Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Child Health and Human Development (NICHD)
National Institute on Minority Health and Health Disparities ( NIMHD )

Funding Opportunity Title

HEAL Initiative: Coordinating Center to Support NIDA Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) Initiative (U24 Clinical Trial Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
  • January 8, 2019 - Notice of NIMHD Participation in RFA-DA-19-034. See Notice NOT-MD-19-005.
  • January 07, 2019 - Notice of Pre-Application Information Webinar and Frequently Asked Questions (FAQs) for HEAL Initiatives RFA-DA-19-035 (UG3/UH3) and RFA-DA-19-034 (U24). See Notice NOT-DA-19-017.
Funding Opportunity Announcement (FOA) Number

RFA-DA-19-034

Companion Funding Opportunity

RFA-DA-19-035, UG3/UH3 Exploratory/Developmental  Phased Award Cooperative Agreement

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.279, 93.213. 93.273, 93.865, 93.242, 93.307  

Funding Opportunity Purpose

 As part of the NIH Helping to End Addictions Long-term (HEAL) initiative to speed development and implementation of scientific solutions to the national public health opioid crisis,

NIDA is seeking cooperative agreement applications to participate in the HEAL Preventing Opioid Misuse and Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) initiative administered by NIDA. This initiative will consist of research grants and a Coordinating Center, focused on establishing the evidence base for interventions and strategies to prevent initiation of opioid misuse and development of Opioid Use Disorder (OUD) in at-risk older adolescents and young adults. Of priority are studies that target older adolescents and young adults in health care settings (including emergency departments, surgical, orthopedic and other specialty care, dental care, primary care, urgent care, HIV/STI and reproductive health clinics, prenatal clinics, federally qualified health centers, school-based health centers, military and veteran health care settings, behavioral health systems, and occupational health settings); justice settings (including criminal justice, juvenile justice, as well as child welfare and other systems that intersect with the justice system); and, other systems and settings opportune for accessing and engaging at-risk older adolescents and young adults. The purpose of this FOA is to fund a single Coordinating Center to centralize support for individual research projects supported through the HEAL Prevention initiative. The Coordinating Center will be responsible for an array of scientific and logistical support activities in the following four broad areas: coordination and communication, data collection and management, implementation design and methodology consultation and economic evaluation.

Key Dates

 

Posted Date

December 10, 2018

Open Date (Earliest Submission Date)

February 13, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

March 13, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. 

No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

June/July 2019

Advisory Council Review

October 2019

Earliest Start Date

September 2019

Expiration Date

March 14, 2019  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    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


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
    Purpose

    As part of NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis, NIDA is launching the HEAL Preventing Opioid Misuse and Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) initiative. The HEAL prevention initiative will consist of up to ten research projects and one Coordinating Center. This prevention initiative is designed to solicit research to develop, adapt and test interventions and strategies to prevent initiation of opioid misuse and development of Opioid Use Disorder (OUD) in at-risk older adolescents and young adults (ages 16-30). Of priority are studies that target older adolescents and young adults in health care settings (including emergency departments, surgical, orthopedic and other specialty care, dental care, primary care, urgent care, HIV/STI and reproductive health clinics, prenatal clinics, primary care, federally qualified health centers, school-based health centers, military medicine settings, and occupational health settings); justice settings (including criminal justice, juvenile justice, as well as child welfare and other systems that intersect with the justice system); and, other systems and settings opportune for accessing and engaging at-risk older adolescents and young adults.

    Background

    An estimated 11.4 million people misused opioids in 2017, of which 11.1 million misused prescription opioid analgesics. Opioid drugs, including opioid analgesics, heroin and illicit synthetics, accounted for more than 60% of overdoses in 2016. There is need to develop preventive strategies that can decrease the incidence and prevalence of opioid misuse and OUD, particularly in at-risk populations. This initiative focuses on older adolescents and young adults (ages 16-30), two of the populations at highest risk for initiation and misuse of opioids, OUD and related consequences, including overdose fatalities.

    Currently, evidence-based interventions exist to prevent substance use broadly, that predominantly target children and adolescents. However, there is a gap in the evidence for interventions and strategies to prevent non-medical use of opioids and OUD in the transition from adolescence to young adulthood.  The urgency of the opioid crisis calls for research to produce evidence based interventions and strategies to prevent older adolescents and young adults from initiating non-medical use of opioids, escalating from initiation to misuse, and escalating from misuse to OUD.

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

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


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

     

    With this FOA, NIDA seeks applications for a Coordinating Center to facilitate cross-site activities and provide centralized support for projects funded under the NIDA HEAL Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) initiative. The objectives of this research cooperative are to support rigorous research to: 1) develop strategies to identify, reach, and engage older adolescent and young adult populations at risk for opioid misuse and OUD in prevention interventions and services, 2) develop and adapt interventions and strategies to prevent initiation of opioid misuse, escalation from initiation to misuse, and escalation from misuse to OUD, 3) test the effect of prevention strategies and interventions on initiation of opioid use, opioid misuse, OUD and other opioid related outcomes, 4) develop and test strategies to facilitate implementation and sustainability of prevention interventions and strategies in health care, justice and other systems and settings opportune for accessing and engaging at-risk older adolescents and young adults, and, 5) economic evaluation (e.g., to quantify programmatic costs and cost-effectiveness of interventions and strategies). Research projects funded via RFA-DA-19-035 are expected to address each of these objectives. 

    For this FOA, opioids include prescription opioids and illicit opioids, such as heroin and illicitly made fentanyl (and related analogs). For the purpose of this announcement, prevention is defined as interventions that occur prior to the onset of OUD and are intended to prevent or reduce risk for OUD. OUD refers to the clinical diagnosis defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

    The Coordinating Center will be funded under a cooperative agreement and will work collaboratively with NIH and the investigators associated with the individual research projects. The Coordinating Center will facilitate activities in the areas of: coordination and communication, data collection and management, implementation design and methodology consultation, and economic evaluation. The Coordinating Center will be a participant on the cooperative Steering Committee (to include research project PIs and Federal Staff) which will manage the overall direction of the collaborative. The Coordinating Center also will facilitate activities of the cooperative internal working groups, which will include project PIs, their staff, collaborators and Federal Staff. Coordinating Center investigators may also participate in these groups, as appropriate.  Further details on the roles and responsibilities of the Coordinating Center are described in Section IV.2 of this FOA.

    Organization of the Cooperative

    The cooperative will include up to ten research projects, one Coordinating Center, a Steering Committee (SC), a SC chairperson, one or more Science Officers from NIDA and/or other Institutes, and NIDA and/or other Institute Program Officers.

    Steering Committee

    A Steering Committee will include at a minimum a) a representative from each research project, b) a NIDA Project Scientist(s), a NIDA/NIH Program Officer(s), and could include select key leaders/stakeholders from systems or settings named as key personnel in the research project applications. NIDA will appoint one Steering Committee Chairperson with relevant expertise to coordinate the activities of the Steering Committee.

    Special Considerations

    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://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding-) for details.

    National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Web site at  http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

    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 (https://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

    Methodological and Statistical Resources:  Applicants are encouraged to employ the strongest and most innovative prevention study designs and analytic methods. For guidance on state of the art study designs, methods and analytic techniques please visit these resources developed by NIH on Training in Prevention Methods Research, Resources for Researchers and GRTs.

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials.

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIDA intends to commit up to $2,000,000 in FY2019 to fund 1 award.

    Award Budget

    Application budgets must not exceed $1.5 million in direct costs for any year of the project.

    Award Project Period

     The maximum project period is 5 years. 

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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)
    • 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
    Foreign Institutions

    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.

    Required Registrations

    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.

    Eligible Individuals (Program Director/Principal Investigator)

    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.

    2. Cost Sharing

    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. 

    3. Additional Information on Eligibility
    Number of Applications

    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).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

    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

    Page Limitations

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

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R or Modular Budget

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

    Cost Matching Requirement for For-profit Applicants

    Cost matching or documented in-kind contributions is required for for-profit organizations responding to this FOA.  The for-profit awardee is required to match funds or provide at least a 50% matching of funds or documented in-kind contributions at a rate of not less than 50% of the for 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.

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Research Strategy:

    The application should describe a plan for carrying out the responsibilities of the Coordinating Center in the following areas. The plan should include a description of the proposed Coordination Center structure, activities, strategies, timeline, platforms and available resources to use.

    Coordination and Communication

    The Coordinating Center will support collaborations and communication across the cooperative research projects and other components (e.g., NIDA, Steering Committee, workgroups, research partners). The application should describe a clear and detailed plan for:

    Providing operational, logistical and technical support for meetings held across the sites participating in the research projects, including in-person meetings, virtual meetings, and webinars (including annual, Steering Committee, and workgroup meetings).

    Providing logistical support for annual, in-person meetings (including a cooperative kickoff meeting) that will take place in the Washington DC area or other locations designated by the Steering Committee/NIDA staff and work with NIH to use government meeting space where possible.  Also, providing support needed to facilitate the meeting, including note takers, book travel, and other needed supports.

    Identifying and providing software platforms to enable conference calls, document sharing and webinars related to the work of internal working groups in core areas of the project such as measures development & harmonization, publication and presentation procedures, etc.

    Working with the Steering Committee to organize and facilitate meetings of an External Advisory Board which will meet periodically to provide input and feedback regarding the research projects funded under the UG3/UH3 mechanism.

    Developing and maintaining a web-based platform to facilitate sharing and monitoring of study protocols, recruitment, data collection, progress, study findings and publications. Also ensuring that this website is in compliance with all applicable Federal and NIH requirements, including Section 508 compliance, security protocols and plain language requirements.

    Maintaining up-to-date versions of policies and procedures developed by the Steering Committee and make them available to the cooperative in a timely manner.

    Overseeing coordination of collaborative publication activities based on procedures developed through working groups in the cooperative, and work with the Steering Committee to develop a plan for dissemination of research findings to key stakeholders in a timely manner.

    Facilitating engagement of local and national stakeholders in relevant cooperative activities (e.g., external scientific workgroups).

    Providing methodological and statistical support in the areas of study design, complex statistical analyses, economic evaluation, and implementation design and methodology consultation, as needed.

    Providing expertise in and coordinating ethical, regulatory, and other required activities for research involving human subjects.

    Data Collection and Management

    The Coordinating Center will provide data infrastructure and support across the cooperative and also conduct foundational analyses to inform and support cooperative research projects. The application should include a detailed plan for:

    Developing standard formats for data collection instruments using measures identified by the research projects and cooperative.

    Providing logistical, scientific, and technical support for data collection and management, including identification of common data elements, data harmonization, and data sharing across projects as relevant. 

    Managing and monitoring data across cooperative projects, including cleaning and maintaining data files, monitoring data quality, and performing systematic checks for completeness and comparability.

    Developing and executing a plan for data sharing across projects and to investigators who are not part of the cooperative. 

    Providing a federally compliant online infrastructure to support the submission/transmission of research data, including clinical data. This includes addressing issues such as HIPAA compliance, as well as procedures for de-identification of clinical or research data.

    Compiling integrated datasets, developing codebooks, and other data file documentation across projects and support individual research projects with these activities as needed.

    Preparing de-identified public use data files and documents for submission into the NIDA supported repository National Addiction and HIV Data Archive Program (NAHDAP), and work with grantees on project-specific sharing plans.

    The Coordinating Center will be responsible for one original data collection activity, through the conduct of Systematic reviews.  As a part of their work, the Coordinating Center will be expected to conduct two systematic reviews. The application should include a plan for conducting the two systematic reviews described below.

    (1) Risk and protective factors specific to the populations and settings targeted for the research projects: As the goal is to target preventive interventions toward high risk populations, the Coordinating Center will work closely with NIDA staff and across the cooperative in the UG3 phase of research projects to conduct a systematic review and/or survey and descriptive analyses to characterize developmental- and context-specific risk and protective factors and pathways for initiation of non-medical opioid use, escalation to opioid misuse, and development of OUD, particularly in the age group under study. Given gaps in what is known, these analyses will be designed to inform research (intervention and strategy development/adaptation) in the UG3 phase.

    (2) Existing preventive strategies: The Coordinating Center will work collaboratively with the cooperative research projects during the UG3 phase to assess what prevention interventions and strategies already are in place in the kinds of systems and settings where the research will be conducted. The review will collect and evaluate available evidence for these interventions and strategies, early in the UG3 phase, with the goal of identifying existing strategies and models that can be leveraged, identifying research gaps, and assessing what strategies are implemented within and across settings and systems.

    Implementation Design & Methodology Consultation and Economic Evaluation

    The Coordinating Center is responsible for providing expertise, scientific and analytical support to the cooperative in the areas of implementation design and methodology consultation and economic evaluation. The application should include a detailed plan for:

    Coordinating with the research projects to provide support and consultation pertaining to implementation design and methods for individual projects to inform implementation aspects of the UH3 phase research.

    Working with research projects to facilitate harmonization of implementation data and meaningful ways to compare outcomes across research projects.

    Working with individual research projects to develop and execute economic evaluations (e.g., to determine programmatic costs, cost-effectiveness, conduct budget impact analysis) for the interventions and strategies studied. This should result in common metrics and methods, where applicable across the cooperative.

    Letters of Support

     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.
    • The Coordinating Center must provide NIDA with access to all data generated under this award, subject to rules specified in any Certificate of Confidentiality obtained by awardees.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    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.

    PHS Assignment Request Form

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

    3. Unique Entity Identifier and System for Award Management (SAM)

    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

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    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.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

    For assistance with your electronic application or for more information on the electronic submission process, visit 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) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDA/NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    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.

    Section V. Application Review Information
    1. Criteria

    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.

    Overall Impact

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the proposed Coordinating Center address the needs of the research cooperative and projects that it will serve? Is the scope of activities proposed for the Coordinating Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research projects and network?

    In particular, does the Coordinating Center address important problems or critical barriers to research with older adolescent and young adult high-risk populations and the systems and settings for accessing, engaging and intervening and issues related to data management, integration, and dissemination in these contexts? To what extent might successful completion of the Coordinating Center's aims improve the capability, methods, and technologies that are utilized in data integration and dissemination in ways that can advance adoption, implementation and sustainability of prevention interventions and strategies that are found to be successful?

    Investigator(s)

    Are the PD(s)/PI(s) and other personnel well suited to their roles in the Coordinating Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing collaborative research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; do they have experience working together on collaborative research; and, are their organizational structure appropriate for the Coordinating Center? Does the applicant have experience overseeing selection and management of subawards, if needed?      

    How adequate is the experience among personnel within the Coordinating Center in working within a cooperative agreement context, particularly, with cooperatives that involve diverse research projects (e.g., diverse settings, diverse populations)? 

    In particular, how adequate is the demonstrated capacity, expertise, and productivity within the Coordinating Center related to (a) novel methodologies and analytics related to data harmonization and the creation of integrated datasets; (b) data management in the context of multi-project or multi-site studies; (c) drug abuse prevention and prevention services research; and (d) addressing appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication?

    Innovation

    In particular, does the application include mechanisms for leveraging novel collaboration and communication strategies? How innovative is the proposed approach to coordination and communication, data collection and management, implementation design and methodology consultation, and economic evaluation for the larger cooperative agreement? Does the application challenge and seek to shift and improve current research paradigms by utilizing novel theoretical concepts, approaches, methodologies, instrumentation or tools for data integration, analysis and dissemination?

    Approach

    How will the proposed activities facilitate flexibility and create policies, practices, protocols, and tools to enable broad collaboration with and participation by research sites and government agencies?

    How well does the application demonstrate an understanding of the challenges underlying the integration of large and complex data sets?

    Does the application demonstrate a familiarity with human subjects research protocols and/or an ability to provide assistance to Research Centers on IRB issues related to data sharing?

    How well does the application evidence a capacity to manage complex and multiple research projects (including multisite projects) including the provision of logistical support and data management?

    How well does the application demonstrate a capacity to process high volumes of quantitative and qualitative data in an efficient and secure way?

    How well does the application demonstrate a capacity to effectively facilitate secure communication, information, data, and document sharing among the project sites? Does the application demonstrate an ability to use state-of-the-art technological resources to enhance the efficiency of this communication? 

    How well does the application demonstrate an understanding of and capacity for the statistical techniques necessary to conduct cross-site analyses for continuous and discrete data, longitudinal and cross-sectional, and for qualitative as well quantitative data?

    How well does the application demonstrate a capacity and understanding of the procedures for eventually releasing the data for public use?

    How well does the application demonstrate an understanding of the applicable Federal laws and the implications of these laws for aspects of project execution, including information security requirements, plain language requirements, and Section 508 compliance?  

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address

    1) the protection of human subjects from research risks, and

    2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? 

    Environment

    How well will the project benefit from unique features of the scientific environment with respect to its capacity to work within a complex multi-project cooperative agreement?  How well does the application document the availability of state-of-the-art technological infrastructure to support the data collection, coordination, data analysis, and communication activities required? 

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Protections for Human Subjects

    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.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

    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.

    Vertebrate Animals

    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.

    Biohazards

    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.

    Resubmissions

    Not applicable.

    Renewals

    Not applicable.

    Revisions

    Not applicable.

    Additional Review Considerations

    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.

    Applications from Foreign Organizations

    Not applicable.

    Select Agent Research

    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).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    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.

    Budget and Period of Support

    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?

    2. Review and Selection Process

    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 appropriate national Advisory Council or Board. 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.
    3. Anticipated Announcement and Award Dates

    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.

    Section VI. Award Administration Information
    1. Award Notices

    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.

    2. Administrative and National Policy Requirements

    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) of the Coordinating Center will have the primary responsibility for:

    Integrating and managing data submitted by the research project grantees that are part of the cooperative.

    Supporting the conduct of data analyses and defining approaches, innovations, and methods related to data integration methods, metrics, and the harmonized cooperative dataset.

    Providing expertise and leadership in addressing issues of broad scientific applicability, such as informed consent, data sharing standards, analysis methodology, implementation design and methodology consultation, economic evaluation, and dissemination of findings to NIDA/NIH and research project grantees in the cooperative related to methods, strategies and approaches within and between the projects.

    Facilitating comparability across the data from the cooperative research projects, when feasible and appropriate to scientific research questions.

    Facilitating data quality monitoring through rigorous data management and identification of data biases and errors as they arise.

    Agreeing to accept close coordination, cooperation, and management of the project with NIH.

    Participating in cooperative activities, including annual project update meetings.

    Planning and hosting the face-to-face annual meetings of the cooperative PIs.

    Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, facilitating work group meetings and conference calls, and preparing concise minutes or summaries of meetings for distribution.

    Coordinating the eventual release to the scientific, public health and other relevant methods, tools, data, results, and other resources.

    Providing salary support to the Chair of the Steering Committee. Budget for the Steering Committee Chair should also include reimbursement for travel expenses to all in-person Steering Committee Meetings. 

    Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the program that will be sufficient for outside users to understand and apply to their research projects with minimal assistance.

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

    NIDA Project Scientist. A designated NIDA Program Official(s) acting as a Project Scientist(s) will have the following responsibilities:

    Serve as a resource for specific information on NIDA's programmatic intentions and priorities, and help to foster collaborations between researchers, public health, and public policy partners both within and across other Federal agencies to increase the value of research to these participants. Similarly, the project scientist will facilitate communication involving the Coordinating Center, the cooperative grantees and others in the cooperative.

    Play an active role in developing innovative methodological strategies to support data collection, management, and analysis (e.g. data quality control, assessing and resolving cross project and site variation, ensuring data comparability).

    Identify research questions relevant to the cooperative objectives based on the integrated cross-project/cross-site datasets. He/she may cooperate with awardees in development, design, and coordination of research plans and study reports emerging from the harmonized cooperative dataset. In instances where significant involvement in the design of studies and/or analysis of results has occurred, the NIDA Project Scientist may cooperate with awardees as coauthor in preparing publications of data resulting from the research. In this regard, he/she will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIDA staff require internal clearances.

    The NIDA Program Official will have responsibility for:

    A NIDA program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIDA Program Official, who will not participate in the research or the preparation of publications, will be responsible for the oversight of the research project and award. The Program Official carries primary responsibility for:

    (1) periodic review and monitoring and approval of the progress of the research plans in relation to their stated objectives, including consistent communication with the PI and the Coordinating Center staff as well as requests for additional reports or documentation; and,

    (2) making recommendations regarding continuance of the program. The NIDA Program Official will be responsible for monitoring the conduct of the project and overseeing the Coordinating Center.

    The Program Official will receive all required progress reports to determine that satisfactory progress is being made and will work collaboratively with the NIDA Grants Management Specialist to assure high quality business management of the program, including the most effective use of Federal financial assistance provided through this cooperative agreement. Additional NIH staff may participate in all cooperative-related meetings and work groups, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.

    The NIH reserves the option to recommend withholding or reduction of support from activities that fail to achieve their goal or comply with the Terms and Conditions.

    Areas of Joint Responsibility include:

    The Steering Committee is the primary governing body of the cooperative. Awardees must participate in the Steering Committee. The Steering Committee 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 Steering Committee.

    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, justice and other systems engaged in research.

    The Steering Committee, with the support of the Coordinating Center, 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. 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. 

    3. Reporting

    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.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    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

    Scientific/Research Contact(s)

    Jacqueline Lloyd, PhD, MSW 
    National Institute on Drug Abuse (NIDA) 
    Telephone: 301-443-8892 
    Email: lloydj2@mail.nih.gov

    Wendy Weber, N.D., Ph.D, M.P.H.
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone: 301-402-1272
    Email: weberwj@mail.nih.gov

    Lori Ducharme, Ph.D.
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-451-8507
    Email: lori.ducharme@nih.gov

    Eve E. Reider, PhD
    National Institute of Mental Health (NIMH)
    Telephone: 301-827-1496
    Email: ereider@mail.nih.gov

    Jennifer Alvidrez, PhD
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-594-9567
    Email: jennifer.alvidrez@nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

     Edith Davis
    National Institute on Drug Abuse (NIDA) 
    Telephone: 301-827-6697 
    Email: edavis1@mail.nih.gov

    Shelley Carow
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone: 301.594.3788
    Email: carows@mail.nih.gov

    Judy Fox
    National Institute on Alcohol Abuse and Alcoholism (NIAAA )
    Telephone: 301-443-4704
    Email: jfox@mail.nih.gov

    Bryan S. Clark, M.B.A
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Phone: 301-435-6975
    Email: clarkb1@mail.nih.gov

    Tamara Kees
    National Institute on Mental Health (NIMH)
    Telephone: 301-443-8811
    Email: tkees@mail.nih.gov

    Priscilla Grant, JD
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-594-8412
    Email: pg38h@nih.gov

    Section VIII. Other Information

    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.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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