As part of the Cancer Moonshot initiative, the National Cancer Institute (NCI) created the Patient-Derived Xenograft (PDX) Research Network (PDXNet), a collaborative network of U54-funded PDX Development and Trial Centers (PDTCs) centers of excellence coordinated by a U24-funded PDXNet Data Commons and Coordinating Center (PDCCC) focused on using patient-derived xenografts and other patient-derived models to accelerate the development of NCI investigational new drug (IND) agents (i.e., those that the NCI is developing in collaboration with pharmaceutical partners) in NCI-sponsored early phase clinical trials. Because PDXNet investigators have valuable models and specialized expertise not usually accessible to most investigators, NCI wanted to make the resources of these centers available to other investigators to test their novel therapeutic concepts.

This NOSI supports supplemental funds to current NCI-funded research projects for new interdisciplinary collaborations between non-PDXNet investigators and PDXNet investigators to perform research within the scientific scope(s) of the parent grant and/or cooperative agreement award(s) that will lead to improved pre-clinical evaluations of novel therapeutic concepts using the large-scale PDX model collections of PDXNet, and that could ultimately be tested in NCI-sponsored clinical trials. This request for administrative supplements supports NCI’s efforts to enhance the development of PDX models as a tool for precision medicine that will guide cancer drug development and cancer therapy. The research project proposed in the administrative supplement should align with the overarching goal of PDXNet, which is to develop pre-clinical data to support novel therapeutic concepts that have a feasible path for clinical validation. Furthermore, each supplement request must propose a collaborative project that is within the scope of work already peer-reviewed and approved in the eligible parent awards.

Budget

To be eligible, the applicant’s parent award must be able to receive funds in FY20 and be active throughout the 1-year project period of the administrative supplement. The parent award must not be in an extension period (e.g., no-cost extension).

FY 2020 supplement budget requests cannot exceed $125,000 in total costs exclusive of Facilities and Administrative (F&A) costs on sub-awards, and they cannot exceed the direct costs of the current parent award. Requests must reflect the actual needs of the proposed project. Administrative supplements can be used to cover cost increases that are associated with achieving certain new research objectives as long as the research objectives are within the original scope of the peer-reviewed and approved project (i.e., award), or the cost increases are for unanticipated expenses within the original scope of the project.

Requests are permitted for 1 year of support only. The earliest anticipated start date is July 1, 2020.

NCI intends to commit $500,000 in FY 2020 to fund four awards.

After the administrative supplements have been selected for funding in FY2020, each collaborating PDTC principal investigator will then be asked to apply for separate administrative supplement funding not to exceed $120,000 total costs for their collaborative research efforts.

Eligible Individuals (Program Director/Principal Investigator)

Awardee/Applicant(s) must hold an active grant or cooperative agreement from the NCI and must be non-PDXNet investigators (see eligible activity codes below). For supplements to parent awards that include multiple program directors/principal investigators (PDs/PIs), the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.

Supplemental funds may be awarded to parent awards using any of the activity code(s) listed below.

Administrative supplement requests must be submitted on paper for the following activity codes:

P01 Research Program Projects
P30 Center Core Grants
P50 Specialized Center
U54 Specialized Center- Cooperative Agreements

UM2 Program Project or Center with Complex Structure Cooperative Agreement

Administrative supplement requests may be submitted electronically for the following activity codes:

R01 Research Project Grant
U01 Research Project Cooperative Agreements

UM1 Multi-Component Research Project Cooperative Agreements

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:

• Application Due Date April 10, 2020, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-CA-20-020” (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.
• Applicants should begin the supplement application abstract by stating “This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-20-020.”
• Requests may be for one (1) year of support only.
• The Research Strategy section of the application is limited to 6 pages.
• Budget: To be eligible, the applicant’s parent award must be able to receive funds in FY20 and be active throughout the 1-year project period of the administrative supplement. The parent award must not be in an extension period (e.g., no-cost extension). FY 2020 supplement budget requests cannot exceed $125,000 in total costs exclusive of F&A costs on sub-awards, and they cannot exceed the direct costs of the current parent award. Requests must reflect the actual needs of the proposed project. Administrative supplements can be used to cover cost increases that are associated with achieving certain new research objectives as long as the research objectives are within the original scope of the peer-reviewed and approved project (i.e., award), or the cost increases are for unanticipated expenses within the original scope of the project.
• Administrative supplement requests must be submitted on paper for the following activity codes: P01 Research Program Projects; P30 Center Core Grants; P50 Specialized Center; U54 Specialized Center- Cooperative Agreements; UM2 Program Project or Center with Complex Structure Cooperative Agreement.
• Administrative supplement requests may be submitted electronically for the following activity codes: R01 Research Project Grant; U01 Research Project Cooperative Agreements; UM1 Multi-Component Research Project Cooperative Agreements.
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.?
• A letter of support written and signed by the principal investigator of the collaborating PDX Development and Trial Center (PDTC; U54) is required. Use the “Add Other Attachments” function to electronically include the letter of support in PDF format. This support letter should corroborate the nature of the collaborative effort, as outlined in the application, and reiterate the specific work that will be done by the U54-supported PDTC group.?
• The application submitted in response to this NOSI (i.e., the administrative supplement request/application) should include a figure or table that outlines the plans for work to be performed by the applicant/awardee and work to be performed by the collaborating PDTC. The chosen approach should clearly separate the work that is planned for performance at the applicant’s laboratory from that proposed for performance at the specified PDTC. (Note: The collaboration can include any one of the four U54 PDTCs or the U24 PDCCC in the PDXNet.) The application should also clearly show how the work planned for performance by each of the partners (i.e., by the applicant/awardee and by the PDTC) is intended to be collaborative.?
• Administrative supplement requests (applications) for support of clinical trials will not be accepted and/or considered in response to this funding opportunity announcement.?
• Note: In order to facilitate efficient processing of the request, applicants are strongly encouraged to notify Kim Witherspoon ([email protected]), as well as the assigned NCI program officer and NCI grants management specialist for the parent award that a request has been submitted in response to this NOSI.

Evaluation Process:

NCI will conduct administrative reviews of applications and will support the most meritorious applications submitted for consideration, based upon the availability of funds.

Critical Considerations:

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of the award, including the degrees to which the administrative supplement request (application):

• Tests therapeutic concepts using the large-scale PDXNet model collections, especially concepts that require identification of molecularly defined subsets of histologically defined tumors.
• Identifies potential biomarkers that could be used to monitor or select patients for therapy.
• Outlines an interactive collaboration between the applicant and the PDXNet investigator.

Applications nonresponsive to the terms and conditions will be not be considered for this NOSI initiative.