Related Announcements

PA-20-272- Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Center for Complementary and Integrative Health (NCCIH)

Purpose

The National Center for Complementary and Integrative Health (NCCIH) announces the availability of funds for one-year Administrative Supplements to promote or support high priority topic areas in NCCIH grants by expanding ongoing basic, translational, technological, or clinical studies in the context of complementary and integrative approaches. Active awards with project end dates in FY 2023 or later are eligible. The award may not be in a terminal no-cost extension or going into a no-cost extension in FY 2022.

As administrative supplements, the work proposed needs to be within the scope of the research or training that is already supported. Center awards and resource awards are most likely to be able to justify these supplements, as they tend to have a broad content scope. Research and training grants are eligible to apply for an administrative supplement if the currently funded award is related to the parent award's funded research (e.g., same intervention, mechanism, and/or outcomes). If a study will be using animal models but the parent award is in human subjects only, or vice versa, the proposed work will be considered as beyond the scope of the parent award.

Eligible NCCIH Grants

All grant awards made by NCCIH with the exception of the following: F30, F31, F32, T32, T35, K99, R13, and U13. Eligibility criteria can be found within PA-20-272

For the administrative supplement, only the following research areas will be considered:

Natural Products (Nutritional Interventions such as herbs, dietary supplement/diets, probiotics/microbial-based therapies):

• 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
• Identifying novel beneficial microbial strains in gut microbiome to improve general physiological function
• Developing novel methodologies or exploring novel mechanisms and biological activities of natural products in multiple organs
• Exploration of how natural products, either as single entities or complex mixtures, interact with multiple organs, tissues, or biological endpoints
• Exploratory studies assessing how natural products, including dietary constituents, may improve health span, resilience, and salutogenesis in appropriate preclinical model systems (e.g., fly, worm, rodent, non-human primate)

Mind and Body Approaches (Psychological and/or Physical Interventions):

• Assessing novel neural or non-neural mechanisms by which acupuncture-based interventions regulate physiological or pathological processes
• Exploring the innovative mechanisms of action of sensory or multisensory-based complementary and integrative approaches
• Developing and validating measures and outcomes for multisystem or multiorgan interactions regulated by mindfulness-based interventions
• Exploring impact of olfaction-based interventions or aromatherapy on symptom management such as pain, sleep, stress, emotion dysregulation and well-being
• Incorporating new mechanistic measures for studies on meditative movements
• Exploring real-time brain responses or activities during meditation

Fundamental Science and Technology Development:

• Developing and testing tools, outcomes and endpoints or exploring innovative mechanisms of glymphatic and/or lymphatic functions or the interactions between glymphatic/lymphatic functions and physiological/pathological processes relevant to health and disease conditions
• 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, electromagnetic signals)
• Developing and testing technology or methods quantifying biomechanical forces applied to internal tissues or cells
• 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
• Developing and testing innovative therapeutic biomarkers (genetic, genomic, imaging, behavioral) for prediction of the impact of complementary and integrative health approaches on health and disease outcomes
• Exploring artificial Intelligence or machine learning approaches to integrate, interrogate, and interpret multiomic data sets to uncover relationships between nutritional inputs, including dietary phytochemicals and probiotics, and cellular variables associated with healthspan, resilience, and salutogenesis
• Developing novel study design and analytic methods to facilitate studies on multi-system or multiorgan interactions or multi-component interventions
• Developing innovative emotional well-being measures that can be regulated by complementary and integrative health approaches

Clinical Research

• Developing or refining artificial intelligence or computational models that could be used to develop and/or refine multi-component complementary interventions to be most impactful; or predict the impact of complementary interventions on multiple outcomes or interconnected systems.
• 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 develop appropriate stakeholder and patient engagement programs to improve diversity and inclusion of participants as appropriate for the study, including but not limited to:

• Developing focus groups to better understand the needs of the relevant patient populations to enhance recruitment and retention of diverse participants
• Addition of culturally and/or linguistically competent patient coordinators, patient navigators, or community health educators to facilitate outreach, recruitment and retention of participants
• Development and dissemination of outreach and study materials that are culturally, linguistically, and/or health-literacy level appropriate, including costs associated with translation of materials into multiple languages
• Development and implementation of participant retention strategies such as maintaining periodic contact with participants outside of study visits (e.g. calls, email, social media, study newsletter, other mailings, etc.)
• Accommodation for patients with diverse scheduling, travel or dependent-care needs
• Other novel approaches to stakeholder or patient engagement, integration of patient engagement with diversity and inclusion efforts, or increasing clinical trial diversity and inclusion

• Improve intervention training materials or methods to improve fidelity of the intervention across multiple sites when the trial is threatened by poor fidelity.
• 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 award aims.
• Addition of implementation science measures or metrics to ongoing pragmatic trials to improve the interpretation and inform dissemination of study results
• Addition of metrics or measures to allow for cost-effectiveness analysis to ongoing efficacy, effectiveness or pragmatic trials. Supplement applications on this topic should consult the NIH priorities for Health Economics Research described in NOT-OD-16-025.
• 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 period to plan and conduct more complex secondary statistical analyses to examine impact on whole person health outcomes
• Pilot new and/or enhanced remote delivery methods (e.g. phone, app, video, web-based platforms, wearables, or other technology) for intervention delivery and/or data collection when necessary for success of the trial or to prepare for future application.
• Addition of new measures that will allow evaluation of outcomes across interconnected physiological systems (e.g., nervous, gastrointestinal, immune, musculoskeletal) and domains (e.g., biological, behavioral, social, environmental) that would provide preliminary data for subsequent studies utilizing a whole person research perspective. Investigators proposing to add measures should justify the added benefit vs. participant burden.
• Addition of measures to assess social and structural determinants of health of relevance to the trial
• Inclusion of pharmacokinetic analysis for natural products including assessments of bioavailability and interaction with Phase I and Phase II metabolizing enzymes and transporters

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Description of circumstances for which administrative supplements are available.

Application and Submission Information

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

• PA-20-272 - 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-20-272 must be followed, with the following additions:

• Application Due Date – Applications may be submitted any time and will be reviewed and considered on a rolling basis. To be considered for funding in FY22, applications must be submitted no later than June 1, 2022, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-AT-22-002” (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.
• Only electronic submissions will be accepted for this funding opportunity. Use one of the methods described in PA-20-272. Paper submissions and applications submitted as attachments will be returned.
• Requests may be for one year of support only.
• Individual requests can be no more than $100,000 in direct costs exclusive of Facilities and Administrative costs on sub-contracts.  Though supplement requests are not limited to one per award, we might consider substantial additional funding to an award as beyond the scope of the parent award.
• Applicants may apply for more than one supplement to a given parent grant/award, provided they are scientifically distinct.
• The Research Strategy section of the application is limited to 6 pages.
• As part of the application, investigators must submit an abstract of the proposed research that shows the relevance to the specified topic areas described in this NOTICE. Place the abstract in the Project Summary/Abstract section of the SF424 (R&R) form. The work may include pilot projects or resource development which are within the scope of the parent active awards.

Review Process

NCCIH will conduct administrative reviews of all applications.

Criteria:

• Is the work proposed within the scope of the active award?
• Is the work proposed focused on one of the seven specified pain research areas described in this NOTICE?
• Is the work likely to stimulate additional activity leading to progress on any, or all, of the specified pain research area?

Inquiries

Please direct all inquiries to the program officer listed in each NCCIH award.