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)

Funding Opportunity Title
Implementing the HIV Service Cascade for Justice-Involved Populations (U01 Clinical Trial Required)
Activity Code
U01 Research Project – Cooperative Agreements
Announcement Type

New

Related Notices

March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077.

July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128

August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137

Funding Opportunity Announcement (FOA) Number
RFA-DA-20-028
Companion Funding Opportunity

none

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

93.279

Funding Opportunity Purpose

NIDA is interested in research that addresses research gaps related to the delivery of integrated treatment services for HIV and opioid use disorder (OUD) among the justice-involved population in the US, with a goal of improving treatment management and implementation. A quarter of all people infected with HIV pass through the justice system each year, making it an important system for HIV prevention and treatment. Community re-entry from incarceration is a time of heightened risk for opioid relapse, mortality, HIV risk behaviors, and discontinuation of HIV treatment. Given these elevated levels of risk, justice-involved people who inject drugs (PWID) should be prioritized for screening and linkage to the full continuum of HIV prevention and treatment services, including Pre-exposure prophylaxis (PrEP) and highly active antiretroviral therapy (HAART). There is a need to better understand the effectiveness of the clinical interventions as received in this population, as well as the methods by which those interventions are delivered (navigation/mobile services).

Key Dates

Posted Date

February 19, 2020

Open Date (Earliest Submission Date)
March 30, 2020
Letter of Intent Due Date(s)

March 30, 2020

Application Due Date(s)

Only accepting applications for the AIDS Application Due Date(s) listed below

AIDS Application Due Date(s)

April 30, 2020. All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

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

Scientific Merit Review

July 2020

Advisory Council Review

August 2020

Earliest Start Date

September 2020

Expiration Date
May 01, 2020
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in 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 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 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    Background

    The justice system is an important target for HIV prevention and treatment, as an estimated 25% of all people living with HIV will pass through the justice system each year. As well, a high proportion of people with opioid use disorder (OUD) and people who inject drugs (PWID) pass through the justice system each year. OUD and injection drug use elevate HIV risk. Community re-entry from incarceration is a time of heightened risk for substance use relapse, opioid-related mortality, HIV risk behaviors, and discontinuation of HIV treatment. Justice involved people who have HIV, or who are at elevated risk for HIV, should have the opportunity to receive evidence-based HIV services appropriate to their level of risk. These include screening, initiation on Pre-Exposure Prophylaxis (PrEP) or highly active antiretroviral therapy (HAART), and engagement in related substance use disorder treatment services. HIV treatment-as-prevention can help reach the goal of ending the HIV epidemic in the United States. This initiative aligns with the NIH-OAR priority of reducing the incidence of HIV, and with the President’s objective to End the HIV Epidemic by 2030.

    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 in testing models to link justice-involved individuals with community-based HIV and OUD prevention and treatment services, recognizing the specific needs, structural challenges, and unique risks for this population. It is not the intent of this RFA to implement treatment services solely within correctional facilities.

    Applicants should propose a hybrid-implementation effectiveness trial that compares two models of linking justice-involved populations to a full continuum of HIV and OUD prevention and treatment services in the community: (1) One model must focus on helping individuals access services in existing community settings, utilizing patient navigators, peer coaches, community health workers, case managers, or similar linkage interventions. Applicants are encouraged to focus on integration or expansion of care in single point of care delivery systems (e.g., Federally Qualified Health Center or Syringe Service Programs). (2) The second model must be structured to bring services to individuals where they can most easily access them, such as by deploying mobile vans or analogous solutions. These interventions have been tested outside of the justice context, but research is needed to understand whether they can be effectively deployed to address the unique needs of patients transitioning between justice and community environments. As a hybrid design, the project should address implementation outcomes (feasibility, acceptability, sustainability, etc.) as well as individual-level effectiveness outcomes. Within this context, studies should consider strategies for addressing the complex needs of justice-involved populations, including mental and physical health comorbidities, housing, recovery supports, and employment.

    Projects must deliver services in at least 4 geographically distinct communities. See description in the Research Plan section of this FOA.

    Research questions of interest include but are not limited to the following:

    • Which model is most effective for linking justice-involved populations with HIV (PrEP and HAART) and OUD services in the community and maintaining continuous care?
    • How do the models influence care case cascade outcomes for PrEP, HAART, and OUD treatment--initiation, engagement, retention, and cost?
    • Which models of care are most effective at improving HIV outcomes, i.e., reductions in transmission, viral load, CD4 counts, and HIV associated morbidity and mortality?
    • How do substance use, recidivism, and social determinants of health influence HIV risk behaviors and other HIV outcomes for justice-involved PWIDs?
    • How does the immediacy of access to services influence care cascade outcomes?
    • For those initiated on PrEP or HAART, how do substance use behaviors (dependence, misuse, polysubstance use, injection drug use, alcohol use) influence initiation, adherence, retention and outcomes associated with PrEP or HAART?
    • What is the relationship between HIV and OUD service adherence and criminal behaviors and recidivism?
    • What are optimal interorganizational relationships between justice and community-based service providers to facilitate and sustain these services?

    Special Considerations:

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

    • Applications that do not emphasize prevention and treatment of both HIV and illicit opioid use or opioid misuse for individuals involved in justice settings. Both HIV and opioid-relevant outcomes must be included.
    • Applications that do not compare the two basic treatment models outlined above (services delivered in existing settings vs. services that are brought to patients (e.g., mobile vans)
    • Research sites in communities outside the US and its territories
    • Applications involving fewer than four communities
    • Applications proposing work in communities that do not meet criteria for HIV outbreak risk (see detail in Research Strategy section)
    • Applications that do not include letters of support from each of the proposed justice settings and community service settings
    • Applications that do not include one or more senior-level collaborators from both justice and community-based settings
    • Applications not providing a PD/PI committing a minimum of two person-months annually over the life of the grant award

    Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.

    Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

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

    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. Only those application types listed here are allowed for this FOA.

    Clinical Trial?
    Required: Only accepting applications that propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIDA intends to commit $4M in FY 2020 to fund 2-3 awards.

    Award Budget
    Application budgets are not limited but need to reflect the actual needs of the proposed project.
    Award Project Period

    The scope of the proposed project should determine the 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:

    • 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)
    • 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.
    • 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

    This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

    3. Additional Information on Eligibility

     

    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 instructions in the Research (R) Instructions in the SF424 (R&R) Application Guideexcept 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.

     

    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.

    Facilities & Other Resources: Applicants should provide an explanation of resources available from each project/performance site on the "Facilities and Resources" attachment

    Specifically:

    • Data should be presented on the nature, severity, and trends in HIV risk or infection, opioid use, opioid-related morbidity and mortality, or other opioid-related outcomes for the targeted communities. If available, data on opioid use in the targeted justice setting specifically should be presented, though not required. This may be presented broadly for the pool of sites and/or specifically for each proposed site, depending on study design.
    • Capacity to recruit additional sites, if needed, should be described.
    • As noted in the Research Strategy Instructions, for each proposed community, letters of support from the participating justice entity(ies) and community-based service provider agencies should be provided. If a study design proposes recruiting sites as part of a study design, strong justifications demonstrating feasibility of recruitment (e.g., letters of support from a state government official overseeing a system with multiple potential sites) and a strong justification for the selection of this strategy must be included.
    SF424(R&R) Senior/Key Person Profile
    All instructions in the SF424 (R&R) Application Guide must be followed.

    Biosketches should describe Senior/Key Personnel recent experience and participation in randomized clinical trials, preferably of a multisite nature. Applicants are expected to provide evidence of their unique strengths, accomplishments and capabilities to conduct the proposed research. Applicants should provide evidence of expertise in the conduct of clinical trials, particularly cooperative, pragmatic, randomized clinical trials. Persons responsible for participant recruitment, enrollment, data collection and data management should be shown to have extensive experience and high qualifications.

    Biosketches must be included for one or more senior leaders from (a) a relevant justice setting (i.e., jail, court, re-entry, probation, parole) and (b) a relevant community-based treatment setting relevant to the proposed study, to be included as key personnel. Senior leaders do not have to be from one of the targeted communities if not appropriate for the study design, but should have relevant expertise and demonstrate the ability to provide guidance to the research team on pragmatic and practice-related issues relevant to research in the targeted setting.

     

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

    Requirements for Senior Personnel

    PD/PIs must expend two (2.0) person-months effort annually on the award over the entire period of support. In a multi-PI application, at least one PD/PI must commit a minimum of 2.0 person-months annually over the life of the grant award.

    One or more senior leaders from (a) a relevant justice setting AND (b) a relevant community-based treatment setting should be named as Key Personnel and should each expend a minimum of .6 person-months effort annually on the award over the entire period of support.

    Requirements for Participating in Cooperative Activities

    Budgets should include funds for travel for the PD(s)/PI(s), the justice and community agency staff named as key personnel, and up to three additional project staff to participate in in-person Steering Committee meetings twice per year, every year of the award, in Rockville, MD. An additional in-person kickoff meeting to be held in Rockville, MD should be included in the year one budget of the award.

    In addition to executing the proposed protocol, applicants will be expected to participate in efforts to harmonize data collection, provide frequent updates on data collection progress (including data deposits), and participate in other collaborative activities. This is expected to be rigorous and adequate time should be budgeted to participate in such activities, including workgroup participation and coordination of data collection activities.

    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:

    The goal of this FOA is to support one or more collaborative multisite hybrid implementation-effectiveness trials for delivering integrated HIV and OUD prevention and treatment services to justice-involved individuals on re-entry to the community.

    Section A: Research Strategy:

    The following elements are required for all applications:

    1. Each applicant will be expected to collaborate with a minimum of 4 communities that are currently experiencing outbreaks of HIV/HCV infection among persons who inject drugs, or are demonstrably vulnerable to such outbreaks. Applicants must provide epidemiological data from 2015 or later demonstrating community-level HIV risk among IDU for each geographic area involved in the proposed study. CDC, state, or local sources may be cited.
    2. Applicants must demonstrate collaboration with a justice agency either located in or serving each participating community (e.g., jail, prison, community corrections). Depending on the communities selected, applicants may choose to partner with a single correctional facility (i.e., jail or prison) that has a large volume of clients returning to multiple distinct communities. In either case, applicants should provide data on the flow of clients from the justice agency to the communities of interest.
    3. Applicants must demonstrate collaboration with relevant HIV, OUD, and related service providers in each participating community. Depending on the communities selected, it is possible that a project-provided mobile unit would be the only service otherwise available. Applicants should clearly explain the local resources available, and demonstrate collaboration with appropriate local service providers.
    4. Applicants must demonstrate access to one or more mobile service delivery units that has the capacity to bring necessary services to patients for the duration of the study. Grant funds may be proposed to acquire a unit for the research project. In either case, applicants must include a sustainability plan for the continued availability of these services without NIDA grant support beyond the end of the grant period.
    5. Utilizing a hybrid implementation-effectiveness design, applications must examine both the effectiveness of the clinical interventions being delivered (PrEP / HAART / OUD treatment / prevention services) as well as the strategies by which those interventions are implemented (navigation/mobile services).
    6. In existing community-based facilities and/or in mobile service units, study sites must deliver a full continuum of evidence-based prevention and treatment services for both HIV and OUD. These should include the full continuum of HIV treatment services including PrEP and HAART; one or more medications for opioid use disorder (MOUDs); and access to behavioral counseling (in person or via telehealth). Studies may propose alternative arrangements across study sites to achieve the availability of these services. Services need not be exclusively available to justice-involved populations, but these populations must be the primary focus of data collection.
    7. Applicants are required to use a care cascade framework to identify relevant outcomes for both HIV and OUD prevention and treatment – i.e., effectiveness outcomes should include the proportion of subjects identified, engaged, and retained in care, as well as appropriate clinical outcomes.
    8. Applicants are not required to deliver services within correctional settings (pre-release), though this can be included as part of study design if desired. This FOA is not intended to support the implementation of services solely within correctional settings.

    Selection and Justification of Proposed Clinical Research Performance Sites:

    A minimum of four clinical research performance sites are required. Required details for each research performance site should be provided in Project/Performance Site Location section, and appropriate letters of support should be provided. The following guidelines should be followed with respect to selecting clinical performance sites:

    • A clinical research performance site is defined as a geographically distinct community (e.g., city, county, State, or other defined area). In each community, HIV and OUD services must be provided by an identified entity, and the target population must share an association with a common justice entity. The actual configuration of justice and health entities is expected to vary based on the study design and the current service delivery system in the target areas. For example, it is acceptable for a project to engage 4 or more communities each having their own justice system (e.g., county jails) and healthcare provider (e.g., FQHCs, SSPs). Likewise, it would also be acceptable for a study to engage one large justice system with individual subjects who are being released to multiple communities, so long as issues pertaining to randomization, contamination, and generalizability are addressed. Regardless of the configuration, the project must include one or more partners from (a) the justice agency(ies) and (b) the HIV/OUD service provider(s) to represent the needs and interests of each targeted community. The definition of the scope of the justice system is outlined within this announcement.
    • If there is any ambiguity with regard to the geographic distinctness of the proposed clinical research performance sites, applicants must provide a clear justification for their site selection approach.
    • Although a minimum of four research performance sites must be engaged, the actual number of clinical performance sites should be justified and scientifically based on power analyses appropriate to the design and outcomes of interest in the proposed study.
    • In general, it is anticipated that in all performance sites, justice settings will be of the same general type (e.g., jails), but applicants can make a case for other designs with a compelling justification.
    • In general, it is expected that applicants will be able to pre-specify their expected clinical research performance sites. If there is a compelling reason why this cannot or should not be done, applicants should provide similar detail to that described below regarding potential sites and what approach will be used in ultimately selecting sites.
    • Additional detail should be included on planned performance sites as detailed in the SF424(R&R) Project/Performance Site Locations

    Section B: Collaboration Capacity

    The research strategy section should also include a general discussion of capacity to engage in collaborative research efforts, including capacity to:

    • Participate in data harmonization, data sharing, and other collaborative efforts with other grantees, including, but not limited to other applicants successfully funded under this FOA; and
    • Demonstrate a track record of collaboration in similar multi-site efforts.

    Letters of Support: For each proposed community, letters of support from the (a) targeted justice entity(ies) and any collaborating community-based service provider entity(ies) must be provided. If an application proposes to recruit sites as part of the study design, strong justifications demonstrating feasibility of recruitment (e.g., letters of support from a state government official overseeing a system with multiple potential sites) and a strong justification for the selection of this strategy must be included. Commitment to working with NIDA and providing NIDA with timely, accurate data to facilitate data-driven updates of study progress.

    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.

    The following modifications also apply:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    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 human subjects research, clinical research, and/or NIH-definedclinical 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 compliancewith application instructions by the Center for Scientific Review, NIH and evaluated forresponsiveness by NIDA. Responsiveness criteria are identified in Section I under "Special Considerations." Applications that are incomplete, non-responsive,or non-compliant 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.

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

     

    Does the project 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 project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

    Specific to this FOA: To what extent does the application address important implementation and effectiveness questions related to preventing and treating OUD and HIV for justice-involved populations? Does the study propose to test scalable, generalizable treatment models in community/justice settings? Does the study generate novel information about how to deliver service? Does the research plan address potential sustainability, especially within the context of the provision of OUD and HIV prevention/treatment services via mobile units? Does the epidemiological data for each proposed community sufficiently demonstrate community level HIV risk among PWID?

     

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

    With regard to the proposed leadership for the study, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multisite trial, is the organizational structure appropriate?

    Specific to this FOA: Is the time commitment of the PD/PI (s) and the justice and community health collaborators appropriate for the stated study goals? If key personnel do not have a history of collaboration, is an appropriate plan in place to ensure successful coordination and communication?

     

    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?

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

    Specific to this FOA:Does this design test interventions or implementation strategies that are potentially generalizable to other communities, systems or settings? Does this design test a practice or intervention that is widespread, but for which limited evidence is available?

     

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    Does the application adequately address the following, if applicable

    Study Design

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

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

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

    Data Management and Statistical Analysis

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

    Does the study address compelling, feasible, and scalable treatment models that combine both OUD and HIV prevention and treatment?

    Are individual-level outcomes appropriate? Are implementation outcomes appropriate given the study design?

    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?

     

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

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

    If multi-sites, is there evidence of the ability of each individual site to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

    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.

    Study Timeline

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

     

    For research that involves human subjects but does not involve one of thecategories 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

    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.

     

    Not Applicable

     

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

     

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

     

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

     

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    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.

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

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

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety

    Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

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

    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.

    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.

    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.htmlhttps://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.htmlor 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.

    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:

    • Organizing local teams, including justice and community health agency collaborators, for day-to-day management of the study.
    • If formed, participating in any Steering Committee activities with other grantees.
    • Participating in other NIDA coordinated research efforts in justice settings. This participation may include collaboration and consultation with other NIDA awardees, the appropriate sharing of information, data, and research materials, and participation in NIDA efforts to standardize and harmonize pre-clinical and clinical data collection.
    • Participating in regular teleconferences and face-to-face meetings with other grantees. .

    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:

    • A NIDA staff member will be assigned as Project Scientist for each award made under this FOA. The NIDA Project Scientist will be responsible for: (1) providing advice and guidance to the awardee to assure the study is run in accordance with NIH policy and procedures, and is consistent with the NIH mission to improve public health; (2) serving as a point of contact for investigators with the NIH; and (3) coordinating with the broader NIDA justice and HIV research portfolios to ensure that each award’s study design and measures are consistent with, but not duplicative of, other ongoing research in this arena.
    • If a Steering Committee is formed, the NIH Project Scientist(s) will have one (1) vote on the Steering Committee, regardless of how many NIH Project Scientists participate.
    • The assigned Project Scientist(s) will be responsible for: (1) providing advice and guidance to the clinical research center to assure the study is run in accordance with NIH policies and procedures, and is consistent with the mission of the NIH to improve public health; (2) serving as a point of contact for investigators with the NIH; and (3) coordinating with related research activities at the NIH and NIDA.
    • .
    • In addition, an NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

    Areas of Joint Responsibility include:

    • Data Management, Analysis, and Access: Data generated are the property of the awardee. Awardees must provide NIDA or a NIDA-designeewith access to all data generated under this award, subject to rules specified in any Certificates of Confidentiality obtained by awardees.
    • If multiple awards are made under this RFA, grantees may be asked to use a common set of measures to facilitate harmonization and reporting across studies. Similarly, to facilitate harmonization with conceptually similar ongoing HIV and justice research projects, awardees will be expected to incorporate common implementation and effectiveness measures to facilitate harmonization across multiple studies.
    • Awardees and NIDA will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data.
    • Awardees and NIDA will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers, practitioners, and policy makers engaged in the research and beyond.

    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 chosen by the individual awardee, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. 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 RPPR, invention statement, and the expenditure data portion of the Federal Financial Report 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 agreementsare 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 threatensubmission 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)

    Minnjuan Flournoy Floyd, PhD
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-827-6474
    Email: Minnjuan.flournoyfloyd@nih.gov

    Peer Review Contact(s)

    Dharmendar Rathore, PhD
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-402-6965
    Email: dharmendar.rathore@nih.gov

    Financial/Grants Management Contact(s)

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