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 Research Adoption Support Center (U2C Clinical Trial Optional)
Activity Code

U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-DA-22-050
Companion Funding Opportunity
RFA-DA-22-049 , U24 Resource-Related Research Project (Cooperative Agreements)
RFA-DA-22-051 , R61/ R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II
RFA-DA-22-052 , U24 Resource-Related Research Project (Cooperative Agreements)
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 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 Grants (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 FOAs to better understand the intended purpose and structure of the HEAL D2A Program.

This FOA seeks applications for one HEAL D2A Research Adoption Support Center to provide coordination and implementation support for the HEAL D2A Innovation Projects. The Center’s primary purpose is to support funded projects in the selection and adoption of evidence-based practices to address specific service delivery gaps in the areas of substance use prevention and treatment and pain management. The Research Adoption Support Center will also engage key stakeholders, conduct rapid-turnaround research projects addressing barriers to adoption, provide implementation science expertise, and conduct a formative evaluation of the HEAL D2A Program.

Key Dates

Posted Date
December 30, 2021
Open Date (Earliest Submission Date)
February 25, 2022
Letter of Intent Due Date(s)

February 25, 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 25, 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 26, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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



  3. 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 (HD2A) 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 Innovation Projects (RFA-DA-22-051), the HEAL D2A Data Infrastructure Support Center (RFA-DA-22-052), 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 Data2Action Research Adoption Support Center

The HD2A Research Adoption Support Center’s primary purpose is to support funded HD2A Innovation Projects in the selection and deployment of evidence-based practices to address service delivery needs, and in the evaluation of the Program overall. Other required elements are described further below. The HD2A Research Adoption Support Center (RASC) will bring synergy to the HD2A Program by working collaboratively with the HD2A Innovation Projects and the related resource and support centers.

The HD2A Research Adoption Support Center will provide coordination, communication infrastructure, logistical support, and limited research support for the broader HD2A Program. These activities include curating a catalog of evidence-based practices aligned with the four pillars of the HHS Overdose Prevention Strategy; providing technical assistance (consultation) to HD2A Innovation Projects on the selection of research-supported interventions for adoption along with appropriate implementation strategies; engaging a variety of key stakeholders whose roles are influential for the adoption of evidence-based practices; conducting rapid turnaround research projects; and conducting a formative evaluation of the HD2A Program.

Scope of Activities and Purpose:

The HD2A Research Adoption Support Center (RASC) will be structured in four cores. Cores may be located at different performance sites as long as there is a strong plan for internal communication and coordination. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team with the necessary expertise to support the implementation of evidence-based clinical interventions and best practices in substance use prevention, pain management, harm reduction, addiction treatment, and recovery support services.

  • Administrative Core: Activities in the Administrative Core will include project management; provision of communication and coordination infrastructure for the HD2A Program; and capacity to convene meetings of HD2A grantees, implementation experts, and key implementation stakeholders.
  • SUD Implementation Support Core: Activities of this core will promote the adoption of research-supported interventions by the HD2A Innovation Projects to address data-derived gaps in substance use prevention and treatment services. This will include (a) curating an online catalog of evidence-based practices, implementation strategies, and related resources in substance use prevention, treatment, harm reduction, and recovery support; (b) providing on-demand technical assistance (consultation) to the HD2A Innovation Projects on the development of logic models, the selection of evidence-based interventions, guidance on implementation strategies to promote their adoption, and selection of measures to assess their outcomes and sustainability; and (c) engaging key stakeholders to identify barriers to the adoption and sustainability of evidence-based interventions to address substance use.
  • Pain Implementation Support Core: Activities of this core will promote the adoption of research-supported interventions by the HD2A Innovation Projects to address data-derived gaps in pain management services, including appropriate opioid prescribing for pain. This will include (a) curating an online catalog of evidence-based practices, implementation strategies, and related resources in pain management, including opioid prescribing guidelines; (b) providing on-demand technical assistance (consultation) to the HD2A Innovation Projects on the development of logic models, the selection of evidence-based interventions, guidance on implementation strategies to promote their adoption, and selection of measures to assess their outcomes and sustainability; and (c) engaging key stakeholders to identify barriers to the adoption and sustainability of evidence-based interventions for pain management.
  • Research and Evaluation Core: This core includes two original research activities: discrete, rapid turnaround research projects to address implementation barriers identified by stakeholders, and a formative evaluation of the HD2A Program. This FOA will not support clinical trials to develop clinical interventions nor to test the efficacy of new or adapted interventions.

Specific detail on the requirements for each of these Cores is provided in Section IV. Collectively, these activities are expected to maximize the adoption of research-supported interventions in the HD2A Innovation Projects and inform a blueprint for further expansion of a Data-to-Action model.

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:

PI Meeting Attendance:  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.

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.

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

  • Applications that propose to conduct clinical trials to develop, adapt, or assess the efficacy of novel clinical interventions.

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

NIDA intends to commit $3 million in FY 2022 to fund one award.

Award Budget

Application budgets limited to $2 million direct costs per year but must reflect the actual needs of the proposed 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 Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
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 or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 INSTITUTES OF HEALTH  
NIDA/DER/OEPR 
3WFN 9th floor MSC 6021 
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.

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 6 Required 1 1
Admin Core Admin Core 12 Required 1 1
FOA-Specific SUD Support Core 12 Required 1 1
FOA-Specific Pain Support Core 12 Required 1 1
FOA-Specific Research Core 12 Required 1 1

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: required
  • Administrative Core
  • SUD Support Core
  • Pain Support Core
  • Research Core

Overall Component

When preparing your application, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims:

Specific aims should comprehensively address the goals of this FOA, which are to provide implementation support to the HD2A Innovation Projects, provide collaborative infrastructure for the larger HD2A Program, and further our understanding of the resources and processes necessary to promote adoption, implementation and sustainment of evidence-based practices to address the overdose crisis.

Research Strategy:

Applicants should describe the overall structure of their proposed Research Adoption Support Center (RASC).  This should include a description of the unique advantages or capabilities of the proposed center and how it will interact with the broader HEAL Data2Action Program. Applicants should demonstrate an understanding of the goals of the overall HD2A Program and how the RASC will relate to the Innovation Projects and other resource centers.  

The RASC should be viewed as interrelated Cores that provide support to individual HD2A Innovation Projects and to the Program as a whole; whose resources may inform other communities and health systems seeking to use data to drive change in service delivery; and whose results will inform a blueprint for potential broader data-to-action initiatives. In the Overall section, applicants should address how the various cores will be coordinated to function as an implementation resource. 

Because each Core should be strong individually and complementary to the other Cores and the broader HD2A Program, it is important to describe the synergy across Cores. Provide a strong plan to ensure that key personnel will collaborate effectively. Describe the organizational structure of the RASC including the Cores. Explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goals of the HD2A Program, and how combined resources create capabilities that are more than the sum of the parts. 

If Cores will be based at different locations, provide a strong plan for communication and collaboration. Applicants are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to the overall initiative. 

Describe work flow plans and timelines. 

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

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. Only letters relevant to the entire application should be submitted in this component. Letters specific to a core or project should be submitted in the relevant component.

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.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. The Data Sharing Plan included in the overall section should cover all general activities of the grant.

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.

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 items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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 (Overall)

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

ADMININSTRATIVE CORE

When preparing your application, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Admin Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

 

PHS 398 Cover Page Supplement (Admin Core)

Enter Human Embryonic Stem Cells in each relevant component.

 

Research & Related Other Project Information (Admin Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Admin Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Admin Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘CoreLead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

 

Budget (Admin Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Admin Core)

Specific Aims: Specific Aims should comprehensively address the goals of the HD2A Research Adoption Support Center, which are to provide coordination and collaboration infrastructure for the HD2A Program, and implementation support for the HD2A Innovation Projects. Specific Aims should identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives. 

 

Research Strategy:

Describe plans for the Administrative Core to provide coordination and collaboration infrastructure for the overall HD2A Program, including management of resources and organizational structure to support the Research Adoption Support Center’s Cores and Projects. 

As part of this section, applicants should describe their plan for completing the following activities: 

Establishing HEAL D2A grantee web portal and communications infrastructure: 

  • The RASC will develop a HD2A grantee portal (password-protected website).  The grantee portal will serve as a central repository for HD2A Program resources, and will facilitate communication between the grantee sites and the HD2A resource and support centers. The portal will host a searchable catalog of evidence-based practices and related implementation resources (the contents of which will be developed in the SUD and Pain Implementation Support Cores, described below). The portal should also host contact forms or similar means by which the Innovation Projects may request technical assistance from any of the Resource and Support Centers (RASC, Data Infrastructure, and/or Modeling and Economics). Applicants should describe other planned or potential features, e.g., contact list, descriptions of funded projects, publications library, resource library, etc. 

  • Describe plans to provide communication and coordination infrastructure for the HD2A Program.  At a minimum, this should include a secure document sharing platform to which grantees will have shared access. The latter should be integrated into, or seamlessly accessible from, the grantee portal. 

  • Confirm that the RASC will secure a HIPAA-compliant videoconferencing license to be used in hosting meetings with HD2A grantees and external stakeholders. 

  • Describe plans to ensure that chosen communication and collaboration infrastructure will be compatible with, and meet all security requirements of, participating sites, which could include hospitals and healthcare systems, community-based agencies, and state or local governments. 

  • It is expected that the Innovation Projects and the other HD2A Resource and Support Centers will supply their own project management, computing, and telecommunications resources to support their respective projects. The RASC shall provide only those additional resources that are necessary to facilitate communication and collaboration between grantees and the HD2A resource and support centers. 

Providing Logistical Support for Project Meetings 

  • Describe plans to provide logistical support and meeting planning support for virtual meetings of all HD2A Program grantees.  Assume 2 meetings per year, including a virtual kickoff meeting within 1 month following the project start date (Fall 2022).   

  • Provide logistical support for recurring virtual meetings between the RASC and the other two HD2A resource centers (Data Infrastructure and Modeling/Economics) to ensure coordinated support of the Innovation Projects. For staffing purposes, assume monthly meetings throughout Year 1, and quarterly meetings in the remaining years. 

  • Provide logistical support for an in-person meeting of HD2A Program grantees in the 4th quarter of Year 1 and the 1st quarter of Year 3. For planning purposes, assume each is a 3-day meeting in the Washington DC area, with 3 participants per grant, including the Innovation Projects, and the Data Infrastructure and Modeling and Economic resource centers, plus NIH staff. Include funds for hotel conference space in the event that NIH facilities are unavailable. (Grantees will cover the costs of their own travel and lodging.) 

  • For all project meetings, support should include but is not limited to scheduling, meeting facilitation, note taking, and posting of recordings and meeting summaries on the Grantee Portal. Meeting planning should be done in consultation with the NIH Program Official(s) and/or Project Scientist(s). 

Project Management for the Research Adoption Support Center 

  • Describe plans for efficient and effective management of the Research Adoption Support Center’s cores, ensuring coordination of the RASC’s activities; communication with NIH Program Official(s) and Project Scientist(s); leadership and oversight of key activities; monitoring of project timelines; rapid identification, mitigation, and reporting of identified problems or risks; and minimizing redundancy between Cores. 

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

Resource Sharing Plan:

A resource sharing plan is not required for the Admin Core. All activities in the Admin Core relevant to data and resource sharing must be covered in the Data Sharing Plan for the Overall component.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

PHS Human Subjects and Clinical Trials Information (Admin Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

 

SUD IMPLEMENTATION SUPPORT CORE

When preparing your application, use Component Type ‘SUD Support Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (SUD Support Core)

Complete only the following fields:

  • Applicant Information

  • Type of Applicant (optional)

  • Descriptive Title of Applicant’s Project

  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (SUD Support Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (SUD Support Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (SUD Support Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (SUD Support Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (SUD SupportCore)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (SUD Support Core)

Specific Aims:

The goal of the SUD Implementation Support Core is to provide informational resources and consultation to the HD2A Innovation Projects to promote the adoption of evidence-based practices in SUD prevention and treatment, harm reduction, and/or recovery support services. The HD2A Innovation Projects will utilize local data to identify service delivery gaps. The SUD Implementation Support Core will be an essential resource to guide the selection, implementation, and monitoring of evidence-based practices to reduce overdose risk using the best available information. Specific Aims should address these central elements of this Core.

Research Strategy:

The Research Strategy should articulate clear plans for achieving the Specific Aims of this Core.  At a minimum, the following elements must be addressed: 

Catalog of Evidence-Based and Promising Practices:  Describe plans for curating a catalog of evidence-based and promising practices for substance use prevention, addiction treatment, harm reduction, and recovery support. Multiple evidence-based practice registries and inventories exist across disparate platforms and formats, using different definitions of “evidence.” Grant funding should not be used to duplicate these existing resources. Rather, applicants should propose a strategy for conducting a rapid inventory of available resources; curating links (or obtaining electronic copies) of relevant resources; and creating a searchable and sortable catalog to be hosted on the web-based grantee portal. Applicants should articulate and justify a framework for assessing the level of evidence for a given intervention and applying this consistently to all entries in the catalog.  

In addition to evidence-based interventions and promising practices to address substance use and addiction, the catalog should also include links to existing resources outlining implementation strategies, measures, and tools to support the adoption of these interventions.   

The catalog should also include resources and best practices for avoiding the use of stigmatizing language or imagery related to substance use, misuse, addiction, HIV, criminal justice involvement, and other domains relevant to the HD2A Innovation Projects, their target populations, and their study settings.  As needed, the RASC should be prepared to consult with the HD2A Innovation Projects on appropriate use of non-stigmatizing and inclusive language and imagery.  

Where there are gaps in existing resources related to interventions, implementation processes, or stigma, or when important updates are needed (e.g., due to changes in Federal policy), the RASC may generate brief evidence summaries, guides, case studies, or reports of current best practices, to guide grantee and provider decision-making in response to these changes or in the absence of a clear evidence base. Applicants should articulate a plan for doing this. Applicants may not propose to conduct clinical trials to develop novel clinical interventions for SUD, nor to demonstrate the efficacy of new or adapted interventions. 

Emerging Research Summaries:  It is likely that new evidence-based and promising practices will emerge from HEAL- or other NIH-funded research projects during the RASC’s performance period. Applicants should articulate plans for developing rapid research summaries suitable for dissemination to HD2A grantees and inclusion in a supplemental section of the curated catalog.  

Technical Assistance (Consultation):  This Core will be responsible for providing on-demand consultation to the HD2A Innovation Projects to support their adoption of appropriate interventions to meet local needs. Propose a plan for providing consultation including but not limited to the development of logic models; selection of appropriate interventions, implementation strategies, and outcome measures; and advising on matters of sustainability, equity, and stigma. Facilitate linkages to the HD2A Data Infrastructure Support Center and the Modeling and Economic Resource Center where appropriate. As lessons are learned from consultations with HD2A Innovation Projects, applicants are encouraged to develop tools and other resources that anticipate these needs and make them broadly available. 

The need for technical assistance is likely to vary across the HD2A Innovation Projects, but applicants should plan to provide at least a baseline level of consultation for all projects. Note that all implementation activity will be carried out by the Innovation Project sites; the RASC’s role is to offer consultation, information, and guidance toward existing resources that may support these activities.  Describe an approach to capturing the nature, quantity, and extent of technical assistance provided to the grantees, such that it can be incorporated into the formative evaluation described in the Research and Evaluation Core.  

Stakeholder Engagement:  Despite best efforts, some interventions remain difficult to adopt, use with fidelity, or sustain over time. Applicants should articulate a plan and demonstrate capacity for engaging a panel of key stakeholders to identify these persistent implementation barriers and identify potential solutions.?Describe plans for identifying and engaging representatives of key stakeholder groups, considering the array of concerned parties (e.g., regulators, funders, insurers, clinicians, patients). Plan one or more virtual meetings per year to discuss implementation barriers with a Stakeholder Panel; these meetings will include NIH staff. Note that applicants should not recruit stakeholders prior to award. Rather, the application should articulate plans for identifying and engaging stakeholders post-award. 

Core Leadership. Leadership of this Core should include individuals with subject matter expertise in addiction health services and in implementation science. Leadership of this Core should also include one or more collaborators with extensive experience working with practitioners in real-world implementation settings. Because the technical assistance needs of the HD2A Innovation Project grantees will not be known until after award, applicants should describe plans for engaging subject matter experts in substance use prevention, SUD treatment, harm reduction, and recovery support services as needed to address grantees’ emergent needs and chosen interventions. This Core should reflect a blend of innovative implementation science approaches with pragmatic-real world focus to meet the projects where they are in their capacity to select, implement, monitor, and sustain adoption of appropriate interventions and services. 

Letters of Support: Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.  Letters of support should not be included from potential stakeholder groups. Rather, a plan for identifying and engaging these groups should be included in the Research Strategy Section, as specified above. Applicants will work with the NIH Project Scientist(s) to select the eventual Stakeholder Panel post-award.

Resource Sharing Plan: All activities in the SUD Support Core relevant to data and resource sharing must be covered in the Data Sharing Plan for the Overall component.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (SUD Support Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

 

 

PAIN IMPLEMENTATION SUPPORT CORE

When preparing your application, use Component Type ‘Pain Support Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Pain Support Core)

Complete only the following fields:

  • Applicant Information

  • Type of Applicant (optional)

  • Descriptive Title of Applicant’s Project

  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Pain Support Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pain Support Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Pain Support Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Pain Support Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pain Support Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Pain Support Core)

Specific Aims:

The goal of the Pain Implementation Support Core is to provide informational resources and consultation to the HEAL D2A Innovation Projects to promote the adoption of evidence-based practices in pain management, including appropriate opioid prescribing, with the ultimate goal of reducing the unnecessary use of opioid medications. These practices may include effective pain management treatments, clinical procedures or prescribing guidelines; nonopioid or nonpharmacologic approaches; multi-component interventions; and strategies to reduce patients’ transition from acute to chronic pain. The HD2A Innovation Projects will utilize local data to identify service delivery gaps. The Pain Implementation Support Core will be an essential resource to guide the selection, implementation, and monitoring of evidence-based practices and guidelines for pain management using the best available information. Specific Aims should address these central elements of this Core.

Research Strategy:

The Research Strategy should articulate clear plans for achieving the Specific Aims of this Core.  At a minimum, the following elements must be addressed: 

Catalog of Evidence-Based and Promising Practices:  Describe plans for curating a catalog of evidence-based and promising practices for pain management and appropriate opioid prescribing. Grant funding should not be used to duplicate existing registries and similar resources. Rather, applicants should propose a strategy for conducting a rapid inventory of available resources; curating links (or obtaining electronic copies) of relevant resources; and creating a searchable and sortable catalog to be hosted on the web-based grantee portal. Applicants should articulate and justify a framework for assessing the level of evidence for a given intervention and applying this consistently to all entries in the catalog. [Applicants are expected to deliver a single, comprehensive, searchable catalog including both SUD and pain-related resources, but for the purpose of the application the proposed staffing and activities should be addressed in their respective Cores.] 

In addition to evidence-based interventions and promising practices to address pain management and opioid prescribing, the catalog should also include links to existing resources outlining implementation strategies, measures, and tools appropriate for supporting the adoption of these interventions.   

The catalog should also include resources and best practices for avoiding the use of stigmatizing language or imagery related to substance use, misuse, addiction, chronic pain, and other domains relevant to the HD2A Innovation Projects, their target populations, and their study settings.  As needed, the RASC should be prepared to consult with the HD2A Innovation Projects on appropriate use of non-stigmatizing and inclusive language and imagery.  

Where there are gaps in existing resources related to interventions, implementation processes, or stigma, or when important updates are needed (e.g., due to recent changes in Federal policy or practice guidelines), the Center may generate brief evidence summaries, guides, case studies, or reports of current best practices, to guide grantee and provider decision-making in response to these changes or in the absence of a clear evidence base. Applicants should articulate a plan for doing this. Applicants may not propose to conduct clinical trials to develop novel clinical interventions for pain management, nor to demonstrate the efficacy of new or adapted interventions. 

Emerging Research Summaries:  It is likely that new evidence-based and promising practices will emerge from HEAL- or other NIH-funded research projects during the Center’s performance period. Applicants should articulate plans for developing rapid research summaries suitable for dissemination to HD2A grantees and inclusion in a supplemental section of the curated catalog. 

Technical Assistance (Consultation):  This Core will be responsible for providing on-demand consultation to the HD2A Innovation Projects to support their adoption of appropriate interventions to meet local needs related to pain management. Propose a plan for providing consultation including but not limited to the development of logic models; selection of appropriate interventions, implementation strategies, and outcome measures (including, where appropriate, the HEAL common data elements for pain and co-occurring conditions); and advising on matters of sustainability, equity, and stigma. As lessons are learned from consultations with HD2A Innovation Projects, applicants are encouraged to develop tools and other resources that anticipate these needs and make them broadly available. 

The need for technical assistance is likely to vary across the HD2A Innovation Projects, but applicants should plan to provide at least a baseline level of consultation for all projects. Note that all implementation activity will be carried out by the Innovation Project sites; the RASC’s role is to offer consultation, information, and guidance toward existing resources that may support these activities. Describe an approach to capturing the nature, quantity, and extent of technical assistance provided to the grantees, such that it can be incorporated into the formative evaluation described in the Research and Evaluation Core. 

Stakeholder Engagement:  Despite best efforts, some interventions remain difficult to adopt, use with fidelity, or sustain over time. Applicants should articulate a plan and demonstrate capacity for engaging a panel of key stakeholders to identify these persistent implementation barriers and identify potential solutions.?Identify potential pain/prescribing stakeholder groups, considering the array of concerned parties (e.g., regulators, funders, insurers, clinicians, patients). Plan one or more virtual meetings per year to discuss implementation barriers with the Stakeholder Panel; these meetings will include NIH staff.  Note that applicants should not recruit stakeholders prior to award. Rather, the application should articulate plans for identifying and engaging stakeholders post-award. 

Core Leadership: Leadership of this Core should include individuals with subject matter expertise in pain management and in implementation science. Leadership of this Core should also include one or more collaborators with extensive experience working with practitioners in real-world implementation settings. Because the technical assistance needs of the HD2A Innovation Project grantees will not be known until after award, applicants should describe plans for engaging subject matter experts in clinician-delivered pain management interventions, opioid prescribing guidelines, and patient self-management of pain as needed to address grantees’ emergent needs and chosen interventions. This Core should reflect a blend of innovative implementation science approaches with pragmatic-real world focus to meet the projects where they are in their capacity to select, implement, monitor, and sustain adoption of appropriate interventions and services. 

Letters of Support: Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.Letters of support should not be included from potential stakeholder groups. Rather, a plan for identifying and engaging these groups should be included in the Research Strategy Section, asspecified above. Applicants will work with the NIHProject Scientist(s)to select the eventual Stakeholder Panel post-award.

Resource Sharing Plan: All activities in the SUD Support Core relevant to data and resource sharing must be covered in the Data Sharing Plan for the Overall component.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Pain Support Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

RESEARCH AND EVALUATION CORE

When preparing your application, use Component Type ‘Research Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

  • Applicant Information

  • Type of Applicant (optional)

  • Descriptive Title of Applicant’s Project

  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Core)

Specific Aims:

This Core will support discrete, rapid turnaround research projects in response to stakeholder-identified implementation barriers, and a formative evaluation of the HEAL D2A Program.  Specific aims should reflect these goals, along with a vision for how these activities will interrelate with the other Cores. 

Research Strategy:

The Research Strategy should describe plans for each of the following activities: 

Formative Evaluation of the HEAL D2A Program:  The HEAL D2A Program is expected to fund a variety of Innovation Projects representing a diverse array of settings, partnerships, and existing data resources. Projects’ needs for technical assistance, and their ability to support data integration, implementation activities, and modeling and economic analyses are likely to be quite variable. Likewise, projects’ local data, service delivery systems, populations and stakeholders may lead to a variety of decisions about service needs and priorities. The Research Adoption Support Center will conduct a formative evaluation to provide NIH with insight about the nature and amount of technical assistance necessary to support the Innovation Projects in creating or augmenting data systems to enable identification of needs, selection of appropriate interventions, implementation, sustainability, and monitoring of outcomes. This information may be used to inform future initiatives of this kind.  

The Research Strategy should describe a plan for conducting this formative evaluation. Data for this evaluation should include, but is not limited to, periodic meetings with each of the Innovation Project teams -- including a baseline needs assessment meeting, an end-of-project exit meeting, and periodic interim meetings as needed; data captured by or from the Data Infrastructure Support Center and Modeling and Economic Resource Center on the timing, nature, and extent of support provided to each of the projects; and other qualitative or quantitative data collected from the Innovation Projects. Applicants are encouraged to minimize data collection burden on the Innovation Project teams. 

Applicants should propose a timeline for delivery of interim reports on the formative evaluation that will allow for timely decision-making and potential course-corrections by NIH.  At minimum, interim reporting intervals should be planned for Year 1 (post-baseline); Year 3 (post-transition); and Year 5. Applicants should also propose a dissemination plan for sharing findings, case studies, and other lessons learned more broadly, as appropriate. 

Applicants are reminded that other grant awardees and project participants (e.g., clinicians, community-based organization staff, stakeholders) from whom qualitative or quantitative data may be collected – including for the evaluation of the HEAL D2A Program – are considered human subjects.  Inclusion and enrollment tables and appropriate human subjects protection plans are required when these activities are proposed. 

 

Rapid Turnaround Research Projects:  Stakeholder Panels engaged in the SUD and Pain Implementation Cores are likely to identify persistent or emerging barriers to the implementation or sustainability of evidence-based practices under a variety of circumstances. Applicants should describe their capacity to conduct discrete rapid turnaround research projects to clearly articulate specific barriers identified by stakeholders and identify potential strategies to mitigate, remove, or overcome these barriers – including whether additional research is needed. The first of these projects, to be conducted in Year 1, must focus on the role of insurance coverage and other financing and reimbursement barriers to the adoption and widespread use of medications for opioid use disorder (MOUD). Propose a project that would gather information needed to identify existing barriers and engage key stakeholders to identify potential transformative solutions. The goal of the project is to identify modifiable barriers and prioritize next steps (i.e., the RASC is not expected to conduct a large implementation trial). Applicants are strongly encouraged to specify one or more implementation science frameworks that will guide the approach to these activities. 

Applicants should not propose specific projects for Years 2-5 in the application. Rapid turnaround research projects to be conducted in Years 2 through 5 are expected to emerge organically from Stakeholder Panel discussions, and to be developed in consultation with the NIH Project Scientist(s). These projects may address a mix of SUD and pain topics. For planning purposes, examples of other such projects might include (but are not limited to) rapid cycle testing of an implementation strategy in one of the Innovation Project sites; pilot testing the feasibility, acceptability, or utility of dissemination materials or media; conducting focus groups with patients and families to assess acceptability of particular clinical interventions or barriers to treatment access; or examination of analogous data-to-action activities outside of the HEAL D2A Program and their impact on real-world adoption of research findings.  

 

For the purposes of this application, the Rapid Turnaround Research Projects planned for Years 2 through 5 should be treated as Delayed Onset studies.  

 

An NIH-defined clinical trial may be proposed as part of Research and Evaluation Core, but is not required. 

 

Leadership of this Core should include investigators with extensive experience in program evaluation, stakeholder engagement, and implementation science, including collaborators with experience working with practitioners and decision-makers in real-world implementation settings.   

 

Letters of Support: Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.Letters of support should not be included from potential stakeholder groups. Rather, a plan for identifying and engaging these groups should be included in the Research Strategy Section, asspecified above. Applicants will work with the NIHProject Scientist(s)to select the eventual Stakeholder Panel post-award.

Resource Sharing Plan: All activities in the Research Core relevant to data and resource sharing must be covered in the Data Sharing Plan for the Overall component.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (SUD Support Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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) using ASSIST or other electronic submission systems. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDA. 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.

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 - Overall

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 - Overall

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?

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?

For the Administrative Core:

  • Is the RASC leadership structure sufficient, including its internal and external procedures for managing the activities of the RASC and supporting the HEAL D2A Program?
  • Does the Director have the leadership and research qualifications to lead the Administrative Core?
  • If investigators for different Cores will be located at different institutions, is a strong plan for coordination presented?

For the SUD Implementation Support Core:

  • Does the investigator team include one or more collaborators with expertise in implementation science? Does the team (internally or via named consultants) have expertise in SUD prevention, harm reduction, addiction treatment, and recovery support services?
  • Does the investigator team include one or more collaborators with experience working with practitioners in real world settings?

For the Pain Implementation Support Core:

  • Does the investigator team include one or more collaborators with expertise in implementation science? Does the team (internally or via named consultants) have expertise in pain management?
  • Does the investigator team include one or more collaborators with experience working with practitioners in real world settings?

For the Research and Evaluation Core:

  • Does the leadership of the Research and Evaluation Core include individuals with the requisite skills to successfully manage and complete the proposed research and evaluation activities?

In addition, for applications involving clinical trials

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Overall:

  • Does the Data Sharing Plan clearly articulate a vision for maximizing sharing of data and resources across all RAS components?

For the Administrative Core:

  • Are there appropriate plans for establishing a web-based grantee portal; internal collaboration and communication infrastructure; and providing required logistical support as outlined in the FOA?
  • Is there an appropriate plan for establishing and maintaining effective communication and cooperation among the RASC cores? With the Data Infrastructure Support Center and Modeling/Economic Resource Center? With the HEAL D2A Innovation Projects?

For the SUD Implementation Support Core:

  • Does the approach demonstrate familiarity with existing evidence-based interventions for SUD prevention, harm reduction, addiction treatment, and recovery support? Does the applicant demonstrate familiarity with existing practice registries or analogous resources that can be curated in support of the D2A Program?
  • Does the approach include a defensible definition of “evidence-based” practices and is this appropriately applied in the plans for curating a catalog of interventions to be used by the Innovation Projects?
  • Does the approach demonstrate working knowledge of implementation strategies, logic models, and other concepts necessary to provide well-reasoned consultation and support to the Innovation Projects?
  • Does the approach articulate a clear plan for assessing the needs of the Innovation Projects and addressing those needs through consultation or, when necessary, the development of additional materials or resources? Do they anticipate potential problems?
  • Does the approach include a plan for identifying and convening relevant SUD stakeholder groups?

For the Pain Implementation Support Core:

  • Does the approach demonstrate familiarity with existing evidence-based interventions for pain management, including appropriate opioid prescribing? Does the applicant demonstrate familiarity with existing practice registries, guidelines or analogous resources that can be curated in support of the D2A Program?
  • Does the approach include a defensible definition of “evidence-based” practices and is this appropriately applied in the plans for curating a catalog of interventions to be used by the Innovation Projects?
  • Does the approach demonstrate working knowledge of implementation strategies, logic models, and other concepts necessary to provide well-reasoned consultation and support to the Innovation Projects?
  • Does the approach articulate a clear plan for assessing the needs of the Innovation Projects and addressing those needs through consultation or, when necessary, the development of additional materials or resources? Do they anticipate potential problems?
  • Does the approach include a plan for identifying and convening relevant pain management stakeholder groups?

For the Research Core:

  • Does the approach articulate a clear and logical plan for conducting a formative evaluation of the HEAL D2A Program? Is the evaluation informed by qualitative and quantitative data gathered from all components of the HEAL D2A Program?
  • Is the formative evaluation, as designed, likely to provide NIH with useful information about the resources needed to support future data-to-action initiatives?
  • Does the approach include a detailed plan to conduct a rapid-turnaround research project focused on the role of insurance coverage and other financing barriers to the widespread adoption of medications for opioid use disorder in clinical practice? Do these plans indicate a working knowledge of existing implementation barriers? Is the project as described likely to elicit actionable suggestions from stakeholders to inform recommendations for next steps to address these barriers?
  • Is there a reasonable plan for developing rapid research projects in response to stakeholder-identified concerns in years 2-5?

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?

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 - Overall

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 - Overall

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).

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in theNIH 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.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the 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).

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

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: Generaland 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 identity, 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 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.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

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 Research Adoption Support Center (RASC) in consult with the NIDA program staff will provide communications infrastructure and logistical support for meetings of the HEAL D2A Program recipients, and provide implementation resources and consultation for the HEAL D2A Innovation Projects. Each individual Innovation Project acts independently to accomplish its research goals.

Under this FOA, the RASC will establish a curated catalog of evidence-based and promising practices to support the prevention and treatment of OUD, effective management of pain, and appropriate opioid prescribing. In addition, the catalog will include a curated set of implementation strategies and related resources to facilitate the adoption of these practices by participating entities, as well as best practice guidance for avoiding stigma and addressing health equity. This searchable and sortable catalog will be made available to all of the HEAL D2A program components via a secure grantee portal. This catalog will form the basis of the technical assistance (consultation) to be provided by the RASC to the Innovation Projects.

  • 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 RASC as stated in these terms and conditions.
  • The PD(s)/PI(s) of the RASC will have the primary responsibility to closely work with the Innovation Project directors 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 RASC PD(s)/PI(s) will have the primary responsibility to convene periodic meetings of the HEAL D2A awardees to facilitate communication about the resources available from the Resource and Support Centers, and to support the Innovation Project teams in sharing their current research efforts that may be mutually beneficial to the broader program.
  • The RASC PD(s)/PI(s) will have the primary responsibility for naming representatives to a Stakeholder Panel, and to periodically convene that panel to discuss barriers and potential solutions to implementing specific evidence-based practices for OUD and pain.
  • The RASC PD(s)/PI(s) will design and execute rapid turnaround research projects to further explore implementation barriers (or to identify potential implementation facilitators) in response to issues raised by the Stakeholder Panel.
  • The RASC PD(s)/PI(s) will have the primary responsibility for conducting a formative evaluation of the HEAL D2A initiative.

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 one or more Project Scientists (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 RASC in coordinating activities of the HEAL D2A Program, providing consultation to the Innovation Projects, engaging the Stakeholder Panel, and designing evaluation and research activities.

Additionally, an agency program official or IC program director 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 coordinate activities of the HEAL D2A Program and monitor the effectiveness of the implementation supports provided to the Innovation Projects under this cooperative agreement.

Given the nature of the activities of this award, where the RASC 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 RASC Program Director/Principal Investigator 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 RASC 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 75and 2 CFR Part 200 – Award Term and Condition 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)

Lori Ducharme, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-827-6331
Email: HEALdata2action@nih.gov

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 and 2 CFR Part 200.

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