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 on Alcohol Abuse and Alcoholism (NIAAA)

National Center for Complementary and Integrative Health (NCCIH)

Funding Opportunity Title
HEAL Initiative: HEAL Data2Action – Acceleration Projects (R33 Clinical Trial Not Allowed)
Activity Code

R33 Exploratory/Developmental Grants Phase II.

Announcement Type
New
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
September 28, 2022 - Notice of Pre-Application Technical Assistance Webinar for NIDA RFA-DA-23-057 and RFA-DA-23-058. See Notice NOT-DA-22-080.

Funding Opportunity Announcement (FOA) Number
RFA-DA-23-058
Companion Funding Opportunity
RFA-DA-23-057 , R61/ R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II
Assistance Listing Number(s)
93.279, 93.213, 93.273
Funding Opportunity Purpose

As part of the NIH HEAL Initiative, the National Institute on Drug Abuse (NIDA) is releasing a set of interrelated Funding Opportunity Announcements (FOAs) to create the HEAL Data2Action (HD2A) Program, a coordinated effort to promote the synthesis and real-world application of existing data to improve epidemiology and guide and monitor improvements in service delivery to prevent or treat opioid use disorder (OUD) and pain. Collectively, these projects will improve the quality, timeliness, accessibility and usefulness of data for epidemiology and service delivery 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 have been issued to support multiple HD2A Innovation Projects (RFA-DA-22-051); one HD2A Data Infrastructure Support Center (RFA-DA-22-052); one HD2A Research Adoption Support Center (RFA-DA-22-050); and one HD2A Economics and Modeling Resource Center (RFA-DA-22-049). It is imperative that prospective applicants read all of these related RFAs to better understand the intended purpose and structure of the HD2A Program.

This FOA seeks applications for HEAL Data2Action (HD2A) Acceleration Projects. Research Projects will focus on developing data or methods that improves timeliness, quality, accessibility, or usefulness of existing data ecosystems to allow for faster and improved responses and allocation of resources to address the overdose crisis. This FOA invites projects for which preliminary or feasibility data are available, such as from an R21 study or its equivalent. This FOA is a companion to RFA-DA-23-057, which seeks Acceleration and Innovation Project applications for which pilot data are unavailable.

Key Dates

Posted Date
September 21, 2022
Open Date (Earliest Submission Date)
October 22, 2022
Letter of Intent Due Date(s)

October 22, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 22, 2022 Not Applicable Not Applicable March 2023 May 2023 July 2023

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.

Expiration Date
November 23, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background: HEAL Initiative

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

Background: HEAL Data2Action (HD2A) Program

In the 12-month period ending in December 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. At the same time, reductions in opioid prescribing have raised challenges for adults in the US struggling with chronic pain, with a need to ensure that comprehensive, evidence-based pain management approaches are utilized. 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 (HD2A) Program is intended to promote near real-time use of available data by health systems, communities, and related stakeholders to improve epidemiology, 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 effective pain management, appropriate opioid prescribing), harm reduction, treatment of opioid use disorder, and recovery support. HD2A Projects will work independently to identify, merge, and analyze data to address data and service gaps along the overdose prevention and opioid care cascade. Three support centers will provide technical assistance and related resources to assist the HD2A Projects in achieving their goals. Applicants to this FOA are strongly encouraged to review the FOAs for HD2A Data Infrastructure Support Center (RFA-DA-22-052), the HD2A Research Adoption Support Center (RFA-DA-22-050), and the HD2A Modeling and Economic Resource Center (RFA-DA-22-049) to understand the scope and structure of the HD2A Program.

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

HEAL Data2Action (HD2A) Projects: Purpose and Scope of Activities

HEAL Data to Action (HD2A) Acceleration Projects are intended to develop data or methods that improve timeliness, quality, accessibility, or usefulness of existing data ecosystems (e.g., electronic health records, syndromic surveillance systems, claims data, registries, pharmacy dispensing, mortality records) to allow faster and improved responses to address the overdose epidemic. Scope of these projects are similar to an R01 and must have preliminary or feasibility data available, such as from an R21 study or its equivalent. These differ from an R01 primarily in that they are expected to engage with the resource centers funded through the HD2A program and as such, may evolve through leveraging these resources.

Acceleration Projects are to develop data or methods that improve the timeliness, quality, accessibility, or usefulness of existing data ecosystems (e.g., electronic health records, syndromic surveillance, claims data, registry data, pharmacy dispensing, and mortality records) to allow for faster and improved responses to address the overdose epidemic. The data or methods must focus on outcomes of interest to the HEAL initiative (e.g., opioid use disorder (OUD), overdose, relapse, chronic pain) or the HHS overdose prevention strategy. Priority will be given to applications that demonstrate the following: 1) translatability of the data or methods to other substance use problems, 2) identification and partnerships with stakeholders/end-users along the research continuum and inclusion of at least one representative of those end-users as a key personnel in the application to ensure that the proposed data or methods will be useful to the stakeholders who drive actions, and 3) evaluation and/or implementation of data or methods in terms of timeliness, quality, accessibility, or usefulness of data for prevention and services planning. There is no requirement or expectation that the data or methods will be used to drive action as part of the award activities.

Applications should describe how the data or methods proposed could be applicable to solving current problems. This may include facilitating the extraction and transformation of data from electronic health records (EHR) for research use and consideration of social determinants of health as crucial contributors to health. This is an opportunity to foster the adoption of standardized data structure such as Fast Healthcare interoperability Resources (FHIR®) in accessing and exchanging data from EHR.

The datasets produced, when applicable, shall adhere to the FAIR principles (Findable, Accessible, Interoperable, Reproducible) and shall be ethically sourced, trustworthy, well-defined, and accessible. The principles also apply to algorithms and other digital assets. The end products of this effort are twofold: 1) methods, algorithms, tools, or technologies that shorten the time lag between data capture and data availability or improve the geographical precision of available data, and 2) linked/integrated datasets or datasets that can be further integrated in an established data ecosystem that improves timeliness, quality, accessibility, or usefulness of the data to provide actionable insights.

Under the R33 award, applicants will develop data or methods and in terms of data timeliness, quality, accessibility, or usefulness that could apply to at least one use case (e.g., improvements in monitoring, early detection, hot spot identification, linkage and modeling for data-driven decision making).

The HD2A Program includes Support Centers that will provide technical assistance and other support to participating HD2A Projects. For Acceleration Projects, the resource centers are intended to assist Projects, for example, in informing benefits and tradeoffs of different data tools, applying simulation modeling in support of forecasting and decision-making, and understanding evidence-based practices that could serve as use cases. Each Acceleration Project will be expected to participate in a baseline needs assessment meeting with the Support Centers to identify opportunities and options for their proposed projects. Acceleration Projects will have an opportunity to access ongoing and on-demand support from each of these resource centers, as relevant and appropriate, throughout the course of the project.

Based on data and input from relevant stakeholders and considering the support available from the HD2A Support Centers, applicants should propose projects likely to have a measurable and sustained impact on overdose, opioid-related outcomes, and/or chronic pain as relevant to their targeted element(s) of the Overdose Prevention Strategy, i.e., primary prevention, harm reduction, treatment of opioid use disorder, and recovery support.

Some examples of projects considered responsive to the Acceleration priority include but are not limited to the following:

  • Enhance or develop methods for forecasting or nowcasting small-area or local estimates to inform public health officials where to allocate public health resources or develop data visualization and dissemination tools for small area estimation or local estimates (e.g., including a feature to implement ‘outbreak’ detection or spatial outlier detection methods to identify counties or small areas)
  • Improve prediction or assessment tools to identify individuals at increased risk for developing substance use disorders using near real-time or real-time data (e.g., social media, EHR)
  • Enhance methods to identify and include individuals who misuse opioids or have OUD who are outside the formal medical treatment system (e.g., syringe service programs (SSPs) data) in the existing data ecosystem
  • Enhance quality, timeliness, and usefulness of data to monitor the use, safety, and effectiveness of prescription opioids in acute or chronic pain management in the context of other evidence-based pain management strategies, and assess the benefits and risks of long-term opioid prescribing for chronic pain
  • Develop methods that can efficiently link data from diverse systems for trackable datasets aggregation or evaluate optimal linkage of data from multiple sources (e.g., incorporation of the drug market data with near or real-time data to understand emerging drug problems) and generate data sources or public health data warehouses that can assemble a bigger picture for opioids misuse to address fundamental issues in prevention, treatment, management, and harm reduction
  • Develop methods to capture data on illicit opioid usage on a near or real-time basis
  • Enhance existing tools, algorithms, or methodologies through additional data, automation, or increased interoperability (e.g., methods to track and categorize emerging illicit drugs, increasing interoperability and automation for data from laboratories and medical examiner/coroner’s office to increase the timeliness of incorporating the information in an existing surveillance system, improve technologies or algorithms to mine or automatically extract unstructured data)
  • Explore methods to model the contribution of illicit opioid drug use on other causes of death, especially for deaths not explicitly recorded as drug overdose or drug-related

Relevant data sets may include but are not limited to:

  • Data collected through unique tools, methodologies, technologies, or other innovative means (e.g., datasets from mobile devices captured, social media data, web-based data)
  • Data collected through local, state, or tribal government agencies (e.g., State birth and death registry, existing nationally representative data, syndromic surveillance data, residential or community service facility data)
  • NIH-supported datasets that are being generated under investigator-initiated research (applicants should describe how they will access data, e.g., through existing repositories or working with collaborators)
  • Data collected through nongovernment organizations such as administrative data from healthcare, clinic, and criminal justice settings (e.g., insurance claims, EHR, prescriptions, laboratory)
  • Data from first responders or other sources integrated into local communities

Pre-Application Consultation

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

Special Considerations:

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

  • Applications that do not have direct relevance to one of the four pillars of the HHS Overdose Prevention Strateg

Further, applications that do not include a timeline and milestones plan will be considered non-compliant.

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. In spite of tremendous advancements in scientific research, information, educational, and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. 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.

Common Data Elements (CDEs)

The HEAL Clinical Pain Common Data Element (CDE) Initiative provides an unprecedented opportunity for the pain research community to access quality and meaningful data across pain conditions, populations, and multiple interventions. The HEAL CDE initiative aims to facilitate cross-study comparisons, improve interpretability of findings for patient-reported outcomes, and improves the ability to compare results across trials to quantify the impact of interventions. For studies focused on pain management, projects will be required to use the HEAL Clinical Pain Core CDEs which include measures within 9 pain domains and are specific to either adult or pediatric populations and acute or chronic pain conditions. The domains include pain intensity, pain interference, physical functioning/quality of life, sleep, pain catastrophizing, depression, anxiety, treatment satisfaction, and a substance use screener (HEAL CDE Program). Studies that use additional pain screening tools must select from a comprehensive set coded through HEAL or submit their tools for coding to comply with HEAL pain data harmonization. Any outcome measures specific to clinical pain should be validated measures appropriate for the pain condition.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIH intends to commit $5 million in FY2023 and the companion FOA RFA-DA-23-057 to fund 6-8 awards, pending availability of funds and receipt of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project. Unless well-justified, it is strongly recommended that applicants not request a budget of more than $750,000 in direct costs per year. Budgets must reflect need to develop tools for immediate public health benefit.

Award Project Period

The maximum project period is 5 years. Applicants are encouraged to streamline the project period to complete the research as efficiently as possible, however. It is recommended that projects not to exceed 4 years unless exceptionally well justified.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are 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. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

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

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

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

Applicants should include a Timeline and Milestone Plan, clearly specifying proposed milestones and when those milestones are expected to be achieved.

Stakeholder Engagement Plan (Required – 2 page maximum):

Applications should include detailed plans for engaging key stakeholders, such as public health practitioners, patients, families, providers, payers, and community leaders, as appropriate to the specific goals of their study. At least one representative from the end-users of the proposed product shall be key personnel in the application.

SF424(R&R) Senior/Key Person Profile

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

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

R&R Budget

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

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

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

Budgets should include funds for travel for up to 3 people to participate in 3-day in-person HEAL Data2Action meetings to discuss findings two times over the course of the award, once within the first year and once in the middle of the project period in the Washington DC area.

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims:

In the single page attachment allowed for the specific aims, applicants should provide an overview of the overarching research question of interest.

Research Strategy:

Section A: Research Strategy

Descriptions of the project should include discussions of the following topics:

    • Rationale on how the proposed data or method would lead to improvement in data timeliness, quality, accessibility and/or usefulness
    • Alignment of the proposed project with the four pillars in the HHS Overdose Prevention Strategy (https://www.hhs.gov/overdose-prevention/)
    • Description of the targeted product and stakeholders/end-users, including the level of interaction with stakeholders and the potential for adoption by the relevant research, prevention, and services communities
    • Scope of the expected impact of the proposed project and potential for adoption by the relevant research, prevention, and services communities
    • Level of innovation of the proposed methods and approaches and the advantages it offers relative to those currently available
    • Potential to be transformative for the relevant area of research in opioid abuse and/or drug overdose

The approach should include preliminary data section demonstrating feasibility of the R33 activities. Applications should also include a Timeline & Milestone plan and a Stakeholder Engagement Plan as an attachment as described in the SF424 (R&R) Other Project Information. The approach sections may reference this attachment and should limit what is repeated from this attachment, except where necessary for clarity.

Pain management outcomes. Studies designed to implement effective pain management strategies should include a plan to collect the HEAL Clinical Pain Common Data Element (CDE) from participants. The HEAL CDE initiative aims to facilitate cross-study comparisons, improve interpretability of findings for patient-reported outcomes, and improves the ability to compare results across trials to quantify the impact of interventions. For studies focused on pain management, projects will be required to use the HEAL Clinical Pain Core CDEs which include measures within 9 pain domains and are specific to either adult or pediatric populations and acute or chronic pain conditions. The domains include pain intensity, pain interference, physical functioning/quality of life, sleep, pain catastrophizing, depression, anxiety, treatment satisfaction, and a substance use screener (HEAL CDE Program). Studies that use additional pain screening tools must select from a comprehensive set coded through HEAL or submit their tools for coding to comply with HEAL pain data harmonization. Any outcome measures specific to clinical pain should be validated measures appropriate for the pain condition.

Section B: Interaction with HEAL Data2Action Supportive Infrastructure

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

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

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

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

At a minimum, applicants should expect to engage in a virtual kickoff meeting with all recipients of the HD2A program and an in-person update meeting toward the end of year 1. In addition, Acceleration Grants will be expected to participate in needs assessments meetings with relevant Resource Centers in the first year of the award and an end-of-project evaluation in the last year of the award.

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

Applicants should include relevant letters of support from targeted stakeholders. Where relationships with relevant stakeholders do not exist or are not yet fully formalized, applicants should include formalizing these relationships as one of the milestones.

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 additional instructions also apply:

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

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

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

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. It 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. Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal.nih.gov/data/complying-heal-data-sharing-policy. Resources and tools to assist with data related activities can be found at https://www.healdatafair.org/.

The Data Management and Sharing Plan represents a commitment by the institution (and its subcontractors, as applicable) to support and abide by the plan. Prior to funding, the approved Data Management and Sharing Plan will be a condition of the award. Guidance for writing and examples of data management and sharing plans can be found on the NIH website: Writing a Data Management & Sharing Plan | Data Sharing (nih.gov).

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.
  • To the extent possible, HEAL awardees are expected to integrate broad data sharing consent language into their informed consent forms and align study consent language with data access and re-use requirements as defined by the repository HEAL investigators select to store their HEAL data long term.

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.

  • 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).
  • Data should be organized according to a standard model that is widely accepted within the field. An example for the clinical research studies would be the OMOP Common Data Model, which has also been successfully adapted for use with observational (including survey) studies more generally. In addition, the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard (NOT-OD-19-122) may facilitate 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. In addition to USCDI, OMOP, and FHIR standards for enhanced interoperability, investigators and data centers should align their data collection and management practices with recommended guidance emerging from the HEAL CDE and Data Ecosystem programs.

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

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

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

Specific to the FOA:

Are the expectations of the project realistic and in line with the planned efforts? Does the proposed data or methods products have the potential to be widely adopted by the relevant research and/or public health community? Do the proposed data or methods have the potential to improve the timeliness, quality, accessibility, or usefulness of existing data ecosystems to allow for faster and improved responses to address the overdose epidemic?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to the FOA:

Do the scientific background and record of the PD(s)/PI(s) or any collaborators establish a strong record of developing data, approaches, and methods that can be applied to the areas of substance use or related field? Does the application include any collaborators who are the stakeholders/end-users of the product proposed? As appropriate to the proposed design, are key partners included as co-investigators and/or collaborators?

Innovation

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

Specific to the FOA:

Is there innovation either in the data or method products developed or in how the data or method products is taken from one field and applied in another? Will the proposed data or method products offer new possibilities for substance use research relative to those currently available?

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to the FOA:

Are the goals well specified and is the length of the project appropriate to the scope of work proposed? Are there well-thought-out plans for stakeholder engagement? Does the application take issues of equity into consideration? Are plans well-articulated, including specification of research questions? Does the preliminary data provide sufficient information that the proposed project can be accomplished and is likely to have a high impact? Is there a well-articulated data sharing plan and is the plan reasonable? Does the application show a well-thought-out consideration for how it might take advantage of the infrastructure and resources offered through the HD2A Program? Does the application include sufficient resources dedicated to interfacing with other elements of the HD2A Program?

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?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender 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 and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Janet Kuramoto-Crawford, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-443-8856
Email: HEALdata2action@nih.gov (preferred method of contact)

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

Laura Elizabeth Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-451-8507
E-mail: laura.kwako@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)

Lennin Greenwood
National Institute on Drug Abuse
Phone: 301-827-0478
Email: lennin.greenwood@nih.gov

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

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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