Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

National Center for Complementary and Integrative Health (NCCIH)

National Institute on Aging (NIA)

Funding Opportunity Title
HEAL Initiative: HEAL Data2Action Innovation Projects (R61/R33 Clinical Trial Optional)
Activity Code

R61/R33 Exploratory/Developmental  Phased Award

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-DA-22-051
Companion Funding Opportunity
RFA-DA-22-049 , U24 Resource-Related Research Project (Cooperative Agreements)
RFA-DA-22-050 , U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements
RFA-DA-22-052 , U24 Resource-Related Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.279, 93.213, 93.866
Funding Opportunity Purpose

As part of the NIH HEAL Initiative, the National Institute on Drug Abuse (NIDA) is releasing a set of interrelated RFAs to create the HEAL Data2Action (D2A) Program, a coordinated effort to promote the synthesis and real-world application of existing data to guide and monitor improvements in service delivery to prevent or treat opioid use disorder (OUD) and pain. Collectively, these projects will address gaps in the delivery of evidence-based practices in each of the four pillars of the HHS Overdose Prevention Strategy: primary prevention, harm reduction, treatment of opioid use disorder, and recovery support. Separate FOAs are being issued to support multiple HEAL D2A Innovation Projects (RFA-DA-22-051); one HEAL D2A Data Infrastructure Support Center (RFA-DA-22-052); one HEAL D2A Research Adoption Support Center (RFA-DA-22-050); and one HEAL D2A Economics and Modeling Resource Center (RFA-DA-22-049). It is imperative that prospective applicants read all of these related RFAs to better understand the intended purpose and structure of the HEAL D2A Program.

This FOA solicits applications for HEAL D2A Innovation Projects, which are phased awards intended to support local efforts, either within a single system or in cross-sector partnerships, to improve utilization of data to drive prediction and real-time proactive responses to the overdose crisis.

Key Dates

Posted Date
December 30, 2021
Open Date (Earliest Submission Date)
February 10, 2022
Letter of Intent Due Date(s)

February 10, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
March 10, 2022 Not Applicable Not Applicable July 2022 August 2022 September 2022

All applications are due by 5:00 PM local time of applicant organization. 

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

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

Expiration Date
March 11, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background: HEAL Initiative

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

Background: HEAL Data2Action Program

In the 12-month period ending in April 2021, more than 100,000 people lost their lives to overdose deaths. Deaths have continued to rise despite significant efforts and resources aimed at reversing these trends. Challenges related to rapidly collecting, interpreting, and using high-quality data to drive decisions and deploy resources in real time represents a major barrier to reversing these trends. The HEAL Data2Action Program is intended to promote real-time use of available data by health systems, communities, and related stakeholders to forecast service delivery needs, identify gaps, and inform proactive response in line with the 4 key pillars of the HHS Overdose Prevention Strategy: primary prevention (including pain management and appropriate opioid prescribing), harm reduction, treatment of opioid use disorder, and recovery support. Multiple Innovation Grants will work independently to identify, merge, and analyze local data to identify or forecast service delivery gaps relevant to addressing the overdose epidemic; select and deploy evidence-based interventions to fill those gaps; and utilize local data to monitor improvements in outcomes along the overdose prevention and opioid care cascade. Three support centers will provide technical assistance and related resources to assist the Innovation Grants in achieving their goals. Applicants to this FOA are strongly encouraged to review the companion FOAs for HEAL D2A Data Infrastructure Support Center(RFA-DA-22-052), the HEAL D2A Research Adoption Support Center (RFA-DA-22-050), and the HEAL D2A Modeling and Economic Resource Center (RFA-DA-22-049) to understand the scope and structure of the HEAL D2A Program.

A visual depiction of the structure and organization of this initiative can be found here: https://www.drugabuse.gov/sites/default/files/data_to_action.jpg

The HEAL D2A (HD2A) Innovation Projects will support local efforts, either within a single system or in cross-sector partnerships, to improve utilization of data to identify needs, drive prediction and inform real-time proactive responses to the overdose crisis. HD2A Innovation Projects will have a variety of infrastructure available to them to support their work.

HEAL Data2Action Innovation Projects: Purpose and Scope of Activities

HEAL Data to Action (HD2A) Innovation Projects are phased awards intended to demonstrate innovative approaches to using data to drive action and change in real-world settings. HD2A Innovation Projects have two tracks: (1) Single System Focus and (2) Cross-Sector Partnership focus. In both tracks, applications must propose a pragmatic, action-oriented project wherein data is used to guide action targeted at improving outcomes relevant to at least one of the four key pillars of the HHS Overdose Prevention Strategy: primary prevention (including pain management and appropriate opioid prescribing), harm reduction, treatment of opioid use disorder, and recovery support. Targeted actions may include, but are not limited to resource allocation; service delivery structure, staffing patterns; policy, practice or procedure changes; improving referrals and service linkages; adoption/implementation of evidence-based practices or measurement-based care; improving service quality, etc.

In the Single System Track, applications may identify key data-related gaps or inefficiencies that exist within a single, targeted system and propose an approach to improve use of existing data to identify service gaps and enhance service delivery. An example of a Single System application might involve a healthcare system that seeks to use data from one or multiple distinct service lines that operate under the same organizational structure.

In the Cross-Sector Track, applications may identify key data-related gaps or inefficiencies that require cross-sector partnerships to identify service gaps and improve service delivery. An example of a Cross-Sector project might involve a healthcare system partnering with community-based treatment providers and first responders to improve the transition of patients between emergency, primary, and specialty care. To maximize feasibility and ensure that the focus is on using data to inform action (rather than simply developing better methods of data integration), applicants are encouraged to limit the number of partnerships and justify the partnerships that will be established and including plans for how data will be integrated.

Across both tracks, examples of systems or stakeholders that could be engaged include, but are not limited to health systems, public health departments, behavioral health agencies, emergency departments, justice agencies, pain clinics, primary care clinics, Federally Qualified Health Centers, patient-advocacy groups, harm reduction agencies, recovery organizations, child welfare agencies, payers, and policy makers at local and state levels.

Applications in both tracks will be phased awards. Support will be provided for up to 5 years, which includes initial support of up to 2 years of the R61 phase, followed by up to 4 years of support for the R33 phase upon successfully meeting R61 milestones, as described herein.

Across both tracks, efforts should focus on improving relevant aspects of the data infrastructure (e.g., data capture, data timeliness, data sharing, data linkage, data utilization etc.) as necessary to support data-driven decision-making and real-time feedback loops. The ultimate goal of proposed projects should be focused on using data to drive action and improve overdose-relevant outcomes. Specifically, outcomes of the targeted actions must be relevant to at least one of the four key pillars of the HHS Overdose Prevention Strategy (primary prevention, harm reduction, treatment of opioid use disorder, and recovery support), and ideally project goals should be able to demonstrate near-term impacts. Applications are strongly encouraged to directly address how, if successful, the targeted actions would have an impact on overdose and/or opioid-related morbidity and mortality outcomes. Alternatively, applications could present a logic model for how, if successful, the proposed efforts are relevant to overdose and/or opioid-related morbidity and mortality and would have a meaningful impact on a related outcome. Applications are also strongly encouraged to consider the relevance of the cascade of care (i.e., prevention, identification, referral, engagement and retention in care, and recovery support) as an organizing framework. Applications are further strongly encouraged to take issues of equity into consideration.

The HEAL D2A Program includes three (3) Resource and Support Centers that will provide technical assistance and other support to participating Innovation Projects. These resource centers are intended to assist Innovation Projects in several ways, including: improving the utility of local data; applying simulation modeling in support of forecasting and decision-making; informing the selection of evidence-based practices and implementation strategies; and estimating the costs associated with various options and outcomes. Each Innovation Project will be expected to participate in a baseline needs assessment meeting with these centers to identify opportunities and options for their proposed projects. Innovation Projects will have access to ongoing and on-demand support from each of these resource centers throughout both phases of the projects.

Based on local data and input from relevant stakeholders and considering the support available from the HD2A Resource and Support Centers, applicants should propose projects likely to have a measurable and sustained impact on overdose and/or opioid-related outcomes, as relevant to their targeted element(s) of the Overdose Prevention Strategy, i.e., primary prevention, harm reduction, treatment of opioid use disorder, and recovery support. These projects should integrate data-driven decision making informed by new or improved partnerships with relevant organizational components (for Single System projects) or stakeholders (for Cross-Sector projects).

Examples of possible data-driven activities may include, but are not limited to:

  • Use of rapid-cycle testing to support the implementation of an evidence-based practice in OUD care, pain-management, or primary prevention not previously in available or provide access through referrals
  • Creation of cross-sector databases to support interdisciplinary patient care teams and successful referrals to relevant services (e.g., prevention, treatment, harm reduction, recovery, etc.)
  • Development of data dashboards and community coalitions to identify and prioritize prevention or treatment service delivery gaps
  • Improve measurement-based care of opioid use disorder
  • Improve measurement-based pain assessment and management with evidence-based treatments to reduce unnecessary opioid prescribing
  • Improve identification and linkage to primary prevention services or treatment for individuals with opioid use disorder (e.g., through use of consultation-liaison services)
  • Integrate data from pharmacies, Prescription Drug Monitoring Programs, or patient-reported outcomes into EHRs to inform clinician prescribing for pain management
  • Create partnerships to integrate research generated data with industry or protected data that are not currently accessible and use the data to improve care delivery
  • Integrate data to inform payer practices for prevention services, pain management, and/or opioid use disorder treatment

Phases of the Award & Milestones

This funding opportunity uses a R61/R33 Exploratory/Developmental Phased Award mechanism. Applications in both the Single System and the Cross Sector tracks will be phased awards. Support will be provided for up to 5 years, which includes initial support of up to 2 years of the R61 phase, followed by up to 4 years of support for the R33 phase upon successfully meeting R61 milestones.

The R61 phase is a planning phase that can be up to two years and will support activities that demonstrate feasibility of bringing together relevant stakeholders and data sources to support the proposed activities. It is expected that work during this phase will largely focus on issues related to (1) improving aspects of data necessary to support R33 phase activities (e.g., quality, timeliness, relevance, availability, interoperability, linkage and integration, privacy issues, etc.), (2) stakeholder engagement to ensure feasibility, buy-in, sustainability, scalability, etc., and (3) pilot testing the ability to use data to inform actions. Applications must delineate milestones that signify the completion of major elements necessary to support a larger scale innovation project in the second phase (e.g., accessing or improving timeliness of a specific dataset; establishing Memoranda of Understanding [MOU] to facilitate data sharing or working relationships with key stakeholders; establishing processes to use data in real-time; building dashboards, etc.). Applications are strongly encouraged to include contingency plans to proactively confront potential delays in meeting the milestones.

For transition to the R33 phase, recipientsmust submit the transition package no less than two months before the completion of the R61 phase. The transition plan should include the R61 progress report describing in detail the progress towards the R61 milestones and a description of how research proposed for the R33 phase will be supported by the completion of the R61 phase milestones. These materials will be evaluated by NIH program staff to determine if the milestones were met.

R33 funding decisions will be based on the original R61/R33 peer review recommendations, successful completion of transition milestones, any proposed changes to the R33 research based on R61 findings, program priorities, and availability of funds. It is not expected that all applications will continue to the R33 phase.

The goal of the R61 phase of the award is to demonstrate capacity to bring together necessary data sources and stakeholders to engage in an action-oriented project in Phase 2 of the project. The primary objective of the R33 phase should be to select and deploy evidence-based interventions or strategies related to service structuring or resource allocation to fill gaps in service delivery and to utilize local data to monitor improvements in overdose-related outcomes along the opioid care cascade. The objectives for the R33 phase should be based, at least in part, on findings from the R61 phase. The R33 phase of the project can include a clinical trial if appropriate to research questions and goals.

Pre-Application Consultation

Potential applicants are strongly encouraged to consult with NIDA Program staff early in the application development process. This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope of the project relative to the HEAL initiative mission and intent of this FOA. Inquiries may be emailed to: HEALdata2action@nih.gov.

Special Considerations:

The following applications will be considered non-responsive and will not be reviewed:

  • Applications that do not have direct relevance to one of the four pillars of the HHS Overdose Prevention Strategy
  • Applications that do not include a milestones plan

PI Meeting Attendance: TheNIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected thatNIH HEAL Initiative recipientswill cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

Diversity: In addition to scientific diversity, applicants should strive to address diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. Please refer to Notice of NIH's Interest in Diversity?NOT-OD-20-031?for more details.

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

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

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

Section II. Award Information

Funding Instrument

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

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

NIH intends to commit $6.75 million in FY2022 to fund 10-12 awards.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project. Unless well-justified, it is strongly recommended that applicants not request a budget of more than $350,000 in direct costs per year for the R61 phase and $750,000 in direct costs per year for the R33 phase.

Award Project Period

The scope of the project should determine the project period for each phase. The maximum period of the combined R61 and R33 phases is 5 years, with 1 to 2 years for the R61 phase and up to 4 years for the R33 phase. The R61 is a milestone-driven planning phase, with possible transition to the implementation phase (R33). Only R61 projects that meet the scientific milestones and feasibility requirements will transition to the R33 phase. The R61/R33 application must be submitted as a single application, following the instructions described in this FOA

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local 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)

Federal Government

  • 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.

  • 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.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from minority Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative, the letter may also be sent to:

Office of Extramural Policy and Review
National Institute on Drug Abuse/NIH/DHHS
301 North Stonestreet Ave
Bethesda, MD 20892

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.

Timeline & Milestone Plan (Required - 2 page maximum):

Applicants should include a Timeline and Milestone Plan, clearly specifying proposed milestones and when those milestones are expected to be achieved. Milestones for both phases should be specified, though it is expected that R33 milestones may change based on results from the R61 phase for awards that transition to the R33 phase.

SF424(R&R) Senior/Key Person Profile

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

Applicants are strongly encouraged to include relevant staff from partnered organizations as part of key personnel.

R&R Budget

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

Meetings and Travel: Applicants should assume that all meetings referenced throughout this RFA will be held virtually unless otherwise specified.

HEAL D2A Program Meeting(s):A virtual kickoff meeting will be held within 1 month of awards being made. PI(s) and other personnel will be expected to participate in baseline needs assessment meetings with the 3 HEAL Data2Action coordinating components during the first quarter of the first year, as well as mid-project needs assessment meetings if successfully transitioning to the R33 phase, and an end-of-project evaluation.

Budgets should include funds for travel for up to 3 people to participate in 3-day in-person HEAL Data2Action meetings to discuss findings in the 4th quarter of the first year of the award and the 1st quarter of the third year of the award in the Washington DC area.

HEAL Investigators’ Meeting: For budgeting purposes,include travel costs to support the attendance of one PD/PI(one person)at a 2-day, in-person HEAL Investigators meeting in the Washington DC area, annually for the duration of the award.

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:

In the single page attachment allowed for the specific aims, applicants should provide an overview of the overaching research question of interest as well as include clearly marked headers for “R61 Specific Aims” and “R33 Specific Aims” with brief descriptions of the aims specific to each phase of the study.

Research Strategy:

Section A: Research Strategy

The Research Strategy should be organized in a manner that will facilitate peer review. The body of the application should present an overview of the state of the science, current status and relevance of the proposed activities, and consideration of long-term sustainability and scalability of the proposed efforts.

The following criteria should be addressed:

Significance: The R61 and R33 should coherently address a single set of research questions and goals, with the R61 phase establishing feasibility and necessary data infrastructure for the R33 phase. Given this tight integration, only one Significance section is needed.

Applications should specify the track they are apply under (single system or cross-sector) and articulate the overall goals and scientific approach that will guide the proposed efforts, clearly specifying the problem that is trying to be solved and articulating the following:

  • Targeted systems and/or stakeholders & the targeted actions that are under the control of these systems/stakeholders, including a discussion of the relevance of these issues to organizations, systems, or communities other than those participating in the study
  • Targeted outcomes, including relevance to the four pillars in the HHS Overdose Prevention Strategy. If overdose-related morbidity and mortality outcomes are not included, applications should specifically address how the targeted outcomes are related to overdose and/or opioid-related morbidity and mortality.
  • Clear justification for why addressing the specific data-related gaps or inefficiencies should be able to lead to improvements in service delivery, including issues of sustainability and scalability
  • Discussion of other efforts funded by other federal, state, or local funders, including settlement funds, with special attention to the relevance of these efforts for sustainability and scalability. Applicants are strongly encouraged to leverage and build on other efforts currently active in the targeted systems/communities.
  • Quantify the scope of the expected impact of the proposed project, e.g.,, quantify the number of patients in the relevant geographic area (state, community, etc.) or targeted system where outcomes would be demonstrated
  • Supporting scientific justification

Innovation: Given this tight integration of the R61/R33 phases, only one Innovation section is needed. The Innovation section should explain how the proposed project, if successful, would lead to innovations that could improve the utilization of data to support and sustain action-oriented approaches to reduce overdoses or improve opioid-relevant outcomes not just in the targeted system or community, but how these findings might be more broadly applicable.

Preliminary data is not required for Innovation Grants nor is it required that teams have worked together previously. The phased award approach allows for earlier stage high risk/high reward projects. However, applications without preliminary data should have a strong scientific premise and establish a strong rationale for how solving the challenges outlined in the application would improve outcomes relevant to overdoses and/or opioid-related morbidity and mortality.

Approach: The application should contain separate Approach sections for the R61 and R33 phases, as described below. It is not necessary to repeat any information or details in the R33 section that are described in the R61 section. Applications should also include a Timeline & Milestone plan as an attachment as described in the SF424(R&R) Other Project Information. The approach sections may reference this attachment and should limit what is repeated from this attachment, except where necessary for clarity.

R61 (Phase 1) Approach:

The R61 Approach section application must include milestones that are expected to be achieved by the end of the R61 phase. Milestones should be specific, quantifiable, and scientifically justified; they should not be simply a restatement of the specific aims for the R61 phase.

All projects should include the following in the R61 approach section:

  • Specify the data-related gaps or inefficiencies being targeted
  • Plans for stakeholder engagement, including, where relevant, engagement with patients
  • Plans to understand and address issues of equity in service delivery
  • Description of plans to enhance the likelihood that innovations developed in the application will be sustained, including engaging relevant stakeholders
  • Length of R61 phase and specification of relevant milestones (see below)
  • Contingency plans if milestones cannot be achieved

Examples of Milestones for the R61 Phase:

  • Fully executed MOUs, letters of support, and data sharing agreements, as relevant to the goals of the study, from partnering departments, agencies or stakeholders
  • Data infrastructure milestones necessary to launch the R33 phase of the project (e.g., quality, timeliness, relevance, availability, interoperability, integration, etc.)
  • Demonstration of active engagement and partnership with key entities and stakeholders (e.g., formation of trans-department or trans-agency change teams)
  • If preliminary data was not included in original application, preliminary data demonstrating feasibility of R33 phase must be included.

For applications where there is no preliminary data or where new partnerships are proposed, applicants should be especially attentive to proposing milestones that will help establish the feasibility of their proposed R33 project.

R33, Phase 2 Approach

Although the Research Strategy for the R33 Phase is expected to be broad and flexible due to the nature of the explorative research in the R61 Phase, the research strategy for the R33 phase of the award should be described in enough detail for reviewers to evaluate the merit of this component of the application, based on anticipated results.

The proposed milestones for the R33 phase may be revised based on activities during the R61 planning phase. In the event of an award, the PD/PI and NIH staff will negotiate proposed changes and a list of appropriate milestones for each year of support.

The R33 phase may include a clinical trial if appropriate for the research questions and study design. Applications that propose a clinical trial in the R33 phase should include relevant information for the proposed clinical trial in the clinical trial attachment. As with milestones, the overall design of the R33 may be modified based on findings from the R61 phase, if appropriate. Any such modifications must be discussed in advance with NIH program staff and would include discussions of relevant changes to the proposed milestones.

Section B: Interaction with Data2Action Supportive Infrastructure

Awards made under this FOA are part of a coordinated initiative and as such will have access to a robust set of supportive infrastructure resources. Applications should demonstrate their capacity to do the proposed work, but it is also expected that additional needs could arise. The supportive infrastructure being funded under the HD2A program is meant to anticipate some of these additional needs. Specifically, the HD2A program will provide R61/R33 applicants with supportive infrastructure in the following areas:

  • Data infrastructure support
    • Data infrastructure, tools, resource support & coordination
    • Measurement & analytic support
    • Data-relevant training and resource support (e.g., access to visualization tools, etc.)
    • Data modernization support
  • Economic & modeling support
    • Predictive, simulation, geospatial, and cost modeling to aid in forecasting service needs
    • Costing tools to estimate costs of implemented changes and their outcomes
    • Consultation on the use of behavioral economic strategies to promote practice change
  • Research adoption support
    • Curated catalog of evidence-based practices and implementation strategies that may be deployed to support the adoption of new approaches to addressing pain and substance use disorder
    • Consultation on selection of implementation options in the absence of a strong evidence base
    • Guidance with the development of logic models and outcome measures

Applications should include a section describing how these resources could be used to extend the work proposed and describe capacity to interface with these resources, specifically addressing:

  • Expected support needed from the Data Infrastructure Support Center and how those resources will enable the acquisition, combination, and/or analysis of local data to drive decisions
  • Expected support needed from the Research Adoption Support Center, e.g., to identify potential evidence-based practices and implementation strategies to be deployed to address identified needs
  • How the project might work with the Economics and Modeling Resource Center, e.g., to forecast patient population needs, compare cost and cost-benefit associated with different implementation options, or to model potential locations for new service delivery sites

At a minimum, applicants should expect to engage in a virtual kickoff meeting with all recipientsof the HEAL Data2Action program and an in-person update meeting toward the end of year 1. In addition, all Innovation Grants will be expected to participate in needs assessments meetings with all Resource Centers in the first quarter of the award, a mid-course needs assessment upon transition to the R33 phase, and an end-of-project evaluation. Applicants should also expect to participate in regular check-ins with NIDA program staff.

Letters of Support: Include letters of support/agreement for any collaborative arrangements, subcontracts or consultants. For activities to be conducted at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the institutional officials, must be submitted with the application.

Applicants should include relevant letters of support from targeted systems or stakeholders. Where relationships with relevant systems or stakeholders do not exist or are not yet fully formalized, applicants should include formalizing these relationships as a milestone for the R61 phase.

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.

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

It is expected that most projects will use existing and/or administrative data that where there might be restrictions to sharing or limitations to the ability to collect new or different data. Even so, applicants should share when possible. Data sharing plans should be clearly described including any limitations on data sharing that may affect ability to comply with the HEAL Initiative Data Sharing Policy as described below .

Data sharing plans should align with the HEAL Initiative Public Access and Data Sharing Policy as described below.

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing.?Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. It isexpected that data generated by HEAL Initiative-funded projects will be submitted to study-appropriate domain-specific or generalist repositories in consultation with the HEAL Data Stewardship Group to ensure the data is accessible via theHEAL Initiative Data Ecosystem. Additional guidance on data related activities can be found athttps://www.healdatafair.org/.

To maximize discoverability and value of HEAL datasets and studies, and facilitate data integration and collaboration, applications submitted in response to this FOA are strongly encouraged to incorporate standards and resources where applicable:

  • Applicants are encouraged to ensure that data collected by the study conform to Findable, Accessible, Interoperable, and Reusable (FAIR) principles.
  • Applicants are specifically encouraged to incorporate into their planning, an alignment with the guidelines, principles and recommendations developed by the HEAL Data Ecosystem, including but not limited to preparing data to store in selected specified repositories, applying minimal metadata standards, use of core HEAL Clinical Data Elements (CDEs,https://heal.nih.gov/data/common-data-elements), and other necessary requirements to prepare data to connect to the HEAL Data Ecosystem.
  • All new HEAL clinical pain studies are required to submit their case-report forms/questionnaires to the HEAL Clinical Data Elements (CDE) Program. The program will create the CDE files containing standardized variable names, responses, coding, and other information. The program will also format the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C § 794 (d)), which “require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities.” HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program.

The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.

  • Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
  • NIH has provided guidance around selecting a repository for data generated by NIH-supported research and has developed desirable characteristics for all data repositories(NOT-OD-21-016).
  • NIH encourages the use of data standards including thePhenXToolkit (www.phenxtoolkit.org) (for example, see NOT-DA-12-008, NOT-MH-15-009
  • NIH encourages researchers to explore the use of the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data (NOT-OD-19-122). The FHIR® standard may be particularly useful in facilitating the flow of data with EHR-based datasets, tools, and applications.
  • NIH encourages clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in theUnited States Core Data for Interoperability (USCDI)standards, as they are applicable (NOT-OD-20-146).Use of the USCDI can complement the FHIR® standard and enable researchers to leverage structured EHR data for research and enable discovery.

Recipientsconducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124,NOT-OD-15-086).

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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. 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.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to the FOA: Does the proposed study propose a project that addresses a critical data-related gap or inefficiency that if addressed, could lead to significant improvements in service delivery ?

Does the application address issues of sustainability and scalability?

Does the application build on relevant efforts in the targeted system or community?

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?

Specific to the FOA: As appropriate to the proposed design, are key partners included as co-investigators and/or collaborators?

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?

Specific to the FOA: Does the proposed project have the potential to lead to innovations that could improve the utilization of data to support and sustain action-oriented approaches to reduce overdoses or improve opioid-relevant outcomes not just in the targeted system or community, but more broadly?

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?

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?

Specific to the FOA:

Are the milestones for the R61 phase well specified?

Does the plan include well thought out plans for stakeholder engagement and patient engagement?

Does the application take issues of equity into consideration?

Does the length of the R61 phase seem appropriate relevant for the scope of work proposed?

Are plans for the R33 phase well-articulated, including specification of research questions?

Do the plans for the R33 phase build in a logical way on the R61 phase?

Is there a well-articulated data sharing plan? Is this plan reasonable?

Does the application show a well-thought-out consideration for how it might take advantage of the infrastructure and resources offered through the HD2A program?

Does the application include sufficient resources dedicated to interfacing with other elements of the HD2A program?

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?

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)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2)  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 will receive a written critique.

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

Recipients 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: Recipient 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 recipient 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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

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.

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 and 2 CFR Part 200.206 “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, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

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

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

Scientific/Research Contact(s)

Tisha Wiley, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-594-4381
Email: HEALdata2action@nih.gov (preferred method of contact)

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

Devon Oskvig, Ph.D.
National Institute on Aging (NIA)
Phone: 301-827-5899
Email: devon.oskvig@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Pamela Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
Email: pfleming@nida.nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Jeni Smits
National Institute on Aging (NIA)
Phone: 301-827-4020
Email: jeni.smits@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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