Notice of Availability of Administrative Supplements for Microphysiological Systems Developers : Development of Tissue Chips to Model Nociception, Opioid Addiction and Overdose

Notice Number: NOT-TR-19-001

Key Dates
Release Date: October 19, 2018

Related Announcements

RFA-TR-16-017
RFA-TR-16-019
PA-18-591
NOT-TR-18-027

Issued by
National Center for Advancing Translational Sciences (NCATS)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute on Drug Abuse (NIDA)

Purpose

This Notice announces the availability of administrative supplements for investigators and institutions funded through:

This administrative supplement program is part of the of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

These grantees may request supplemental funding that will be used to create and test tissue chip devices that can model the mechanisms or effects of nociception/pain-relevant signaling, addiction or opioid overdose using human tissues in an in vitro microphysiological system (MPS). There should be a clear utility in the use of these physiologically-relevant MPS to investigate novel pain-related mechanism(s), discover novel therapeutic targets or pathways, or develop and evaluate drugs and therapeutics for pain-related processing or physiological responses to pain/opioids. Integrated models of peripheral and central nervous tissue are encouraged.

Of particular interest are models that may include the following:

  • The development of tissue chips for trigeminal ganglia, dorsal root ganglia and/or dorsal horn of the spinal cord that is integrated to crucial brain regions, including the blood-brain barrier (BBB), to better understand local pain circuitry, barrier function and therapeutic testing.
  • Dopaminergic and opioidergic areas of the brain (e.g. rostral ventromedial medulla, prefrontal cortex, basal ganglia) that could inform therapeutic/intervention development, interruption of addictive circuitry.
  • Adaptation of existing non-nervous tissues that are involved in nociceptive responses, pain sensation, and/or drug addiction or overdose mechanisms.
  • Targets related to mitigating overdose, such as respiratory suppression.

In addition to being within the scope of the awards, administrative supplement requests are intended to support:

  • Development of activities that can be maintained after the period of supplemental support. Depending on the success of these administrative supplement projects, consideration will be given to establishment of a new program on Tissue Chips for Nociception, Opioid Use Disorder (OUD) and Opioid Overdose
  • Sharing of any information, methods, resources, or products developed using these funds widely and without charge to other institutions, via publications, presentations, and workshops.
  • For the purpose of this consideration, a Tissue Chip program-funded investigator is defined as the recipient of an active Tissue Chip award (UG3/UH3) made under the following funding opportunities: RFA-TR-16-017 "Microphysiological Systems (MPS) for Disease Modeling and Efficacy Testing (UG3/UH3)", RFA-TR-16-019 "NIH-CASIS Coordinated Microphysiological Systems Program for Translational Research in Space (UG3/UH3)", as well as any of Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]: PA-14-071, PA-15-269, PA-16-302, PA-17-302, PA-18-573 or PA-18-574; and Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42]): PA-14-072, PA-15-270, PA-16-303, PA-15-270, PA-17-303, PA-18-575 or PA-18-576). Applicants who are not currently-funded as Tissue Chip program investigators may apply if they are funded under other microphysiological systems program funding opportunities from across NIH, including PAR-16-398, RFA-DK-17-035, and RFA-DE-19-004.

Recipients of supplemental funds under this announcement will be expected to provide monthly updates to NIH program staff on funded projects. Those under RFA-TR-016-017 and RFA-TR-16-019 are also expected to attend Tissue Chip Consortium meetings in the Washington D.C. area, as per the Terms and Conditions of the parent award. Funds for travel to Tissue Chip Consortium meetings should not be included in this supplemental request.

Submissions Requested

NIH is encouraging requests for administrative supplements from MPS program-funded investigators. This supplemental support is for the development or adaptation of existing MPS platforms to model key aspects of pain-related processing or physiological responses to pain/opioids, which can be used to investigate novel pain/addiction/overdose-related mechanism(s) and to discover novel therapeutic targets or pathways for pain-related processing or opioid addiction/overdose.

Applicant organizations may submit one application per parent grant.

Budget and Available Funds

Budgets are limited to no more than 25% total costs of the amount of the current parent award and must reflect the actual needs of the proposed projects and be reasonable with respect to the activities proposed. All program-related expenses must be justified as specifically required by the proposed activities and must not duplicate items generally available from other sources at the applicant or collaborating institutions.

Supplement project and budget periods cannot exceed 12 months. To be eligible, the parent award must be active (i.e. not be in an extension period) at the time of anticipated award, and the research proposed in the supplement must be able to be accomplished within 12 months. The earliest anticipated start date is December 1, 2018.

Supplemental funds awarded under this Notice are subject to the requirements of Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018), which includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

This Notice details how this matching requirement applies to for-profit organizations that apply to PA-18-591 and cite this Notice. Requests ?from for-profit organizations that do not comply with the budget requirements or provide the required letter(s) of support documenting cost-sharing will be withdrawn as non-compliant.

Highest priority for funding consideration will be given to applications that entail collaboration with investigators outside the current Tissue Chip Consortium, for example, with pain/nociception/addiction/overdose researchers and clinicians in other programs at their institutions or with outside institutions.

Submitting an Application

Applicants should begin their applications by stating: This application is being submitted in response to NOT-TR-19-001".

Through this Notice, NCATS will only consider submissions in which the Research Strategy does not exceed 6 pages and that include a summary or abstract of the funded parent award.

Projects should:

  • Appropriately model a nociception/addiction/overdose-relevant organ system to fit the objectives of the funding opportunity.
  • Utilize MPS that can be demonstrated to provide a better model than currently existing tissue models or other model systems.
  • Build up key resources and components for future development of better platforms to model pain-relevant pathways/outcomes, including the selection of appropriate cell sources from induced pluripotent stem cell (iPSC) sources or commercially available cell lines.
  • Include endpoints (molecular, electrophysiological, imaging, etc.) that can be demonstrated to correlate with clinical measures of nociception/addiction/overdose.
  • Adhere to milestones and an overall timeline to ensure completion of the project within the first phase of a parent biphasic grant or within the remaining timeframe of a monophasic grant.

Applications are due by 5:00 PM local time on October 26, 2019 and should be submitted per instructions in Part 2, Section IV. of "Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)" PA-18-591, with the following modifications:

Part 2, Section I, Funding Opportunity Description

Background

Additional language:

Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award. NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement. See 45 CFR 75.306 for additional details.

Part 2, Section III, Cost Sharing

Current language:

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

Revised language:

For grantees from a for-profit organization, this FOA does require cost sharing, as defined in the NIH Grants Policy Statement. More information on cost matching requirements is in Section IV.2 R&R or
Modular Budget

Part 2, Section IV, R&R Budget

Current language:

All instructions in the SF424 (R&R) Application Guide must be followed.

Revised language:

All instructions in the SF424 (R&R) Application Guide must be followed.

Cost Matching Requirement for For-profit Applicants

Cost matching or documented in-kind contributions is required for for-profit organizations responding to this FOA. The for-profit awardee is required to match funds or provide at least a 50% matching of funds or documented in-kind contributions at a rate of not less than 50% of the for the total-Federally awarded amount (direct costs, as well as facilities and administrative costs), as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.

Federal funds may not be used as a source of matching funds. Generally, cost matching requirements may not be met from the following sources:

  • Costs borne by another Federal grant or sub award;
  • Costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds;
  • Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient);
  • Program income; and
  • Patient incentives.

The for-profit organization will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applicants must submit budgets that clearly document the total costs, the source and amount of matching funds, and how valuation was determined in the case of in-kind contributions, as well as the Federal and Institutional (non-Federal) components of the budget. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award. NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement. See 45 CFR 75.306 for additional details.

Budget Justification: All for-profit applicants must document the matching (non-Federal) component and the federal (non-matching) component in the total project budget. That is, the requested budget plus the cost-matching budget must be detailed in tabular format to document the cost-matching (non-Federal) component and the federal (non-cost matching) component. The amount of matching is subject to adjustment based on total allowable costs incurred. All costs and contributions used to satisfy the matching requirement must be documented by the recipient, including how the value for in-kind contributions was determined, and are subject to audit. The cost matching requirement is not negotiable for for-profit organizations.

Part 2, Section IV, Letters of Support

Additional language:

Letters of Support

For-profit applicants must include a letter(s) of support confirming that the required secured cost matching (cash; in-kind commitments such as salary, consultant costs, equipment) is available and confirm that the essential personnel have the authority within the organization to allocate resources.

Part 2, Section V, Budget and Period of Support

Budget and Period of Support

Additional language:

Specific to this FOA:

How likely is it that the plans for cost matching will be adequate?

Part 2, Section VI, Award Administration Information, Award Notices

Additional language:

Special award condition specific to this FOA: A grantee from a for-profit organization funded under this announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018. See 45 CFR 75.306 for additional details. Matching funds must be non-Federal funds set aside for this project and are available from the source(s) identified in the application, as committed to by the recipient. Cost matching will be evaluated by the awarding office to ensure that this requirement is being met. Compliance with the matching requirement must be verified on an annual basis and must be documented in the annual and final FFR.If it IS a cooperative agreement, fill out the template Cooperative Agreement Terms and Conditions of Award as appropriate. THEN, copy and paste all the text from that template into this section, replacing Not Applicable (below) with your text.

Part 2, Section VI, Reporting

Current language:

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report
are required for closeout of an award, as described in the NIH Grants Policy Statement.

Revised language:

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final Research Performance Progress Report (F-RPPR), invention statement, and the expenditure data portion of the Federal Financial Report, including Federal and non-Federal share for cost matching, are required for closeout of an award, as described in the NIH Grants Policy Statement.

Application Review

Requests will be reviewed as described in Section V. of PA-18-591: Administrative Supplements to Existing NIH Grants and Cooperative Agreements.

Inquiries

Please direct all inquiries to:

Danilo Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: [email protected]

Lucie Low, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-7609
Email: [email protected]

Lili Portilla, M.P.A.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-7170
Email: [email protected]

Shannon Oden
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-3028
Email: [email protected]

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