Part 1. Overview Information

Key Dates

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This FOA invites applications to provide infrastructure support for advancing the development of high-priority effectiveness research on recovery support services for individuals with opioid use disorder who received or who are being maintained on an FDA-approved medication for the treatment of this disorder. The infrastructure support will facilitate multi-stakeholder research networks through meetings, conferences, small-scale pilots, data development activities, short-term educational opportunities (such as intensive workshops, summer institutes, or visiting scholar programs), and dissemination to encourage growth and development of specified priority areas and build resources for advancing recovery support services efficacy/effectiveness research in the field at large. NIDA defines recovery as a process of change through which people improve their health and wellness, live self-directed lives, and strive to reach their full potential, and being in recovery is when positive changes and values become part of a voluntarily adopted lifestyle. Other definitions of recovery may exist and be relevant to this RFA. Recovery support services are thought to assist individuals with the recovery process.

Research is sought on the following recovery support services and settings:

• Peer-based recovery support services: Coaching, mentoring, education, support, linkage and other recovery-focused services delivered by individuals who have experienced substance use disorder and who are in recovery.
• Recovery community centers: Physical, community-based locations that offer a variety of peer-delivered services that may include those addressing basic needs (e.g. housing, income), linkages to social services, educational, employment, and social/leisure and activities, and offer a sense of identity and belonging to a positive peer group.
• Active recovery communities: Physical locations that offer exercise and community to those in recovery.
• Recovery residences: A supportive living environment for individuals in recovery from substance use disorder, which may or may not offer clinical services.
• Education-based recovery support services: Recovery high schools or collegiate recovery programs that support students in their recovery while also helping them achieve their academic goals.
• Clinical continuing care: Clinical recovery management interventions delivered after an index treatment episode.
• Other recovery support services for which significant efficacy or effectiveness research gaps exist.

Relevant stakeholders should include, but need not be limited to, researchers and students, recovery support services providers, public or private payers of services, and individuals in recovery.

Background

Effective treatments for opioid use disorders exist but may not be sufficient to assure long-term reductions in use and return to functioning. Though patients may be stabilized via formal treatment, changes in the structure and functioning of the brain due to drug use may affect reward processes, memory, motivation, impulse control and judgement that may take months or years to resolve and leave individuals vulnerable to resumption of use. At the same time, addictive behaviors may lead to unemployment, housing loss, criminal justice system involvement, and social isolation that can hamper a return to functioning. Furthermore, recovery needs may differ across the lifespan. Recovery support services have been developed to provide a variety of non-clinical services such as recovery coaching, linkages to employment, training and other social services, opportunities for rewarding social community activities, and community engagement, to address these needs. Such services may be provided as part of peer-based recovery supports, or by peers or professionals in recovery community centers, active recovery communities, recovery residences, and/or recovery high schools/collegiate recovery programs. Clinical continuing care services provided by professionals have also been designed to assist individuals during recovery. Although such services are proliferating, their effectiveness has not been adequately studied, and they may not be designed to meet the needs of individuals who have been prescribed medications approved by the FDA for the treatment of opioid use disorder, especially those who wish to continue on these medications indefinitely.

Recovery support services research is an emerging field that could benefit from infrastructure support. There is an urgent need to advance the field by promoting collaborative discussions of research priorities and development of the tools and methods that promote rigorous, comparable analyses that yield generalizable results useful to providers, individuals in recovery, payers and others. Such collaboration could also advance work on scientific principles that could lead to improved services and interventions. Agreed upon tools such as theoretical and conceptual models, valid and reliable instruments, uniform data sets, rigorous research designs and related statistical methods, could form a strong basis to provide needed, generalizable, information. Opportunities for students, junior investigators, and those from other fields interested in recovery research could add to the workforce needed to address these issues going forward as treatment research yields new and promising treatments, services evolve and substance use changes in response to emerging crises and policies.

The purpose of this FOA is to provide support for multi-stakeholder research networks, including researchers and students, persons in recovery, recovery services providers, public and private payers, and others, to develop the scientific foundations needed to drive meaningful, actionable advances in knowledge in this area.

Scope

This FOA is designed to address the network development needs of researchers interested in working with relevant stakeholders to advance actionable scientific research on the efficacy and/or effectiveness ("efficacy/effectiveness") of recovery support services for those in recovery from opioid use disorders. The goal is to produce resources that will serve the field at large.

For the purposes of this FOA, efforts to advance scientific research on the efficacy/effectiveness of recovery support services could include, but are not limited to, the following:

• Development and application of theoretical or conceptual models that elucidate appropriate targets and likely effects of recovery support services that may lead, for example, to widely used primary outcome measures
• Development and pilot testing of valid and reliable instruments to be used in the study of recovery support services
• Development of and dissemination uniform data sets to be used in the study of recovery support services
• Development of rigorous research designs and associated statistical methods tailored to the field of recovery support services in cases where randomized-control trials are not possible.

Network support includes all activities designed to bring together leading scientists across disciplines and institutions and relevant stakeholders to develop actionable research in an emerging priority area. This program is intended to be flexible and support the creation of innovative networks that will propose activities and bring unique resources necessary to advance a set of well-articulated research goals. The application should be designed to substantially advance the field of efficacy/effectiveness research on recovery support services via the proposed activities. Networks are intended to serve the broader community of individuals engaged in rigorous recovery support services research and are consequently unlikely to be limited to a single institution. Applications should propose activities designed to advance a field to the point of no longer requiring network support to sustain growth. Applicants should articulate criteria for assessing this progress.

Examples of network support activities include, but are not limited to, the following:

• Meetings, both large and small, to develop novel research areas and interact on the development of infrastructure.
• Small-scale pilots to develop data, theoretical frameworks, empirical methods, or support the development of novel or high-risk approaches requiring collaboration.
• Dissemination and outreach activities to draw researchers from relevant disciplines into the field.
• Educational activities such as intensive summer institutes, series of workshops, advanced seminars on methodology, or short-term residential opportunities.

A goal of network projects is to disseminate network resources to the field at large. These resources can include (but are not limited to) meeting papers/summaries; scientific publications; web resources; tools or guides to support research or data enhancement; data sets ranging from public-access "user-friendly" research data to meta-data, macro data or other aggregations of data to support research; and harmonized versions of existing data or instruments.

Networks may propose to support small-scale pilot projects. Network funding for pilot projects should either advance broad network goals or support preliminary studies with potential to form the basis for independent research applications consistent with network goals. Projects proposing small-scale pilot programs must propose how pilot projects will be solicited and reviewed in the Approach section of the Research Plan.

NOTE: Applicants are strongly encouraged to limit the number of key personnel on network applications, to avoid establishing conflicts of interest throughout the emerging field. Participation in network activities, including presentation at workshops, or serving as faculty on summer institutes, or receiving pilot funding, will not constitute formal collaboration from the perspective of NIH, with the exception of those key personnel listed on the application. An important consideration in developing a network is the potential to grow the field through recruitment of new investigators rather than sustaining only the original team.

For network activities that span multiple institutions, applicants are encouraged to propose how those activities will be coordinated across institutions, and how the proposed activities will effectively engage with other relevant activities at participating institutions. Projects are expected to propose a plan for dissemination of network products to the field at large, consistent with achieving the goals of the program.

Although applications for research on all populations who have received or are being maintained on medications to treat opioid use disorder are welcome, NIDA encourages applicants to consider including in their plans research related to individuals between the ages of 16-25 and those who use multiple substances.

NIDA encourages potential applicants to contact Scientific/Research staff listed in Section VII to discuss potential network development programs prior to submission of an application. NIDA encourages network applicants to support activities that will foster diversity of the scientific workforce.

Responsiveness Criteria

Responsive applications to this FOA must propose network activities (described above) that advance efficacy/effectiveness research on one or more of the recovery support services, either among the six specifically identified or others for which a strong justification can be made based on the lack of efficacy and effectiveness research and importance to the field. The application must reflect the intent of the FOA for developing research infrastructure as outlined in the Purpose and Scope sections. Applications in other areas will not be deemed responsive to this announcement and will not be reviewed.

Applications that propose activities that only serve investigators at a single institution will not be considered responsive and will not be reviewed.

Applications proposing to test the efficacy or effectiveness of therapeutic interventions are not responsive and will not be reviewed.

Section II. Award Information

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

• 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

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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 OR

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

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

Research Strategy: The application must propose research activities related to one or more of the above-mentioned types of services (peer-based recovery support, recovery community centers, active recovery communities, recovery residences, education-based recovery support services, clinical continuing care, other services that can be justified on the basis of lack of efficacy or effectiveness research and importance to the field).

The application must describe the state of the science related to the chosen recovery support services(s) and the importance of that service/those services to the field, and address how the proposed project will have a substantial impact on the progress and quality of efficacy and/or effectiveness research on them via the proposed activities. The application must address how the proposed networking activities will advance the field to the point of no longer requiring network support to sustain growth, and articulate criteria for accessing that progress. The application must propose new high impact activities that are not feasible with existing resources.

The proposed activities must advance a set of well-articulated research goals designed to substantially advance the field.

Networks are intended to serve the broader community of researchers engaged in recovery support services research and are consequently unlikely to be limited to a single institution. For network activities that span multiple institutions, applicants must explain how those activities will be coordinated across institutions, and how the proposed activities will effectively engage with other relevant activities at participating institutions.

The application must include plans for dissemination and access to ensure that the network and its products will be appropriately targeted for the highest impact to potential participants and beneficiaries in the field at large.

The application must describe how the proposed activities will have the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team.

Networks may propose to support small scale pilot projects. Network funding for pilot projects should either advance broad network goals or support preliminary studies with potential to form the basis for independent research applications consistent with network goals. Projects proposing small scale pilot programs must include a description for how pilot projects will be solicited and reviewed in the Approach section.

The application must describe the roles of PD/PIs and describe how they are suited to those roles given their experience and training, especially that related to experience and ongoing record of accomplishments in managing research projects related to recovery and coordinating collaborative research, as well as experience managing subawards if appropriate to the project. The application must describe the project team, including the inclusion of both established and emerging leaders in the scientific area of focus, and must describe expertise in resource sharing through web-based platforms or other means.

MPI Leadership Plan: In addition, for applications proposing multiple PDs/PIs, the application must describe the MPIs' complementary and integrated experience and skills, and the leadership plan must describe an approach, governance, and plans for conflict resolution and organizational structure appropriate for a network.

Letters of Support: The application must identify relevant stakeholders, including at a minimum a representative from a public or private payer and an individual in recovery, who will participate in the network. A letter of support from that individual or entity and a description of their planned participation in the network must be included. Such individuals may serve as key personnel.

The following modifications also apply:

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

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 with the following additional instructions:

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.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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.

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?

How well has the application justified the chosen recovery support service(s) based on research gaps and importance to the field? In what ways does the proposed Network address the needs of the research area that it intends to develop, and how well does the scope of activities proposed for the Network meet those needs ? What unique advantages or capabilities will successful completion of the aims bring to the emerging field?

In addition, for applications involving clinical trials

How well are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention 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?

Do the PD(s)/PI(s) have demonstrated experience coordinating collaborative research? Does the team include both established and emerging leaders in the scientific area of focus? Does the team include expertise in resource sharing through web-based platforms or other means? Do the PD(s)/PI(s) have experience overseeing selection and management of subawards, if needed?

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?

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 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 appropriately address how the proposed network will have a substantial impact on the progress and quality of research on the efficacy/effectiveness of recovery support services, by virtue of the proposed activities?

Are the proposed network activities likely to successfully solicit participation and input from multiple stakeholders and promote the production of research that can inform their decisions?

Are the proposed network activities likely to serve the broader community of recovery researchers in the designated scientific area beyond a single institution or set of institutions? For applications that span multiple institutions, are appropriate procedures in place for coordination across institutions and for effectively engaging with other relevant activities at participating institutions?

Is there an appropriate plan for dissemination of network products to the field at large that will ensure that the network and its products will be appropriately targeted for the highest impact to potential participants and beneficiaries? Does the application address how the proposed activities will have the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team?

Networks may propose to support small scale pilot projects to either advance broad network goals or support preliminary studies with potential to form the basis for independent research applications consistent with network goals. If proposed, is the approach for soliciting and reviewing pilot projects appropriately aligned with networks goals and likely to advance progress in the field at large?

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 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?

Are resources available within the participating scientific environment to support electronic information handling and development of web resources for dissemination of network products, if applicable?[

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?

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)?

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

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.

• 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.

• 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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

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

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

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

2. Administrative and National Policy Requirements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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.

3. Reporting

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Sarah Q. Duffy, Ph.D.
National Institute on Drug Abuse
Telephone: 301-451-4998
Email: duffys@nida.nih.gov

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

Jennifer Cho
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-0019
Email: jennifer.cho@nih.gov

Section VIII. Other Information