Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Center for Complementary and Integrative Health (NCCIH)

Funding Opportunity Title
HEAL Initiative: Coordinating Center for National Pain Scientists Career Development (R24 Clinical Trial Not Allowed)
Activity Code

R24 Resource-Related Research Projects

Announcement Type
New
Related Notices
Funding Opportunity Announcement (FOA) Number
RFA-NS-22-046
Companion Funding Opportunity
RFA-NS-22-045 , K12 Physician Scientist Award (Program)
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.853, 93.865, 93.213
Funding Opportunity Purpose

There is an urgent need for more research to establish best practices in the pain management field, however, there is a limited workforce pipeline of pain researchers to meet NIH’s long-term goals of providing effective non-opioid options for the treatment of pain conditions and better pain management overall. The Interagency Pain Research Coordinating Committee (IPRCC) has identified the workforce problem as a barrier for new pain research, and has identified factors that contributed to it, including challenging environments for clinicians to practice research and a high departure rate among senior investigators and mentors. The IPRCC also identified a need for more structured opportunities for early-stage investigators to learn from experienced investigators. The pain management field has further recognized that basic, translational, and clinical researchers do not regularly collaborate when developing grant applications. If pain management researchers across all disciplines were to work together, it would enhance the innovation, relevance, and practical application of pain management research.

To support the NIH HEAL Initiative’s response supporting new investigators, promoting multidisciplinary collaborations among pain researchers, and identifying innovative treatments to manage pain, this FOA invites applications for the Coordinating Center for National Pain Scientists (CCNPS). The CCNPS will be a central facilitator for integrating training and mentoring across a network of mentors and early-stage investigators funded by NIH (e.g., NIH trainees, NIH fellows, and Career Development Awardees). The main purpose of the CCNPS is to enhance the training experience of new pain researchers across the continuum of basic, translational, and clinical research and create a vast network of NIH-funded pain researchers to promote multidisciplinary collaborations in pain research. The CCNPS will create and run a coordination center to connect NIH-funded pain researchers with each other with the goal of enhancing the innovation, relevance, and practical application of pain management research, as well as increase communication among pain management researchers across all disciplines.

Key Dates

Posted Date
January 10, 2022
Open Date (Earliest Submission Date)
February 24, 2022
Letter of Intent Due Date(s)

30 days before application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
March 24, 2022 Not Applicable Not Applicable July 2022 October 2022 December 2022

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
March 25, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

There is an urgent need for more research to establish best practices in the pain management field, however, there is a limited workforce pipeline of pain researchers to meet NIH’s long-term goals of providing effective non-opioid options for the treatment of pain conditions and better pain management overall. The Interagency Pain Research Coordinating Committee (IPRCC) has identified the workforce problem as a barrier for new pain research, and has identified factors that contribute to it, including challenging environments for clinicians to practice research and a high departure rate among senior investigators and mentors. The IPRCC also identified a need for more structured opportunities for early-stage investigators to learn from experienced investigators. The pain management field has further recognized that basic, translational, and clinical researchers do not regularly collaborate when developing grant applications. If pain management researchers across all disciplines were to work together, it would enhance the innovation, relevance, and practical application of pain management research.

This FOA invites applications to develop a Coordinating Center for National Pain Scientists (CCNPS) that will support the NIH HEAL Initiative’s goal of supporting new investigators, promoting multidisciplinary collaborations among pain researchers, and identifying innovative treatments to manage pain. The CCNPS will be a central facilitator for integrating training and mentoring across a network of mentors and early-stage investigators funded by NIH (e.g., NIH trainees, NIH fellows, and career development awardees). The CCNPS will also synergize the specific efforts of NIH HEAL Initiative's two previously released FOAs (a K24 (NOT-NS-21-026) to support mentors and a K12 (RFA-NS-22-045) to develop a structured mentorship/career development program) which are in response to the need to increase the clinical research workforce. The main purpose of the CCNPS is to enhance the training experience of new pain researchers across the continuum of basic, translational, and clinical research and create a vast network of NIH-funded pain researchers to promote multidisciplinary collaborations in pain research. The CCNPS will create and run a coordination center to connect NIH-funded pain researchers with each other with the goal of enhancing the innovation, relevance, and practical application of pain management research, as well as increase communication among pain management researchers across all disciplines.

Coordinating Center for National Pain Scientists Career Development

This program would serve as a central facilitator to integrate training and mentoring across a network of all early-stage pain investigators funded by NIH (e.g., NIH trainees, NIH fellows, and Career Development Awardees) and pain mentors funded by Institutes. The goal is to enhance the experience of all newly funded NIH pain researchers across the spectrum of basic, translational, and clinical research and to promote multidisciplinary research that is meaningful for those living with pain. The CCNPS should ultimately be an engaging network where: 1) all NIH funded early-stage pain investigators can connect and learn from NIH funded pain mentors across the U.S.; 2) early-stage NIH funded investigators can learn from and collaborate with each other; 3) collaboration along the continuum of pain research is facilitated. Additionally, the CCNPS wouldbe required to organize and host an annual meeting that should be widely attended by NIH funded pain researchers across the entire research continuum (i.e., basic, clinical and translational researchers) and acrosscareer levels. Attendance at this meeting will be mandatory for the scholars funded by an accompanying K12 (RFA-NS-22-045). Attendance at this meeting will be recommended for all NIH-funded pain early-stage investigators (researchers on K grants, T grants, F grants, etc.). The CCNPS will be responsible for promoting this meeting and networking opportunities to NIH-funded early-stage investigators and mentors.

Key components of the program:

  • Create a governing body composed of multidisciplinary pain researchers and pain patients from across the United States.
  • Create a networking system to connect pain researchers across the continuum of pain research, from all disciplines, and at all career levels.
  • Create a medium that facilitates communication between basic, translational, and clinical researchers.
  • Plan and host an annual meeting for all NIH-funded pain trainees and mentors.
  • Disseminate information about the annual meeting, collaboration and education events, successes of trainees, etc.
  • Regular hosting of collaboration and educational events to connect early-stage investigators among themselves and with more experienced investigators on a regular basis.
  • Assess educational courses offered for trainees and mentors, and then develop and offer courses that would help enhance the field of pain management, if necessary.
  • Conduct an external evaluation of the accompanying K12 program’s effectiveness in its last year (RFA-NS-22-045).
  • Create and utilize objective criteria to 1) measure success of the network (e.g. participation, engagements, publications with multiple network participants); and 2) evaluate the impact of the network on career success and development (e.g. correlate network participation with traditional criteria for success such as publications or promotions).

Elements of the CCNPS Program:

Administrative Coordination

There are several administrative coordination components of the CCNPS:

  • Create a network/networking system for NIH-funded pain researchers. Specifically, the network should help connect early-stage investigators to established mentors around the country and should help enhance collaboration among early-stage investigators who are along the pain research continuum (i.e., basic, translational, and clinical researchers). It is required that the network have an online space/platform component that CCNPS uses to engage network participants regularly throughout the year.
  • Survey early-stage investigators and NIH-funded mentors to obtain their input about the types of activities (e.g., social networking, pain seminars, leadership training, mentoring experiences) that should be incorporated into the network.
  • Identify NIH-funded early-stage career investigators (e.g., those who have received a K grant, are on a T grant, etc.) as well as NIH-funded mentors to inform them about, and encourage their participation in, the network.
  • Plan and implement activities that will enhance and facilitate communication across the pain research continuum with the goal of increasing multidisciplinary collaborations.
  • Disseminate information about all CCNPS activities, including the annual meeting, collaboration events, education events, successes of trainees, etc., to all awardees of NIH pain grants.
  • Assist early-stage NIH pain grant awardees in navigating systems (i.e., connecting to a senior mentor at an outside institution, identifying helpful courses and training, running webinars to provide information that might help early-stage NIH pain grant awardees progress to mid-stage investigators, etc.)
  • Create and utilize criteria/methods to measure the success of the CCNPS at meeting its stated objectives. It is recommended that these methods include an element that can be used to compare success of network participants to non-participants
  • There should be a clear logistical plan and timeline that explains how and when activities will occur within the coordinating center

Organization of an Annual Meeting and Networking Activities

A required element of this FOA is the planning and hosting of an annual meeting for all NIH-funded early-stage pain researchers (i.e., researchers on K grants, T grants, F grants, etc.) and NIH-funded mentors. The PD/PI, along with the governing board, will organize this meeting annually to serve a forum where mentoring and career development activities can be discussed and take place. The meeting should also serve the purpose of connecting investigators across the continuum of pain research to facilitate multidisciplinary collaborations. The main scope of the annual meeting should be to help build a network of pain researchers from across the United States, as well as across the scientific continuum, who are working towards the common goal of improving pain management by openly sharing and communicating their knowledge in a collegial atmosphere. The annual meeting should also povide enhanced mentorship opportunities, leadership courses, and any additional trainings that maybe ncessary for early-career scietistis. The CCNPS should encourage all NIH-funded early-stage pain investigators and NIH-funded mentors to attend the annual meeting. The CCNPS also should incorporate a mechanism to fund a portion of all NIH-funded early-career pain researcher trainees’ travel to the annual meeting. Meeting attendance is required for K12 scholars, and it is expected that the K12 Advisory Committee members will attend.

The network also should include regular activities to keep pain scientists engaged in the network throughout the year and add value to the training experience of NIH pain early-stage researchers. These activities would support the overall goals of the CCNPS to 1) enhance the training experience of early-stage career researchers; 2) facilitate/enhance communication/collaboration between pain researchers across the continuum of scientific disciplines; and 3) enhance the access of trainees to more senior mentors. The CCNPS should seek out stakeholders’ perspectives on what activities would be most useful to host throughout the year to achieve the CCNPS’s goals and encourage maximum participation from NIH pain early-stage investigators and NIH-funded mentors.

Research education infrastructure

The CCNPS is expected to survey early-stage investigators, mentors, and the governing board to understand potential educational activities, webinars, training or courses that would maximize the potential of pain researchers. The CCNP should consider administering the educational activities, training and/or courses at the annual meeting, or make them available at regular intervals throughout the year. If necessary, the CCNPS will develop and administer the necessary courses and training. In addition, the CCNPS may decide to improve access to key trainings or courses, that are already available, by focusing on disseminating this information across the network.

Program Evaluation

The CCNPS would berequired to conduct an external review of the success of the K12 program (see accompanying K12 FOA; RFA-NS-22-045). The governing board and PD/PI would be required to create objective criteria by which to measure the success of the program. The governing board and PD/PI also would be responsible for conducting the review, preparing a report and presenting their findings to NIH program staff.

PD/PI Responsibilities

The PD/PI(s) would be expected to coordinate meetings and events, monitor and assess the program, and submit all documents and reports as required. The PD/PI(s) would be responsible for the day-to-day administration of the program, appointing members of the governing board, conceptualizing and establishing the network/networking system, designing an outreach plan to recruit eligible participants to the network, planning and leading governing board discussions, monitoring the success and reach of the CCNPS program, leading the development of the review criteria for the K12 program and dissemination of information about/promotion of the CCNPS. This R24 grant will provide PD/PI(s) 50% protected time in order to run the CCNPS. PD/PIs and NAC members from the K12 award cannot apply to be PD/PI(s) for the R24. PD/PI(s) also are responsible for hiring the program staff needed to execute CCNPS operations. This R24 grant would support an administrative staff member for up to 6 calendar months/year and one IT/web support staff for 4 months/year. In addition, if extensive coordination is required to achieve the goals of the CCNPS, an additional 6 month/year salary support may be requested to support a CCNPS administrative position designed to accomplish these goals.

It is expected that the PD/PI(s) will provide detailed information about the specific goals and expectations of the CCNPS to all governing board members, and when appropriate, department chairs of early-stage NIH grantees, and ensure that the governing board agrees with the goals, expectations, and requirements of the CCNPS. The PD/PI(s) may wish to assign significant programmatic roles to faculty members (e.g., name co-directors) or administrative staff who do not serve as PD/PI(s). These individuals should agree to perform the described duties and should have documented, sufficient time to commit to the program.

The PD/PI(s) would be required to submit annual progress reports, in the Research Performance Progress Report (RPPR) format, and financial statements as required in the NIH Grants Policy Statement.

Governing Board

The governing board, chaired by the PD/PI(s), is a select group of multidisciplinary scientists who have established records of research and mentoring, as well as pople with pain. The governing board should include approximately 10 members (eight established research investigators as well as at least two patients with lived experience). This committee must be diverse with respect to scientific interests, geographic location, clinical scientist and non-clinical scientists, and prior training affiliations (i.e., multidisciplinary). The committee also should have appropriate representation of experts with regard to gender, socioeconomic background, disability, and race/ethnicity. While the governing board will likely contain mostly mid-career and senior scientists, the PD/PI(s) may also wish to add additional individuals who are more junior scientists but are clearly outstanding for their career stage (i.e., individuals who have published high quality research and recently received their first R01). Note that not all members of the board must have identical roles in the program, and the PD/PI may wish to assign subcommittee roles to board members. The governing board will plan, design and help run CCNPS activities including the annual meeting, provide input on the quality of CCNPS activities to ensure that the goals are being met and help evaluate the K12 program. Due to the role of the governing board in evaluating the K12 program, PD/PI(s) and K12 AC members from the K12 program cannot serve on the governing board for the CCNPS. The duration of service of individuals on the board should be negotiated between individual members and the PD/PI and generally should be a minimum of three years.

A description of the governing board should be included in the grant application; however, board members need not be named in the grant application. The application should mention how the PD/PI(s) will propose to achieve the composition of the governing board. The application should include descriptions as to how the board will provide oversight and guidance within CCNPS. After the NOA has been issued, NIH must approve the composition of the governing board, including the individuals’ names, expertise, current affiliation, and prior training affiliations, as well as their roles and responsibilities, and other relevant information. Board members should be paid a yearly honorarium for their participation in the CCNPS, and honorariums should be in line with NIH guidelines of a maximum of $400 per meeting.

HEAL

In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. Please refer to Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details.

The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative recipientswill cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIH intends to fund one award, corresponding to $1,893,240 direct costs in FY 2022. Future year amounts will depend on annual appropriations.

HEAL intends to commit approximately $2,499,120 (direct cost) in FY23, $1,893,240 (direct cost) in FY24, $1,893,240 (direct cost) in FY25, and $1,893,240 (direct cost) in FY26.

Award Budget

Application budgets are not limited, but need to reflect the actual needs of the proposed project.

Award Project Period

The project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

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

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

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Laura D Wandner, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Email: Laura.Wandner@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Personnel Costs: Individuals designing, directing, and implementing the career development program may request salary and fringe benefits to support up to 6 person-months (50% effort total for all individuals) and 4 person-months of IT/web support. In addition, if extensive coordination is required to achieve the goals of the program, an additional 6 person-month salary may be requested to support a CCNPS administrative position designed to accomplish these goals. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap.

Other Program Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution. Honoraria for attending meetings and travel to meetings may be requested for members of the governing board. Honoraria also may be offered for planning the annual meeting and the evaluation of the K12 program.

The salaries of administrative and clerical staff should normally be treated as indirect (F&A) costs. Direct charging of these costs may be appropriate only if all of the following conditions are met: (1) Administrative or clerical services are integral to a project or activity; (2) Individuals involved can be specifically identified with the project or activity; (3) Such costs are explicitly included in the budget or have the prior written approval of the Federal awarding agency; and (4) The costs are not also recovered as indirect costs. When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget. It is anticipated that support will not exceed 16 person-months for administrative support, which can only be requested for work directly performed for the CCNPS program.

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.

Program Plan

Program Administration:

Describe the strengths, leadership and administrative skills, scientific expertise, and training experience of the CCNPS PD/PI(s). Particular attention should be paid to the qualifications of the PD/PI(s) to lead and oversee this national coordinating center. Describe the strategy and administrative structure that is intended to be used to plan, execute and monitor the program.

If the CCNPS program will have co-directors, these individuals, as well as their roles, should be identified, and qualifications to perform these responsibilities should be discussed. All PD/PI(s) should provide a letter documenting their willingness to serve in their proposed capacity. The letters should be included in the “Letters of Support” section.

Governing Board:

Describe the planned make-up of the governing board. Describe how the PD/PI(s) will identify and approach potential board members. Describe how the governing board will operate and how the input of patients with lived pain experience will be incorporated into board decision-making. Describe the proposed roles for patients with lived pain experience.

After the NOA has been issued, the PD/PI(s) needs to report the composition of the governing board, including name, expertise, current affiliation, and prior training affiliations, as well as their roles and responsibilities, and other relevant information. NIH program staff will have to approve the governing board composition and may make changes to the composition of the board, if necessary.

Proposed Activities:

Networking. Describe how the coordinating center will implement and design a network/networking system for NIH-funded pain early-stage investigators and NIH-funded mentors. NOTE that it is required that the network have an online component so that the network regularly engages participants throughout the year, across the U.S. Explain how the CCNPS program will enhance communication between scientists across the continuum of pain research. Describe how the program intends to recruit NIH-funded pain researchers from across the pain research continuum and how the program intends to connect researchers of different career stages. Delineate how the coordinating center intends to achieve buy-in from both early and late-stage investigators, as well as researchers from all levels across the pain research continuum (i.e., basic, clinical, and translational scientists) to participate in this network.

Annual Meeting. Describe the type of content and information that would be included in an annual meeting for all NIH-funded early-stage pain researchers (i.e., researchers on K grants, T grants, etc.) and NIH-funded mentors. Explain how the CCNPS would organize this meeting and how it would promote and build a network of pain researchers from across the United States and the scientific continuum, who are working towards a common goal of improving pain management. Describe how the CCNPS would promote the meeting and encourage all pain NIH-funded early-stage investigators and NIH-funded mentors to attend the annual meeting. Also, provide a proposal to fund a portion of all pain-focused NIH-funded early-career trainees travel to the annual meeting.

Research education infrastructure. Describe how the program will survey early-stage investigators, mentors, and the governing board to assess potential educational activities, webinars, trainings or courses that would maximize the potential of pain researchers. Explain how the program will provide educational activities, training and/or courses at the annual meeting or make them available at regular intervals. Detail how the CCNPS, if necessary, will develop and provide the necessary courses and trainings throughout the year. Discuss how the program will improve access to key training or courses that already are available, by disseminating this information across the network.

Program Evaluation. Describe how the governing board and PD/PI will create objective criteria by which to measure the success of the K12 program. Discuss how they will be responsible for conducting the review, preparing a report and presenting their findings to NIH program staff.

Stakeholder Engagement. Describe how the program will educate early-stage investigators on the role of stakeholder and community engagement across the continuum of scientific research. Discuss community stakeholder activities and trainings that are planned as part of the program. Explain how patients with lived experience will be utilized on the governing board. Describe how the program will engage NIH grant awardees to encourage participation in the network as well as gather input for the network’s design.

Dissemination. Describe how the program plans to disseminate program information (i.e., information about the annual meeting, training, and networking events) as well as the successes of program participants across the network. Discuss how the program plans to ensure that the network is as expansive and diverse as possible and how the program plans to track the success, or limitations, of information dissemination strategies and engagement in research education activities.

Leadership. Describe the plan for using the CCNPS program to contribute to the development of future leaders within the pain management community.

Institutional Environment and Commitment to the CCNPS

The PD/PI’s sponsoring institution must assure support for the proposed CCNPS program, including assurance that sufficient time will be allowed for the PD/PI(s) to contribute to the proposed program (a minimum of 6-person months per year, equivalent to 50% effort) will be maintained.

PHS 398 Research Plan

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

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.

HEAL

Datasharing: Under Research Strategy/Resource Sharing Plan

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), , all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. It is expected that data generated by HEAL Initiative-funded projects will be submitted to study-appropriate domain-specific or generalist repositories in consultation with the HEAL Data Stewardship Group to ensure the data is accessible via the HEAL Initiative Data Ecosystem. Additional guidance on data related activities can be found at https://www.healdatafair.org/.

To maximize discoverability and value of HEAL datasets and studies, and facilitate data integration and collaboration, applications submitted in response to this FOA are strongly encouraged to incorporate standards and resources where applicable:

  • Applicants are encouraged to ensure that data collected by the study conform to Findable, Accessible, Interoperable, and Reusable (FAIR) principles.
  • Applicants are specifically encouraged to incorporate into their planning, an alignment with the guidelines, principles and recommendations developed by the HEAL Data Ecosystem, including but not limited to preparing data to store in selected specified repositories, applying minimal metadata standards, use of core HEAL Clinical Data Elements (CDEs, https://heal.nih.gov/data/common-data-elements), and other necessary requirements to prepare data to connect to the HEAL Data Ecosystem.
  • All new HEAL clinical pain studies are required to submit their case-report forms/questionnaires to the HEAL Clinical Data Elements (CDE) Program. The program will create the CDE files containing standardized variable names, responses, coding, and other information. The program will also format the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C § 794 (d)), which “require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities.” HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program.

The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.

  • Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
  • NIH has provided guidance around selecting a repository for data generated by NIH-supported research and has developed desirable characteristics for all data repositories (NOT-OD-21-016).
  • NIH encourages the use of data standards including the PhenX Toolkit (www.phenxtoolkit.org) (for example, see NOT-DA-12-008, NOT-MH-15-009)
  • NIH encourages researchers to explore the use of the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data (NOT-OD-19-122). The FHIR® standard may be particularly useful in facilitating the flow of data with EHR-based datasets, tools, and applications.
  • NIH encourages clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standards, as they are applicable (NOT-OD-20-146). Use of the USCDI can complement the FHIR® standard and enable researchers to leverage structured EHR data for research and enable discovery.

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

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

Late applications will not be considered.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Webinar

In order to learn more about this RFA and to have the opportunity to ask questions, a pre-application webinar will be held on February 15th from 12:00-1:00pm EST (9:00-10:00am PST). Information on how to join the webinar is provided below.

RFA-NS-22-046: Heal Initiative: Coordinating Center for National Pain Scientists Career Development

To join the web presentation:

1.Go to https://nih.zoomgov.com/j/1617279730?pwd=ZlRjcGo3WDF3R2tlQmh1MTk1Y2dRUT09

2. Click "Join Now"

For audio you can follow the prompts on your monitor, or

Call-in number (US): 551 285 1373

Meeting ID: 161 727 9730

Passcode: 060708

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.

After the NOA has been issued, the PD/PI(s) needs to report the composition of the governing board, including name, expertise, current affiliation, and prior training affiliations, as well as their roles and responsibilities, and other relevant information. NIH program staff will have to approve the governing board composition and may make changes to the composition of the board, if necessary.

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 that the proposed coordinating center will create a network for researchers across the spectrum of pain research, bring early-stage investigators and mentors together, organize an annual meeting, and offer courses and trainings throughout the year to help enhance the field of pain management, in consideration of the following review criteria and additional review.

Scored Review Criteria

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

Significance

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

Investigator(s)

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

  • Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
  • Are the PD/PI(s) research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed coordinating center?
  • Are the PD/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
  • For applications designating multiple PDs/PIs:
    • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
    • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

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?

Approach

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

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

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

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.

Administrative Coordination

  • Is there evidence that the proposed network/networking system can reach and disseminate information about the R24 activities to NIH-funded pain early-stage investigators who could benefit from receiving support from the network?
  • Is the proposed program likely to entice NIH pain grant awardees (early-stage investigators and NIH funded mentors) across the research continuum to participate in the network?
  • Are there proposed activities to ensure that NIH early-stage investigators will gain a thorough appreciation of how all levels of scientific research (i.e. basic/clinical/translational) interact?
  • Is there a plan to effectively deliver or facilitate access to necessary educational courses/trainings to members of the network?
  • Is there a thoughtful plan for maximizing the participation of pain researchers in the network who are diverse in the field by gender, socioeconomic background, training, geographic location, disability, as well as race and ethnicity?
  • Are the guidelines proposed for oversight of didactic, training-related, and research-related activities of the program appropriate?
  • Is there a plan to objectively evaluate the success of the network? Would the evaluation method permit the comparison of program participants to non-program participants?

Network

  • Does the proposalapplication describe the creation of an innovative network that NIH-funded early stage-investigators and NIH-funded mentors will engage in?
  • Does the proposalapplication describe an online or virtual networking system that engages participants regularly and semi-frequently throughout the year?
  • Is the network an innovative way to engage the NIH trainee community and foster a collegial atmosphere that will facilitate multidisciplinary collaborations?
  • Will the proposed network and network activities be valuable to early-stage investigators?
  • Does the proposed program clearly outline a plan to identify and recruit NIH pain grant awardees (NIH-funded early-stage investigators and NIH-funded mentors) to participate in the network?
  • IsAre the proposed amount and mode of communication to NIH early-stage investigators appropriate?
  • Will the proposed communication plan ensure participation and buy-in from a diverse group of NIH early-stage investigators representing the whole continuum of pain research?
  • Is there a proposed method to survey the community about their educational and collaborative needs? Is the plan appropriate?
  • Will the proposed networking activities help prepare early-stage pain researchers for successful, impactful careers regardless of their home institution?
  • Is there a proposed plan to facilitate communication/collaboration between researchers across the pain research continuum, between early-stage investigators and mentors, and among early-stage investigators?

Education/Training Component

  • Does the application propose a useful and helpful course (or courses) for the pain community?
  • Is there a plan to engage the community to determine what is needed to fulfill the educational goals of this program?
  • Is there a plan for fostering leadership skills and opportunities for all early-stage investigators?
  • Is there a plan to evaluate and measure educational activities?
  • Does the proposalapplication include courses on scientific leadership, mentoring, how to serve on review panels, and grant writing (i.e., courses preparing early-stage investigators for an impactful and successful academic research career)?

Annual Meeting

  • Does the program describe a detailed plan for an annual meeting that will serve to foster career development and encourage multi-disciplinary collaborations among pain researchers of diverse career stages and specialties?
  • Does the program discuss how the program will disseminate information about the meeting to potential attendees?
  • Is there a well-considered plan for inclusion of an appropriate number and type of attendees at this annual meeting, to include not only the K12 scholars but all NIH-supported pain researchers?
  • Is there a plan about how to distribute funds to early-career researchers?

Program Evaluation

  • Is there a clear and objective standard for evaluating the K12 program

Governing Board

  • Is the proposed constitution of the governing board appropriate?
  • Is there a strong plan to recruit the governing board?
  • Is the role of pain patients on the board defined?
  • Is there a plan to maintain patient representation for the duration of the award?
  • Is there a strong plan to include junior pain scientists -- who could provide diverse insights and helpful advice to the program design -- who have launched successful research programs, with appropriate attention to diversity, including gender, socioeconomic background, training, geographic location, disability, and race/ethnicity?

Protections for Human Subjects

Generally not applicable. Reviewers will bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Reviewers will bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers will bring any concerns to the attention of the Scientific Review Officer.

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

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 NINDS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

PD/PI(s) mustsubmit annual progress reports to NIH. Progress reports should describe all relevant outcomes related to CCNPS activities over the years funded. This should include a summary describing the types of NIH grant awardees participating in the network, including their institutions and research specialties. Progress reports should describe how the CCNPS program has evolved in response to feedback and the results observed in previous years. Progress reports should describe efforts to evaluate the program, and any changes made to the program based on those evaluations. The reports also should describe in general terms the makeup of the governing board and any changes to this makeup.

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Laura D Wandner, Ph.D.
National Institute of Neurological Disorders and Stroke
Email: Laura.Wandner@nih.gov

Linda Porter, Ph.D.
National Institute of Neurological Disorders and Stroke
Email: Porterl@ninds.nih.gov

Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: lanay.mudd@nih.gov

Karen Lee, M.D., M.P.H.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301) 827-3973
Email: karen.lee2@nih.gov
Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email:ChiefGrantsManagementOfficer@ninds.nih.gov

Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: shelley.headley@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 63A and 45 CFR Part 75 and 2 CFR Part 200.

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