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

Laboratories for Early Clinical Evaluation of Pharmacotherapies for Substance Use Disorders (UG1 Clinical Trials Required)

Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DA-19-018

Companion Funding Opportunity

None

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

 93.279 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications from clinical investigators to establish Laboratories for Early Clinical Evaluation of Pharmacotherapies for Substance Use Disorders (SUDs). The purpose of this FOA is to support the creation of Laboratories with expertise and resources and to conduct early clinical evaluation of potential pharmacotherapies for SUDs. The goal is to accelerate the clinical development of medications to treat SUDs by establishing Laboratories possessing the highest expertise and sufficient resources to timely and efficiently conducting FDA-defined Phase 1 and/or Phase 2 clinical trials of new or repurposed compounds for SUDs indications.

Key Dates

 

Posted Date

December 21, 2018

Open Date (Earliest Submission Date)

February 15, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

March 15, 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.

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 2019

Advisory Council Review

October 2019

Earliest Start Date

November 2019

Expiration Date

 March 16, 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

    The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the clinical development of medications to treat Substance Use Disorders (SUDs) by establishing Laboratories with the expertise and resources to timely and efficiently conduct early (Phase 1 or Phase 2) clinical trials of potential pharmacotherapies for SUDs.

    A significant challenge in the development of medications for SUDs is the need of specialized Laboratories that have the knowledge and expertise to timely and efficiently conduct FDA-defined Phase I and Phase II clinical trials. For example, Phase I clinical trials in addictions have to evaluate the medical safety of compounds and may involve the evaluation of safety of the interaction with a drug of abuse or pharmacokinetic or pharmacodynamic studies. Such studies require an inpatient unit where subjects can feel comfortable and have adequate medical monitoring and other safety protection measures in place. These studies will also require a pharmacy support with a set of licenses and permits to allow the storage and administration of some substances, for example DEA scheduled drugs.

    Phase II studies mainly focus on the evaluation of the safety and early efficacy of medications. They can be conducted in outpatient settings, with treatment-seeking populations, and may have strict inclusion/exclusion criteria, as well as specific treatment outcomes.  The settings where Phase II studies are conducted must have personnel with the knowledge and expertise in the area of early clinical research, ability to recruit study participants, and clinical services to attend to the needs of patients participating in clinical trials. Also, they must possess the necessary licenses and certificates to conduct these types of trials and the ability to follow Good Clinical Practice (GCP) guidelines. The data collected from these studies must also satisfy the FDA quality requirements to support the approval of the medication.

    Given the high level of specialization and strict regulatory requirements to conduct early clinical trials of medications for SUDs, it is critical to strengthen the capacity to execute and/or increase the availability of Laboratories able to perform high quality early studies in a cost-effective way. These Laboratories must have the ability to recruit participants with SUDs who are not seeking treatment. Moreover, they must be able to conduct GCP quality studies that satisfy the FDA requirements to accept the data for approval purposes.

    It is expected that each laboratory will be able to provide leadership and technical expertise for the field and will be GCP-compliant. The Laboratories will have access to an Institutional Review Board (IRB) to perform timely and efficient review and oversight, are expected to possess a track record of success in key operational aspects of drug development, such as successful clinical study initiation and recruitment, demonstrated ability to complete clinical studies within standards and timelines comparable to the pharmaceutical industry.

    Without being constrained by staying within the limits of one theme or indication (e.g., one SUD), the Laboratories can have a broad range of projects that could be independent or connected and executed simultaneously or overlap, or be sequential. The Laboratory can be a stand-alone site or have networked sites and Laboratories each with their own clinical studies capabilities and infrastructure.  Integration of data, resources and instruments across projects is allowed as well, based on where and if needed.

    It is important to note that Phase I clinical trials in SUDs have to evaluate the medical safety of compounds and may involve the evaluation of safety of the interaction with a drug of abuse. Early phase trials can also include the following types of trials:

    • Early clinical studies with potential medication candidate, such as First time in Humans (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) or SAD-MAD combination, food effect
    • Drug-Drug interaction (DDI) studies, including safety interaction studies of medications with drugs of abuse.
    • Other studies related to aspects of formulation development (e.g. bioavailability)
    • Translational Phase 2A proof-of-mechanism (POM) studies. It is expected that neuroimaging and other technologies will be used where appropriate.
    • Phase 2B dose-ranging and/or Early Signal of Efficacy (ESoE) type of trials
    • Proof of Concept (POC) efficacy and safety clinical trials

    This FOA aims to support clinical research Laboratories with the basic resources and services necessary to conduct early clinical trials. Each application must include one or two clinical trials that can be conducted in the first two years of the project and will serve to demonstrate the ability of the laboratory to conduct such trials.  The compounds to be tested in the clinical trial may be proposed/supplied by any academic, industry or government sponsor.   It is expected that each laboratory will participate in at least one clinical trial at a given time. Failure of a laboratory to participate in clinical trials may jeopardize future funding of the laboratory.

     As the opportunity arises, requests for subsequent clinical trials can be submitted by the Principal Investigator (PI) as an administrative supplement request.

    Special Considerations

    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.

    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.

    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.

    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 $500,000 per year and intends to fund an estimate of 2 awards, corresponding to a total of $1,000,000.00, for the fiscal year 2019. Future year amounts will depend on annual appropriations.

    Award Budget

     Application budgets are limited to $500,000 per year per each award in direct costs.

    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)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    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.
    • o    NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    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
    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

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    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.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    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.  Bio sketches must describe the recent experience and participation in randomized clinical trials, preferably of a multicenter nature. Specific roles (PD/PI, participating site, leadership committee, lead investigator, trial design and development) should be described for each study. Publications should be listed that resulted from participation in the studies. Applicants are expected to provide evidence of their unique strengths, accomplishments and capabilities to contribute to shared Division of Therapeutics and Medical Consequences (DTMC) activities. Applicants should provide evidence of expertise in the conduct of clinical trials, particularly phase 1 and/or 2 clinical trials in SUDs. Persons responsible for participant recruitment, enrollment, data collection and data management should be shown to have extensive experience and high qualifications.

    R&R Budget

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

    PD/PIs must expend 2.4-4.2 person-months effort annually on the award over the entire period of support.

    Once an application has been favorably recommended and is being considered for funding, the applicant may be required to propose protocol budgets to participate in those protocols suggested. For trials starting after awards are made from this FOA, annual negotiated protocol budgets will consist of specific protocol-related allowances (protocol costs) and will be awarded as such. Successful applicants will be required to project patient enrollment for a specific protocol during a specified time frame. Federal agencies shall use the negotiated rates for F&A costs in effect at the time of the initial award throughout each competitive cycle of the project. Supplemental funding will be considered for research costs in excess of annual awards. 

    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 Laboratories should be able to conduct inpatient Phase I clinical trials in addictions and have to evaluate the medical safety of compounds, which may involve the evaluation of safety of the interaction with a drug of abuse or pharmacokinetic and pharmacodynamic studies.
    • An inpatient unit should be available where subjects can feel comfortable and have adequate medical monitoring and other safety protection measures in place.
    • Pharmacy support is also required with a set of licenses and permits to allow the storage and administration of some substances, for example DEA scheduled drugs.
    • The settings where Phase II studies are conducted must have staff with the best knowledge and expertise in the area of early clinical research, the laboratory must be able to actively and timely recruit study participants, and have all clinical services to attend to the needs of patients participating in clinical trials. Phase II studies mainly focus on the evaluation of the safety and early efficacy of medications. They can be conducted in outpatients, in treatment-seeking populations and assess a range of clinical treatment outcomes.
    •  The Laboratories must possess all the necessary licenses and certificates to conduct these types of trials and the ability to follow Good Clinical Practice (GCP) guidelines. The data collected from these studies must also satisfy the FDA quality requirements to support the approval of the medication.
    • It is expected that each laboratory will be able to provide leadership and technical expertise for the field.
    •  The Laboratories must have access to an Institutional Review Board (IRB) and must possess a track record of success in key operational aspects of drug development, such as successful clinical study initiation and recruitment, demonstrated ability to complete clinical studies within standards and timelines comparable to the pharmaceutical industry. The study(ies) timeline should be detailed, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment. Projected timelines should be feasible and well justified
    • The study(ies) can incorporate operational efficiencies and utilize existing resources whenever possible (e.g., practice-based research networks, electronic medical records, administrative databases, or patient registries) to increase the efficiency of participant enrollment and data collection.
    • The Laboratory can have a broad range of projects/studies that could be independent or connected and executed simultaneously or overlap, or be sequential.
    • The Laboratory can be a stand-alone site or have networked sites and Laboratories each with their own clinical studies capabilities and infrastructure. Integration of data, resources and instruments across projects is allowed as well, based on where and if needed.
    • Adhering to the highest standards of quality in clinical research, the Laboratories are expected to conduct the following types of clinical trials:
    • Early clinical studies with potential medication candidate, such as First time in Humans (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) or SAD-MAD combination, food effect
    • Drug-Drug interaction (DDI) studies, including safety interaction studies of medications with drugs of abuse.
    • Other studies related to aspects of formulation development (e.g. bioavailability)
    • Translational Phase 2A proof-of-mechanism (POM) studies. It is expected that neuroimaging and other technologies will be used where appropriate.
    • Phase 2B dose-ranging and/or Early Signal of Efficacy (ESoE) type of trials
    • Proof of Concept (POC) efficacy and safety clinical trials
    • The scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention must be 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, the clinical trial must be necessary for testing the safety, efficacy or effectiveness of a potential new medication and overall could lead to a change in clinical practice, community behaviors or health care policy.
    • Trials that include mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, should advance scientific understanding.

     

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    Appendix:

    Only limited 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

    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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    A proposed Clinical Trial application may include study design, methods, and intervention. In the case where those are not by themselves innovative, they must address unmet needs or an important question. 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.

    Significance

    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?

    Investigator(s)

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

    Innovation

    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?

    Approach

    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 in regards to the proposed clinical trial(s):

    Study Design

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

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

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

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at a central "hub" Laboratory, 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?

    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

    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) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If multi-sites/centers, is there evidence of the ability of the individual site or center 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)?

    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.

    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  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

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

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

    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 (NIH UG1), 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, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

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

    The Program Director/Principal Investigator (PD/PI) will have the primary responsibility for defining the details for the project within the guidelines described in the Request for Applications DA-19-018 and for performing the scientific activity. The PD/PI agrees to accept close coordination, cooperation, and participation of NIDA Program staff in those aspects of scientific and technical management of the project described in these terms and conditions. The PD/PI agrees to accept close coordination and to cooperate fully with NIDA designated coordinating centers and contractors.

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

    a. Generally, Awardees under this agreement have the following rights and responsibilities:

    Provide leadership for their Laboratory. The Laboratory refers to the combination of the awardee organization and the partnering satellite recruitment sites and contract organizations (e.g., CRO) where applicable. The awardee provides scientific leadership and management of clinical trials as well as administrative and study operations services for the Laboratory. The awardee agrees to negotiate and establish formal working relationships with healthcare organizations and/or CROs if needed. These agreements will include, at minimum: 1) a statement of work defining the goals and objectives of the research projects to be undertaken under this cooperative agreement; 2) a budget for support of the research projects that clearly identifies the personnel, equipment, materials, and other costs required to successfully conduct high quality research according to the requirements of specific protocols approved for implementation by the PO and SO of the grant; and 3) a financial and program reporting requirement, including access to data and materials, to facilitate DTMC program operation and research project oversight and monitoring. Initial agreements between the awardee Laboratory and healthcare organizations or CROs may be more general as specific details will depend on the particular research projects and participating sites.

    Core functions - This includes but is not limited to 1) arranging and managing the participation of partnering healthcare organizations; 2) providing scientific and technical expertise for protocol development and research operations; 3) coordinating and providing resources for clinical trials activities.   

    b. Data Rights:

    The NIH expects investigators supported by NIH funding to make their research data available to the scientific community for subsequent analysis based on a data sharing plan approved as part of the award; see the NIH data sharing policy website at https://grants.nih.gov/grants/policy/data_sharing.  The Awardee of this agreement acknowledges that NIH has access to any  and all data generated under this cooperative agreement and the Awardee agrees to provide royalty-free, nonexclusive, and irrevocable license for the government to reproduce, publish, or otherwise use the material and data derived from research conducted under this cooperative agreement. The Awardee agrees to register the trials in the clinicaltrials.gov database and submit results according to NIH policy http://clinicaltrials.gov/ct2/manage-recs/fdaaa.  The awardees will retain custody and primary rights to their Laboratory data consistent with current DHHS and NIH policies, including a policy to provide public access to selected, significant data sets generated with the use of public funds, within a reasonable period after primary analysis or publication. The awardee must agree to retain records for each completed study for a minimum of 3 years (or more if necessary) after study data lock. Each site must also comply with their respective IRB and other regulatory entities regarding records retention.

    c. Study Management:

    The awardee is responsible for the proper conduct of studies at the Laboratory and any satellite recruitment sites. All studies conducted in the Laboratory are subject to the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. The awardee must provide resources to ensure that (1) staff receive adequate training and resources to conduct the studies; (2) the studies are conducted according to the protocol and applicable regulatory requirements; (3) the studies recruit and retain participants per approved recruitment plans, including appropriate number of women and minorities per NIH policy; (4) staff perform adequate data entry; (5) corrective actions are implemented when appropriate; (6) study materials and records are kept and/or disposed appropriately; and (7) study personnel participates in all study related activities. Each study site must agree to monitoring activities that will be specified in each protocol.

    d. Reporting Requirements:

    In addition to periodic financial and administrative reports required by NIH for administration of this cooperative agreement, the Awardee agrees to furnish the following reports according to the schedule indicated:  

    Investigational New Drug (IND) Reports: Awardees are required and agree to provide reports according to regulations and guidelines established by the Food and Drug Administration (FDA).

    Final Study Report: Primary Investigators are required to provide a Final Study Report within 120 days of data lock upon completion of the protocol. In addition, the Primary Investigator will present primary outcome results to the trial DSMB, where applicable and also to other satellite participating sites where applicable prior to publication.

    e. Publication of Data:

    Prompt and timely presentation and publication in the scientific literature of findings resulting from research undertaken is required. It is expected that the Primary Investigator will complete and submit the initial outcome paper to an appropriate peer-reviewed scientific journal within 180 days of study data lock. The Awardee agrees to acknowledge NIDA support in the publications and oral presentations resulting from research conducted under this cooperative agreement. 

    f. Protocol Closure:

    Throughout the term of the cooperative agreement NIDA may request that a research project or study site be terminated for reasons including but not limited to: 1) insufficient participant accrual; 2) poor performance in conducting the protocol; 3) safety of the participants in the study; 4) achievement of conclusive study results; 5) emergence of new information that diminishes the scientific importance of the study question; 6) misuse of federal funds; and 7) shortfalls in appropriated funds available to pursue the study. Financial support from NIDA and access to further investigational drug supplies through this cooperative agreement will cease upon project closure, except that funds and other resources may remain available for participants already enrolled in the study.

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

    NIDA Program staff has substantial scientific and programmatic involvement throughout this cooperative agreement through technical assistance, and advice and coordination extending beyond normal program stewardship for grants as described below.

    a. NIDA’s Scientific Role

    The Director of the Division of therapeutics and Medical Consequences (DTMC)of NIDA will appoint NIDA Program Officers and Science Officers with expertise in clinical research to participate in the development of study plans and protocols, and to coordinate projects. NIDA Science Officers may initiate or participate in publications in accordance with established professional and NIH guidelines for authorship.

    The DTMC Director, and/or designated staff, will work closely with the Program and Science Officers to assure that DTMC efforts are consistent with NIDA’s research objectives and complement other clinical research activities supported by NIDA under other means.

    NIDA Science Officers will advise the clinical investigators, as requested or needed, of results from other studies (e.g., adverse experiences and study termination) that could influence the design, development, or conduct of clinical studies under this cooperative agreement. NIDA will serve as a resource, and will communicate information regarding promising new therapies.

    NIDA will appoint advisory boards within and outside of the Laboratories as deemed necessary during the development and progress of protocols and trials.

    For ongoing research projects NIDA Science Officers and its contractors will monitor study progress through incremental review of case report forms. Laboratories will prepare periodic reports profiling the conduct of the study including the safety of study participants for review by the DTMC Data and Safety Monitoring Board (DSMB) where/if applicable. The DSMB may recommend to NIDA a need to alter, suspend, or close an ongoing study due to safety concerns, study performance issues, or early evidence of efficacy or futility.

    b) NIDA Monitoring of Trials

    All Laboratory studies are subject to monitoring according to protocol-specific monitoring plans. The Laboratory must agree to periodic monitoring by DTMC representatives. In addition, formal site audits will be conducted if necessary. Laboratory must also agree to remote, central monitoring by Data and Statistics Center representatives where applicable. The monitoring may include periodic on-site visits and remote document reviews by staff from the Laboratory and the NIDA DTMC appointed representatives to perform the following: (1) investigational drug accountability; (2) compliance with applicable federal, state and local regulations for Human Subject Research, including Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46); (3) compliance with protocol specifications; quality control and accuracy of data recording; and (4) completeness of reporting adverse events. Monitoring is conducted to assure that: the rights and well-being of participants are protected; the reported trial data are accurate, complete, and verifiable from source documents; and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with all applicable regulatory requirements. Reports of all monitoring activities and audits will be reviewed by the DTMC and study performance will be reported to the DTMC.  Where applicable summary reports from DSMB meetings will be provided to the Primary Investigator, who in turn will provide necessary documentation to the participating sites Institutional Review Board(s). NIDA DTMC program and grants management staff will review protocol accrual, and fiscal and administrative procedures. NIDA DTMC reserves the right to discontinue Laboratory participation in clinical trials.

    c. NIDA Review of Performance

    The performance of the Laboratory will be periodically reviewed by NIDA DTMC. The review will be based on information provided in periodic trial progress reports compiled from data on recruitment, retention, follow-up, treatment exposure, monitoring reports, and other factors. Insufficient patient accrual, substandard data quality, inadequate progress in executing the research agenda, or noncompliance with the Terms and Conditions of Award may result in a reduction in budget, withholding support, suspension, or termination of award. It is expected that each laboratory will participate in at least one clinical trial at a given time. Failure of a Laboratory to participate in clinical trials may jeopardize future funding of the laboratory.

    d. Normal Program Stewardship    

    A separate NIDA Program Official other than the DTMC Director will be responsible for the normal programmatic stewardship of the award and will be identified in the Notice of Grant Award. 

    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 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 on-time submission, 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 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)

    Tanya Ramey, M.D., Ph.D.
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-827-5944
    Email: tanya.ramey@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)

    Pam Fleming
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-253-8729
    Email: pfleming@mail.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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