To evaluate complementary health approaches.

The following objectives support this goal: (1) coordinate and facilitate the investigation of complementary health approaches through peer-reviewed grant solicitations; (2) interface with the Center's National Advisory Council; (3) conduct technology

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assessment conferences for the purpose of establishing areas of Clinical and Pre-clinical research that need to be further developed within complementary health approaches; and (4) maintain a comprehensive bibliographic data base in conjunction with the National Library of Medicine.

The National Center for Complementary and Integrative Health (NCCIH) regularly examines and redefines its research priorities.

In setting research priorities, NCCIH considers its existing research portfolio, its 5-year strategic plan, the recommendations of the National Advisory Council for Complementary and Integrative Health, current scientific advances, the plans of other NIH institutes and centers, and input from expert panels and stakeholders.

Research constituting a rigorous evidence base for complementary health approaches will be developed through a range of research strategies including basic and translational research, and clinical investigation.

Priority setting also takes into account: 1)scientific promise, 2)amenability to rigorous scientific inquiry,3) potential to change health practices, and 4) relationship to use and practice.

Research Approaches
Basic, translational, efficacy and effectiveness research
Complementary health approaches need to be studied across the continuum of basic, translational, efficacy, and effectiveness research.

NCCIH continues to emphasize basic research that defines biological effects and mechanisms of action; NCCIH's basic research is aimed at understanding the nature of complementary health approaches such as their biology, physiology, and physical, chemical and behavioral properties.

NCCIH also supports the development of tools, models, and methodologies for studying these approaches.

NCCIH continues to encourage efficacy studies to determine specific clinical effects of complementary health approaches under carefully controlled conditions that minimize nonspecific and contextual effects.

There is also the need to strengthen translational and preliminary clinical research required to design and implement definitive clinical research and 'real world' outcomes and effectiveness research that capitalizes on the reality that many complementary health approaches are in widespread public use.
NCCIH?s support of translational research addresses the need for valid, reliable and relevant research tools, outcome measures, and innovative methodology to enhance the rigor of complementary health approaches within clinical studies and to ensure that they are maximally informative.

NCCIH emphasizes studies that inform the design of future trials such as those that will: develop and validate outcome measures; standardize treatment protocols or algorithms; validate treatment algorithms and/or; develop measures of quality control or treatment fidelity; assess effects of various doses or intervention durations; develop preliminary clinical evidence regarding efficacy and safety to support estimates of sample size; or establish feasibility of interventions or study designs in specific populations for future studies.
NCCIH's clinical research portfolio utilizes clinical trial, case-control, observational, cohort, qualitative, and other experimental methodologies to determine safety and estimate the efficacy of complementary health approaches .

The clinical research portfolio includes effectiveness studies of the contribution to improved health and wellness made by complementary health approaches as they are practiced in 'real-world' settings.
In general phase III clinical trials will be supported under the cooperative agreement mechanism after careful consideration by NCCIH Staff.

Investigators interested in proposing phase III studies are strongly encouraged to contact a relevant NCCIH Program Officer (https://nccih.nih.gov/tools/emailprogramofficers)
Areas of Special Interest
Fundamental scientific inquiry is essential to the progress of biomedicine by enhancing the understanding of how living systems work.

This understanding serves as a foundation for translational and clinical studies that can lead to improved approaches to the management, treatment, and prevention of diseases and symptoms.

One key goal is to advance our understanding of basic biological mechanisms of action of natural products including prebiotics and probiotics.

NCCIH will continue to sponsor research on compounds isolated from natural products as well as complex mixtures from which they originate.

Additionally, NCCIH will continue to support research to elucidate the effects of prebiotics and probiotics on the microbiota naturally present in the human body.

Another key goal is to advance our understanding of the mechanisms through which mind and body approaches such as meditation, spinal manipulation, massage, yoga, tai chi, hypnosis and acupuncture affect health, resiliency, and well-being.

A third key goal is to develop new and improved research methods and tools for conducting rigorous studies of complementary health approaches and their integration into health care.

These new methods could catalyze advances in natural product methodology and support development of novel technology and instruments to carry out rigorous research on symptom management and functional changes primarily for mind and body approaches.

To improve care for hard -to-manage symptoms such as pain, anxiety, and depression, both mind and body practices and natural products will be rigorously studied using well-established methodology.

NCCIH will also support studies in 'real world' clinical settings to test the safety and efficacy of complementary health approaches, including their integration into health care.

Individual behavior plays a key role in health promotion and disease prevention.

It is well established that adopting and maintaining healthy behaviors (diet and exercise) and modifying unhealthy behaviors reduces risks of major chronic diseases.

NCCIH will investigate mechanisms of action of complementary and integrative health approaches in health resilience and practices that improve health and prevent disease.

These approaches will be studied across the lifespan and in diverse populations.

NCCIH will also explore research opportunities to study and access the safety and efficacy of complementary health approaches in nonclinical settings such as community- and employer-based wellness programs.


Top Scientific Priorities
The top scientific priorities include the 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, and clinical trials utilizing innovative study designs to access complementary health approaches and their integration into health care.

Pain is the condition for which adults in the United States most often use complementary and integrative health approaches.

Growing evidence indicates that some complementary health approaches may help in its treatment and management.

Discovering the mechanisms by which a complementary approach exerts its effects could help in the design of better treatments and predict which people are most likely to respond.

Whether and how complementary health approaches directly modulate or modify the structure and/or the function of the entire or part of the nervous system remains understudied.

Advances in genomics, neuroscience, stem cells, systems biology, and neuroimaging offer excellent conceptual resources and opportunities for innovative and impactful mechanistic studies of complementary health approaches.

The purpose of innovative approaches for establishing biological signatures of natural products is to advance the characterization of the biologic activity of complex natural products broadly with an emphasis on determining metabolic profiles.

There has been a growing interest in the use of complementary health approaches for the prevention of mental, emotional, and behavioral disorders and for the promotion of psychological and physical health, well-being, and resilience.

However, the evidence for the use of complementary modalities in the context of prevention and health promotion is modest.

Rigorously designed, developmentally appropriate studies are needed to determine the efficacy and effectiveness of complementary health approaches for health promotion and disease prevention across the lifespan.
Early Stage and New Investigators
NCCIH is strongly committed to assisting new and early stage investigators in establishing a research career.

Early stage investigators are those within 10 years of completing their terminal research degree, or their medical residency, or its equivalent.

New investigators are those who have yet to compete successfully for a substantial (e.g., R01) NIH research grant.

Each Advisory Council round, based on available funds, NCCIH: 1) will consider early stage or new investigator status as one of the criteria for designating grant applications as being of high program priority and 2) may make additional R01 grant awards to new and early stage investigators with percentiles or scores out of payline order.

NCCIH continues to accept applications in areas not listed as a specific priority area via the investigator initiated funding opportunities.

All investigators are urged to discuss potential applications with the relevant NCCIH Program Officer (https://nccih.nih.gov/tools/emailprogramofficers).

Selected Recipients for this Program

Not Applicable.

Uses and Use Restrictions

Research Grants provide funds for salaries, equipment, supplies, travel, and other expenses associated with scientific investigation relevant to program objectives.

Individual National Research Service Awards (NRSAs) are made to individuals for research training in specified biomedical shortage areas.

In addition, grants may be made to institutions to enable them to make NRSAs to individuals selected by them.

Each individual who receives a NRSA is obligated upon termination of the award to comply with certain service and payback provisions.

Small Business Innovation Research (SBIR) Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process.

Phase II grants are for the continuation of the research initiated in Phase I that are likely to result in commercial products or processes.

Only Phase I awardees are eligible to receive Phase II support.

Small Business Technology Transfer (STTR) Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application.

Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential on Phase II application.

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Eligibility Requirements

Applicant Eligibility

Universities, colleges, hospitals, laboratories, and other public or private nonprofit domestic institutions, including State and local units of government, and individuals are eligible to make application for grant support of research by a named principal investigator or a research career development candidate.

For-profit organizations are also eligible, with the exception of NRSA.

Individual NRSA awardees must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program.

All NRSA awardees must be citizens or have been admitted to the United States for permanent residence.

To be eligible, predoctoral candidates must have completed the baccalaureate degree, and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., ND, DC, D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree).

SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is being proposed and have no more than 500 employees).

Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project.

In both Phase I and Phase II, the research must be performed in the U.S.

or its possessions.

STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which researches proposed and have no more than 500 employees) which 'partner' with a research institution in cooperative research and development.

At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution.

In both Phase I and Phase II, the research must be performed in the U.S.

and its possessions.

To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.

Beneficiary Eligibility

Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Credentials/Documentation

Each applicant for research projects must present a research plan and furnish evidence that scientific competence, facilities, equipment, and supplies are appropriate to carry out the plan. For SBIR and STTR grants, the applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Individual NRSA applications for postdoctoral training must include the candidate's academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training. Institutional Training grant applications for predoctoral and postdoctoral training must show the objectives, methodology and resources for the research training program; the qualifications and experience of directing staff; the criteria to be used in selecting individuals for stipend support; and a detailed budget and justification for the amount of grant funds requested. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulations 45 CFR, Part 74, Subpart Q. Grant form PHS 398 is used to apply for SBIR and STTR Phase I Phase II and Phase I/Phase II Fast Track. OMB Circular No. A-87 applies to this program. This program is excluded from coverage under 2 CFR 200, Subpart E - Cost Principles.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is not applicable.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.

12372.

Application Procedures

2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. Research grants: Single project grant applications must be prepared electronically through grants.gov (http://www.grants.gov) using the SF 424 (Research and Research-Related) and PHS 398 instructions.Multi-project grant applications must be submitted through the A.S.S.I.S.T (Application Submission System & Interface for Submission Tracking) system. Individual funding opportunity announcements will indicate the appropriate application format to be used. A listing of NCCIH and other funding opportunities can be found through the NCCIH web site (http://www.nccih.nih.gov/grants/funding), through the Grants.gov web site (http://www.grants.gov/), or on the NIH Guide to Grants and Contracts (http://grants1.nih.gov/grants/guide/index.html). For applications that require the PHS 398, the most recent version of the form and instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Electronic applications are submitted through the Grants.gov website. Completed PHS 398 applications should be submitted to the National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710 or Bethesda, MD 20817 (for express/courier service). For assistance contact GrantsInfo, Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov. National Research Services Awards: Completed application forms should be submitted to the Office of Research Manpower, Center for Scientific Review, Grants, National Institutes of Health, Bethesda, MD 20892. This program is subject to the provisions of 45 CFR, Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's 'Small Business Research Funding Opportunities' web page at http://grants1.nih.gov/grants/funding/sbir.htm . A limited number of hard copies of these publications are produced. Subject to availability, they may be obtained by contacting the NIH support services contractor: Telephone: (301) 206-9385; Fax: (301) 206-9722; E-mail: a2y@cu.nih.gov. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. SBIR and STTR grant applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710. Application forms for SBIR and STTR grants may be obtained through the SBIR/STTR funding announcements posted on the Grants.gov sites and the NIH Guide to Grants and Contracts (see URLs listed above). All SBIR and STTR applications must be submitted electronically. Electronic applications are submitted through the Grants.gov website. This program is subject to the provisions of 45 CFR Part 92 for State and local governments, OMB Circular No. A-110 for nonprofit organizations, cost principles of A-21 for educational institutions, and 42 CFR Part 42.

Award Procedures

Award Procedure: All accepted applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score ranging from the best (10) to worst (90) compete for available funds based on scientific merit, program relevance, and program balance and are made annually. Initial award provides funds for the first budget period (usually 12 months) and Notice of Grant Award (Form PHS 1533) indicates support recommended for remainder of project period, allocation of Federal funds by budget categories, and special conditions, if any. . All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines

Contact the headquarters or regional office, as appropriate, for application deadlines.

Authorization

Public Health Service Act, Section 485D , Title VI, Section 601, Public Law 105-277, 112 Stat. 2681-387, 42 U.S.C 281.

Range of Approval/Disapproval Time

Overall from 120 to 300 days. Research Grants and Cooperative Agreements: Approximately 6-10 months; National Service Research Awards: 6-9 months; SBIR/STTR awards 6-7 months.

Appeals

A Program Director/Principal Investigator (PD/PI) may question the substantive or procedural aspects of the review of his/her application by submitting an appeal. An appeal is a written communication from a PD/PI and/or applicant institution that meets the following four criteria: 1) is received after issuance of the summary statement and up to 30 calendar days after the second level of peer review, 2) describes a flaw or perceived flaw in the review process for a particular application, 3) is based on one or more of four allowable issues (described below), and 4) displays concurrence from the Authorized Organization Representative (AOR). The four allowable issues are (1) evidence of bias on the part of one or more peer reviewers; (2) conflict of interest, as specified in regulation at 42 CFR 52h.5.?Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects?, on the part of one or more peer reviewers; (3) lack of appropriate expertise within the SRG; and (4)factual error(s) made by one or more reviewers that could have altered the outcome of review substantially.A description of the NIH Peer Review Policy and Procedues is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html.

Renewals

Research grants: renewals by competitive application and review. Extension by request and administrative action. National Research Service Awards: individual awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula. Matching requirements are not applicable to this program. MOE requirements are not applicable to this program.

Length and Time Phasing of Assistance

Project Grants: Awards are usually made for a 12-month period with recommendation of up to 4 years of additional support. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years. See the following for information on how assistance is awarded/released: The Notice of Award (NoA) is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office. An NoA is issued for the initial budget period. If subsequent budget periods are also approved, the NoA will include a reference to those budgetary commitments. Funding for subsequent budget periods are generally provided in annual increments following the annual assessment of progress. This funding is also contingent on the availability of funds. The NoA includes all applicable terms of award either by reference or specific statements. It provides contact information for the assigned program officer and grants management specialist. The grantee accepts an NIH award and its associated terms and conditions by drawing or requesting funds from the Payment Management System, or upon the endorsement of a check from the US Treasury for foreign awardees. Method of awarding/releasing assistance: lump sum.

Post Assistance Requirements

Reports

Final progress reports must be submitted within 90 days after the expiration of the award.

The progress reported in a competitive renewal application may be accepted in lieu of a final progress report.

The final progress report should include (at a minimum): summary of progress toward the achievement of the originally stated aims; list of results (positive or negative) considered significant; list of publications resulting from the project as well as plans for further publications' and copies of manuscripts that have been accepted for publication, but not yet published.

No cash reports are required.

Project Grants: Expenditures and other financial records, including documents supporting accounting records and substantive charges to each grant, must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.

The Federal Financial Report (FFR) is due 120 days after the final day of the project period.

NRSAs: Documentation of expenditures and other fiscal records must be kept readily available for examination by authorized Government personnel and must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.

Reports are required after termination of NRSAs to ascertain compliance with service and payback provisions.

Expenditure reports on a quarterly basis are sent to the data warehouse.

Performance monitoring is not applicable.

Audits

In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. For specific audit requirements, please see 45 CFR 75.

Records

Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual financial status reports (FSR) is submitted. For awards under the Streamlined Non-competing Award Process (SNAP) (other than those to foreign organizations and Federal institutions), the 3-year retention period will be calculated from the date the FSR for the entire competitive segment is submitted. Those grantees must retain the records pertinent to the entire competitive segment for 3 years from the date the FSR is submitted to NIH. Foreign organizations and Federal institutions must retain records for 3 years from the date of submission of the annual FSR to NIH. See 45 CFR 75 for exceptions and qualifications to the 3-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including F&A cost proposals and property records. See 45 CFR 75 for record retention and access requirements for contracts under grants. In accordance with 45 CFR 75 the HHS Inspector General, the U.S. Comptroller General, or any of their duly authorized representatives have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to awards in order to make audits, examinations, excerpts, transcripts, and copies of such documents. This right also includes timely and reasonable access to a recipient?s personnel for the purpose of interview and discussion related to such documents. The rights of access are not limited to the required retention period, but shall last as long as records are retained.

Financial Information

Account Identification

75-0896-0-1-552.

Obigations

(Project Grants) FY 16 $93,982,220; FY 17 est $97,133,393; and FY 18 est $71,057,000

Range and Average of Financial Assistance

FY16 total cost range from low to high: R34 - $157,306 to R01 - $1,945,782; average financial assistance is: $488,761.

Regulations, Guidelines, and Literature

Not Applicable.

Information Contacts

Regional or Local Office

None. Project Grants: Program Analyst; Division of Extramural Research, National Center for Complementary and Integrative Health, National Institutes of Health; 6707 Democracy Blvd, Suite 401, Bethesda, MD, 20892-5475; email: NCCIHDERINQUIRIES@MAIL.NIH.GOV. Small Business Innovation Research Grants Contact: Anastasia Solis; Division of Extramural Research, National Center for Complementary and Integrative Health, National Institutes of Health; 6707 Democracy Blvd, Suite 401, Bethesda, MD, 20892-5475; Telephone: (301) 594-8018. Training Portfolios: Lanay Mudd, Ph.D.; Division of Extramural Research, National Center for Complementary and Integrative Health, National Institutes of Health; 6707 Democracy Blvd, Suite 401, Bethesda, MD, 20892-5475; Telephone: (301) 594-9346.

Headquarters Office

Partap S. Khalsa 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892 Email: partap.khalsa@nih.gov Phone: 3015943462

Criteria for Selecting Proposals

The major elements in evaluating proposals include assessments of: (1) the scientific merit innovation and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; (6) the relevance and importance to the announced program objectives and when applicable,and (7) the adequacy of assurances detailing the proposed means for safeguarding human or animal subjects. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.