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 Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Center for Complementary and Integrative Health (NCCIH)

Funding Opportunity Title
HEAL Initiative: HEAL Data2Action (HD2A) Data Infrastructure Support Center (U24 Clinical Trial Optional)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-DA-22-052
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-22-051 , R61/ R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II
Assistance Listing Number(s)
93.279, 93.213, 93.846
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 (HD2A) 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 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 Modeling and Economic 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 seeks applications for one HEAL D2A Data Infrastructure Support Center (DISC) to provide support for the HEAL D2A Innovation Projects. The Center’s primary purpose is to facilitate the compilation and use of data by local communities and health systems to identify trends and service delivery gaps, and to monitor improvements, related to substance use, pain management, and reduction of overdose outcomes. Activities will include (1) data infrastructure support and tools; (2) data measurement, analytical, and visualization support and coordination; (3) data training and resources; and (4) rapid data infrastructure modernization.

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 overdose-related 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 Innovation Projects (RFA-DA-22-051),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 at: https://www.drugabuse.gov/sites/default/files/data_to_action.jpg

HEAL D2A Data Infrastructure Support Center (DISC): Purpose and Scope of Activities

The HEAL D2A Data Infrastructure Support Center (DISC) will provide centralized support, resources, and coordination of all data-related needs for the HEAL D2A Innovation Projects. Ultimately this requires meeting the grantees where they are in their process of building capacity for using data to select, deploy, and monitor the impact of evidence-based services to address OUD and pain (targeting primary prevention, harm reduction, treatment of opioid use disorder, and/or recovery support). The DISC will develop an in-depth understanding of the HEAL D2A Innovation Projects selected for funding and identify and provide individual and cross-project grantee data-related support and resources needed to successfully carry out the Innovation Projects.

The HEAL D2A Data Infrastructure Support Center will:

  • Provide individualized, flexible support to the Innovation Projects for all data-related needs. The DISC will assist Innovation Projects in selecting and accessing appropriate tools, platforms, and other resources needed to support and sustain increased data infrastructure and use; provide technical support in utilizing these tools to support data-driven decision making about service delivery gaps and related needs in addressing the overdose epidemic; and identify cross-cutting resources that may be of general benefit to many or all Innovation Projects, and work collaboratively to make them available.
  • Provide measurement, analytical, and data visualization support to the Innovation Projects to build local capacity for data-driven decision-making.
  • Develop and deliver training and technical assistance resources.
  • Create a system for delivering rapid data infrastructure modernization support to Innovation Projects to respond to unforeseen or newly emerging, time-sensitive challenges and opportunities related to data acquisition and use.

The DISC will work collaboratively with the Research Adoption Support Center and the Modeling and Economic Resource Center to provide coordinated and non-duplicative support for the HEAL D2A Innovation projects. The HD2A Innovation Projects are 5-year phased awards, with a 1-2 year preparation phase and a 2-3 year implementation phase. Applicants to this FOA are strongly encouraged to read RFA-DA-051, HEAL Initiative: HEAL Data2Action Innovation Projects (R61/R33 Clinical Trial Optional) carefully to ensure they understand the nature and structure of the projects they will be supporting and take this phased structure into consideration as part of their planning.

Applications to this FOA should articulate a vision for providing infrastructure support to not only help accelerate the progress of the Innovation Centers, but also to translate and disseminate lessons learned about how to effectively use data to support a broader impact on the field. Note that HD2A Innovation projects may focus on enhancing capacity to use data to drive improvements in service delivery in either a single system or in cross-sector partnerships. The DISC is expected to be able to address the data-relevant needs that emerge in both of these settings. The DISC should have a strong scientific vision for how to address data-related barriers around actively using existing data that have hindered progress toward addressing the overdose crisis.

Note that RFA-DA-22-044, HEAL Initiative: Data and methods to address urgent needs to stem the opioid epidemic, and RFA-DA-22-045, HEAL Initiative: Exploratory Data and methods to address urgent needs to stem the opioid epidemic have related goals, but are not part of the HD2A initiative. RFA-DA-22-044 and RFA-DA-045 focus specifically on methods and tool development for improving use of existing data, with a particular emphasis on reducing data lags and improving efficient and practical surveillance. In contrast, the HD2A initiative focuses specifically on using data within organizations or cross-sector partnerships to improve capacity to identify service delivery gaps or enhance the delivery of evidence-based services. Therefore, applicants to this FOA (HD2A Data Infrastructure Support Center) should focus their scientific vision and proposed activities specifically on these data-related pragmatic and logistical issues that hinder and/or facilitate data use within organizations or in cross-sector partnerships.

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. A technical assistance webinar for applicants to the Data2Action initiative will be held on January 24th, 2022 at 2 pm EST. Information, including links, will be posted here: https://www.drugabuse.gov/news-events/meetings-events

Special Considerations:

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

  • Applications that exclusively or primarly focus on methodological issues that are most relevant to survelleince rather than service delivery. Applicants interested in these issues are encouraged to consider applying to RFA-DA-22-044 or RFA-DA-045 instead.
  • Applications that do not provide robust plans for providing individualized, flexible support to the Innovation Projects for all data-related needs

PI Meeting Attendance HEAL PI Meeting: The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH 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

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

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

The HEAL Initiative intends to commit $1.5 million in FY 2022 to fund 1 award.

Award Budget

Application budgets are limited to $1 million in direct costs per year but must reflect the actual needs of the project.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

  • 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.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

For budgeting purposes, applicants should assume that the HEAL D2A Program will support 12 Innovation Projects and 2 other Resource Centers (Research Adoption; Modeling and Economic).

Rapid DIMS: The DISC should budget at least $200,000 in direct costs each year to provide the HEAL D2A Innovation Projects with rapid data infrastructure modernization support (Rapid DIMS). Rapid DIMS awards can support a mix of direct purchases, contracts, and when appropriate, sub-awards.

Meetings and Travel: For budgeting purposes, applicants should plan for staff participation in the following meetings:

  • A virtual kickoff meeting for all HEAL D2A Program awardees to be held within 1-month post-award. (To be coordinated by the Research Adoption Support Center.)
  • Coordinating meetings (virtual) with the Modeling and Economic Resource Center and the Research Adoption Support Center, to be held monthly in Year 1 and quarterly thereafter, for the purpose of ensuring coordinated and non-duplicative support to the Innovation Projects.
  • Baseline needs assessment meetings with each of the Innovation Project grantees within 2 months of award; these should be coordinated with the other resource and support centers.
  • Applicants should budget for up to 3 staff to attend a 3-day in-person meeting of all HEAL D2A awardees in the 4th quarter of Year 1. Include travel, lodging and related expenses for the Washington DC metro area.
  • Applicants should budget for up to 3 staff to attend a 3-day in-person meeting of all HEAL D2A awardees in the 1st quarter of Year 3. Include travel, lodging and related expenses for the Washington DC metro area.
  • The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative recipients will 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. Applicants should budget travel expenses for one PD/PI to attend a 2-day in-person HEAL PI Meeting, in the Washington DC area, annually for the duration of this 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: The specific aims should address the overall goals of the Data Infrastructure Support Center, key research questions to be addressed, and how the applicants will support the Innovation projects and collaborate with the other HD2A Resource and Support Centers.

The Research Strategy should specify the overall vision of the HEAL D2A Data Infrastructure Support Center (DISC) and how this supports the overall HEAL Data2Action Program objectives. A clear plan should be included for coordinating with the HEAL D2A Research Adoption Support Center, the HEAL D2A Modeling and Economic Resource Center, and NIH program and scientific staff.

The research plan should include a description of the proposed DISC structure, activities, strategies, and timeline, as well as available data platforms and resources for use in supporting the Innovation Projects in the following areas.

Across the areas outlined below, applications should describe an overall vision for providing infrastructure support to not only help accelerate the progress of the Innovation Centers, but also to translate and disseminate lessons learned about how to effectively use data to support a broader impact on the field. The DISC should have a strong scientific vision for how to address data-related barriers around actively using existing data to support service delivery and proactive response in line with 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.

Data infrastructure support and tools

Applicants should describe how they will determine the data infrastructure and access needs across the Innovation Projects and provide access to a broad array of data tools, data resources, and existing datasets that will support the projects in meeting their aims.

Applicants should describe a clear plan and strategy to:

  • Assist Innovation Projects in selecting and accessing a broad array of tools, platforms, and other resources needed to support and sustain increased data infrastructure and use, including increased capacity for modernizing, collecting, sharing, storing, linking, visualizing, and analyzing data (e.g., Sharepoint/Box, Gen3 platforms, Tableau, Monday, R, Python, etc.). Applicants must demonstrate their capacity to identify project needs and to help Innovation Project grantees understand the benefits and tradeoffs of different tools specific to their local data environment, needs, and project aims.
  • Demonstrate flexibility in the amount and types of support provided to grantees, being capable of providing on-site, higher levels of support if necessary.
  • Provide logistical, scientific, and technical support for data collection and management by the Innovation Projects.
  • Identify potential key datasets that may be of broad interest to the Innovation Projects and/or to the HEAL D2A Program at large, and facilitate access to these datasets (e.g., Medicaid, IQVIA, NSDUH, etc.)
  • Coordinate information sharing across grantees about strategies for building data capacity, providing opportunities to learn more about successes, challenges, and solutions encountered.

The NIH HEAL Initiative also supports a HEAL Data Ecosystem, which aims to provide virtual open access to HEAL research data, findings, and publications as well as to establish a secure data access and computing environment. The research strategy should describe a plan for communicating and coordinating with the HEAL Data Ecosystem over the life of the HEAL D2A Initiative. Example activities might include participating in HEAL Data Ecosystem meetings, assisting Innovation Project grantees in responding to NIH requests for information about the HEAL D2A data, assisting Innovation Projects in complying with relevant HEAL Data Ecosystem requirements, and facilitating coordination between the HEAL Data Ecosystem team and the Innovation Project teams. See also healdatafair.org for more information on the HEAL Data Ecosystem resources to date.

Data measurement, analytic, and visualization support and coordination

Across the HEAL D2A Innovation Projects there will likely be a wide range of capabilities and needs for data measurement, analytics, and visualization, and the DISC will provide consultation and support as needed to assist the projects in meeting their aims. Applicants should describe their capacity, capabilities, and strategy for responding to a broad range of data-related consultation needs.

The research strategy should describe a plan to:

  • Provide individual Innovation Projects with analytic, measurement, and visualization consultation and support, as requested.
    • Applicants should be able to provide expertise and support across a broad range of basic analytic techniques and approaches. (Note that support with simulation modeling, cost analyses, and related economic analyses will be provided by the HEAL D2A Modeling and Economic Resource Center).
    • Areas of preferred expertise for the DISC include: administrative data management and analysis; measurement validation; data linkages; missing data techniques; analysis of randomized controlled trial data; data visualization and visual analytics; and qualitative data analysis.
    • The level of support needed for consultation will be unknown until Innovation Projects are selected for funding and might vary over time as projects carry out their work. Applicants should describe a flexible plan that allows for increasing or decreasing the level of consultation support as needed over the course of the initiative.
  • Assist in identifying advanced, novel data visualization opportunities for individual Innovation Projects as well as across projects. Provide resources and supports for creating and presenting data visualizations.
  • Routinely (virtually) convene staff across the Innovation Projects to create opportunities to share and learn about data measurement, analytic, and visualization experiences, challenges, and successes.

Data harmonization across projects is not required in this initiative. However, in case there is interest from the Innovation sites, the DISC applicants should describe their capability to support cross-project collaboration in establishing core measures for harmonization and establishing common data elements for both quantitative and qualitative data. The research strategy should include a plan for providing recommendations & infrastructure for a cross-project measures library, if relevant.

Data training and resources

The DISC is expected to develop a deep understanding of the data challenges and needs faced by the HEAL D2A Innovation Projects and offer a robust set of trainings, resources, and assistance to overcome those needs, meeting the grantees where they are in their process of building data capacity to take evidence-based action. In addition, the DISC will be responsible for dissemination of lessons learned about data sharing and data modernization with a wide audience of stakeholders across systems and communities similar to those where Innovation Projects are funded.

The research strategy should articulate a vision for providing infrastructure support to help accelerate the progress of the Innovation Centers, while also translating and disseminating those lessons learned to support a broader impact on the field. Specifically, the research strategy should include plans to:

  • Conduct a training needs analysis and develop and implement a series of trainings that address the most pressing and common challenges to modernizing, sharing, accessing, or using data across the Innovation Projects. Describe expertise and capacity to provide training on a wide variety of topics, including: data sharing best practices; data sensitivity and privacy concerns, particularly with regard to protection of personally identifiable information; information security; data linkage methodology and considerations; systems and tools for collecting, storing, and analyzing data; data visualization; IRB policies and procedures; data use agreements; etc.
  • Provide direct assistance or consultation with technical aspects of data sharing or linking protocols for individual Innovation Projects, as needed.
  • Based on common needs identified in the Innovation Projects and in collaboration with the NIDA Project Scientist, applicants should be prepared to develop a core set of these trainings to be made publicly available (i.e., beyond the D2A program grantees) to share lessons learned with other communities and systems, especially small, underserved and under-resourced communities and systems. Describe capacity and experience in developing and publicizing analogous trainings/webinars and evaluating their reach.
  • Build a public-use library of resources related to sharing and accessing data, for example model data user agreements, data transfer agreements, MOUs, IAAs, consent forms, etc., to be included on the HEAL D2A grantee portal (to be maintained by the Research Adoption Support Center).
    • Note that the Heal Data2Action Research Adoption Support Center (RASC) will be responsible for setting up a grantee portal for sharing information. Where possible, training and resources should leverage this portal and the DISC should coordinate closely with the RASC to avoid duplication of efforts. When relevant, the DISC should also coordinate and leverage resources available through the HEAL Data Ecosystem. However, grantees may also expand on existing resources they have already established (e.g., existing websites, listservs) to disseminate resources beyond the Data2Action initiative.
  • Coordinate and communicate with the HEAL Data Ecosystem Support Team to be sure data-related trainings provided through HEAL D2A are complementary to trainings and support services provided by the HEAL support team.

Rapid data infrastructure modernization support (Rapid DIMS)

The DISC will make available at least $200,000 in direct costs annually to provide the HEAL D2A Innovation Projects with rapid data infrastructure modernization support (Rapid DIMS) during the HEAL D2A Initiative. These resources are intended to support needs or opportunities unanticipated prior to award of the Innovation Projects. Rapid DIMS will provide flexible, timely financial support to assist HEAL D2A projects in overcoming unforeseen barriers, adapt to newly established policies or procedures affecting data sharing or linkage plans, or support unexpected opportunities for project enhancements that result due to increased partnerships and planning occurring in the early phases of the Innovation Grants. Example activities that might be funded include purchasing, testing, and implementation of new tools needed to build data infrastructure, developmental work necessary to establish new or strengthen existing intra-system or cross-sector data-sharing partnerships, and other research to inform newly emerging, time-sensitive issues related to data modernization, acquisition, and use. The Research Strategy for the Rapid DIMS program should not specify any planned awards or projects; these will emerge organically as the HEAL D2A Innovation Projects are carrying out their work. Final decisions about the selection, amount, timing, and duration of support will be made in consultation with the NIDA Project Scientist and Program Official.

The research strategy should provide a vision for structuring the Rapid DIMS program. The plan should describe:

  • A plan for administering the Rapid DIMS program.
  • A strategy for outreach and communication about the goals of the DIMS program to Innovation Project grantees.
  • A strategy for seeking applications, rapidly reviewing applications for need and merit (e.g., is the application addressing a time-sensitive, unforeseen need or opportunity? Will the DIMS funding help to overcome a challenge or enhance the project?), and making a funding recommendation to the NIDA Program Official, with input from the NIDA Project Scientist.
  • The timeline and workflow for application process. Applications must be received on a rolling basis, with funding awarded within 2 months of application submission.

Please note the following guidelines that must be incorporated into all plans for the Rapid DIMS award program:

  • All awards must observe regulations and policies that would apply if the award was made directly by NIH, including, but not limited to, clinical trials registration, IRB approval, OHRP approval, public access compliance for manuscripts, etc., as applicable.
  • The NIDA Program Officer will provide final approval on all Rapid DIMS program awards, with input from the NIDA Science Officer and the DISC.
  • The process should be as transparent as practicable. A summary of the awards made via the Rapid DIMS Program must be made available to all of the HEAL D2A Innovation Projects and Centers via a web-based grantee portal to be developed by the Research Adoption Support Center.
  • These awards should be to support data infrastructure, data acquisition, data visualization, or related data activities. Awards may not support activities for which technical assistance is available from the other resource and support centers (e.g., simulation modeling, cost analyses, development of logic models).

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.

It is not expected that the DISC will generate novel data, but where relevant, 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 is expected 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 the HEAL Initiative Data Ecosystem. Additional guidance on data related activities can be found at https://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 the PhenX Toolkit (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 the United 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.

Recipients conducting 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 NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. 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 this FOA: How strong is the overall scientific vision? How well does the proposed DISC support the overall mission of the HEAL D2A Initiative to promote real-time use of available data to forecast service delivery needs, identify gaps, and inform proactive response? Will the proposed DISC contribute significantly to advancing local data capacity needs? To what extent does the proposed DISC contribute to national resources and training around data innovation and capacity building, while also being aware of and leveraging existing resources? How robust are plans to translate and disseminate lessons learned about how to effectively use data to support a broader impact on the field?

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 this FOA: How adequate is the demonstrated capacity, expertise, and productivity among proposed DISC personnel related to: (a) selecting and identifying tools to increase data infrastructure, (b) providing measurement, analytical, and data visualization support to increase data-driven decision-making, and (c) developing and delivering training and technical assistance related to data capacity building? Do personnel have demonstrated experience working with diverse types of data, including potential datasets that might be accessible to enhance the work being carried out by the Innovation Projects or the other HEAL D2A centers? Do the key investigators have experience working collaboratively across diverse systems or with diverse teams that might be part of the HEAL D2A Initiative? Are the key investigators knowledgeable about or experienced working within a cooperative agreement grant?

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 this FOA: In particular, how innovative is the proposed DISC plan for assessing and responding to the needs of the Innovation Projects? How innovative are the proposed DISC efforts around training and resource sharing?

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 this FOA: Does the application include a detailed approach for providing tailored, broad, high-quality data-related support to the Innovation Projects? Does this approach take into account the breadth and range of assistance that might be needed across the Innovation Projects? How well does the application describe the DISC’s ability to provide data measurement, analytic, and visualization support and coordination? Is there a comprehensive plan for providing training, technical assistance, and access to model data-related policies and other documents that are available to the Innovation Projects and a broader audience? Does the application include a detailed, adequate plan for providing rapid data infrastructure modernization support (Rapid DIMS) to the Innovation Projects? Is there a clear approach for coordinating with the other HEAL D2A Centers over the life of the HEAL D2A Initiative?

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?

Specific to this FOA: How well does the application document the availability, knowledge of, and potential access to appropriate tools, platforms, technologies, and other resources needed to support the data related needs of the Innovation Projects and to broadly disseminate lessons learned about data sharing and data modernization?

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) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipient(s) in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipient(s) for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

The PD(s)/PI(s) of the HEAL D2A Data Infrastructure Support Center (DISC) in consultation with the NIH program staff will provide consultation and resources to support the HEAL D2A Innovation Projects, and will collaborate with the other HEAL D2A Resource and Support centers to ensure coordinated and non-duplicative support to these projects. Each individual Innovation Project acts independently to accomplish its research goals.

  • The PD(s)/PI(s) agrees to accept close coordination, cooperation, and participation of NIDA staff in those aspects of scientific and technical management of the DISC as stated in these terms and conditions.
  • The PD(s)/PI(s) of the DISC will have the primary responsibility to closely work with the Innovation Project directors to identify and respond to their needs for data infrastructure and analytic support to facilitate the selection, implementation, and measurement of interventions to be deployed in response to data-driven decisions to improve OUD- or pain-related care at their respective sites.
  • The PD(s)/PI(s) of the DISC will have the primary responsibility for designing and delivering appropriate training and technical assistance to support the access, integration, and use of local data.
  • The PD(s)/PI(s) of the DISC will have the primary responsibility for assisting individual Innovation Projects with analytic, measurement, and visualization consultation and support, as requested.
  • The PD(s)/PI(s) of the DISC will have the primary responsibility for developing a system to seek, review, and award funds to support specific, emergent Innovation Project data needs to modernize, enhance, or otherwise improve the utility of local data to support data-driven decision making and outcome monitoring.
  • The PD(s)/PI(s) will have the primary responsibility for measuring the nature, amount, and timing of technical assistance (consultation) provided to the Innovation Projects, and will provide this information to the Research Adoption Support Center to inform a formative evaluation of the HEAL D2A Initiative.
  • The PD(s)/PI(s) of the DISC will ensure ongoing communication and coordination with the Research Adoption Support Center and the Modeling and Economic Resource Center to ensure coordinated, timely, and non-duplicative support of the Innovation Projects.

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

The cooperative agreement will be assigned to a NIDA Project Scientist (PS). The PS will have substantial programmatic involvement that is above and beyond the normal stewardship role in the award and will be named in the award notice. The responsibilities of the PS include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities that is above and beyond normal program stewardship for grants. The PS will participate in the definition of objectives and approaches used by the Data Infrastructure Support Center in identifying data resources to be developed and delivered, providing consultation to the Innovation Projects, coordination with the other Resource and Support Centers, and contributing to a formative evaluation of the HEAL D2A Program.

Additionally, an NIH program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The PD(s)/PI(s) and the PS will work closely in evaluating the most appropriate methods used to support the HEAL D2A Program and monitor the nature, quantity, and utility of the data infrastructure and related supports provided to the Innovation Projects under this cooperative agreement.

Given the nature of the activities of this award, where the Data Infrastructure Support Center works with multiple Innovation Projects each executing their own local studies, it is recognized that timelines, activities, and interim objectives may require revision and renegotiation during the course of the project period. The Center’s PD(s)/PI(s) and NIDA Program Officer must agree to all such revisions.

Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three academic members who are not involved in the study will be convened. The first member will be named by the EMRC PD/PI; the second will be named by NIH; and a third individual with relevant expertise will be named by the other two appointees. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, 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)

Barbara Oudekerk, Ph.D.

National Institute on Drug Abuse (NIDA)
Telephone: 301-827-0641
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

Leslie K Derr, PhD
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: (301) 594-8174
E-mail: derrl@mail.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

Erik Edgerton
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-7760
E-mail: erik.edgerton@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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