Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Complementary and Integrative Health (NCCIH)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Nursing Research (NINR)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Funding Opportunity Title
Limited Competition: NIH-DoD-VA Pain Management Collaboratory - Coordinating Center (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects Cooperative Agreements

Announcement Type
New
Related Notices

  • June 30, 2023 - Notice of Participation of the OBSSR in RFA-AT-24-002 "Limited Competition: NIH-DoD-VA Pain Management Collaboratory - Coordinating Center (U24 Clinical Trial Not Allowed) . See Notice NOT-OD-23-154.
  • August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023 - See Notice NOT-OD-22-198.
  • August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy - see Notice NOT-OD-22-189.

Notice of Funding Opportunity (NOFO) Number
RFA-AT-24-002
Companion Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.213, 93.361, 93.273
Funding Opportunity Purpose

The purpose of this NOFO is to solicit applications for continuation of a Coordinating Center (CC) to provide national leadership for the NIH-DoD-VA Pain Management Research Collaboratory program on evidence-based non-pharmacological approaches to pain management for U.S. veterans, military personnel, and/or their families. For brevity, this initiative will be referred to as the NIH-DoD-VA Pain Management Collaboratory, or PMC. Eligibility is limited to the current recipient of the NIH-DoD-VA Pain Management Collaboratory - Coordinating Center award (RFA-AT-17-002) Coordinating Center applicants will need to: 1) develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of research in partnership with health care systems focused on V eterans, military personnel, and their families; 2) work collaboratively with and provide technical, design, and other support to Demonstration Project teams, to develop and implement a pragmatic trial protocol; and 3) disseminate widely Collaboratory-endorsed policies and best practices and lessons learned in the Demonstration Projects for implementing research within health care settings. The Coordinating Center will also serve as the central resource for the activities of the NIH-DoD-VA Pain Management Collaboratory program, including providing administrative support for a Steering Committee and its subcommittees.

Key Dates

Posted Date
June 28, 2023
Open Date (Earliest Submission Date)
July 01, 2023
Letter of Intent Due Date(s)

August 01, 2023

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
August 31, 2023 Not Applicable Not Applicable November 2023 January 2024 March 2024

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
September 01, 2023
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 NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Since 2001, more than 2.77 million U.S. troops have been deployed for Operation New Dawn, Operations Enduring Freedom (OEF) in Afghanistan and Iraqi Freedom (OIF) in Iraq. The all-volunteer military experienced multiple redeployments to the war zone, extensive use of the reserve components of the military and National Guard, that also involved the deployment of women and parents of young children. Many of these deployed service members sustained severe injuries that in previous wars would have resulted in death. Significant and continuing improvements in outer tactical vests (body armor) and helmets have saved lives. However, despite these improvements, many service members returning from these operations, and from other military operations, experienced pain, traumatic brain injuries (TBIs), symptoms of post-traumatic stress disorder (PTSD), suicidal thoughts or behaviors, substance abuse, and/or related comorbidities. Studies report nearly 45% of active-duty service members and 50% of Veterans experience pain on a regular basis and there is significant overlap between chronic pain, PTSD, and persistent post-concussive symptoms. There is an ongoing challenge with pain among military and Veteran populations and an incomplete evidence base for effective pain management. Opioid medications are often prescribed for the treatment of chronic pain, despite the association of chronic opioid use with the potential for misuse and they often fail to adequately control pain. As a result, there continues to be a need for additional nonpharmacologic approaches to complement or replace pharmacological strategies for pain management and to reduce the needs and risks associated with excessive reliance on opioids.

In June 2011, the Institute of Medicine (IOM) released a Consensus Report on "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (http://iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx). The report notes that chronic pain affects an estimated 116 million American adults more than the total affected by heart disease, cancer, and diabetes combined. Pain also costs the nation up to $635 billion each year in medical treatment and lost productivity. The report notes that ideally, most patients with severe persistent pain would obtain pain care from an interdisciplinary team using an integrated approach that would target multiple dimensions of the chronic pain experience including disease management, reduction in pain severity, and improved functioning, emotional well-being, and health-related quality of life.

The NIH, Department of Defense (DoD), and U.S. Department of Veterans Affairs (VA) have been working individually and collaboratively to develop and improve pain management approaches for veterans, military personnel, and their families. In 2014, NCCIH partnered with the National Institute on Drug Abuse (NIDA) aVA to fund 13 grants to research military and Veteran health with a focus on nonpharmacologic approaches to pain and related conditions. This important partnership was expanded in 2017 to include theDoD and additional NIH agencies (NINDS, NIAAA, NICHD, ORWH, OBSSR, and NINR) to initiate the NIH-DoD-VA Pain Management Collaboratory (PMC). The first wave of the Pain Management Collaboratory resulted in the support of 11 research projects focused on the development and testing of nonpharmacologic approaches to pain management (RFA-AT-17-001) as well as a Coordinating Center (RFA-AT-17-002). A twelfth research project was funded in FY22 (RFA-AT-22-006).

Military and Veteran health care systems (HCS) and other HCS that provide services to military personnel, Veterans and their families are the targeted organizations for this program. Research conducted in partnership with eligible VA and DoD health care providers is essential for obtaining meaningful and relevant research results in real world health care delivery systems serving Veterans and service members.

Team-based care is increasingly recognized as fundamental to effective health care systems. Defined as the interprofessional, multidisciplinary team approach to patient-centered care coordinated across a variety of systems, the National Academy of Medicine (formerly known as the Institute of Medicine) predicts team-based care models will cut down significantly on health care costs, estimating savings of $240 billion annually in national health care expenditures.

Despite the recognized and compelling need for research to identify and implement effective complementary nonpharmacologic approaches for pain management and comorbid conditions in military and Veteran populations, many challenges exist. Ethical and regulatory issues must be addressed to perform research in health care delivery settings. Health care providers focus on providing the best treatment, based on current knowledge, whereas research typically focuses on studying which treatments work best in a precisely defined population. Further, research studies have frequently used endpoints that are not part of routine patient assessments of care and may support adoption of interventions that are challenging to implement in many health care delivery settings. Multiple challenges remain in identifying the best strategies to successfully integrate evidence-based interventions within specific health care settings. Bridging the gap between research and practice is an important step in the direction of providing increased effective treatment options to patients.

Pain is a subjective experience impacted by a variety of biological, psychological, and social factors. Moreover, pain rarely occurs in isolation and is often accompanied by comorbid conditions or even additional pain conditions, as well as mental health disorders such as anxiety and depression. The multifaceted nature of pain necessitates a multifaceted, interdisciplinary approach in its treatment that is by definition complex, involving multiple domains spanning an individual’s physiology, emotional well-being, and environment, the physical as well as social. Past models of pain management that focus mainly on physiological systems are incomplete and fall short of accessing the full capacity of human health and health restoration. Recognizing the importance of a multi-domain approach to health, the Department of Defense (DoD), Veterans Health Administration (VA), and NCCIH have each developed programs or strategic plans that address health through multiple domains, namely, Total Force Fitness (DoD), Move to Health (DoD), Whole Health (VA), and Whole Person Health (NCCIH). These initiatives share a common principle that health and health restoration is most effectively achieved through addressing the whole person, not just the disease. A recent report by the National Academies of Sciences, Engineering, and Medicine highlights the need for a whole person health approach to medicine that emphasizes greater focus on promoting health, rather than reacting only to disease. A whole person health approach encompassing the full spectrum of health and social needs of Veterans, service members, and their families could have a profound impact on pain management by addressing what is most important to the individual and treating, not just the pain, but also the comorbidities that so often occur with and exacerbate and are exacerbated by pain. It is also important to note the well-documented racial and ethnic disparities in both the experience and treatment of pain. Pain disproportionately impacts African American and Hispanic adults, and those of low socioeconomic status. Compounded with findings that minorities receive less analgesics for their pain compared to whites, a whole person approach to health has the potential to bridge the pain management divide for minorities by taking into account all the factors that affect physical, emotional, social, and spiritual well-being.

Purpose

The purpose of this NOFO is to solicit applications for the continuation of a Coordinating Center (CC) to provide national leadership for the NIH-DoD-VA Pain Management Collaboratory Research Program on evidence-based non-pharmacological interventions for pain management in U.S. Veterans, military personnel, and/or their families. Other NOFOs will solicit high-impact Demonstration Projects, will expand the PMC program to include pain management approaches not presently being addressed by the current PMC studies, especially studies that take into account whole person outcomes. The Pain Management Collaboratory program will continue to leverage the infrastructure, experience, and expertise thus far established by the Coordinating Center to provide technical expertise and support to investigators conducting efficient, large-scale pragmatic or implementation clinical trials to evaluate evidence-based non-drug interventions, either alone or in combination with pharmacologic treatment, to improve pain management for U.S. Veterans, military personnel, and/or their families, while prioritizing integrative approaches that address the whole person. Military and veteran health care systems and other health care systems that provide services to Veterans, military personnel, and their families are the targeted organizations for this program. Research conducted in partnership with eligible VA and DoD health care providers is essential for obtaining meaningful and relevant research results in real world health care delivery systems serving veterans, service members, and their beneficiaries.

The NIH-DoD-VA Pain Management Research Collaboratory will:

  • establish a Coordinating Center to provide leadership and technical expertise in all aspects of research supporting the design and execution of high impact Demonstration Projects that conduct pragmatic clinical trials on non-pharmacologic approaches for pain management and other comorbid conditions in Veteran and/or military health care systems (supported by this NOFO);
  • support the design and execution of additional high-impact pragmatic clinical trials focusing on effectiveness research, implementation research, or hybrid effectiveness-implementation research on approaches to pain management and comorbidities with patients in health care delivery systems that provide care to Veterans, military personnel, and their families; and
  • make available data, tools, best practices, and resources from these and other projects to facilitate a research partnership with health care delivery systems that provide care to Veterans, military personnel, and their families.

Demonstration Projects, solicited under separate NOFOs by the partnering funding agencies, will be selected based on the importance of the scientific questions and the potential to address impediments to research on nonpharmacologic approaches for pain management and comorbid conditions in Veterans, service members and/or their families within health care delivery organizations serving these populations. Demonstration Projects will need to collaborate with the coordinating center to develop, initiate and implement a research protocol, which includes ethical and regulatory oversight. Demonstration projects will be phased awards with an initial research planning phase (year 1) followed by a research execution phase (years 2-5). During the research planning phase, the Demonstration Project teams, in cooperation with the Coordinating Center, will determine resource needs, pilot test data extraction methods for patient identification and outcome assessment, and protection of human subjects. Those demonstration projects meeting milestones during the research planning phase (UG3) will be approved to move to the research execution phase (UH3).

Coordinating Center Overview

The Coordinating Center is expected to provide leadership for the NIH-DoD-VA Pain Management Collaboratory Research Program. The Coordinating Center will need to:

  • further develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of pragmatic clinical trials in partnership with health care systems focused on U.S. Veterans, military personnel, and their families;
  • work collaboratively with, and provide technical, design, and other support to Demonstration Project teams, to develop and implement a research protocol; and
  • widely disseminate Pain Management Collaboratory-endorsed policies and best practices and lessons learned for implementing research within health care settings that deliver health care to U.S. Veterans, military personnel, and their families.

The Coordinating Center will also serve as the central resource for the activities of the NIH-DoD-VA Pain Management Collaboratory Program, including providing administrative support to a Steering Committee and its work groups. The coordinating center will be responsible for facilitating harmonization and sharing of tools and approaches within, and across Demonstration Projects.

Work Groups will be established and managed by the coordinating center as a core collaborative activity. The Work Groups will provide a forum for discussion of challenges and solutions across projects; harmonized and standardized policies and processes will be vetted in these groups. Work Groups are expected to address key areas of the program activity, such as: ethical/regulatory issues, study design/biostatistics, phenotypes/outcomes, electronic health records utilization, data sharing, stakeholder engagement, and implementation science. Work Groups will be chaired by Coordinating Center staff and include individuals from the Demonstration Projects, and staff from the NIH, DoD, and VA.

A Steering Committee will address issues that span all projects, provide input into the policies and processes of the PMC Program, provide guidance to the Coordinating Center and Demonstration Projects, and assist in dissemination of policies and processes that enable research in health care systems that serve U.S. Veterans, military personnel, and their families. At a minimum, the Steering Committee will be chaired by the PD/PI(s) of the Coordinating Center and have representation from the following groups: one representative from each of the Demonstration Projects; one representative from each Work Group; Program Coordinators from the NIH, DoD, and VA, and other representatives as appropriate from various NIH, DoD, and VA programs; and NIH/VA/DoD program officers for each award made as part of the initiative. All members are expected to actively participate in all Steering Committee activities. Representation from sponsor organizations (i.e., NIH, DoD, or VA) may not exceed 40 percent of the total committee membership.

It is also expected that the Coordinating Center will engage with groups and organizations (e.g., NIH, DoD, VA, private organizations) working in similar areas, and will stay abreast of extant and emerging information and efforts (e.g., HealthMeasures, CTSAs, The Interagency Pain Research Coordinating Committee), regulations, and technical advances that could facilitate research on non-pharmacological approaches to improve the health of U.S Veterans, military personnel, and/or their families.

The Coordinating Center is expected to have at a minimum significant knowledge in the following areas:

  • Providing national leadership and engage all stakeholders in advancing policies and practices that enhance the broad participation of researchers and health care systems in research focused on non-pharmacologic approaches for the management of pain and comorbid conditions in U.S. Veterans, service members, and/or their families.
  • Improving the capability, methods, and technologies used in addressing research important to effect health improvement regarding non-pharmacological approaches.
  • Specific tasks and accomplishments of the Coordinating Center and associated Working Groups.
  • Approaches that allow the use of patient reported outcomes or other descriptive protocols, and algorithms developed elsewhere to address questions relevant to the PMC Collaboratory.
  • Basic requirements for technical, policy, and workflow practices, needed for health systems participation in research.
  • Defining the needs, requirements, and approaches to conduct pragmatic clinical trials on non-pharmacological approaches to health promotion in partnership with eligible health care systems.
  • Processes and agreements needed to address regulatory requirements for single and multiple health care systems that provide services to Veterans, military personnel, and/or their families.
  • Processes and best practices for ethical conduct of pragmatic clinical trials in eligible health care settings that obtain input from health care system leadership, patients, family members, providers, and researchers.
  • Mechanisms for leveraging novel collaboration and communication strategies, as well as creativity and flexibility to innovate on an ongoing basis.

Administrative support for PMC Program

The Coordinating Center will continue to provide administrative support for the activities of the PMC program, which should include, but are not limited to:

  • Rapid deployment of Coordinating Center personnel and collaborative tools to enable timely Demonstration Project team planning and testing.
  • Expanding and maintaining a public website for communication and sharing of activities, events, and resources of the program.
  • Providing a private collaboration space for the demonstration projects and Coordinating Center.
  • Organizational and logistical support for facilitating the activities of the Steering Committee and Work Groups (e.g., Stakeholder Engagement, Patient Resources, Ethical/Regulatory, Study Design/Biostatistics, Phenotype/Outcomes, Electronic Health Records, Data Sharing, Implementation Science).
  • Developing and supporting standards and mechanisms for publicly sharing data, resources, and code developed and utilized under this initiative in compliance with privacy regulations.
  • Organizing and supporting the costs and logistics for a face-to-face annual meeting of the PMC Steering Committee in the greater Washington, D.C. area.
  • Planning and hosting face to face, video or tele-conference meetings of the Work Groups, Steering Committee, and any subcommittees on a regular basis.
  • Organizing and supporting logistics of a face-to-face or virtual Kickoff Meeting as needed for new Demonstration Projects as they join the PMC Research Collaboratory Program.

NIH-DoD-VA Pain Management Collaboratory Resources, Data, and Software Sharing

The PMC encourages sharing of data, resources policies, best practices, materials, and tools to facilitate collaboration, use, and replication of results. The PMC Coordinating Center will provide guidance to Demonstration Projects in the following areas:

  • Development of data management and sharing plan options for Demonstration Projects and advise on best practices for data sharing across the PMC.
  • Provide consultations related to the project data management and sharing plans.
  • Promote the use of common data elements across Demonstration Projects.
  • Harmonize, as appropriate, data elements to create opportunities for combined datasets across projects for cross-project analyses.
  • Lead the identification and creation of a PMC Data Sharing Collections repository destination by working with an NIH approved, reputable repository.

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 NOFO .

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 NOFO.

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

Issuing IC and partner components intend to commit an estimated $1.8 million total costs to fund 1 award in FY2024.

Award Budget

Direct costs requested for the first three years may not exceed $1.3 million per year; direct costs for years 4 to 6 may not exceed $1.0 million per year.

Award Project Period

The total project period for an application submitted in response to this NOFO may not exceed 6 years.

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

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

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

Eligibility is limited to the current recipient of the NIH-DoD-VA Pain Management Collaboratory - Coordinating Center award (RFA-AT-17-002)

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. 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 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 their 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.

In terms of experience and expertise, in addition to a strong experienced leader, the Coordinating Center PD/PI should have the following qualities:

  • Technical expertise in accessing and extracting information from electronic health records (EHRs) of the health care systems that deliver care to all of the following groups: U.S. military, Veterans, and their families and relevant clinical systems for research purposes.
  • Knowledge of the regulatory requirements for conducting pragmatic or implementation clinical trials within both military and Veteran health systems including knowledge of policies and procedures for the use of health care data for research purposes and experience in conducting research that complies with clinical practice and research regulations for these systems.
  • Experience with the ethical issues related to pragmatic clinical trials, clinical care, quality improvement, population health, and surveillance. Specifically, knowledge of the human subjects protection requirements for military and Veteran health care systems.
  • Ability to provide technical support for multisite pragmatic and implementation clinical trials involving multiple health care delivery organizations providing services to Veterans, military personnel, and their families.
  • Experience working with a variety of stakeholders including patients, research participants, practitioners, researchers, hospital and research informatics and technical personnel, and senior managers of health care and research organizations on workflows and practices of military and Veteran health care systems.
  • Knowledge of workflows and research team practices in design and implementation of pragmatic clinical trials.
  • Knowledge of current data models, algorithms, and approaches used by the various eligible networks and practices to define clinical phenotypes, extract information, define endpoints, and discover errors in data.
  • Knowledge of privacy regulations related to both the military and Veteran health care systems
  • Project management experience in taking a research question from idea, through implementation, to completion.
  • Study design and statistical expertise, particularly in pragmatic clinical trial methodology, including cluster randomization and stepped-wedge designs.
  • Ability to solve technical challenges effectively and respectfully with all relevant communities.
  • Knowledge of patient reported outcomes and patient reported assessments in health care EHRs of military and Veteran health care systems, research study management tools, including electronic transfer of information from mobile and other devices.

2. Cost Sharing

This NOFO 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 NOFO. 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 notice of funding opportunity 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:

Jessica McKlveen, Ph.D.
Telephone: 301-594-8018
Fax: 301-480-1587
Email: jessica.mcklveen@nih.gov

Page Limitations

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

For this specific NOFO , the Research Strategy section is limited to 30 pages.

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 NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:

Biographical Sketches should reflect how the investigator team, collaborators, and other personnel are well suited to the project. The team should include expertise and experience in non-pharmacological approaches to improving the health and well-being of U.S. Veterans, military personnel, and/or their families, including but not limited to, experience with data extraction in meaningful ways from EHRs and other clinical systems, experience with ethical issues related to research and care boundaries, experience in design, conduct, and analysis of pragmatic clinical trials, and experience in collaborative research with a variety of stakeholders.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:

Coordinating Center Director Effort

The NIH-DoD-VA Pain Management Collaboratory Coordinating Center Director will be the individual responsible for the overall management of the Coordinating Center including coordination with each of the Demonstration project teams. The relationship between the Coordinating Center and the Demonstration Projects should be a partnership in the planning phase.

The Coordinating Center Director must be able to devote at least 30% effort (3.6 person months) to this program.

The applicant must include funds for the Coordinating Center PD/PI and key personnel to support and attend annual one-and-half-day meetings in the greater Washington D.C. area. Funds need to be included for the coordinating center to host the meeting, including the meeting room and all other expenses. Demonstration project staff will travel their own people on their budgets.

The budget should be structured to allow for the scaling of activities of the Coordinating Center based on the number of pragmatic or implementation trials that are supported by the partnering Institutes/Centers/Offices. The initial award will provide Coordinating Center support for a lower number of pragmatic and implementation trials and additional trials will be added in the out-years. The budget should describe how the minimum budget will be used to provide the base funding of the PMC program. As additional trials are added to the program the budget will increase at an amount of $100,000 total costs per year for each trial above the IC base number of trial support. The budget section should justify why additional resources are needed to increase the support for additional pragmatic and implementation trials (e.g., expansion of Work Groups, increased staff requirements, onboarding costs for new trials, monitoring of recruitment and retention). Thus, the total budget will be determined by the number of trials linked to the Coordinating Center resources.

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:

Research Strategy: Coordinating Center applicants must indicate their willingness to cooperate with Demonstration Project teams, the NIH, DoD and VA in the development and design of research approaches, methods, processes, policies, and tools used in this program.

The Coordinating Center will have several Work Groups that will work with the Demonstration Projects to assist with optimizing the design and implementation; gathering lessons learned across projects; and developing guidance and best practice documents. The application must provide details of the Work Groups including staffing, planned activities, and deliverables. For example, the application must describe how Coordinating Center Work Groups will review the study design and biostatistical assumptions of the proposed Demonstration Projects; work with the Demonstration Project teams to develop detailed plans for site implementation, determine resource needs, test data extraction methods for patient identification and outcome assessment; and review plans for all aspects of ethical and regulatory oversight and protection of human subjects.

To meet the needs and responsibilities of the Coordinating Center, applicants should describe their group expertise and prior experience working collaboratively in research consortia and other collaborative projects to accomplish shared goals for the team as a whole, without repeating information on individual biosketches. Additionally, applications should describe the team's experience conducting pragmatic trials in both military and Veteran healthcare settings such that they can provide technical expertise to other investigators proposing to do pragmatic trials in these settings. A description of the team's ongoing record of accomplishment in support of coordination, collaboration, and communication of large national-level inclusive networks or consortia should be provided.

The applicant should also describe the specific tasks and accomplishments needed to meet the objectives of the NIH-DoD-VA Pain Management Collaboratory Coordinating Center, which could include, but are not limited to:

  • Provide national leadership and engage all stakeholders in advancing policies and practices that enhance the broad participation of researchers and health care systems in research focused on non-pharmacological approaches to improving the health and well-being of U.S. Veterans, military personnel, and/or their families
  • Improve the capability, methods, and technologies used in addressing research important to effect health improvement regarding non-pharmacological pain management
  • Specific tasks and accomplishments of the Coordinating Center and associated Working Groups
  • Approaches that allow the use of patient reported outcomes or other descriptive protocols, and algorithms developed elsewhere to address questions relevant to NIH-DoD-VA Pain Management Collaboratory
  • Basic requirements for technical, policy, and workflow practices, needed for health systems participation in research
  • Defining the needs, requirements, and approaches to conduct pragmatic clinical trials on non-pharmacological approaches to pain management and other comorbid conditions in partnership with eligible health care systems
  • Processes and agreements needed to address regulatory requirements for single and multiple health care systems that provide services to Veterans, military personnel, and/or their families
  • Processes and best practices for ethical conduct of pragmatic clinical trials in eligible health care settings that obtain input from health care system leadership, patients, family members, providers, researchers.
  • Mechanisms for leveraging novel collaboration and communication strategies, as well as creativity and flexibility to innovate on an ongoing basis

Coordinating Center Transition Plan

Although it is unknown whether the Coordinating Center will be renewed, the applicant should provide an administrative support plan describing how it would facilitate the transition of activities to a potential successor at the end of the period. This should include describing the transition of any software, hardware, and licenses, as well as standard operating procedures, best practices, content of the public website and collaboration site and other documentation for management of the coordinating center period. Applicants should describe processes through which these resources will be made available to the community after the NIH-DoD-VA Pain Management Collaboratory period of support ends.

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.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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

In order to expedite review, applicants are requested to notify the NCCIH Referral Office by email at jessica.mcklveen@nih.gov when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

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.


Does the proposed Center address the needs of the research projects that it will administer? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research projects?

Will the Coordinating Center provide national leadership and engage all stakeholders in advancing policies and practices that enhance the broad participation of researchers and health care systems in research focused on non-pharmacological approaches to pain management in U.S. Veterans, military personnel, and/or their families? If the aims of the center are achieved, how will clinical research, translation of research into practice, and participation by relevant health care delivery organizations in research be improved? How will successful completion of the aims change the capability, methods, and technologies used in addressing research important to effect health improvement regarding non-pharmacological approaches to pain management in U.S. Veterans, military personnel, and/or their families?


Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Are the PD(s)/PI(s), collaborators, and other personnel well suited to the project? Do the personnel have the appropriate breadth of expertise and experience in non-pharmacological approaches to pain management in U.S. Veterans, military personnel, and/or their families, including but not limited to, experience with data extraction in meaningful ways from EHRs and other clinical systems, experience with ethical issues related to research and care boundaries, experience in design, conduct, and analysis of pragmatic clinical trials, and experience in collaborative research with a variety of stakeholders? Do the PD(s)/PI(s) and collaborators have experience conducting pragmatic trials in both military and Veteran health care settings such that they can provide technical expertise to other investigators proposing to do pragmatic trials in these settings? Have they demonstrated an ongoing record of accomplishment in support of coordination, collaboration, and communication of large national-level inclusive networks or consortia? Are the investigators willing to collaborate with the NIH, DoD, and VA, and Demonstration Project awardees to meet the goals and objectives of this program?


Does the application propose novel organizational concepts management strategies in coordinating the research projects the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Does the application include mechanisms for leveraging novel collaboration and communication strategies? Does the application indicate creativity and flexibility to innovate on an ongoing basis?


Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research projects the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects , 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 operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the [program/projects/network/consortium/resource]? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Will the proposed approach allow for rapid deployment of Coordinating Center personnel and collaborative tools to enable speedy Demonstration Project team planning and testing? Is the plan for administrative support of the NIH-DoD-VA Pain Management Collaboratory program facilitative of the proposed plan for support of the Demonstration Projects and will it add to the productivity of the program?


Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research project it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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.



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.


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.


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 Animals Section.


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.


Not applicable


Not applicable


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.


Not applicable


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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.


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


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 ) convened by the National Center for Complementary and Integrative Health (NCCIH), 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 NOFO.

Applications will be assigned to the National Center for Complementary and Integrative Health (NCCIH). Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Complementary and Integrative Health. 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.
  • Willingness of PD(s)/PI(s) to collaborate with the NIH, DoD, and VA.

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.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 NOFO 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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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 NOFO.

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 Part 75 and 2 CFR 200, and other DHHS, 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 recipients 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 recipients 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:

  • Determining approaches, designing, and setting project milestones and implementing the project plan for the Coordinating Center.
  • Cooperating in sharing knowledge and experience with various tools and approaches utilized in conducting research in health care settings on non-pharmacological approaches to improving the health and well-being of Veterans, military personnel, and/or their families, including their strengths and weaknesses.
  • Cooperating in sharing issues related to data quality, data management, data biases and errors, query quality and sampling challenges, and pitfalls in utilization of health care data for research.
  • Collaborating with Demonstration Project recipients in harmonizing and sharing of tools, methods, and approaches.
  • Cooperating with others in sharing of study designs, methods, protocols, tools, and strategies.
  • Participating in group activities, including program-wide Work Group and Steering Committee meetings.
  • Facilitating comparability across Demonstration Projects when possible.
  • Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, and facilitating work group meetings, committee meetings, and conference calls, preparing concise minutes or summaries of meetings for distribution.
  • Cooperating with Demonstration Project recipients in the publication and dissemination of program results and the eventual release to the scientific and healthcare communities of methods, tools, results, and other resources.
  • Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the program that will be sufficient for outside users to understand and apply to their research projects with minimal assistance.
  • Providing expertise and leadership in addressing issues of broad applicability, such as informed consent, data sharing standards, analysis methodology, and dissemination
  • Sharing resources, data, and software according to the goals for the NIH-DoD-VA Pain Management Collaboratory program and approved plans.
  • Planning and hosting the face-to-face meetings, video conferencing, or teleconferences of the Work Groups, Steering Committee, and any subcommittees.
  • Agreeing to accept close coordination, cooperation, and management of the project with NIH staff and to also work closely with DoD, and VA staff involved in Coordinating Center activities.
  • Submitting periodic progress reports, in a standard format, as agreed upon by the Steering Committee and the NIH
  • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

  • The Coordinating Center will have an NIH Project Coordinator provide substantial programmatic assistance related to the award. In addition, NIH will assign a Project Scientist who will be substantially involved in the scientific activities of the Coordinating Center. Note that each of the accompanying pragmatic trials will also be assigned an NIH Program Official (PO) and Project Scientist
  • The designated NIH Project Coordinator / Project Scientist for the Coordinating Center and NIH, DoD, and VA PO and Project Scientists for the accompanying Pragmatic Clinical Trials will work with the Principal Investigator and the Steering Committee to ensure the objectives of the program are being met. The dominant role and prime responsibility for the program resides with the awardee, although specific tasks and activities will be shared among the awardee and the NIH, Program Coordinator.
  • The NIH PO/ Project Coordinator and Project Scientists will provide technical assistance, advice, and coordination; however, the role of the NIH staff will be to facilitate and not to direct activities. It is anticipated that decisions in all activities will be reached by consensus of the program and NIH. All parties will be given the opportunity to offer input to this process.
  • The NIH Project Coordinator and Project Scientists serve as the contact points for addressing the program objectives with the awardee.
  • Additional NIH Project Coordinators, POs and Project Scientists may participate in all workgroups, implementation teams, and committees, including the Steering Committee, as appropriate. Participation by POs and Project scientists from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.
  • The NIH reserves the option to recommend withholding or reduction of support from activities that fail to achieve their goals or comply with the Terms and Conditions.
  • NIH Project Coordinators, POs and project scientists may serve as resources for, or interface with, other ongoing NIH, DoD, and VA activities that may be relevant to the activities in the NIH-DoD-VA Pain Management Collaboratory to avoid duplication and facilitate collaboration and communication in overlapping areas.
  • Assist in development, design, and coordination of activities and projects.
  • Responsibility for monitoring progress, which could include regular communications with recipient and coordinating center staff, periodic site visits, observation and review of demonstration project implementation plans and testing, annual face to face in progress reviews that will be held in the greater Washington D.C. area, and requests for additional reports or documentation.
  • Reporting periodically on progress of the program to the Director, NCCIH; other interested NIH IC Directors; and the National Advisory Council for Complementary and Integrative Health.
  • An NIH program official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. Additionally, an agency project scientist will be responsible for the scientific stewardship of the cooperative agreement award and will be named in the award notice.

Areas of Joint Responsibility include:

  • Recipient (s) agree to the governance through a Steering Committee. An NIH-DoD-VA Pain Management Collaboratory program Steering Committee will be established to address issues that span all projects, provide input into the policies and processes of the NIH-DoD-VA Pain Management Collaboratory, and assist in dissemination of policies and processes that enable research in partnership with health care systems, their patients, and practitioners. At a minimum, the Steering Committee will comprise one representative from each of the Demonstration Projects; one representative from each Work Group; one representative from the Coordinating Center; the NIH Project Coordinator, POs and Project Scientists for each of the awards in the program; and representatives from various NIH ICs, the DoD, and VA. All members are expected to actively participate in all Steering Committee activities. The combined vote of NIH, DoD, and VA programmatic members may never exceed 40 percent of the total.
  • NIH-DoD-VA Pain Management Collaboratory Work Groups will be established as the core collaborative activity of this program. The Work Groups will provide a forum for discussion of challenges and solutions across projects; harmonized and standardized policies and processes will be vetted in these groups. Work Groups are expected to address key areas of the program activity, such as: ethical/regulatory issues, study design/biostatistics, phenotypes/outcomes, electronic health records utilization, data sharing, stakeholder engagement, and implementation science. Work Groups will be chaired by Coordinating Center staff and include individuals from the Demonstration Projects, and staff from the NIH, DoD, and VA.
  • Establishment and adherence by each Demonstration Project Team (Demonstration Project recipient , Coordinating Center recipient , and NIH, DoD, and VA staff) to a written plan of engagement with timelines to ensure delineation of roles and timely delivery of the tested implementation plan.
  • Demonstration Project recipients will work with the Coordinating Center and NIH, DoD, and VA, through all phases of their projects, including the implementation and close out phase, to assure all resources, materials, protocols, data, best practices, and lessons learned, as well as software or sets of code, are disseminated broadly through the Coordinating Center with all NIH-DoD-VA Pain Management Collaboratory program resources.
  • All recipients and NIH, DoD, and VA will cooperate to ensure the timely and broad dissemination of all NIH-DoD-VA Pain Management Collaboratory program endorsed policies and practices and lessons learned in the program to inform researchers and health care systems engaged in research in health care settings.

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 will be convened. It will have three members: a designee of the Steering Committee chosen without NIH PO or Project Scientist voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. 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. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. 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 NOFOs 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 75.113 and 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 75 and 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: https://www.era.nih.gov/need-help (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: 301-637-3015

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)

Peter Murray, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-4054
Email: peter.murray@nih.gov

Elizabeth L. Neilson, PhD, MPH, MSN
Office of Disease Prevention (ODP)
Phone Number: 301-827-5578
Email: Elizabeth.Neilson@nih.gov

Qi-Ying Liu, M.D., M.S.
National Institute on Alcohol Abuse and Alcoholism
Phone Number: 301-443-2678
Email: liuqiy@mail.nih.gov

Karen A. Kehl, PhD, RN
National Institute of Nursing Research
Telephone: 301-594-8010
Email: karen.kehl@nih.gov

Peer Review Contact(s)

Jessica McKlveen, Ph.D.National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-8018
Email: jessica.mcklveen@nih.gov

Financial/Grants Management Contact(s)

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

Judy Fox
National Institute on Alcohol Abuse and Alcoholism
Phone Number: 301-443-4704
Email: jfox@mail.nih.gov

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: osterk@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 and 2 CFR Part 200.

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