The National Center for Complementary and Integrative Health (NCCIH) announces the availability of funds for one-year Administrative Supplements to promote highly innovative and scientifically, high-risk exploratory studies in areas of high programmatic interest in NCCIH grants by expanding ongoing basic, translational, technological, or clinical studies in the context of complementary and integrative health approaches. The supplemental research proposed must be within the scope of the parent grant or cooperative agreement (e.g. animal model research or clinical research). The administrative supplement should be described as sub-aims of the existing specific aims of the parent award.

Eligible NCCIH Grants

All grant awards made by NCCIH with activity codes as listed in PA-18-591 (and its reissue) are eligible, with the exception of the following: F30, F31, F32, T32, T35, K99, R13, and U13. Eligibility criteria can be found within PA-18-591.

For the administrative supplements, only the following research topics will be considered:

• Development of novel tools, methodologies and technologies for the analysis of complex natural products chemical and/or biological data to rapidly identify active components of complex mixtures
• Exploring impact and/or contribution of microbial metabolism of orally consumed natural products (not amino acids or fiber) on observed biological activity; also exploring role of orally consumed phytochemicals (not amino acids or fiber) on function of gut microflora
• Inclusion of pharmacokinetic analysis for natural products including assessments of bioavailability and interaction with Phase I and Phase II metabolizing enzymes and transporters
• Early phase preclinical exploratory natural product discovery for pain as appropriate
• Developing and testing pilot reliable objective measures of pain outcomes generated by injuries to peripheral tissues such as muscles, fascia, connective tissues, joints, and others
• Developing and testing measures, outcomes and endpoints of pain in patients of sickle cell disease
• Developing and testing in vivo labeling technology of tissues or cells responsible for generating signals in response to different internal senses (e.g. mechanical force, temperature, osmolarity, oxygen levels)
• Developing and testing technology or methods quantifying biomechanical forces applied to internal tissues or cells
• Exploring the innovative mechanisms of action of sensory-based complementary and integrative approaches
• Developing and testing mobile health technology or non-mobile technology and methods to monitor or quantify diet (food frequency questionnaires), physical and/or emotional well-being, breathing, sleep
• Computational models or artificial intelligence incorporating moods and other affective components into physical-based interventions such as massage, yoga, chiropractic manipulations, acupuncture, Taichi; or combining diet, microbiome and physiological responses (e.g. immunological, neural, metabolic) to predict health impact. When planned methods for recruiting have been ineffective for meeting the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm), administrative supplement funds can be requested to conduct focus groups with stakeholders, develop and test new recruitment methods, add technical expertise, and improve outreach for study recruitment to meet the NIH Policy.
• Improve intervention training materials to improve fidelity of the intervention across multiple sites.
• Addition of new validated measures to ongoing trials that would permit concurrent validity testing comparing the new measure to existing legacy measures.
• For trials that were required to perform additional pre-clinical testing in order to address FDA concerns about natural products for the IND submission, administrative supplements can be requested to support the completion of the original grant submission aims.
• Addition of implementation science measures or metrics to ongoing pragmatic trials to improve the interpretation and dissemination of study results
• Addition of metrics or measures to allow for cost effectiveness analysis to ongoing efficacy, effectiveness or pragmatic trials
• Translation and cognitive testing of measures into other languages that are needed in clinical trials. Addition of statistical expertise near the end of the award to plan and conduct more complex secondary statistical analyses

Applications that propose the following will be considered non-responsive and will be administratively withdrawn without review:

• Studies that are not within the scope of the parent grant or cooperative agreement
• Use the supplement to initiate a new clinical trial
• Studies that are outside the research topic areas listed above

Budget and Available Funds

Supplement budget requests must reflect actual needs of the proposed project and cannot exceed $100,000 in direct cost or the total budget of the existing grant award per year, whichever is the smaller amount. Requests may only be for one year of support. Only one supplement application per grant will be accepted for consideration through this Notice.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

• The deadline of applications in response to this Notice is June 1, 2020 by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-AT-20-004” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for one year of support only.
• The Research Strategy section of the application is limited to 6 pages. Applicants should begin this section by stating: “This application is being submitted in response to NOT-AT-20-004". As part of the application, investigators should submit an abstract (R&R Other Project Information form) of the proposed research that describes the relevance to the active NCCIH grants. Applications should include a strong scientific justification for the requested supplement. As part of the budgetary justification (R&R Budget Form), a statement regarding the expenditure of currently available unobligated grant funds should be included.
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Active grants with project end date on July 31, 2021 or later are eligible. The active award should not be in a terminal no-cost extension. The research proposed in the supplement must be accomplished within the remaining active budget period for the existing parent award. The earliest anticipated start date is no later than September 2020.

Applicants are strongly encouraged to discuss the aims of the proposed work with the NCCIH program officer assigned to the active parent grant to assess suitability for this funding opportunity.