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

Purpose

The National Center for Complementary and Integrative Health (NCCIH) intends to solicit applications for one research resource center to build an Open-Access Repository and Database for Anatomical and Physiological Correlates of Acupoints. This FOA will support the development and maintenance of a repository and database for commonly used acupoints along with key anatomical specifications and other relevant parameters as well as integration with other databases with physiological correlates. The ultimate integrated database should be suitable for data from human subjects in an open-access and searchable format. A parallel repository and database for an appropriate animal also desired. This FOA will utilize a cooperative agreement funding mechanism, U24, to support the development and maintenance of the repository and database to serve the research community. The repository and database should select high quality research data and aim to bring transformative values to support rigorous research on acupuncture-related interventions, which may also benefit evidence-based clinical practices and education.

Background

Acupuncture points, or acupoints have a long-standing history of controversy in acupuncture research. Criticism of acupuncture as prescientific largely refers to a lack of objective basis for acupoints. Meanwhile, a growing scientific literature is demonstrating the clinical usefulness of acupuncture and revealing novel scientific insights in basic science studies using acupuncture needles to stimulate peripheral tissues. However, the use of acupoint terminology in basic and clinical research has continued to undermine the credibility of the field. On the other hand, in acupuncture research, the term acupoint is increasingly used as anatomical shorthand to describe individual anatomical locations where insertion of an acupuncture needle is thought to produce specific physiological effects. For the purpose of this FOA, acupoints include anatomical points used in acupuncture, acupressure, or other anatomically specific transcutaneous stimulation.

At a two-day workshop on February 11-12, 2019, the National Center for Complementary and Integrative Health (NCCIH), in collaboration with the National Cancer Institute (NCI) on Translating Fundamental Science of Acupuncture into Clinical Practice for Cancer Symptom Management, Pain, and Substance Abuse, the value of the continued use of acupoints in acupuncture research was discussed. A consensus was reached that:

1) Using acupoint terminology as anatomical shorthand is useful, ties acupuncture research to traditional practice and facilitates communication between clinicians and researchers;

2) Creating a standardized database to translate traditional acupoint nomenclature and conventional anatomy/physiology would be useful as a common reference for past and future research. Such as database can be thought of as a Rosetta stone allowing classical knowledge about acupoint locations to be preserved and coexist with clinical and animal model data in a standardized way.

In response to this need, NCCIH sought input from the broader research community on the value of a potential open-access repository or database for acupoints and on key criteria and elements that would make this resource most useful through a Request for Information (RFI): Important Considerations for Potential Creation of an Open-Access Repository or Database for Anatomical and Physiological Ontology of Acupoint: NOT-AT-19-030. More than one hundred unique individuals and organizations contributed to the responses to the questions including important impact of database, appropriateness of anatomical references and anatomical regions for acupoints, and outcome measures and nomenclature standards for acupoints, and enthusiastically supported the idea of developing an NIH-sponsored open-access repository and database for Anatomical and Physiological Ontology of Acupoints.

Objectives

The proposed resource center for the Open-Access Repository and Database should:

be developed and maintained by lead experts of the acupuncture research community partnering with acupuncture or peripheral nerve stimulation organizations, in collaboration with the NIH;

serve the acupuncture research community, including both basic research and mechanistic clinical research by having standardized language, ontology, and common data elements;

select and deposit high-quality research data and support bidirectional translational research;

be open-access and searchable, and include notifications/update/alert systems;

be capable of storing, organizing, managing, and tracking access inquiries and retrievals of the data;

be compatible with other databases with relevant physiological correlates.

Requirements

This database and repository development should include four components:

1) Development of Acupoint Ontology using both the Eastern and Western nomenclature systems of acupoints;

2) Development of Acupoint Atlas and Repository, which include acupuncture point anatomical locations entered into processed imaging dataset using a 3D coordinate system with a common origin reference point;

3) Integration of physiological database(s) to the developed Acupoint Atlas and Repository; and

4) Design and development of integrative database system for data search, analysis, and retrieval system (including Ontology Query, data mining, Reports, etc.).

Milestones and Timeline

A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project activity. Applications must be driven by milestones, which should be objective and performance-based goals to achieve completion of the project on time and on budget (see example milestones at https://www.nccih.nih.gov/grants/toolbox#milestone).NCCIH staff, in collaboration with the awardee, will closely monitor progress, milestones, and accrual of the project.

Completion of the four components of development must be milestone-driven over five years.A suggested timeline of milestones and deliverables should include, but not restricted to, the followings:

Year 1 and 2:

1. Ontology Development: Development of Acupoint terminology (using both Eastern and Western nomenclature systems of Acupoints) and anatomical descriptions of the Acupoints.

2. Acupoint Atlas Development: Acupoint Atlas will contain 3D representation of acupoints in sample bodies (human and animal) including relative positions to anatomical structures (muscles, nerves, blood vessels). Acupuncture point locations into processed imaging dataset need to be entered to the Acupoint Atlas.

a. Whole-body imaging data (from computerized tomography (CT), Magnetic Resonance Imaging (MRI), or Positron emission tomography (PET)) should be used and processed using imaging analysis tools/software programs. Examples include raw data (.DICOM files) (satellite images) or post-processing anatomy models (discretized models).

b. All annotation imaging data should be constructed into x,y,z coordinates for individual pixels in sample 3-D human body images. The 3D coordinate system should use a common origin (0,0,0) reference point for all acupoints.

c. The Acupoint Atlas should contain well-chosen acupoints for indications of high interest to NCCIH.

d. All acupuncture point anatomical locations should be described and incorporated into the Acupoint Atlas.

3. Acupoint Repository Development: Development and pilot test of Acupoint Repository to incorporate acupoint anatomical data from high quality research or publications related to acupuncture.

Year 3 to Year 5:

4. Integrative Acupoint Database System Development: Integrating the Acupoint Atlas and Repository with existing physiological databases.

1. 1. The identification or development of appropriate physiological databases. Examples of potentially suitable databases include Stimulating Peripheral Activity to Relieve Conditions (SPARC), The Brain Research Through Advancing Innovative Neurotechnologies (BRAIN), The Human BioMolecular Atlas Program (HuBMAP).
   2. Integration of physiological databases to the developed Acupoint Atlas/Repository.
   3. Development and pilot test of integrative database system for data search, analysis, ontology query, and data mining.

Scope

Applications that include the following topics will not be considered responsive to this RFA, and will be withdrawn without review:

• HIV/AIDS related research.
• Applications not relevant to Acupoints as defined in this FOA.
• Applications not meeting at least first two of the four requirements specified above.
• Applications with no specified milestones
• Applications not including Acupoint ontology, atlas, and repository

Potential applicants are highly encouraged to reach out the Scientific Contact well in advance to programmatic guidance for this RFA. Applicants should read the Section IV on Application Information, PHS 398 Research Plan instruction carefully prior to submission.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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.

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:

Emrin Horgusluoglu, PhD.
Telephone: 240-383-5302
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) 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.

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:

Specific Aims page should include:

1. A Summary of the goals for the proposed Research Resource Center to build Acupoint Atlas and Repository, connect with existing physiological databases, and develop integrative database system to the stated objectives of this solicitation.
2. A Summary of general structure and governance of Research Center.
3. A Summary of expertise to be recruited to develop the Repository and Database.
4. A Summary of various components related to the Repository and Database that the Resource Center intends to build .

Research Strategy: The Research Strategy should consist of the following sections:

1. Scientific Objective and Significance: The proposed application should describe the significance of the proposed Research Resource Center to the field of acupuncture, as well as to acupuncture research overall. The Research Resource Center should present metrics and other evidence to demonstrate past and/or future use, utility, and scientific impact.
2. The Structure and Governance: Research Resource Center should document processes for developing terms of use, appropriate processes for data licenses and policies for privacy and ethics. This application should include a management plan for coordination across institutions for applications spanning multiple institutions, and how the proposed activities will effectively engage with other relevant activities at participating institutions.
3. Expertise, Community Needs and Engagement: The Research Resource Center should demonstrate that there is sufficiently large or potential usage of Acupoint database and a userbase to warrant NIH support. The application should document impact and methods/strategies used to engage targeted research community(ies).
4. Acupoint Ontology, Atlas, Repository and Database Development Plan for milestone-driven four components of the development of Acupoint Atlas and Repository and Integrative database following the steps below:

1. How to develop Acupoint Ontology to be used for the Acupoint Atlas and the database including nomenclature systems of acupoints and anatomical locations?
   • • Please describe the process and the expertise to be involved to develop Acupoint Ontology.
2. How to develop the Acupoint Atlas and incorporate acupuncture point locations into processed imaging dataset?
   • • Please describe types of atlas (e.g. human/animal, whole body or partial images, 2D or 3D, etc.).
     • Please describe the sources of images to build the atlas (e.g. Raw CT/MRI/PET images or processed imaging data, etc.)
     • Please describe the coordinates constructed from imaging data to be used for the atlas.
     • Please specify the number of commonly used and well-chosen acupoints for Acupoint Atlas.
     • Please describe the detailed process to incorporate all acupuncture point anatomical locations into the Acupoint Atlas images.
3. How to develop the Acupoint Data Repository?
   • • Please describe how to generate database entries including acupoint names, anatomical structures (e.g. muscles, nerves, blood vessels), etc.
     • Please describe the process to select the data to be deposited into the Repository and to ensure the quality of the data.
     • Optional: Please describe any pilot tests of Acupoint Repository to incorporate acupoint anatomical data from at least 10 high quality published research papers related to acupuncture.
4. How to connect physiological database(s) with the developed Acupoint Repository and develop an Integrative Database System?
   • • Please describe how to build physiological database to be linked with Acupoint Repository if no existing databases are available. OR please describe how to identify and connect the Acupoint Repository with relevant NIH physiological databases (e.g. SPARC, BRAIN, HuBMAP) if it is available and possible.
     • Please describe how to identify physiological outcomes to be integrated with the developed Acupoint Repository if possible.
     • containing desired physiological outcomes if appropriate.
     • Please describe how the integrated data and resources will be stored, organized, managed, and tracked.
     • Please describe pilot tests of integrative database system for data search, analysis, ontology query, and data mining.

5. Open-Source Integrative Database Development and Management Plan:

• Please describe the strategy for developing desired functionality of the four components: (1) how to engage lead experts of the acupuncture research community partnering with acupuncture and/or peripheral nerve stimulation organizations, in collaboration with the NIH? (2) how to serve the acupuncture research community, including both basic research and mechanistic clinical research by having standardized language and common data elements? (3) how to select and deposit high-quality data and support bidirectional translational research? (4) how to ensure open-access and searchability of the repository and database, and include notifications/update/alert systems? (5) how to store, organize, manage, and track access, inquiries and retrievals of the data? (6) how to be compatible with other relevant NIH Databases such as SPARC and BRAIN if appropriate and possible? (7) how to support annotation of safety issues and confounding factors and practitioner utility.

6. Quality of Repository and Database: The Research Resource Center should address adherence and support of the FAIR data principles as well as use of community standards for data, provenance of data, adequate infrastructure, and data storage. The Data Repository should employ a digital identifier to track usage of the resource itself. The application should also address unique capabilities such as search, user portals and other activities that pertain to data management and infrastructure management. Repositories will need to provide appropriate policies for data privacy, data licenses and ethics. The application should address innovations and improvements in the efficiency of operations.

Applications must include milestones and timelines for the deliverables of the four components of the proposed Resource Center.

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.
• Resource Sharing products can include (but are not limited to) meeting papers/summaries, scientific publications, web resources, tools or guides to support research or data enhancement, and data sets, such as public-access "user-friendly" research data; metadata, to support research; and harmonized versions of existing data or instruments.

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 Center of Scientific Review and responsiveness by National Center for Complementary and Integrative Health, NCCIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

This FOA is primarily focused on 1) Acupoint Ontology development using both the Eastern and Western nomenclature systems of acupoints; and 2) Acupoint Atlas and Repository development which include acupuncture point anatomical locations entered into processed imaging dataset. Secondly, this FOA supports 1) the integration of physiological database(s) to the developed Acupoint Atlas and Repository; and 2) the development and pilot test of integrative database system for data search, analysis, ontology query, and data mining.

The priority of this FOA is the development of Open-access Acupoint Atlas and Repository. Applications not including Acupoint ontology, atlas and repository will not be deemed responsive to this announcement and will not be reviewed.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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.

• 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.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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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 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 recipientsis anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipientsfor the project as a whole, although specific tasks and activities may be shared among the recipientsand the NIH as defined below.

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

• Developing objectives, approaches, and research strategies to build open-access Acupoint Atlas and Repository, integrative database system.
• Defining general structure and governance of Resource Center with well-delineated roles and responsibilities.
• Designating investigators to serve as members on a Steering Committee and other subcommittees, as appropriate.
• Attending quarterly (or as needed) virtual Steering Committee meetings.
• Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined below in the "NIH Staff" section. The PD/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.
• Managing and coordinating project activities scientifically and administratively at the recipientinstitution and with any collaborating institutions.
• Ensuring that all data and information are disseminated according to the FAIR principles
• Developing and proposing milestones that will be achieved during the project period
• Updating goals and milestones at the time of award and provide summaries of progress toward those goals, including the Project Management Plan, at least yearly, as requested by NIH.
• Collaborating and communicating effectively with NIH and across the NIH Program Official to achieve project goals.
• Participating in regular discussions with the NIH staff.
• Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved sharing policies for NIH.
• Recipientswill 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 Program Officer(s) who will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice
• 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 staff 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 staff will provide input, expert advice, and suggestions in the design, development, and coordination and implementation of the study objectives.
• NIH reserves the right to terminate or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting.
• NIH staff will make recommendations to the NIH for continued funding based on performance and compliance with the Terms and Conditions of the award.
• An agency program official(s) or IC program director(s) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Collaborative Responsibilities:

• Clarifying and negotiating the milestones and timelines.

• Coordination of site visits, if needed, at critical milestones or transition points of the award.

• Participating in quarterly (or as needed) virtual Steering Committee meetings.

The members of this collaborative effort should be made aware of the requirement for confidentiality due to any intent of the recipient to pursue commercialization of any qualified outcomes. Contractors and consultants of NIH will be made aware of the confidential nature of work done under this collaborative effort.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel 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]

Emrin Horgusluoglu, PhD.
National Center for Complimentary and Integrative Health (NCCIH)
Telephone: 240-383-5302
Email: [email protected]

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

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 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.