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 Methodology and Advanced Analytics Resource 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. Additional information about this component can be found at: [RFA-DA-19-024]

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.

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.

Methodology and Advanced Analytics Resource Center: Scope of Activities and Purpose

It is imperative that applicants for the Methodology and Advanced Analytics Resource Center carefully review the companion JCOIN FOAs for the Clinical Research Centers (UG1) (RFA-DA-19-025) and the Coordination and Translation Center (U2C) (RFA-DA-19-024) to understand the full mission of JCOIN.

The JCOIN Methodology and Advanced Analytics Resource Center (MAARC) is expected to provide analytic and data support for the network, which will include 8-12 Clinical Research Centers and the Coordination and Translation Center. The Advanced Analytics and Methodology Resource Center will also conduct novel empirical research to ensure timely understanding of changes in current practices in the United States related to addressing opioids in justice settings. Activities will include providing overall leadership and coordination of data storage; data collection and harmonization activities; providing resources for advanced methodological and analytical techniques across the network; conducting research on dynamic changes in policy and practice in justice and relevant community-based service settings; and conducting novel studies applying cutting edge analytical techniques to existing data and data collected across the JCOIN network.

Expected components of the Methodology and Advanced Analytics Resource Center (MAARC) include:

Administrative Core: The Administrative Core provides overarching resources and organizational structure and management to the Center. The Administrative Core will collaborate closely with the Coordination and Translation Center to provide monitoring of progress of research projects across the entire JCOIN network. The Administrative Core will also collaborate closely with the Coordination and Translation Center to ensure findings are translatable and relevant to stakeholders within justice and community-based service settings.

Data and Analytics Support Core: The purpose of the Data and Analytics Support Core is to facilitate the collection, archiving, storage, and access within the JCOIN network and for external stakeholders.

Policy & Practice Observational and Survey 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 purpose of this core is to provide support to conduct research on existing and dynamic changes in policy and practices within the justice system as well as in community-based service provider systems that provide treatment to justice-involved individuals who use or are at risk for using opioids.

Advanced Methodological Research Core(s): The Advanced Methodology Research Core(s) will provide methodological consultation in novel analytical techniques and will leverage these advanced analytical approaches to conduct novel research using existing data and data acquired through the network. Applicants should propose one or more novel research projects that leverage expertise in these areas and available existing data sources. At least one research project must be included that uses modeling techniques to provide insights into the complex dynamics of addressing the issue of illicit opioid use and opioid misuse in justice settings.

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

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: NIDALetterofIntent@mail.nih.gov .

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative, the letter may also be sent to:

Office of Extramural Policy and Review
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core (use for Admin Core)	12
Data Core (use for Data and Analytics Support Core)	12
Survey Core (use for Policy & Practice Observational and Survey Research Core)	12
Methods Core (use for Advanced Methodological Research Project Core(s)	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; Max:1
• Administrative Core: Required; Max: 1
• Data and Analytics Support Core: Required; Min: 1, Max: 1
• Policy & Practice Observational and Survey Research Core: Required; Min: 1, Max: 1
• Advanced Methodological Research Project Core(s): Required; Min: 1, Max: 3

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. The biosketch should detail the PD/PI's experience overseeing selection and management of sub-awards, and the management of multi-component projects.

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 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.

Specific Aims: Specific Aims should comprehensively address the goals of the Methodology and Advanced Analytics Resource Center (MAARC), which is to provide data 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: Applicants should describe the overall structure of their proposed Methodology and Advanced Analytics Resource Center. 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 MAARC 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 MAARC 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 the 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.

Participation in Steering Committee Meetings: Budgets should include funds for travel for the PD(s)/PI(s), including each Core Lead, and up to three additional project staff to participate in 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.

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 Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy: The Administrative Core of the Methodology and Advanced Analytics Resource Center (MAARC) provides overarching resources and organizational structure and management of the Cores and Projects. As part of this section, applicants should address the following:

Governance and Coordination Within the MAARC

• Explain how the Core will establish and implement the basic governance, operational, and policy structures. This involves setting up committees and coordinating their execution;
• Explain how the Core will interface with the other Cores and the Advanced Methodological Research Project(s);

Coordination with Other Components of JCOIN

• Explain how Core staff will lead the proposed program and interact with any other program and organizational components within and outside the institution, including interfacing with the rest of the JCOIN network, with a particular emphasis on collaboration and coordination with the Coordination and Translation Center;
• Describe a plan for providing support and coordination for Data Safety and Monitoring Boards, as needed;
• Describe a plan for providing training infrastructure for data set utilization, data archiving support, and analytic techniques both within the JCOIN network and to external stakeholders;

Ensuring Rigor

• Provide a plan for providing seamless coordination with the Coordination and Translation Center to provide near real-time updates on data collection progress, harmonization activities, key outcomes and metrics as needed to NIDA via a user-friendly data portal. A framework such as Results Based Accountability or similar should be used as an organizing framework;
• Describe an appropriate plan for work-flow and a well-established timeline;
• Describe internal evaluations, self-assessment processes, and progress reporting activities that have the ability to assess and anticipate needs of JCOIN network stakeholders;
• Describe a plan for performing site visits to address emergent problems in data collection or study execution, if needed.

Facilitating Public Dissemination and Engagement with Data (in collaboration with the Coordination and Translation Center)

• Describe a plan for creating and maintaining both internal and external facing data portals, with appropriate sensitivities to data privacy;
• Describe a plan for working collaboratively with the Coordination Translation Center, Clinical Research Centers, NIH staff, and relevant public data/resource repositories to ensure the dynamic dissemination of network data as well as long-term archiving and distribution of the most important datasets and resources developed by the network beyond its funding period;
• Describe a plan for developing and supporting, in coordination with the Data and Analytics Support Core, creative approaches to data dissemination to promote collaboration between JCOIN study investigators and investigators outside of the JCOIN network to promote utilization of JCOIN data and resources (e.g., Hackathons, trainings, webinars, etc.);

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 Data 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 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: Describe the specific aims of the Data and Analytics Support Core and how these goals will facilitate the development of a management system for the collection, storage and quality control of data; promote the use of data standards; and provide a portal for data use and sharing, as appropriate and consistent with achieving the goals of the program. The aims should address not only the delivery of services or materials, but also the processes for ensuring the consistent quality of the services or materials, fair access by users and efficient use of the resources.

Research Strategy:

The Research Strategy should specify the overall vision of the Data and Analytics Support Core and how this supports the overall JCOIN objectives. The Research Strategy should attend to the following issues:

Trans-JCOIN Coordination

• Ensuring coordinated, comprehensive monitoring of all trials and data collection activities funded through JCOIN;
• Establishing and supporting state-of-the-art common tools and systems for the collection, management, storage and archiving of quantitative and qualitative data across studies funded through the Clinical Research Centers and the Coordination and Translation Center;
• Establishing core measures for harmonization and establishing common data elements for both quantitative and qualitative data collection across the network;
• Developing data sharing and data use agreements to support harmonization and data use among research sites and the eventual creation of public use datafiles.

Data Security and Standards

• Anticipating data usage needs with consideration of data sensitivity and privacy concerns, particularly with regard to protection of personally identifiable information;
• Developing a rigorous approach to information security and data sharing, including attending to the highest standards of data security.

Ensuring Data Quality

• Establishing a Good Data Practices work group with representatives from each Clinical Research Center;
• Reviewing and monitoring the quality of study data;
• Promoting the use of clinical and research data that are machine readable and that adhere to the FAIR (findable, accessible, interoperable, and re-useable) principles;

Analytic Support and Coordination

• The Data Core should be able to provide expertise and support across a broad range of analytic techniques and approaches. Areas of preferred expertise for the Data and Analytics Support Core include: economic and cost-effectiveness analyses; big data analytics; multi-level modeling; longitudinal data analysis; administrative data management and analysis; electronic health record data analysis; missing data techniques; analysis of randomized controlled trial data; data visualization and visual analytics; and qualitative data analysis. Applicants should include a description of the team's analytic expertise and capacity to provide expert consultation to members of the JCOIN network in these and any other domains of specialized expertise.
• Providing comprehensive data analytics strategies for cross-cutting research questions in the network;
• Planning and performing statistical analyses;
• Providing expertise, support and assistance with rigorous qualitative coding and analysis;
• Providing support to the Clinical Research Centers in conducting sophisticated statistical analyses in a range of areas;

Integration with other Data Sources

• Identifying relevant sources of data external to the JCOIN network and establishing protocols and linkages between those data sources and JCOIN data to advance the overall scientific goals of the network;
• Providing expertise in processes for linking administrative data across systems (e.g., justice and behavioral health) with appropriate considerations for privacy, as well as expertise in analyzing this kind of linked data;

Data sharing under this FOA is expected to be handled to increase the value of the significant public investment in the creation and operation of the Network. Consistent with achieving the goals of the program, NIH expects that JCOIN datasets will be widely shared with the scientific community for research, while carefully observing standards of patient privacy, confidentiality, and management of health information. Information such as study protocols, descriptions, bioinformatics tools, and publications is expected to be made available through a public-facing portal and publication in the scientific literature.

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 (Data and Analytics Support 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.

When preparing your application in ASSIST, use Component Type Survey 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.

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 Policy & Practice Observational and Survey Research Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy:

Policies and practices are rapidly changing and many opportunities for generating insights into the effectiveness of emerging policies and practices go uncaptured. The purpose of this core is to provide support to conduct research on existing and dynamic changes in policy and practices within the justice system as well as in community-based service provider systems that provide treatment to justice-involved individuals who use or are at risk for using opioids.

The research plan should include a detailed description of the approach to:

• Using a range of scientific strategies and cutting-edge tools to provide real-time or near-real time tracking of changing policies and practices in justice settings around the country.
• Using surveys and other structured data collection approaches as needed to fill in gaps in knowledge regarding current practices and laws, adoption of evidence-based practices (including MOUD), barriers and facilitators of evidence-based practice adoption, financing, and training needs within the justice system and community-based service provider settings.
• Applying a high degree of scientific rigor to all data collection approaches;
• Ensuring rapid translation of insights and findings through collaboration with the Coordination and Translation Center.

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 (Policy & Practice Observational and Survey Research)

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.

When preparing your application in ASSIST, use Component Type Methods 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.

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: Specify a set of aims for a project that leverages one or more advanced methodological techniques to yield a unique contribution to the JCOIN network.

Research Strategy:

Advanced Methodology Research Project(s) will provide methodological consultation in novel analytical techniques and will leverage these advanced analytical approaches to conduct novel research using existing data and data acquired through the network.

Up to three Advanced Methodological Research Projects may be proposed, but a project leveraging one or more modeling techniques must be included. Examples of modeling techniques that could be used in the required project include, but are not limited to: simulation modeling, agent-based modeling, system science, network analysis, or similar.

Examples of techniques that could be leveraged in optional Advanced Methodological Research Projects include, but are not limited to: geospatial modeling, technological infrastructure development, data visualization and visual analytics, and social media surveillance or analytics.

Applicants must propose at least one, but no more than three, Advanced Methodological Research Projects that leverage expertise in these areas and available data sources. Clinical Trials are not allowed for this component, so proposed projects should leverage existing data sources and/or observational data only.

The research strategy section for each Advanced Methodology Research Project should address the following:

• How the proposed project will be a unique and valuable contribution to the JCOIN network;
• Justification for selection of data sources and analytical techniques;
• Plans for participant recruitment and retention, if proposed;
• Detailed timeline for data acquisition and analysis;
• It is expected that the proposed project will not take 5 years, but applicants should provide a plan and framework for how the methodologies developed and applied in the proposed project could lead to additional projects utilizing data that will be collected and available later from the Clinical Research Sites and can be leveraged as an integral infrastructure component for the network.
• How this project will function in tandem with the Data and Analytics Core to provide consultation with investigators across the JCOIN network to develop, apply, and test novel and advanced analytic and methodological approaches in the context of JCOIN-supported 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.

PHS Human Subjects and Clinical Trials Information (Advanced Methodological Research Project(s))

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.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the 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 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 are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center proposes a project that 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?

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?

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.

Review Criteria for the Administrative Core

• Is the proposed Administrative Core well matched to the needs of the JCOIN network and to coordination across the MAARC?
• Are the proposed strategies and processes that will be used to manage the MAARC appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting, etc.?
• Is the MAARC structure sufficient, including its internal and external procedures for managing the activities of the MAARC and the JCOIN network?
• 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 MAARC cores? With the CTC? With the JCOIN Clinical Research Centers? Across the network as a whole?
• Is the environment for the Administrative Core adequate and appropriate to support the overall MAARC? Is there evidence of institutional support for the management of the MAARC?

If investigators for different Cores will be located at different institutions, is a strong plan for coordination presented?

Review Criteria for the Data and Analytics Support Core

• Does the Core provide a comprehensive and detailed plan for providing supports to ensure smooth coordination around data across the entire JCOIN network?
• Does the plan adequately address data security and data standards?
• Is the plan sufficiently rigorous for ensuring data quality?
• Is there a strong plan for providing analytic support and coordination?
• Does the Data and Analytics Core include investigators with a breadth of relevant areas of quantitative analytic expertise?
• Does the Data and Analytics Core include investigators with relevant areas expertise in qualitative data analysis?
• Does the team have experience in supporting large-scale multi-site studies and/or networks?
• Is there a strong plan for integration with existing data sources?

Review Criteria for the Policy & Practice Observational and Survey Research Core

• Does the approach include a plan for utilizing a range of approaches that can provide real-time or near-real-time insights into dynamic changes in the justice system across the entire U.S.?
• Does the approach include rigorous methodological approaches?
• Do the investigators have relevant experience executing similar projects with the highest degree of methodological rigor?
• Is there a plan for rapid translation of insights through coordination and collaboration with other components of the JCOIN network?

Review Criteria for the Advanced Methodological Research Project(s) Core (s)

• Does the research strategy propose one or more innovative modeling techniques that can help accelerate the work of the network?
• Is there a strong plan for how the research projects will interface with other components of JCOIN?

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.

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.

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.If it IS a cooperative agreement, fill out the template Cooperative Agreement Terms and Conditions of Award as appropriate. THEN, copy and paste all the text from that template into this section, replacing Not Applicable (below) with your text.

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 MAARC.
• Organizing a local Executive Committee for day-to-day management of the MAARC, coordinating across all of the MAARC components,
• Serving as a member of the JCOIN Steering Committee
• 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 MAARC.
• 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 MAARC, 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 MAARC 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 MAARC 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.

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: GrantsInfo@nih.gov (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: support@grants.gov

Tisha Wiley, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-4381
Email: jcoin@mail.nih.gov

Gerald McLaughlin, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5819
Email: gmclaughlin@nida.nih.gov

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@mail.nih.gov

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.