It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide, or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of the National Center for Complementary and Integrative Health (NCCIH) Administrative Supplement to National Center for Advancing Translational Sciences (NCATS) supported Clinical and Translational Science Awards (CTSA) program is to develop a pipeline of qualified clinician-scientist investigators with complementary and integrative health degrees and expertise conducting clinical or translational research on complementary clinical interventions for NCCIH high-priority research topics.

The CTSA program supports a national network of medical research institutions, called hubs, that work together to identify and test promising translational innovations and develop, demonstrate, and disseminate advances across the translational science research spectrum. The program, as a whole, supports the full spectrum of clinical and translational research with an overarching goal to advance the science of translational research, bringing more treatments to more patients more quickly.

The CTSA program is envisioned to be an integrated research and training environment for clinical and translational science that aims to dramatically improve efficiency and quality across the translational research spectrum. To meet the training and career development needs of translational science, NCATS encourages innovative research training and career development programs that impart the knowledge, skills, and attitudes particular to translational science. A key objective of the CTSA program is to promote team science and the development of a well-trained and skilled translational research workforce. The translation of basic research discoveries into clinical interventions to improve human health requires teams of scientists, clinicians, and other stakeholders with a wide range of expertise. Early exposure to collaboration leveraging disparate areas of expertise and perspectives will better prepare investigators to tackle current and emerging challenges facing clinical research.

The KL2 Institutional Career Development Core supports research experience and career guidance activities expected to foster high-impact research careers in translational science. The KL2 program provides educational resources and access to research resources offered across the CTSA hub and integrated across multiple departments, schools, and clinical research institutes. The hubs promote a team science approach to research collaboration that includes a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, biostatistics, bioinformatics, and bioengineering).

Each CTSA is comprised of a UL1 infrastructure component and a KL2 career development component. The KL2 program is led by a program director/principal investigator (PD/PI) who is distinct from the UL1 PI. The KL2 PI manages and oversees the program, identifies appropriate faculty expertise, solicits mentoring team members, and selects KL2 scholar candidates. KL2 scholars receive support for a minimum of 2 years and a maximum of 5 years. Selected KL2 scholars receive a rich career development experience in a multidisciplinary setting.

The KL2 program combines formal course work with translational research experience and an opportunity to pursue additional advanced degrees. All scholars, including those at CTSA partner institutions, have access to CTSA resources, which may include:

• Training courses, seminars and workshops
• Use of specialized core facilities, laboratories, and databases
• Access to a team of clinical research mentors
• Administrative and regulatory support for research protocols
• Funding for pilot research projects

The goal of this NCCIH KL2 administrative supplement program is to leverage the CTSA program network to enhance and foster research training, in NCCIH high-priority research areas (e.g., pain management), for scholars with clinical complementary and integrative health degrees (i.e., DAOM, DC, DO, DPT, and/or ND). This initiative directly responds to the National Advisory Council for Complementary and Integrative Health Working Group Report on Clinician-Scientist Workforce Development, and in particular, its Recommendation #2: Continue 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.

The goals of this KL2 administrative supplement program are consistent with the NCCIH Strategic Plan. This KL2 administrative supplement program encourages formation of interdisciplinary research teams with the required expertise to conduct high-quality studies. The NCCIH-supported KL2 scholars will become members of a large collaborative research network prepared to tackle the biomedical challenges of today and tomorrow to improve human health.

NCCIH Programmatic Requirements

PDs/PIs of active CTSA KL2 programs will recruit and nominate scholars for NCCIH KL2 administrative supplement awards. The applications are expected to propose:

• An individualized program of translational science education and career development that leverages the infrastructure support, curriculum, and mentorship expertise of the CTSA program.
• Mentors with complementary and integrative health expertise in translational or clinical research, if appropriate for the scholar's research and career goals.
• A proposed research experience integrated with the KL2 career development core and aligned with the NCCIH Strategic Plan. Top Scientific Priorities include:
• Nonpharmacologic Management of Pain
• Neurobiological Effects and Mechanisms
• Innovative Approaches for Establishing Biological Signatures of Natural Products
• Disease Prevention and Health Promotion Across the Lifespan
• Clinical Trials Utilizing Innovative Study Designs To Assess Complementary Health Approaches and Their Integration Into Health Care
• Communications Strategies and Tools To Enhance Scientific Literacy and Understanding of Clinical Research

The research experience supported under this FOA is intended to enhance the scholar's transition to an independent research career as a principal investigator or subject matter expert in a collaborative team science approach. In addition, this program is intended to provide a foundation for subsequent grant applications and support for continued research training, or for independent research funding from NIH or other sources. KL2 PD(s)/PI(s) should encourage scholars to submit applications for fellowships, individual career development awards, research grants, and other sources of independent support before the supplement period ends.

Scholars may propose to conduct basic, mechanistic, clinical, or observational research on a natural product or mind-body approach. Scholars are encouraged to justify how this mentored research experience will help to support subsequent grant applications. The proposed work should be designed to conduct pilot studies, formative work, feasibility studies, observational studies, and/or secondary analyses, as appropriate. NCCIH will not support applications proposing to examine efficacy, effectiveness or "preliminary efficacy" through this funding opportunity.

KL2 PD(s)/PI(s) and potential scholars are strongly encouraged to contact NCCIH program staff to discuss their concepts prior to submitting their application.

The following topics are considered of high programmatic priority for natural products research:

• Basic or translational studies to better understand the mechanisms of action of a natural product for symptom management. Studies to understand the bioavailability and pharmacokinetics of a natural product are also of interest.
• Early phase human clinical trials to study the postulated mechanism of action of a natural product when it is used for symptom management, particularly management of pain conditions, mental health conditions such as those commonly managed in primary care (e.g., mild to moderate depression, anxiety, and posttraumatic stress), or sleep disturbance.
• Basic or mechanistic studies or an early phase human clinical trial to examine the effects of probiotics and other natural products on gut-microbiome interactions with the brain and/or immune system.
• Rigorously designed observational studies or secondary data analyses of a natural product.

The following topics are considered of high programmatic priority for mind and body research. High-priority mind and body or integrated approaches include spinal manipulation or mobilization, massage, tai chi, qi gong, yoga, acupuncture, hypnosis, guided imagery, progressive relaxation, meditation, biofeedback, mindfulness techniques, or complex approaches like music- and art-based therapies:

• Studies of a high-priority mind and body approach for symptom management, particularly for management of pain conditions, mental health conditions such as those commonly managed in primary care (e.g., mild to moderate depression, anxiety, and posttraumatic stress), or sleep disturbance.
• Studies of a high-priority mind and body approach for promotion of psychological resilience or well-being; or for promotion of healthy eating and physical activity.
• Basic or translational studies to better understand potential mechanisms of action for a high-priority mind and body intervention.
• Formative work or early stage clinical studies to adapt or refine a high-priority mind and body intervention and/or examine the feasibility and acceptability of the intervention.
• Rigorously designed observational studies or secondary data analyses on a high-priority mind and body approach.

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

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

All organizations administering an eligible parent award may apply for a supplement under this announcement.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

The CTSA hub must have at least 2 budget periods remaining past the anticipated start date on the award to be eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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.

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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

Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.

NCCIH will support up to two KL2 scholars per CTSA hub. More than one application may be submitted per CTSA hub, although each administrative supplement application for NCCIH KL2 scholar support must include a request for support of only one scholar.

Eligible scholars must have a doctoral, clinical, complementary and integrative health degree (i.e., DAOM, DC, DO, DPT, and/or ND).

By the time of award, the individual must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Individuals on temporary or student visas are not eligible.

At the time of award, scholars must have a staff appointment at the application institution or a partnering institution. The institutional commitment letter should confirm plans to appoint the clinician-scientist to the KL2 if the supplement is funded.

Former PD/PIs on NIH research projects (R01), program projects (P01), center grants, FIRST Awards (R29), or subprojects of program projects (P01) or center grants are not eligible. Former PD/PIs on NIH career development awards (K awards), or the equivalent, are not eligible. Former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

At the time of award, the scholar may not have pending an application for any other PHS mentored career development award (e.g., K08, K23) that duplicates any of the provisions of the KL2 administrative supplement. In keeping with the type of mentoring and career development being provided by the CTSA, a KL2 scholar who is already in the process of applying for an independent mentored career development grant or a P01 or R01 level grant is likely too senior for the KL2 award.

Appointed scholars are encouraged to apply for individual mentored K awards (e.g., K01, K07, K08, K22, or K23) and independent awards (R01, R03, R21) during their KL2 support. If successful, scholars may be required to reduce effort on the mentored career award to a minimum of 6 person-months and hold concurrent support on their mentored career award and a competing PHS research grant on which they are the PD/PI or terminate the KL2 appointment depending on program requirements (See NOT-OD-08-065).

For this KL2 supplement award, scholars must be pursuing research in complementary and integrative health science that aligns with the mission of NCCIH. Scholar appointments must be a minimum of 2 years in duration.

Applicants must prepare applications using current forms in accordance with the Application Guide.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions:

PHS 398 Research Training Program Plan Form:

Program Plan: 12 pages

Administrative supplement requests for most single-project activity codes can be submitted using electronic submission processes. Administrative supplement requests for multiproject activity codes must be submitted using the paper submission process. See the Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.

Instructions for Electronic Application Submission through Grants.gov

Use the Apply button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

• R&R Cover form: Select Revision in the Type of Application field.
• PHS 398 Research Training Program Plan Form: At a minimum, the Program Plan and Letters of Support attachments should be completed and must include a summary or abstract of the funded parent award or project. Describe in detail the CTSA Network Resources and Optional Modules that will support the proposed project. Other sections should also be included if they are being changed by the proposed supplement activities.
• Program Plan
• Background: Include a summary or abstract of the funded parent award project. Provide rationale for the proposed supplement program and its alignment with the NCCIH mission.
• Research Program Plan: The proposed plan should align with the missions of the NCCIH and the NCATS CTSA program. Describe how the proposed project will contribute to the scholar's career goals and path to independence. Present a timeline for research and training activities and potential publications and grant applications for future support.
• Career Development Plan: Describe key activities of the candidate scholar during the supplement, included mentored team science activities, didactic coursework (including formal degree programs if appropriate), and other activities. Describe how the proposed training experiences will enhance the candidate's clinical and translational science skills and prepare them for an independent research career.
• Mentoring Faculty: Provide information about the program faculty who will be involved in the supplement activities, including the complementary expertise and experiences, active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stages. If any co-mentor is not located at the sponsoring institution, describe the frequency and type of communication that will be used to engage the scholar.
• Institutional Environment and Commitment to Training: Include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned proposed research project. The letter should provide assurance that the candidate scholar will be able to devote a minimum of 9 person-months (75 percent of full-time professional effort) to the supplement project. The letter should confirm that the scholar will be supported by the KL2 if the supplement is funded. The letter should also identify the laboratories, centers, and other specialized institutional facilities that will be made available to the scholar for the research project.
• Letters of Support: Attach appropriate letters from all individuals confirming their roles in the proposed supplement program.
• Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel form:
• List the PD/PI as the first person (regardless of their role on the supplement activities).
• List Senior/Key Personnel who will be serving as members of the scholar's mentoring team.
• List the scholar proposed to be added through this supplement. Scholars for this supplement support must have an eRA Commons account, and the scholar's Commons Username must be entered in the Credential field.
• Biographical sketch Senior/Key Personnel: Include a biographical sketch of the KL2 PD/PI(s) and of each of the individuals who will compose the scholar's mentoring team. The personal statement of each individual who will serve on the scholar's mentoring team should include a description of his/her specific role in mentoring the scholar, how the mentoring will occur (e.g., frequency and mode), and how the scholar's progress will be monitored during the supplement award period.
• Biographical sketch Scholar: The personal statement of the scholar's biographical sketch should include a description of his/her research objectives and career goals, and why their experience and qualifications make them particularly well-suited to receive an NCCIH KL2 supplement award. Relevant factors include previous training and research accomplishments in complementary and integrative health research and any source(s) of current funding.
• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
• R&R Other Project Information form:
• Facilities and Other Resources: Describe how the scientific environment in which the research training will be done contributes to the probability of the scholar's success (e.g., institutional support, physical resources, and intellectual rapport). For CTSA Hub Training Resources, describe the training resources that are available to the scholar.
• Human Subjects: Complete this section if the scholar will design and conduct their own independent human subjects research. Approval by the human subjects Institutional Review Board (IRB) at the grantee institution is required prior to award. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.
• Vertebrate Animals: Complete this section if the scholar will design and conduct their own independent vertebrate animal research. Approval by the Institutional Animal Care and Use Committee (IACUC) at the grantee institution is required prior to award.

Special Instructions for Streamlined Submissions using the eRA Commons for Electronic-Based Submissions

NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available, with the following additional guidance:

• Note: Scholars for this supplement support must have an eRA Commons account and the scholar's Commons Username must be entered in the Credential field.
• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the Add Other Attachments function to include the following PDF documents:
• Program Plan:
• Background: Include a summary or abstract of the funded parent award project. Provide rationale for the proposed supplement program and its alignment with the NCCIH mission.
• Research Program Plan: The proposed plan should align with the missions of the NCCIH and the NCATS CTSA program. Describe how the proposed project will contribute to the scholar's career goals and path to independence. Present a timeline for research and training activities and potential publications and grant applications for future support.
• Career Development Plan: Describe key activities of the candidate scholar during the supplement, included mentored team science activities, didactic coursework (including formal degree programs if appropriate), and other activities. Describe how the proposed training experiences will enhance the candidate's clinical and translational science skills and prepare them for an independent research career.
• Mentoring Faculty: Provide information about the program faculty who will be involved in the supplement activities, including the complementary expertise and experiences, active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stages. If any co-mentor is not located at the sponsoring institution, describe the frequency and type of communication that will be used to engage the scholar.
• Institutional Environment and Commitment to Training: Include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned proposed research project. The letter should provide assurance that the candidate scholar will be able to devote a minimum of 9 person-months (75 percent of full-time professional effort) to the supplement project. The letter should confirm that the scholar will be supported by the KL2 if the supplement is funded. The letter should also identify the laboratories, centers, and other specialized institutional facilities that will be made available to the scholar for the research project.
• Letters of Support: Attach appropriate letters from all individuals confirming their roles in the proposed supplement program.
• Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Senior/Key Personnel form:
• List the PD/PI as the first person (regardless of their role on the supplement activities).
• List Senior/Key Personnel who will be serving as members of the scholar's mentoring team.
• List the scholar proposed to be added through this supplement. Scholars for this supplement support must have an eRA Commons account, and the scholar's Commons Username must be entered in the Credential field.
• Biographical sketch Senior/Key Personnel: Include a biographical sketch of the KL2 PD/PI(s) and of each of the individuals who will compose the scholar's mentoring team. The personal statement of the individuals who will serve on the scholar's mentoring team should include a description of his/her specific role in mentoring the scholar, how the mentoring will occur (e.g., frequency and mode), and how the scholar's progress will be monitored during the supplement award period.
• Biographical sketch Scholar: The personal statement of the scholar's biographical sketch should include a description of his/her research objectives and career goals, and why their experience and qualifications make them particularly well-suited to receive an NCCIH KL2 supplement award. Relevant factors include previous training and research accomplishments in complementary and integrative health research and any source(s) of current funding.
• R&R Other Project Information form:
• Facilities and Other Resources: Describe how the scientific environment in which the research training will be done contributes to the probability of the scholar's success (e.g., institutional support, physical resources, and intellectual rapport). For CTSA Hub Training Resources, describe the training resources that are available to the scholar.
• Human Subjects: Complete this section if the scholar will design and conduct their own independent human subjects research. Approval by the human subjects Institutional Review Board (IRB) at the grantee institution is required prior to award. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.
• Vertebrate Animals: Complete this section if the scholar will design and conduct their own. independent vertebrate animal research. Approval by the Institutional Animal Care and Use Committee (IACUC) at the grantee institution prior to award.

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.

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit electronic 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.

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

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted using the instructions specified above.

Applicants must complete all required registrations prior to submission. Section III. Eligibility Information contains information about registration.

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

Important reminders:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Not Applicable

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

NIH staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award.

• Will the administrative supplement increase the likelihood that the award will enhance the scholar's potential for, and commitment to, a productive, independent scientific research career in complementary and integrative health science?
• Does the scholar have the appropriate clinical expertise (i.e., DAOM, DC, DO, DPT, or ND)?
• Will the administrative supplement increase the likelihood for the scholar to develop a strong clinical and translational research program, or to develop collaborative expertise and contribute as a strong member in team science approaches?
• Do the proposed mentors have the appropriate research qualifications, including mentoring experience, expertise, and research accomplishments, in the area of the proposed research?
• Is active research funding available to support the scholar's proposed research project?
• Is there clear commitment of the sponsoring institution to ensure that the required minimum of the scholar’s effort will be devoted directly to the research training and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities, if applicable?
• Is the proposed research experience aligned with NCCIH high-priority areas and appropriately scoped for the KL2 experience? Is it likely to yield preliminary data to support a subsequent grant application?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, NIH staff will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, NIH staff will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Not Applicable

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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.

Individual awards are based on the application submitted to, and as approved by, 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 of all trials whether required under the law or not. For more information, see http://grants.nig.gov/ClinicalTrials_fdaaa/.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee 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 https://humansubjects.nih.gov/data_safety 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).

Prior Approval of Pilot Projects:

• Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.
• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH data and safety monitoring policies.
• The awardee institution will provide NCCIH with a Study Accrual and Retention Plan and report recruitment quarterly as described in the NCCIH Policy on Study Accrual and Retention for Human Subject Research.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the KL2 training grant. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.

A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.

Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more.

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 on-time submission, 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 processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

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

Not Applicable

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

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.