Key Dates

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 Advancing Translational Sciences (NCATS)

Purpose

This Notice of Special Interest informs current awardees that the National Center for Advancing Translational Sciences (NCATS) is providing another opportunity for supplemental funding to support deposition of data generated from tissue chips (also known as microphysiological systems, or “organs on chips”) into the NCATS-funded Microphysiology Systems Database (MPS-Db).

This Notice announces the availability of administrative supplements for active awards (e.g., award not in an extension period) funded through the he NIH Microphysiological Systems (MPS) Program under the following Funding Opportunities (Note: Administrative supplement projects must be within the scope of the parent award.):

• • Tissue Chips for Disease Modeling and Efficacy Testing (RFA-TR-16-017)
  • “Clinical Trials” on a Chip (RFA-TR-19-014)
  • Tissue Chips in Space (RFA-TR-16-019 and RFA-TR-18-001)
  • HEAL Initiative: Tissue Chips to Model Nociception, Addiction and Overdose (RFA-TR-19-003)
  • ImmuneChip: Engineering Microphysiological Immune Tissue Platforms (PAR-19-138)
  • Human Three-Dimensional Cell Model Systems for Alzheimer’s Disease-Related Dementias (RFA-NS-19-027); or
• SBIR/STTR-supported investigators, provided the award involves tissue chips.

Background

There is a critical need for publicly accessible data generated from tissue chips to inform researchers about the types of data that can be generated from MPS, as well as the reliability and reproducibility of platforms and their resulting data. The MPS-Db, funded and supported by NCATS through the University of Pittsburgh Drug Discovery Institute, is an online resource that houses tissue chip data and provides tools for reviewing, analyzing and modeling data, which can inform stakeholders on assays, models, cell sources, and responses to compounds. The MPS-Db aggregates MPS data with linked preclinical and clinical databases for analysis in the context of human exposure. The MPS-Db also facilitates submission of data on disease models and is expanding a specific disease model portal. Built-in tools enable the assessment of the reproducibility and transferability of MPS models, while computational models embedded in the Db are designed to enhance the value of MPS models for understanding disease mechanisms, compound toxicity, and prediction of drug pharmacokinetics (PK). This information is important for tissue chip technology validation efforts and contributes significantly to informing researchers on appropriate contexts-of-use of specific platforms and contributes towards validation and standardization of MPS platforms.

Data that have already been generated are eligible for submission, as are data that are yet to be generated as described in the project milestones.

All initiatives within the NIH Microphysiological Systems Program are funded with the expectation that all data acquired from funded projects will be managed in a coherent database that will be available to government and private partners. Additionally, upon completion or termination of the project, all data are expected to be publicly available according to the NIH-approved plan submitted for each project.

Specific Areas of Research Interest

Data that is responsive to the following criteria is of specific interest for deposition into the MPS-Db:

• Data that represents new tissues, organs or disease models to the MPS-Db
• Data representing disease models that are not yet represented in the MPS-Db, e.g., opioid use disorders, neurodevelopmental disorders, rare diseases, etc.
• Data that can be aligned with clinical datasets which are accessible (or can be made accessible) through the MPS-Db, e.g., on biomarkers, patient subgroups including pediatric populations, etc.
• Data that adds to existing datasets or aligns with data already deposited in the MPS-Db, e.g., data generated by the Tissue Chip Testing Centers.
• Data that contributes towards reproducibility efforts for tissue chip technology, e.g., toxicology screening data, drug response data, etc.

Administrative Review

NIH will conduct administrative reviews of submitted applications and will support the most meritorious applications based upon programmatic priorities and availability of funds. Funds should not be requested for experimental development or optimization of platforms, but should focus on logistics of data submission; e.g., structuring of datasets, personnel requirements etc.

The following criteria will be used to assess the supplement requests and should be addressed in the application:

1. Does the proposed project plan to deposit informative and relevant data to the MPS-Db that is responsive to the areas of interest described above?
2. Is the proposed dataset already published or currently under development? Does the application indicate the anticipated timeline by which the dataset can be expected to be made public?
3. Does the project design include clear and specific details of the data to be deposited, such as: models or diseases being deposited; types of dataset; formats of data that are already compatible with MPS-Db data deposition formats; description of how data will be made compatible for data deposition as required?
4. Does the application provide proof of discussion with MPS-Db staff regarding potential data deposition?
5. Does the application demonstrate the feasibility of accomplishing data deposition within the time and budget?

Application and Submission Information

Applications for this initiative must be submitted using the following Funding Opportunity Announcement (FOA):

• 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 must be followed, with the following additions:

• Application Due Date: Submissions must be received by June 18, 2021, at 5:00 PM local time of applicant organization for FY 2021 funding.
• For funding consideration, applicants must include “NOT-TR-21-028” (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 up to one year of support only.
• The Research Strategy section of the application is limited to 3 pages and should briefly summarize the activities of the parent grant and describe how the broader MPS field will benefit by deposition of data into the MPS-Db by:
  • Describing the data being generated by the parent grant
  • Describing how the data proposed for deposition are responsive to the areas of specific interest outlined above
  • Providing evidence of discussions with MPS-Db staff to demonstrate feasibility of data deposition plans
  • Providing details of the timeline of data collection and deposition within the funding period OR providing details on how infrastructure will be developed during the funding period to enable immediate deposition of data to be generated in future award years (if applicable)
• Only existing active award recipients of all NIH-funded Microphysiological Systems programs as stated above are eligible to apply.
• Recipients of supplemental funds under this announcement will be expected to provide regular updates to NIH program staff on progress of data deposition to the MPS-Db.
• Applicant organizations may submit one application per parent grant.

Budget and Period of Support:

• The budget should not exceed $50,000 in direct costs.
• The supplement application budget period requested should be consistent with the parent award and should not exceed 12 calendar months.
• All project-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.

Applicants are strongly encouraged to notify the program contact at NCATS and the Institute supporting the parent award (if applicable) that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Applications that do not meet these requirements will be not be considered for this NOSI initiative.

Inquiries

Please direct all inquiries to:

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