Notice Number: NOT-TR-19-019

Key Dates
Release Date: April 18, 2019

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Center for Advancing Translational Sciences (NCATS) encourages eligible awardees to apply for administrative supplements through PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) .

NIH recently published Notice NOT-OD-19-042, Notice of Intent to Publish a Funding Opportunity Announcement for Research to Develop, Demonstrate, and Validate Experimental Human Tissue Models that Do Not Rely on Human Fetal Tissue . In support of this effort, the National Center for Advancing Translational Sciences (NCATS) is encouraging requests for administrative supplements for grants awarded under any existing grant or cooperative agreement awards for which the scientific focus is tissue chips.

The investigators and institutions funded through these FOAs may request supplemental funding:

• The NIH Tissue Chip Program: Microphysiological Systems (MPS) for Disease Modeling and Efficacy Testing (UG3/UH3) (RFA-TR-16-017) and the NIH-CASIS Coordinated Microphysiological Systems Program for Translational Research in Space (UG3/UH3) (RFA-TR-16-019,RFA-TR-18-001) or;
• Associated SBIR/STTR-supported investigators (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-18-575or PA-18-576)

This supplemental support is to develop and/or further refine the use of alternatives to human fetal tissues. Research proposals may include using these models to understand human tissue development, function, and disease.

The types of studies that should be submitted under this FOA include research to develop alternative models to the use of human fetal tissue in biomedical research. These may include cell culture models using induced pluripotent stem cells (iPSC), iPSC-derived organoids, or other three-dimensional culture systems, such as in vitro microphysiological system (MPS). Studies may also include new approaches or advances on existing methods to significantly improve current approaches to recapitulate the human immune system.

Funds can be requested for up to a year provided the proposed activities can be completed within the parent grant’s FY 2019 remaining active budget period. 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 project 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.

Recipients of supplemental funds under this announcement will be expected to provide monthly updates to NIH program staff on funded projects. Awardees are also expected to present findings at the 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.

Scope of Support

Human fetal tissue and embryonic stem cell-derived systems have been used for understanding and modeling human developmental and disease processes. Research using these tissues has been important in shedding light on scientific questions fundamental to biomedical research, ranging from understanding basic physiologic mechanisms to understanding normal human tissue developmental and disease processes. However, new technologies raise the potential of reconstituting these model systems without fetal tissue yielding more replicable and reproducible system for broader uses. Such alternative technologies would benefit from an investment to accelerate research in these areas. Examples of topics of interest include, but are not limited to:

• Studies to develop and characterize iPSC-derived hematopoietic stem cells towards use in transplantation
• Studies using organoids to model development and diseases of specific tissues, including but not limited to placenta, eye, and brain
• Studies using organoids to understand tissue-specific functions
• Studies to build new technologies that allow for modeling and studying function of multiple tissues at the same time (e.g., integrated tissues-on-chips systems)
• Studies using iPSCs to understand cellular-level mechanistic functions, including generation of female gametes to study meiosis and aneuploidy
• Development of iPSC lines to better understand intellectual and developmental disorders
• Studies to characterize, validate, and reproduce iPSC lines toward commercialization and broader use

Applicants are strongly encouraged to leverage existing research resources for their studies whenever possible.

Submitting an Application

The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative. For funding consideration, applicants must include NOT-TR-19-019 (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. For additional information, see the parent program announcement for Administrative Supplements to Existing NIH Grants and Cooperative Agreements(Parent Admin Supp Clinical Trial Optional)PA-18-591.

The Research Strategy should address the scope of the overall project and provide a description of the supplement’s purpose with a clearly delineated time-frame to complete the supplement within one year. The supplement should identify and clearly state how the supplement request fits within one or more of the specific areas of interest or high priority research areas. As applicable, the supplement request must provide a strong rationale for the proposed research effort and how it will contribute to advancing translational sciences.

Page Limits

The Research Strategy should not exceed 5 pages, not including the abstract.

Due Date

All requests, regardless of the parent award funding mechanism, must be received by 5:00 PM local time on July 10, 2019, for funding in FY 2019.

Applicants are strongly encouraged to notify the program contact listed below that a request has been submitted in response to this notice in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

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