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)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.  The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Tribal Health Research Office (THRO)

Funding Opportunity Title

Responding to Opioid Use Disorders (OUD) in Tribal Communities in the Context of SAMHSA and CDC Funding (R61/R33 - Clinical Trials Optional)

Activity Code

R61/R33 Exploratory/Developmental Phased Award

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-DA-19-013

Companion Funding Opportunity

None  

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

93.279  

Funding Opportunity Purpose

   The purpose of this Funding Opportunity Announcement (FOA) is to leverage SAMHSA funding (including TI-18-016, TI-18-015, and TI 17-014) and CDC funding (including CDC-RFA-OT18-18030101supp) for

tribal responses to the opioid crisis by supporting culturally relevant research built upon projects supported by SAMHSA or CDC. The topic of the research project will vary depending on how funding is used in tribal communities. Potential topics include, but are not limited to, studies of evidence-based interventions adapted to enhance their feasibility, acceptability, availability and/or effectiveness in tribal communities; assessing the effectiveness of interventions with an evidence base from another population when implemented to address the opioid crisis and associated comorbidities (e.g. alcohol use and mental health disorders) in tribal communities;  augmenting hypothesis-based data collection to inform intervention adaptation and implementation; or epidemiologic studies that assess the reach or implementation of interventions. Research supported through this FOA will be performed in two phases. The first phase (R61) will provide support for up to two years and allow for development of the project including, where relevant, development and pilot testing of study elements including measurements, the study design, and/or adaption of intervention. This phase will identify and meet pre-specified milestones ensuring that the results of this phase inform and provide a foundation for the second phase of the research. Phase two (R33) is dependent upon successful completion of the R61 phase and an approved plan for the R33 phase. Phase two will provide possible funding for up to four years to expand to a full test of the research aims.  The total duration of the award (R61 and R33 phases) may not exceed five years.

Key Dates

 

Posted Date

September 18, 2018

Open Date (Earliest Submission Date)

October 29, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

November 29, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

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

AIDS Application Due Date(s)

November 29, 2018, 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 these dates.

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

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

Scientific Merit Review

February/March 2019

Advisory Council Review

May 2019

Earliest Start Date

July 2019

Expiration Date

November 30, 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

    American Indians and Alaska Natives (AI/AN) have been significantly impacted by the opioid crisis, with AI/AN and Non-Hispanic Whites having the highest rate of overdose deaths and diagnosis for OUD. AI/AN had the highest drug overdose death rates in 2015, were second to Whites in 2017, and had the largest percentage change increase in the number of deaths from 1995 to 2015. Despite this health burden, few studies focused on opioid use and disorder or its prevention or treatment have been conducted with AI/AN populations.

    Tribes and tribal organizations have both unique opportunities for and barriers to responding to the opioid crisis. The status of tribes as sovereign nations uniquely positions them to use tribal policymaking in response to the opioid crisis. This status provides an opportunity for research and practice partnerships to demonstrate and assess how tribal responses, including those focused on prevention, treatment, recovery or multi-level, community wide responses, can address the risks for opioid use and related comorbidities, improve treatment outcomes and reduce overdose deaths (intentional and nonintentional) and addiction. AI/AN communities also have inherent strengths and resiliencies that can be drawn upon to address opioid use and misuse, including traditional practices and close communities, and these can also be the focus of research.

    Some unique barriers exist for responding to OUD for tribes and tribal organizations as well. For example, barriers exist for making available effective medication assisted treatment (MAT), using FDA-approved medications for OUD, including methadone, buprenorphine/naloxone, buprenorphine, and naltrexone. Some communities are effectively using MAT to treat tribal members, but research is needed to identify barriers and enhance the availability and acceptability of this treatment approach. Moreover, there are no published outcome studies of MAT for AI/AN and the availability of this treatment for AI/AN is not clear. Standard treatment is often long distances away or not sufficiently funded. Many treatment programs do not reflect the AI/AN value for a holistic approach to recovery that includes bringing mental, emotional, physical and spiritual aspects of health into balance, nor do they incorporate traditional practices or other culturally appropriate, often strength-based, strategies.  Research has not addressed the efficacy of these approaches or how they might be combined with MAT to improve outcomes. Responding to OUD and related comorbidities in tribal communities in a culturally appropriate manner might require that all dimensions are addressed, and research is needed to identify how this can be done most effectively in the context of evidence-based programs.

    The Substance Abuse and Mental Health Services Administration (SAMHSA) recently released a funding opportunity announcement to help improve funding for treatment, prevention and recovery from OUD in tribal communities. Tribal Opioid Response (TOR) Grants (FOA TI-18-016: https://www.samhsa.gov/sites/default/files/grants/pdf/tor_6-21-18.pdf), will provide $50,000,000 to tribes and tribal organizations to build prevention, treatment and/or community-based recovery support services. The FOA also focuses on increasing access to culturally appropriate and evidence-based treatment, including medication-assisted treatment (MAT) and improving retention in care. Other funding is available to tribes and others to respond to OUD for AI/AN from SAMHSA (e.g. tribes are eligible to receive funds through TI-17-014 State Targeted Response to the Opioid Crises (STR)and TI-18-015 State Opioid Response Grants (SOR) programs via states) and studies responsive to this NIH FOA could leverage these funds as well.

    The Centers for Disease Control (CDC) recently announced funds are newly available to support tribal opioid overdose prevention. The competitive supplement program will provide $10,000,000 and is available to AI/AN tribes and tribal organizations that were awarded under Tribal Public Health Capacity-Building and Quality Improvement Umbrella Cooperative Agreement (CDC-RFA-OT18-18030101supp: https://www.grants.gov/web/grants/search-grants.html?keywords=CDC-RFA-OT18-18030101SUPP18). The supplemental funds will need to address opioid overdose prevention by using either 1) epidemiologic surveillance and public health data infrastructure to address issues of data quality and timeliness, 2) implementation of evidence-based health systems interventions that are appropriate to tribal communities; or 3) innovative community-based strategies that build upon strengths inherent to tribal organizations.

    Research Goals

    The goal of this FOA is to support culturally relevant research to improve responding to the opioid crisis in tribal communities, leveraging SAMHSA or CDC funding by soliciting applications from researchers in or partnering with AI/AN communities, tribes or tribal organizations to use community engaged research approaches to build science around SAMHSA or CDC supported programs. This research will help to identify the most efficacious prevention and/or treatment approaches for opioid use, misuse and OUD and related comorbidities in tribal communities, where unique culture, structures for and access to health care, and beliefs about treatment all impact health and social outcomes.

    Research Topics

    Research topics will stem from the programs developed with SAMHSA or CDC funding.

    Intervention research in response to this FOA should inform enhancing the feasibility, acceptability, availability, optimization, efficacy and/or effectiveness of prevention, treatment and/or recovery services.

    Treatment research topics may include, but are not limited to, studies focused on assessing:

    • Integration of MAT with traditional healing, spiritualty, cultural factors and/or ceremonies to improve treatment outcomes
    • The level at which MAT improves treatment outcomes for AI/AN compared to treatment-as-usual
    • Telehealth approaches to prevention, treatment or recovery services for addressing OUD
    • Whether the use of long acting MAT (Sublocade, Vivitrol, Probuphine) helps in making MAT available to remote communities, helps reduce stigma, or otherwise improves treatment use and outcomes for AI/AN.
    • Workforce and/or community factors and how they relate to the availability, quality and treatment outcomes of OUD and related comorbidities
    • Adapt and optimize evidence-based behavioral approaches and other strategies to promote adherence to medications and other opioid use disorder treatment for use in AI/AN contexts.
    • Integrate novel technologies or other methods to develop, improve and systematically measure behavioral treatment outcomes for OUD

    Prevention research topics of interest include, but are not limited to, studies:

    • Testing approaches to prevent the onset and escalation of opioid misuse in emerging adult and adult populations
    • Testing prevention models informed by both traditional practices and technological advances to improve management of pain and encourage safe use of pharmaceuticals
    • Research testing interventions to mitigate the effects of trauma among individuals at elevated risk for opioid misuse and related comorbidities (alcohol, suicide, mental health disorders)
    • Examine the acceptability, effectiveness, and reach of efforts to reduce the supply of unused prescription opioids and discourage diversion, such as targeted communications and prescription drug take-back programs.
    • Examine the impact of efforts to increase the availability of naloxone, provide bystander training, and provide linkage to treatment and other support services following an overdose
    • Research on strategies to reduce the risk of prenatal opioid exposure and interventions to improve outcomes for mothers and infants exposed to opioids in this population.

    Research on recovery strategies could focus on studies:

    • Test recovery practices to improve OUD outcomes and related comorbidities, potentially including peer supports, recovery coaches and recovery housing.
    • Examine efficacy or effectiveness of treatment transition plans and implementation for patients re-entering communities from criminal justice or other rehabilitative settings.

    Epidemiologic research in this area could be limited to being conducted in phase one to inform phase two or could be the focus of both phases one and two. It could include studies to:

    • Characterize the opioid epidemic for AI/AN including what substances are first used and who is at greatest risk for addiction and/or mortality to inform intervention development.
    • Assess how multi-sector community responses, possibly including behavioral health, prescribing practices and information, drug take back, law enforcement response, etc. contribute to improved opioid related outcomes.
    • Identify who participated in interventions and who did not, further explicating why interventions failed to reach people in need
    • Identify community reactions to the opioid epidemic including causal attributions about opioid use and other types of self-harm, reactions to intervention strategies, indicating how these relate to the reach of intervention and opioid outcomes
    • Examine whether overdoses that occur are intentional or non-intentional and gain a better understanding of the context of their occurrence
    • Identify how transitions from urban or rural residences to locations where treatment resources are available influences short- and long-term treatment outcomes

    The proposed projects must meet the following criteria and applications will be returned if they do not address these factors:

    • Projects must leverage an opportunity made available by funding from SAMHSA or CDC to enhance responses to opioids to improve outcomes for AI/AN. While urban Indian organizations are not eligible to apply for SAMHSA or CDC funding without a tribe or tribal organization partner, they can apply for this NIH FOA if they are eligible for NIH funding or partner with a research organization and include in the application services delivered with the support of SAMHSA or CDC funding in some manner.
    • For reservation-based research, tribal-level approval and support from the community are critical to the research and also to the implementation of the interventions. Letters of support should reflect this engagement. More detailed information on letters of support is provided in the PHS 398 Research Plan section.
    • PDs/PIs must plan to use some of the funds awarded by this FOA to attend an annual meeting of investigators funded under the FOA and engage in other activities, such as periodic conference calls, designed to facilitate appropriate standardization of measures, collaboration and other mechanisms for maximizing the scientific yield from this FOA. The investigators may form committees that would meet periodically by conference calls as needed. PDs/PIs will be expected to participate in these conference calls for planning purposes at monthly or other appropriate intervals.

    Investigators should also consider the following:

    • Given the developmental nature of phase one of the research, researchers may choose to incorporate a mixed-methods approach, with the addition of qualitative data for measurement or adaptation, using talking circles, interviews, focus groups, and surveys. Mixed methods may also be used in phase two if appropriate.
    • Although the studies supported by this initiative will not use a common study protocol, whenever possible, investigators should, to the extent possible, collaborate and report in a standardized manner when they are measuring key common variables. Investigators may also use different methods of measuring similar outcome variables when justified. Investigators may also collaborate in the development of formative assessment measures, such as survey instruments and focus group guidelines. 
    • Project teams should include relevant tribal or tribal organization staff as key personnel (or the equivalent).
    • Investigators are encouraged to collaborate for data archiving, such as selecting a single archive and archiving format, if that is acceptable to community collaborators
    • Outcomes of interest could include decreases in drug use and/or overdose deaths; length of time in treatment or recovery, including time using OUD medications and time to reuse; reducing treatment dropout; time to relapse; a resilience or physical or mental health or health-related outcome; and additional outcomes identified by the tribe, tribal organization or community as important.
    • Research should be consistent with community attitudes and desires
    • Interventions should be culturally appropriate and consistent with community values; they may include traditional health, medicine, and/or cultural practices. They could also consider resilience factors, both at the individual and community level.
    • For intervention research, applicants should choose rigorous study designs to test the effectiveness or efficacy of the proposed intervention and justify their approach. Designs for intervention research may include randomized controlled explanatory trials, randomized controlled pragmatic trials, or other types of controlled designs employing statistical approaches that mitigate bias and support causal inferences. Hybrid effectiveness-implementation designs may also be appropriate. Projects may incorporate randomization approaches appropriate to the research question, such as by cluster or timing of implementation. If another method is used to generate the comparison group, perhaps by staged assignment or staged implementation of the approach, it should provide comparable rigor. Randomization may occur at the patient, provider, clinic, or community level, as is appropriate to the research question. 

    Applicants proposing cluster-randomized trials are encouraged to consult relevant guidance documents issued by the NIH Health Care Systems Research Collaboratory: (http://sites.duke.edu/rethinkingclinicaltrials/biostatistical-guidance-documents/).  

    Applications focused on interventions that propose to use only pre- post-test designs without employing strong statistical methods designed to mitigate bias and support causal inferences are not responsive to this FOA and will not be reviewed or considered for funding. 

    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). PhenX measures related to mental disorders, suicide and demographic factors should be considered as well. 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

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

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

    Clinical Trial?

    Optional: Accepting applications that either propose or do not 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 $3,000,000 in FY 2019 to fund 3-4 awards.

    Award Budget

     Direct costs will vary with the scope of the project. Support for the R61 phase may not exceed $500,000 in any one year. The R33 phase direct costs must not exceed $500,000 in direct costs in any one year.

    Award Project Period

      The project period is limited to up to 2 years for the R61 phase and up to 4 years for the R33 Phase. Awards cannot exceed a total of 5 years of funding for combined phases one and two.   

    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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number 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.

     Involvement of American Indian and/or Alaska Native researchers and other appropriate professionals is encouraged.

    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. 

    R&R or Modular Budget

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

    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: 

    Specific Aims:

    The application should contain separate Specific Aims sections for the R61 and R33 phases and aims for both phases must fit in the one-page, single attachment.

    Research Strategy:

    Exploratory/Developmental Phased Award

    The application should contain separate Approach sections for the R61 and R33 phases.

    Separate Significance and Innovation sections may be included, but they could also be combined into a single section within the R61 section as appropriate.  It is not necessary to repeat any information or details in the R33 section that are described in the R61 section.

    Preliminary data, extensive background material or preliminary information are not required for an R61/R33 application; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  

    Milestones:

    A Milestone section must be included in the application. It must propose at least 3 milestones for completion of the R61 phase, a discussion of the suitability of the proposed milestones for assessing success in the R61 phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 study. Milestones should be specific, quantifiable, and scientifically justified; they should not be simply a restatement of the R61 specific aims.  At least one milestone must involve an assessment of the continued feasibility and value of the proposed R33, using information obtained in the R61 phase, and specifically considering any changes in the Opioid Tribal funding program.

    An example of a basic milestone might involve a power calculation demonstrating that the planned sample size is sufficient for the goals of the project.

    Recruitment of Individuals and Communities: 

    Applicants can propose to include one or more AI/AN communities to achieve the necessary sample size or otherwise enhance the scientific value of the study sample. Applicants must provide evidence of community support and of their ability to recruit participants in each community involved in the study, to implement measurement and intervention protocols in the target population, to provide appropriate oversight, and to maintain high rates of retention throughout the intervention and follow-up period.

    Study Design: 

    Applicants should choose rigorous study designs in general and where applicable to test the efficacy or effectiveness of the proposed intervention. While randomized designs are ideal for reducing threats to internal validity, other research designs will be given consideration. The research approach is a key factor and  investigators are encouraged to select a research design that will provide convincing evidence regarding the research questions. Applications must address concerns related to the quality of the research such as outcome variables and anticipated magnitude of change, psychometrics for planned measures, expected attrition, power estimation, and statistical analyses planned. Applicants should also provide plans for assessing fidelity of implementation and other relevant process measures, where relevant. Applicants are advised to consult with a methodologist and/or statistician when proposing a design with regard to its appropriateness for testing the proposed intervention, level of rigor, handling of missing data, and with regard to the data points needed for the planned analyses.

    It is imperative that applicants describe and justify the nature of any comparison/control group, including addressing, for example, whether the comparison group will receive usual care, information only, minimal treatment, or delayed intervention. Applicants should consult with collaborating communities to discuss the appropriateness of the selected approach to the comparison group, as tribal leaders and community members may believe that comparison group members should receive something more than usual care.

    Awardees will have primary responsibility for collecting, editing, storing, and analyzing their data. Awardees should oversee testing of their interventions and adherence to their protocols, and assure that appropriate quality control procedures are in place. Each awardee will be responsible for training and certification of personnel.

    Collaborations:

    Collaborators should address issues of ownership, control, and storage of data and biological samples in the application. However, NIH recognizes that communities may wish to retain ownership or control of data and biological samples. After award, partners should negotiate a formal and written data and biological sample agreement. This written agreement, once signed by all parties, should be submitted to NIH after award.

    Community Engaged Research and Community-based Participatory Research (CBPR):

    The community-researcher partnership should be documented in the grant application under Research Strategy to demonstrate the community's involvement in development, design, testing, and dissemination of the study, including establishing a Community Advisory Board if the community desires one. If this approach is used, the application should provide sufficient description of the anticipated intervention approach and its implementation for reviewers to assess its significance, innovation, and potential for public health impact. 

    Community Support: 

    Applications are expected to include evidence of: 1) strong scientific capabilities; and 2) community involvement and support.  Applications that represent collaborations between a tribe or community and a research organization should describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. The application should also describe the history of the partners in collaborating on prior research projects, or other mutually beneficial activities, the mutual understanding and cooperation among the partners, procedures for resolving disagreements, and the relative contributions to the previous projects.

    Standardization and Coordination 

    When applicable, Investigators should indicate in their application their willingness to collaborate on the development and use of standardized measurement protocols, and coordination of formative assessment and possibly of intervention approaches.

    Letters of Support: If the applicant(s) is working with tribes/Tribal governments then

    Tribal/community resolutions of support, or equivalent documents, must accompany the application.

    1. Applications that represent a partnership between a tribe or community and a research organization should include a resolution from the tribal or community government or equivalent document, specifying that the community or tribe agrees to participate as a partner in the project and will strongly support the project for its entire duration.

    2. Applications that include more than one tribe or community should include a resolution of support, or equivalent document from each participating tribe and community.

    3. If the application includes a consortium of tribes or communities, applicants should provide a resolution of support from each tribe or community of the consortium.

    4.  If the applicant is a tribally sanctioned non-profit tribal organization, specific tribal resolution(s) of support will not be required if the current tribal resolution(s) under which the organization operates encompasses activities proposed in the application. A copy of the current operational resolution(s) must be submitted with the application.

    5. Each tribal organization that participates in the project should also submit such a letter of support.

    6. If tribes seek ownership or control of all data and all biological samples, then universities and other partners should be prepared to negotiate data sharing and biological sample sharing agreements as appropriate and provide letters of agreement/partnership.

    7. In recognizing that tribal governments are legal sovereign nations, potential partners should be informed that tribes may seek ownership or control of all data and all biological samples; therefore, universities and other partners should be prepared to negotiate data sharing and biological sample sharing agreements with tribes/tribal government(s) as appropriate. If such an agreement is in place the applicant(s) should provide the letter of such an agreement with the application. Letters of Support should also explicitly stipulate that tribes agree to respond expeditiously to requests for approval of the protocol, protocol modifications, approval of abstracts for presentation to scientific meetings, and approval of manuscripts for submission for publication in scientific journals. The time required for approving each of these (protocol, abstracts, manuscripts): 1) must be proposed and stated within the resolution of support, 2) may differ for each of these activities, 3) may be modified by study investigators only in consultation with the tribal/community leadership, and 4) should identify an individual or entity within the tribe or community to whom a request for waiver of the time requirement can be directed if circumstances arise.

    8. To aid in the dissemination of study results to improve public health generally and for other AI/AN communities, PD/PI(s) and tribes/communities are expected to publish scientific papers, present at scientific conferences/associations/meetings; and may also be expected to develop fact sheets/materials for dissemination to the tribe/community.

    9. Because the application represents collaboration(s) between tribe(s)/community(ies) and research organization(s), the letters of support should also describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. The letter(s) of support should also describe the history of the partners in collaborating on prior research projects, or other mutually beneficial activities, the mutual understanding and cooperation among the partners, and the relative contributions to the previous projects.

    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:

    • Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    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

    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 components of participating organizations, 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.

    In addition, for applications involving clinical trials:

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

    For this particular announcement, note the following:

    An R61/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Reviewers will assign a single impact score for the entire application, which includes both the R61 and R33 phases.

     
    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 there a strong scientific premise for the project? 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? Note that generalizability to other populations is not necessary for significance, given that the population of focus for this FOA will, in some cases, be characterized by small samples and culturally distinct practices.

    In addition, for applications involving clinical trials

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

    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? Is there substantial and appropriate integration of community partner investigators into the research plan? Do the investigators commit adequate effort to successfully fulfill the program needs? Does the research team include adequate community and tribal representation that can ensure that the research will be acceptable and relevant for the setting? If investigators are located long distances from the research site, are plans for working within the site adequate?

    In addition, for applications involving clinical trials

    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? Is innovation apparent in that the concepts, approaches, methodologies or interventions are novel for the proposed population?

    In addition, for applications involving clinical trials

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

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?  Is there evidence of support for the approach by tribal leaders, if relevant, and/or other community members? Where relevant, will the study substantially involve tribal community members in study design, development, implementation, and interpretation, with the goal of engaging local and regional expertise? Are plans adequate for a strong collaborative environment? Does the approach include constructs and theoretical approaches that are of importance to the community, including cultural, resilience and/or strength-based approaches if relevant? While pilot data are not required, is the proposed work well justified through literature citations, or, when available, data from other sources or from investigator generated data?

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

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

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

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

    Data Management and Statistical Analysis

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

    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 children, 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? 

    In addition, for applications involving clinical trials

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

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

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    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

    Specific to applications involving clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the 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)?

    Does the project adequately consider the additional time it can take to conduct research in tribal communities given the tribal approvals and other factors that can increase the time it takes to conduct research?

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six 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 six 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 Children 

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

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    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.

    Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA.  For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. 

    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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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

    Not Applicable

    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)

    Kathy Etz, Ph.D.
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-402-1749
    Email: ketz@nih.gov

    Sarah Duffy, Ph.D.
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-443-6504
    Email: duffys@nida.nih.gov

    Mike Spittal, Ph.D.
    Office of Behavioral and Social Sciences Research (OBSSR)
    Telephone: 301-451-4286
    Email: Michael.Spittel@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: 301-480-1159
    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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