Part 1. Overview Information

Key Dates

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.

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The National Center for Complementary and Integrative Health (NCCIH) recognizes a compelling need to support the development of clinician scientists trained in complementary and integrative health practices to pursue clinically informed research careers. Academic institutions training health care practitioners in the use of complementary approaches (i.e. complementary and integrative health clinical institutions) often lack key resources to fully support clinician scientist research careers of their faculty. The REACH Virtual Resource Centers are intended to fill that gap by fostering partnerships with accredited, academic institutions providing clinical degrees in complementary and integrative professions and by providing a wide array of research and training resources to support clinician scientist faculty at accredited complementary and integrative health clinical institutions, such as: schools of acupuncture, chiropractic, osteopathy, naturopathy, physical therapy, music and art therapy.

This initiative aligns with NCCIH Strategic Priorities for workforce development and with recommendations of the NCCIH Working Group Report on Clinician-Scientist Workforce Development, specifically the following recommendations:

• To support a variety of career paths to the goal of clinician-scientist, addressing specific roadblocks in each type of path. As part of this effort, develop innovative approaches to support research training for clinicians with complementary and integrative health degrees;
• Develop programs to support the host environments at all types of institutions involved in research training in complementary and integrative health. This effort should include incentivizing institutions to reward teams of scientists and clinicians.

NCCIH currently invests in several individual-level efforts to support complementary health practitioner clinician scientists, including administrative supplements for individual practitioners to gain a research experience on a funded grant (NOT-AT-22-010), supplemental slots on funded T32 programs to support a practitioner at the pre- or post-doctoral level pursue research training (NOT-AT-21-014), and supplemental slots on funded KL2 programs to support complementary health practitioner clinician scientists at the early career level (NOT-AT-20-010). This FOA will support institutional level partnerships and provide resources for clinician-scientist faculty located at complementary and integrative health clinical institutions to pursue research careers.

Objectives

The REACH virtual resource centers will be scientific hubs that provide resources to virtually support the research environment and provide resources for faculty at partnering complementary and integrative health clinical institutions to pursue a research career. It is expected that the REACH Virtual Resource Centers program will lead to the following outcomes:

• Increase in the quality and quantity of grant applications submitted by clinician scientists at the partnering complementary and integrative health clinical institutions
• Formation of multi and interdisciplinary research partnerships across partnering complementary and integrative health clinical institutions
• Enhanced research environments at complementary and integrative health clinical institutions, thereby exposing more students to research
• A stronger pipeline for developing clinician scientists trained in complementary and integrative health practices to gain expertise in clinical science and to pursue research careers at clinical institutions.

Scope

The REACH Virtual Resource Centers are expected to provide a range of resources for clinician scientist faculty at partnering complementary and integrative health clinical institutions to support the development, submission, and management of federal research grant applications (e.g., NIH, VA, DoD sources of funding). REACH centers should propose resources that would support investigators pursuing clinical research aligned with NCCIH Strategic Priorities on complementary and integrative health approaches for symptom management.

Approaches may include natural products, such as dietary supplements, plant-based products, and probiotics, as well as approaches with physical and/or psychological therapeutic inputs, (often called mind and body interventions) such as spinal manipulation or mobilization, massage, tai chi, qi gong, yoga, acupuncture, hypnosis, guided imagery, breathing exercises, progressive relaxation, meditation, biofeedback, mindfulness techniques, or music or art therapies; and multicomponent interventions such a naturopathic medicine, traditional Chinese medicine, Ayurvedic medicine, chiropractic care, or a combination of two or more of the specific complementary health approaches. Proposed resources should support investigators utilizing clinical research designs including observational or epidemiological studies, clinical mechanistic studies, qualitative and mixed methods research, and work to develop and test clinical interventions.

For this FOA, a resource is defined as an activity that provides research and technical capabilities and expertise to researchers and is available to faculty located at a partnering complementary and integrative health clinical institution. Plans for overall financial support of the resource can include fees for service if they are well justified.

Overall, REACH virtual resource centers should provide a scientific hub that virtually supports clinician scientist faculty at partnering complementary and integrative health institutions to expand their research skills, develop collaborative interdisciplinary research teams that may span multiple institutions, and to develop and submit competitive NIH research grant proposals. The REACH center resources should also help support the preparation, submission, management and execution of successfully funded grant proposals. Applicants may consider proposing resources in the following categories, but do not need to provide resources in all categories:

• Administrative support: Resources in this category would support administrative and technical aspects of proposal development and submission, award negotiation and acceptance, award management, and award closeout.
  • Examples include but are not limited to assistance with budget development, regulatory requirements, just in time documentation, subaward and contract negotiations, financial and technical reporting, etc.
• Research support: Resources in this category would support activities related to designing and conducting clinical research relevant to NCCIH Strategic priorities for symptom management.
  • Examples include but are not limited to access to research methods and statistical expertise, tools/technologies for data collection and analysis, computational software, specialized research materials, data cleaning and storage, central IRB services, participant recruitment and retention methods, etc.
• Grantsmanship: Resources in this category would support conceptual grant development assistance for NIH funding opportunities
  • Examples include but are not limited to assistance with identifying funding opportunities of interest, understanding requirements of different funding mechanisms, understanding NCCIH goals and research priorities, conceptual development of the research plan, critical review of proposals including mock study section review, assistance with resubmissions, etc.
• Mentorship and Training: Resources in this category would help promote the scientific career development of faculty at partnering institutions and facilitate the pairing of clinician scientist faculty with successful scientific mentors.
  • Examples include but are not limited to formal and informal mentorship programs, soft-skills training, individual development plans, cohort-building events for mentees, specific skills-based training programs, etc
• Team Building: Resources in this category would support the creation and sustainability of diverse, collaborative and interdisciplinary research teams
  • Examples include but are not limited to matchmaking services to fill gaps in expertise, training in team science methods, opportunities for interdisciplinary workshops and research collaborations, etc.

Applicants for the REACH virtual resource centers should provide a strong rationale for the resources they propose based on the needs of their partnering clinical institutions and should demonstrate their ability to provide expertise for the proposed resources. Administrative and research support costs that are directly charged should be integral to the project and not costs that are also recovered as indirect costs.

The REACH center should propose specific milestones and metrics to evaluate the effectiveness of the proposed resources, such as tracking outreach efforts, engagement, training, mentoring, team building, and grant applications. Funded REACH Centers will be evaluated based on NCCIH approved milestones and metrics, which must include goals for the number of NIH grant applications submitted, scored, and funded to faculty located at the partnering integrative health clinical institutions.

Partnerships with Complementary and Integrative Health Institutions

The proposed REACH Center should demonstrate their ability to partner with accredited, U.S. domestic complementary and integrative health clinical institutions, such as: Schools of acupuncture, chiropractic, osteopathy, naturopathy, physical therapy, and music and art therapy. Please note that for schools of osteopathy, only those institutions that teach manual manipulation as part of the core curriculum required for all students for a doctoral degree will be considered as an eligible partnering complementary and integrative health institution.

The application must include letters of support from at least three different, accredited, complementary and integrative health clinical institutions who agree to partner with the REACH center to provide access for their faculty to the available resources, as well as plans to outreach and expand partnerships to additional institutions throughout the course of funding. The initial partnerships must demonstrate a breadth of clinical disciplines and cannot all come from a single complementary or integrative health discipline (e.g., letters of support from three schools of acupuncture would not be acceptable, but letters of support from two schools of acupuncture and one school of chiropractic would be acceptable). The letters of support must demonstrate the willingness of the partnering complementary and integrative health institutions to engage with the REACH center to support the research careers of their faculty, and must commit in kind support to provide at least 20% effort protected time for selected faculty to participate in REACH center activities for at least one year.

This RFA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. As described in the Notice of NIH’s Interest in Diversity (NOT-OD-20-031), 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. REACH center applicants should consider strategies to enhance diverse perspectives from partnering institutions, faculty, staff and students within the PEDP. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Responsiveness Criteria:

Applications nonresponsive to terms of this RFA will not be reviewed.

• Applications that do not include at least three letters of support from partnering integrative health institutions with varying clinical disciplines are not responsive to this RFA
• Applications proposing to provide funds to support pilot studies are not responsive to this RFA
• Applications that do not include a PEDP are not responsive to this RFA
• Applications including resources that are not virtually available from remote locations are not responsive to this RFA

Technical Assistance Webinar

NCCIH will provide a technical assistance webinar for potential applicants and institutional partners for REACH Virtual Resource Centers on Wednesday, September 21, 2022 from 2-3pm ET. Please register to attend the webinar at https://nih.zoomgov.com/webinar/register/WN_eHIplM_tQ4qFoH8y_CffhQ. Attending the technical assistance webinar is encouraged for all potential applicants, but is not required for submission of an application.

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

Section II. Award Information

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

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.

For the FOA, the Program Director/Principal Investigator (PD/PI) must devote at least 2.4 person-months of effort. If multiple PD/PIs are proposed, the combined effort must equal at least 2.4 person-months, and each of the multiple PD/PIs must devote at least 1.2 person-months.

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:

Martina Schmidt, PhD
Telephone: 301-594-3456
Email: [email protected]

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) Project/Performance Site Locations

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

SF424(R&R) Cover

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.

Other Attachments: The following attachments must be included in the application:

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

SF424(R&R) Senior/Key Person Profile

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

Key personnel should describe their experience and record of accomplishments in facilitating the development of interdisciplinary collaborations, managing clinical research on complementary and integrative health approaches for symptom management, and providing support for developing federal grant applications. Teams should include personnel with scientific, technical, and administrative expertise.

R&R Budget

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

The PD/PI is required to devote 2.4 person-months to provide overall center guidance and resource management. If multiple PD/PIs are proposed, the combined effort must equal at least 2.4 person-months, and each of the multiple PD/PIs must devote at least 1.2 person-months.

In the budget justification, provide detailed information about support received or anticipated from other entities. This could include additional funding from another government agency, user fees, or institutional support, for example. These costs should not be included in the SF-424 budget pages; only the budget justification. Administrative and research support costs that are being charged as direct costs should be integrical to the project and not also recovered as indirect costs.

When transition to other means of support is feasible for specific resources, the funding requested should align with a transition plan. A reduction in requested support as the project period progresses and the resource transitions to other sources of support is appropriate.

Funds to support pilot projects are not allowed.

PEDP Implementation costs:

• Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Describe the overall aims of the resources the REACH center proposes to provide. Include an aim focused on outreach, capacity building and sustainability activities to develop partnerships with additional complementary and integrative health clinical institutions throughout the period of support.

Research Strategy: The application must detail virtual resources that the REACH center will provide to qualified investigators located at partnering accredited complementary and integrative health clinical institutions. Applicants may propose to provide resources in Administrative Support, Research Support, Grantsmanship, Mentoring and Training, and/or Team Building categories, but do not need to cover every category. Applicants must provide strong justification for how the proposed resources will enable the REACH center to meet the overall objectives of the program based on the needs of their initial partnering complementary and integrative health clinical institutions. The proposed resources should be well designed to support investigators interested in pursuing clinical research on complementary and integrative health approaches and symptom management, including observational or epidemiological studies, clinical mechanistic studies, qualitative and mixed methods research, and/or work to develop and test clinical interventions. The REACH center may propose many different models for supporting NIH grant applications from faculty at partnering institutions, which may include submitting applications as a multiple PD/PI partner when appropriate.

Applicants must demonstrate partnerships with at least three complementary and integrative health clinical institutions representing a breadth of clinical practices. The Research Strategy must provide plans for how the REACH center and the partnering institutions will interact, and how faculty at the partnering institutions will access and use the proposed resources. Applications should also address outreach and must include plans to expand partnerships to additional integrative health clinical institutions over the course of the award.

Applications must describe milestones appropriate for assessing the use and value of proposed resources, as well as the overall productivity of the REACH center including benchmarks for the total number of NIH grant applications submitted, scored and awarded to faculty from the partnering complementary and integrative health clinical institutions.

Letters of Support: Letters of support from at least three partnering accredited, U.S. domestic complementary and integrative health clinical institutions representing at least two different clinical disciplines are required. Eligible clinical institutions include, but are not limited to Schools of acupuncture, chiropractic, osteopathy, naturopathy, physical therapy, and music and art therapy. For schools of osteopathy, only those institutions that teach manual manipulation as part of the core curriculum required for all students for a doctoral degree will be considered as an eligible partnering complementary and integrative health institution.

The letters of support must demonstrate the willingness of the partnering complementary and integrative health institutions to engage with the REACH center to support the research careers of their faculty, and must commit in kind support to provide at least 20% effort protected time for selected faculty to participate in REACH center activities for at least one year.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

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

Appendix:

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applications must include milestones and a timeline. Applications that fail to include milestones and a timeline will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

In order to expedite review, applicants are requested to notify the NCCIH Referral Office by email at [email protected] 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. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

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).

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.

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.

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.

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. 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 including the PEDP.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this 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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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.

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

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
  
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Determining objectives and approaches for all proposed resources
• Developing and maintaining partnerships with complementary and integrative health clinical institutions
• Ensuring virtual access for all proposed resources
• Provide updates at least annually on implementation of the PEDP
• Designating investigators to serve as members on a Steering Committee and other subcommittees, as appropriate.
• Attending biannual (or as needed) virtual Steering Committee meetings
• Complying with Federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.
• Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined below in the NIH Staff section. The PD(s)/PI(s) will be expected to maintain close communications with the NIH Project Scientist(s) and, where appropriate, the Program Officer(s). The Project Scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards.
• Cooperating in the reporting of the study progress and findings.
• Overseeing the overall budget, activities, and performance of the cooperative agreement.
• Accepting the participatory and cooperative nature of the collaborative research process and complying with policies and practices of NIH.
• Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved sharing policies for NIH.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• NIH will assign a Project Scientist(s) as the point of contact to work with the PD(s)/Pl(s) and participate in the Steering Committee to ensure the objectives of the program are being met. The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the recipient and the NIH Project Scientist(s).
• NIH will assign a Program Officer(s) who will be responsible for retaining overall programmatic responsibility for the award, and will clearly specify to the recipient the name(s) and role(s) of any additional individuals with substantial involvement in the project and the lines of reporting authority.
• NIH may designate additional staff to provide advice to the recipient on specific scientific and/or analytic issues. Such staff may include another Project Scientist(s) or Analyst, who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.
• NIH Project Scientist will serve as a resource with respect to other ongoing NIH activities that may be relevant to the Resource Center to facilitate compatibility and avoid unnecessary duplication of effort.
• NIH Program Officer and Project Scientist will interact with the PD(s)/Pl(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/Pl(s) and his/her staff.
• NIH Project Scientist will provide input, expert advice, and suggestions in the design, development, and coordination and implementation of the Resource Center objectives.
• NIH reserves the right to suspend and/or terminate or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting

Section_8.5.2.

• NIH staff will make recommendations for continued funding based on: a) overall Resource Center progress, b) cooperation in carrying out the Resource Center activities (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); c) maintenance of a high quality of resources; and/or d) maintenance of strong collaboration with partnering complementary and integrative health clinical institutions.
• An NIH program officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Establishing a Steering Committee consisting of the PD(s)/PI(s) of funded REACH centers, representatives of partnering complementary and integrative health clinical institutions, and NIH Project Scientists to coordinate and manage collaborations among Resource Centers postaward and to promote harmonization activities and reduce duplication of efforts. The NIH Program Officer(s) will serve as ex officio member(s) of the Steering Committee with no voting rights. The NIH Program Scientist(s) will share 1 vote on the steering committee.
• Selecting a Steering Committee Chair. A Steering Committee Chair will be elected every 12 months from among the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NIH staff cannot serve as Steering Committee Chair.
• Organizing and participating in biannual (or as needed) virtual Steering Committee meetings.
• The PO/PS will assist and facilitate the group process and not direct it.
• The Steering Committee may invite additional, non-voting scientific advisors to the meetings.
• It is expected that most of the decisions on the activities of the Steering Committee will be reached by consensus. If a vote is needed, at least 60% of the voting members most vote in favor of the proposal.
• NIH staff will review and approve policies developed by the Steering Committee. NIH staff will maintain authority on all matters regarding funding or expenditure of funds.
• Ensuring that sites and investigators as well as NIH and other research partners fully comply with Federal regulatory requirements.

All responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Lanay M. Mudd, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: [email protected]

Martina Schmidt, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3456
Email: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]

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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.