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 Drug Abuse (NIDA)
Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

NIH-DoD-VA Pain Management Collaboratory - Coordinating Center (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
  • May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062.
  • January 09, 2017 - Notice of a Pre-Application Technical Assistance Webinar for RFA-AT-17-001 and RFA-AT-17-002. See Notice NOT-AT-17-001.
Funding Opportunity Announcement (FOA) Number

RFA-AT-17-002

Companion Funding Opportunity

RFA-AT-17-001, UG3/UH3 Exploratory/Developmental  Phased Award Cooperative Agreement

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.213, 93.279; 93.313; 93.273

Funding Opportunity Purpose

The purpose of this FOA is to solicit applications for a Coordinating Center (CC) to provide national leadership for the NIH-DoD-VA Health Care Systems (HCS) Research Collaboratory program on non-pharmacological approaches to pain management and comorbidities in U.S. military personnel, veterans and their families. For brevity, this initiative will be referred to as the “NIH-DoD-VA Pain Management Collaboratory.” 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 military personnel, veterans, 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

December 12, 2016

Open Date (Earliest Submission Date)

February 3, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

March 3, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2017

Advisory Council Review

August 2017

Earliest Start Date

November 15, 2017

Expiration Date

March 4, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Since 2001, more than 2.5 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 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 soldiers 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 problem 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, but chronic use is associated with the potential for misuse, abuse, and dependence and often fails to adequately control pain.  As a result, there is a need for non-pharmacological approaches to complement pharmacological strategies for pain management and to reduce the needs and hazards of excessive reliance on opioids.

The NIH, DoD, and VA have been working individually and collaboratively to develop and improve pain management approaches for military personnel, veterans and their families by adopting changes in clinical protocols, and implementing research initiatives.  Some of these efforts include: 1) increasing availability of non-pharmacological approaches for pain management in some VA and DoD medical facilities;  2) DoD funding of studies on comparative effectiveness of integrative approaches for chronic pain and co-morbid conditions; 3) VA funding of studies examining the efficacy of yoga therapy for chronic pain, including low back pain, and for PTSD; 4) funding of the Defense and Veterans Center for Integrative Pain Management; and 5) a 2014 NIH-VA joint funding initiative resulting in  the support of 13 research projects focused on the development and testing of non-pharmacological approaches to pain management.

In a separate but related effort, the 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem.  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. 

In the last two decades, health care delivery organizations have played valuable roles in research projects and health surveillance activities funded by NIH institutes and centers (ICs), other U.S. Department of Health and Human Services agencies, the DoD, and the VA. The increased adoption of health information technology tools contributes to the increased feasibility for researchers, in partnership with health care delivery organizations, to conduct studies in “real world” settings with large numbers of participants.

Although there is a recognized and compelling need for research to identify effective complementary non-pharmacological approaches for pain management and other 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 assessment or care, and may propose interventions that are challenging to implement in many health care delivery settings. Bridging the gap between research and practice is an important step in the direction of providing increased benefits to the patients.  Education and engagement of providers and patients on the value of research in health care settings are urgently needed. This NIH-DoD-VA Pain Management Collaboratory will create a broad framework to address and overcome these challenges.

Purpose

The overall goal of this initiative, jointly supported by the NIH, DoD, and VA, is to develop the capacity to implement cost-effective large-scale pragmatic clinical research in military and veteran health care delivery organizations focusing on non-pharmacological approaches to pain management and other comorbid conditions. Types of non-pharmacological approaches to study could include, but are not limited to, mindfulness/meditative (e.g., mindfulness based stress reduction, meditation), and movement (e.g. structured exercise, tai chi, yoga) interventions, manual (e.g. spinal manipulation, massage, acupuncture) therapies, neuromodulation (e.g., electrical stimulation), and psychological and behavioral interventions (e.g., cognitive behavioral therapy), or an integrative approach that involves more than one intervention.  Of special interest are integrated models of multi-modal care that are delivered in different settings (e.g. pain care that could include collaborative care, care management, care delivered through tele-care, peer-coaches, or informal caregivers etc.)

The NIH-DoD-VA Pain Management Collaboratory Initiative, 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-pharmacological approaches for pain management and other comorbid conditions in veteran or military health care systems (supported by this FOA).
  • support the design and execution of a set of high-impact Demonstration Projects that will conduct pragmatic clinical trials on non-pharmacological approaches to pain management and comorbidities with patients in health care delivery systems that provide care to military personnel, veterans and their families (supported through the companion FOA)
  • make data, tools, best practices, and resources from these and other projects available to facilitate research partnerships with HCS.

Demonstration Projects, solicited under a separate companion FOA (RFA-AT-17-001), will be selected based on the importance of the scientific questions and the potential to address impediments to research on non-pharmacological approaches to pain management and other comorbid conditions in health care delivery organizations serving military personnel, veterans and their families. 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 planning (UG3) phase followed by an implementation (UH3) phase.  During the UG3 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 UG3 planning phase will be approved to move to the implementation phase (UH3).

Coordinating Center Overview

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


1) 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 military personnel, veterans, and their families; 

2) work collaboratively with, and provide technical, design, and other support to Demonstration Project teams, to develop and implement a research protocol; and


3) widely disseminate NIH-DoD-VA 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. military personnel, veterans, 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. 

Program Governance will be accomplished using the NIH cooperative agreement mechanism (see Section VI.2 Cooperative Agreement Terms and Conditions of Award).  Close interaction with the NIH, DoD and VA and Demonstration Project awardees will be required under this program.

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, at a minimum, the following areas:  Stakeholder Engagement, Ethical/Regulatory, Study Design/Biostatistics, Phenotype/Outcomes, Electronic Health Records (EHR), and Data Sharing.  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 NIH-DoD-VA Pain Management Collaboratory, 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. military personnel, veterans, and their families.  At a minimum, the Steering Committee will be chaired by the PD/PI 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/project scientists for each award made as part of the initiative.  All members are expected to actively participate in all Steering Committee activities.  NIH, DoD, and VA representation may not exceed 40 percent of the 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., PROMIS, CTSAs, The Interagency Pain Research Coordinating Committee), regulations, and technical advances that could facilitate research on non-pharmacological approaches to pain management and other comorbid conditions.

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

  • 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 and comorbidities in U.S. military personnel, veterans and 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 military personnel, veterans and 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 Director Effort

The NIH-DoD-VA Pain Management Collaboratory program 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.

Administrative support for NIH-DoD-VA Pain Management Collaboratory Program

Administrative support for the activities of the NIH-DoD-VA Pain Management Collaboratory program, should include, but not be limited to:

  • Rapid deployment of Coordinating Center personnel and collaborative tools to enable speedy Demonstration Project team planning and testing.
  • Developing 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, Ethical/Regulatory, Study Design/Biostatistics, Phenotype/Outcomes, Electronic Health Records (EHR), and Data Sharing).
  • 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 two face to face meetings in the first year, and an annual meeting in subsequent years of the NIH-DoD-VA Pain Management Collaboratory Steering Committee in the greater Washington, D.C. area.
  • Planning and hosting face to face, video or tele-conference meetings of the Working Groups, Steering Committee, and any subcommittees on a regular basis.

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

The NIH-DoD-VA Pain Management Collaboratory program encourages sharing of data, resources policies, best practices, materials, and tools to facilitate collaboration, use, and replication of results.  In addition, the NIH-DoD-VA Pain Management Collaboratory program  encourages sharing of data from Demonstration Projects; data sharing should be done in a timely manner with appropriate privacy and confidentiality protections.  Thus, the NIH-DoD-VA Pain Management Collaboratory program expects grantees to implement a Resources and Data Sharing Plan consistent with these program goals. 

While software development is not the primary goal of this program, it is expected that software or sets of code may be developed under this program by the Coordinating Center or the Demonstration projects.   The NIH-DoD-VA Pain Management Collaboratory program, therefore,  encouragessharing of software and code that is developed under this program.  Grantees and their sub-contractors are  expected to implement software sharing plans consistent with the goals of this program, if sharing of this information will be useful to the scientific community to more efficiently conduct pragmatic trials in the future. This may include, but is not limited to, software, tools, or code sets for extraction of or for defining data in EHRs, clinical systems, and other health care data systems; software developed for implementation of new workflows for research studies; analytic and analysis programs; or tools for incorporation of patient input.  Sharing software under this program, will broaden its availability to researchers, health care delivery organizations, research institutions, and government health care systems.  The conditions for sharing should include terms that permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation into other packages. The software should be available to and modifiable by individuals outside the applicant institution and its collaborating organizations. 

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

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIH ($1,650,000 from NCCIH, $ 250,000 from NIDA and $100,000 from ORWH) intends to commit $2 million in FY 2017 to fund 1 award.

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 FOA 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 in response to 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)

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)
  • 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  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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – 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. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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 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 clinical trials involving multiple health care delivery organizations providing services to military personnel, veterans 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 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.  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 NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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 Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

Martina Schmidt, Ph.D
National Center for Complementary and Integrative Health (NCCIH)
6707 Democracy Blvd.
Suite 401, MSC 5475
Bethesda, MD 20892-5475 (For FedEx, etc., use 20817)
Telephone: 301-594-3456
Email: SchmidMa@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For this specific FOA, 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 FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

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 pain management and comorbidities in U.S. military personnel, veterans and 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 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 two one and half day NIH-DoD-VA Pain Management Collaboratory program meetings in the first year and an annual one-and-half-day meeting in subsequent years 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.

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 five to seven 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 health care 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 pain management and comorbidities in U.S. military personnel, veterans and 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 military personnel, veterans and 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 expected to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applicants are expected to  provide a description of the resources that will be made broadly available including policies, practices, materials, and tools to facilitate collaboration, reuse, and replication of the project.  Applications should provide descriptions of how privacy and confidentiality will be maintained.  The plan must include a description of how data will be shared to allow for transparency and reproducibility of study findings (e.g. access to data, data enclave, or data repository). The Data Sharing Plan should describe how information will be shared in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication.

Software Sharing Plan

A Software Sharing Plan, with appropriate timelines, is expected to be included in the application. Applicants should describe what software will be generated by the award and how they will determine which software is potentially useful to the scientific community and how it will be shared.  There is no particular software dissemination license required for this program. However, NIH does have goals for software sharing applicants should keep in mind the following goals:

  • The software should be freely available to biomedical researchers, health care delivery systems, research institutions, and government health care systems and researchers.
  • The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages.
  • The terms of software availability should include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with other colleagues.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NCCIH Referral Office by email at SchmidMa@mail.nih.gov when the application has been submitted. Please include the FOA 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.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: This FOA includes Additional Review Considerations on Resource and Data Sharing and Software Sharing which will be considered by reviewers but will not be scored individually or influence the overall impact score.

 
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 there a strong scientific premise for the project? 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?

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 and comorbidities in U.S. military personnel, veterans and 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 pain management and comorbidities in U.S. military personnel, veterans and their families?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

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 and comorbidities in U.S. military personnel, veterans and 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 objectives of this program? 

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?

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? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?

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?    

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 six 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 six 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 Children 

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 children 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

Not Applicable

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; (3)  Genomic Data Sharing Plan (GDS); and Software Sharing Plan.

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 NCCIH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Because the DoD, VA, and several NIH ICOs (NCCIH, NINDS, NIDA, NIAAA, NICHD, NINR, ORWH) are participating in this FOA even though they are not contributing funds and they are participating in the companion FOA, they will be allowed to provide recommendations for reviewers and attend the review of the applications for this FOA.  Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all 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.
  • Will receive a written critique.

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

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 . 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.
  • NCCIH will be the primary funder of this U24; For the companion FOA, each participating IC/agency will fund or co-fund individual UG3/UH3s. The applications, scores and summary statements will be shared with the DoD and VA since they are participating in this FOA even though they are not contributing funds
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 grantee’s business official.

Awardees 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 “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 other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH, DoD, and the VA 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 pain management and comorbidities in military personnel, veterans and 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 other awardees in harmonizing and sharing of tools, methods, and approaches within and between Demonstrating Projects
  • 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 other awardees 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, DoD, and VA, including those outlined under “NIH, DoD, and VA Responsibilities”
  • Submitting periodic progress reports, in a standard format, as agreed upon by the Steering Committee, and the NIH, DoD, and VA.
  • Awardees 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, DoD, and VA 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, or the equivalent from the DoD or VA if they are the funder of the Pragmatic Trial.
  • 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 (UG3/UH3s) 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, DoD, and VA PO/ Project Coordinator and Project Scientists will provide technical assistance, advice, and coordination; however, the role of the NIH, DoD, and VA 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, DoD, and VA 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, DoD, and VA Project Coordinators, POs and Project Scientists may participate in all work groups, 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 in consultation with DoD and VA 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, DoD, and VA 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 grantee 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; the National Advisory Council for Complementary and Integrative Health, the DoD, and VA.
  • 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:

  • Awardee(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, DoD and VA 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 membership may never exceed 40 percent.  
  • 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 be established in the following areas, at a minimum:  Stakeholder Engagement, Ethical/Regulatory, Study Design/Biostatistics, Phenotype/Outcomes, Electronic Health Records, and Data Sharing.  Work Groups will be chaired by Coordinating Center staff and open to participation by individuals from all funded Demonstration Projects, the Coordinating Center, and the NIH, DoD, and VA. 
  • Establishment and adherence by each Demonstration Project Team (Demonstration Project grantee, Coordinating Center grantee, 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 grantees 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 awardees 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. Reporting

When multiple years are involved, awardees 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 progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Eve E. Reider, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 301-443-8374
Email:  ereider@mail.nih.gov

Will M. Aklin, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone:  301-443-1428
Email:  aklinwm@mail.nih.gov

Lisa Begg, Dr.P.H., R.N.
Office of Research on Women’s Health (ORWH)
Telephone: 301-496-3975
Email: beggl@od.nih.gov

Peer Review Contact(s)

Martina Schmidt, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 301-594-3456
Email: SchmidMa@mail.nih.gov

Financial/Grants Management Contact(s)

Shelley Carow
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 301-594-3788
Email:  CarowS@mail.nih.gov

Pamela G. Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: pfleming@nida.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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