.

Note that the audiences for this component are justice and community-based service provider stakeholders. Researcher-oriented education should be separate, as specified in the instructions for the Research Education Core. Applicants are strongly encouraged, however, to create synergies between the Stakeholder Outreach and Training and the Research Education Core.

Dissemination and training activities should be tracked and included in metric-based reporting to NIDA. In addition, applicants are strongly encouraged to leverage outreach and training activities conducted as part of the Stakeholder Engagement Core in the design and execution of the Implementation and Translation Research Project Core.

Rapid Translation of Research Findings for Stakeholder Audiences

The Dissemination and Stakeholder Engagement Core should collaborate closely with the Advanced Analytics and Methodology Resource Center to rapidly translate emerging findings into user-friendly materials for a variety of audiences, including researchers; justice and community-based practitioners; local, state and federal policy makers; patients; and families. Examples of materials include, but are not limited to:

• Systematic evidence reviews written with a pragmatic, practitioner-oriented focus;
• Evidence-based menus and electronic tools and templates designed for community-based practitioners;
• Practitioner-focused training webinars and courses.

Research Strategy should outline approach to rigorously evaluating usability and responsive to the researcher and stakeholder needs. A plan for monitoring uptake and engagement with these materials must be included.

Plans for providing on-demand training and support to external stakeholders are strongly encouraged. This may include training on data-driven decision making, tool and template utilization, etc. Ideally these plans would leverage research designs to generate novel insights into the most effective approaches of information dissemination as described in the Implementation and Translation Research Project Core.

Identifying and Engaging Potential Sites for Future JCOIN Network Activities

In the course of engaging with stakeholders, the Coordination and Translation Center will likely identify potential sites for future JCOIN studies. The Research Strategy section should describe an approach to how these sites will be monitored, engaged, and provided access to JCOIN resources as needed. The Dissemination and Stakeholder Engagement Core should provide a platform for potential matchmaking between sites interested in engaging with researchers and researchers looking for opportunities to conduct studies in new sites.

Letters of Support: Letters of support should not be included from potential stakeholder groups. Rather, a plan for identifying and engaging these groups should be included in the Research Strategy Section, as specified above. No letters should be sought or included from potential external stakeholder advisory groups as part of the Dissemination and Stakeholder Engagement Core. NIDA will work closely with the Coordination and Translation Center to appoint the eventual External Advisory Committee. Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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.

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.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Dissemination and Stakeholder Engagement Core)

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

When preparing your application in ASSIST, use Component Type Impl Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

Application guide states that Project Narrative is required. However, it is only required for the Overall component.

List all performance sites that apply to the specific component.

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

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

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

Cost Matching Requirement for For-profit Applicants

Cost matching or documented in-kind contributions are 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.

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

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

Specific Aims: Specific aims must be included and must specify aims for at least one hypothesis-driven project as well as a broader strategy for how this Core will function within the broader context of the CTC and JCOIN network.

Research Strategy:

The goal of the Implementation and Translation Research Project Core is to support one or more hypothesis-driven research projects that generate evidence regarding effective approaches to translating scientific findings in to wide-spread practice via dissemination and implementation research. One challenge with implementation science is that, to date, findings from rigorous implementation science studies rarely lead to actionable lessons that can speed the translation of research findings into widespread practice. The purpose of the Implementation and Translation Research Project Core is to facilitate the closing of this ironic gap. Applicants should outline a rigorous approach to closing the science-to-service gap in the context of the overall scientific goals of the JCOIN network.

The Implementation and Translation Research Project Core should leverage resources generated by the network and propose strategies to ensure those resources and/or findings are disseminated widely and utilized within the targeted settings. The research strategy should outline at least one specific project, but should also include a detailed approach to how this Core will function as a resource that evolves as the Network matures.

Examples of specific research projects include, but are not limited to:

• Testing innovative dissemination techniques, such as web-based approaches, social network dissemination, and other approaches using experimental designs to expand knowledge about the most effective ways to disseminate information broadly and enhance implementation in practice;
• Embedding research questions into activities planned as part of the Dissemination and Stakeholder Engagement Core;
• Conducting brief, low-cost pragmatic trials in the design of dissemination implementation activities.

The research strategy should specify at least one specific research project, as well as a broader approach to providing research infrastructure to complement the activities of the Dissemination and Stakeholder Engagement Core. Applicants are strongly encouraged to specify one or more implementation science frameworks that will guide the approach to this activity.

Leadership of this Core should include investigators with extensive experience in multi-site implementation science research studies. Leadership of this Core should also include one or more collaborators with extensive experience working with practitioners in real-world implementation settings. This Core should reflect a blend of innovative implementation science approaches with pragmatic-real world focus and should synergistically interact with all components of the Coordinating Center, with a particular emphasis on the Dissemination and Stakeholder Engagement Core.

A clinical trial can be proposed as part of the Implementation and Translation Research Project Core, but is not required.

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

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.

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.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Implementation and Translation Research Project Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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. Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

When preparing your application in ASSIST, use Component Type Research Education .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

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

Complete only the following fields:

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

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

List all performance sites that apply to the specific component.

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

Research & Related Other Project Information (Research Education Core)

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

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

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

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

Application guide states that Project Narrative is required. However, it is only required for the Overall component.

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Other Attachments. Provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. The Advisory Committee should draw from the membership of the JCOIN Network, but applicants can propose an initial core set of members for the Advisory Committee. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Please name your file Advisory_Committee.pdf

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

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

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

Budget (Research Education Core)

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

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

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

Budgets for the Research Education Core are limited to $500,000 in direct costs annually plus applicable F&A.

Cost Matching Requirement for For-profit Applicants

Cost matching or documented in-kind contributions are 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.

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

PHS 398 Cover Page Supplement (Research Education Core)

Follow all instructions provided in the SF424 (R&R) Application Guide.

PHS 398 Research Plan (Research Education Core)

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims

Specific Aims should outline the overall goals of the Research Education Core component, providing an overview of specific activities planned, targeted audience for training, priority content areas, and plan for evaluation of the success of the research education activities.

Research Strategy

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following elements described below.

• Proposed Research Education Program
• Core Leads
• Program Faculty
• Program Participants
• Diversity Recruitment Plan
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Dissemination Plan

Research Education Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

The research education program plan should provide programmatic detail and a timeline on the program's objectives and specific activities proposed (e.g., courses, curricula, seminars, short-term research experiences), and how these objectives align with the overall objectives of the JCOIN network.

Examples of key domains that should be covered in the education program include, but are not limited to:

• Ethics of working with justice-involved populations
• Working across justice systems and behavioral health settings, with a special emphasis on addressing challenges in data sharing and collaboration across systems
• Overcoming challenges in designing, fielding, and analyzing pragmatic trials in justice settings
• Applying implementation science tools and frameworks in justice settings

The research education plan should provide for a plan for facilitating the engagement of participants with the JCOIN network. Specific activities for participants must include:

• Ensuring participants have an opportunity to engage in a research experience or activity that leverages the resources of the JCOIN network
• Ensuring participants have an opportunity to receive individualized mentoring from one or more JCOIN investigators they have not previously worked with
• Ensuring participants can attend at least one face-to-face JCOIN network meeting
• Ensuring opportunity for participants to engage in at least one face-to-face training activity

In addition, the research education plan should also address the capacity to create resources that with the intent of sharing these resources for utilization by the broader JCOIN network and/or readily disseminated to relevant external stakeholders (e.g., virtual grand rounds lectures accessible via platforms such as YouTube or similar).

Core Lead(s). Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in the areas of clinical effectiveness and/or implementation research in justice settings and with justice-involved populations. Further, evidence should be provided that the Core Lead(s) can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple Leads, describe the complementary and integrated expertise of the Leads their leadership approach, and governance appropriate for the planned project.

Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. The JCOIN Research Education Core is expected to utilize the resources available through the JCOIN network. Applicants should propose program faculty who will be considered Core Faculty as well as outlining a plan for how investigators participating in the JCOIN network more broadly will be approached and engaged as part of the Research Education program. Proposed Core Faculty should have research expertise and experience in the domain of clinical and/or implementation research in justice settings and with justice-involved populations.

Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.

Eligibility to participate should be made available to participants with appropriate educational backgrounds, irrespective of whether they are affiliated with any JCOIN network components.

The proposed research education program must include a focus on building the capacity of research investigators to conduct rigorous research in justice settings. Applicants have the option of including an additional focus on building the capacity of research staff embedded in justice and behavioral health organizations to conduct scientifically rigorous, pragmatic studies and evaluation activities. If applicants include research staff embedded in justice and/or relevant behavioral health settings, they must discuss how this component will interface with and be non-duplicative of efforts planned in the Dissemination and Stakeholder Engagement Core. If included, the primary emphasis of training for research staff embedded in justice and/or relevant behavioral health settings in the Research Education Core must be on capacity to conduct research or engage in data-driven evaluation activities.

Recruitment Plan to Enhance Diversity: Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-15-053). Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

C. Individuals from disadvantaged backgrounds, defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

For this specific program, the disadvantaged background category (C1 and C2) is not applicable. In addition, NIH encourages women faculty participation as described below.

D. Women faculty at doctorate-granting research institutions that have an appointment in medicine, engineering, or other relevant field and are underrepresented according to national data such as the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at http://www.nsf.gov/statistics/wmpd/2013/sex.cfm, especially the table describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank (Table 9-23 of Special Report NSF 13-304 from 2013).

New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of trainees from underrepresented backgrounds and may wish to include data in support of past accomplishments.

Applications lacking a diversity recruitment and retention plan will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research: All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

Evaluation Plan: Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Dissemination Plan. A specific plan must be provided to disseminate nationally in conjunction with components of the JCOIN Coordination Center any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops. This section should specifically address how information will be leveraged in other components of the JCOIN Coordination Center.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education 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.

Resource Sharing Plans

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 Guide, with the following modification:

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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. Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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.

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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.

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 (SAM). 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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.

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

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the Center t address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed Center rigorous? If the aims of the Center t 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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center t? 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 Center 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 Center?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the Center, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Specific to this FOA: Does the application propose innovative approaches to integrating and coordinating activities across all of the components of the Coordination and Translation Center?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center t? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Center? 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 Center 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?

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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 Center proposed? Will the Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If Cores will be located at different locations, is there evidence of the ability of the individual Cores to: (1) adhere to overall plan for coordination; (2) collect and transmit data in an accurate and timely fashion; and, (3) operate within the proposed organizational structure?

Reviewers will provide an overall impact score for each Core to reflect their assessment of the likelihood for the core to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria.

Review Criteria for the Administrative Core

• Is the proposed Administrative Core well matched to the needs of the CTC?
• Are the proposed strategies and processes that will be used to manage the CTC appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting etc.?
• Is the CTC structure sufficient, including its internal and external procedures for managing the activities of the CTC and the JCOIN?
• Are there appropriate plans for establishing an external-facing website, internal collaboration and communication infrastructure; providing required logistical support; and executing progress monitoring across the JCOIN network as outlined in the FOA?
• Does the Director have the leadership and research qualifications to lead the Administrative Core?
• Is there an appropriate plan for establishing and maintaining effective communication and cooperation among the CTC cores? With the MAARC? With JCOIN Research Centers? Across a network as a whole?
• Is the environment for the Administrative Core adequate and appropriate to support the overall CTC? Is there evidence of institutional support for the management of the CTC?
• Does the research plan include administrative support for a Steering Committee Chair, to be named by NIDA at a later date? If investigators for different Cores will be located at different institutions, is a strong plan for coordination presented?

Review Criteria for the Rapid Response and Pilot Research Core

• Does the Core provide a comprehensive and detailed plan for how the Pilot & Rapid Research program will be executed?
• Does the plan outline an appropriate plan for evaluating proposed projects?
• Does the plan provide a transparent process to ensure fairness in the awarding of these funds?
• Does the plan incorporate all required parameters as specified in Research Strategy Section for the Rapid Response and Pilot Research Core?

Review Criteria for the Dissemination and Stakeholder Engagement Core

• Does the approach include a plan for identifying and convening relevant stakeholder groups?
• Does the plan for stakeholder engagement include a wide, representative array of stakeholder groups?
• Is a strong plan for developing practitioner-oriented materials based on research findings presented? Is there a strong evaluation plan for examining the utilization and usability of materials developed for practitioners?
• Is there a strong plan for training practitioner audiences?

Review Criteria for the Research Education Core

• Is a strong plan set forth for recruiting participants, both within and external to the JCOIN network?
• Is the proposed Research Education Core likely to result in an increase in the availability of well-trained researchers who can execute complex studies in justice settings?
• Does the Research Education Core include a strong plan for enhancing diversity of trainees?

Review Criteria for the Implementation and Translation Research Project Core

• Does the investigative team include one or more collaborators with expertise in multi-site implementation studies? Does the investigator team include one or more collaborators with experience working with practitioners in real world settings?
• Does the application identify novel approaches to conducting pragmatic implementation studies that leverage the other resources of the network?
• Is at least one rigorous, hypothesis-driven study proposed? Does the application outline a rigorous strategy for approaching implementation and translation research as the Network matures?

As applicable for the Center 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.

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

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

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 individuals of all ages (including children and older adults) 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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the Center incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, 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)?

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 .

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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this 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.

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.

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

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

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

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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 programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

Serving as Core Director(s) responsible for the integration and management of activities within the CTC.

Organizing a local Executive Committee for day-to-day management of the CTC, coordinating the JCOIN Steering committee, and organizing and an External Advisory Committee, with scientific, clinical and patient or stakeholder representation. The role of these Committees will include the oversight, review, and evaluation of the CTC, and the selection and prioritization of projects that will use resources and services that are provided through the JCOIN.

Serving as a member of the JCOIN Steering Committee and participating in required activities, including primary responsibility for organizing regular conference calls and 1-3 annual JCOIN face-to-face meetings.

Participating in the overall coordination of NIH research efforts in justice settings; this participation may include collaboration and consultation with other NIH awardees, the appropriate sharing of information, data, and research materials, and participation in NIH efforts to standardize and harmonize pre-clinical and clinical data collection.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The NIH Project Scientist(s) will work closely with the PD(S)/PI(S), the Steering Committee, and the PIs of all JCOIN network components in order to ensure proper conduct of the Coordination and Translation Center. Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The NIH Project Scientist(s) will work closely with the PD(S)/PI(S), the Steering Committee, and the PIs of all JCOIN network components in order to ensure proper conduct of the CTC.

The NIH Project Scientist(s) will have one (1) vote on the Steering Committee, regardless of how many NIH Project Scientists participate across the network

The assigned Project Scientist(s) will be responsible for: (1) overseeing the activities of the CTC, along with the other entities delineated above, to ensure that activities and services are properly conducted and completed in a timely fashion; (2) providing advice and guidance to ensure that the CTC runs in accordance with NIH policies and procedures, and is consistent with the mission of the NIH to improve public health; (3) serving as a point of contact for investigators with the NIH; and (4) communicating with Center leadership to ensure that the CTC operates smoothly.

NIDA, as the 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. NIH support of this study is contingent upon adequate study progress based on the Grantee’s Milestone Plan submitted at the time of funding.

An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

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.

Data Management, Analysis, and Access: Data generated are the property of the awardee. Research sites must provide requested data to the CTC and MAARC in a timely fashion in accordance with the policies and procedures established in study protocols and by the SC. In addition, the CTC, MAARC and all research sites must provide NIDA 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.

JCOIN is intended to be a national resource, and as such, the CTC must be prepared to share their data under provisions that safeguard the privacy and confidentiality of respondents. Thus, the CTC proposal should include explicit indications of how they will make their data available for broad use and on what timetable. The CTC 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 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 and NIDA will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data.

All awardees and NIDA will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care systems engaged in research and beyond.

The SC, with the support of the CTC, 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 Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual 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 submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Tisha Wiley, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-4381
Email: [email protected]

Lori Ducharme, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-8507
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]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA )
Telephone: 301-443-4704
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.