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 Cancer Institute (NCI)

Purpose

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 through this Notice of Special Interest (NOSI) intends to make the resources of these centers available to other investigators to test their novel therapeutic concepts.

Research Objectives

This NOSI will support supplemental funds to current NCI-funded research projects outside the PDXNet 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. The ultimate goal is to test the novel therapeutic concepts 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 the PDXNet, which is to develop pre-clinical data to support novel therapeutic concepts that have a feasible path for clinical validation. Furthermore, each supplemental request must propose a collaborative project that is within the scope of work already peer-reviewed and approved in the eligible parent awards.

Responsiveness

Applicants submitting administrative supplement requests in response to this NOSI must:

1. be a non-PDXNet investigator;
2. have an active parent award, which is able to receive FY21 funds;
3. have a parent award that is active throughout the 1-year project period of the supplement;
4. have a parent award that is not in an extension period (e.g. no-cost extension).

Applicants are encouraged to discuss their application with the scientific/research contact listed in this NOSI prior to submission.

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:

Eligibility and Eligible Individuals (Program Director/Principal Investigator): Applicant(s) must hold an active grant or cooperative agreement from the NCI and must be non-PDXNet investigators. For administrative 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. To be eligible, the applicant’s parent award must be able to receive funds in FY21 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).

NOTE: There is no requirement for the parent award to have been supported via any existing or prior Cancer Moonshot funding opportunity.

Application Due Date: All requests, regardless of the parent award funding mechanism, must be received by 5:00 PM local time on January 8, 2021, for possible funding in FY 2021. This NOSI will expire on January 9, 2021.

Budget: FY 2021 supplement budget requests cannot exceed $125,000 in total costs and 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 January 25, 2021.

NCI intends to commit $750,000 in FY 2021 to fund six awards.

After the administrative supplements have been selected for funding in FY2021, each collaborating PDXNet or Minority PDXNet principal investigator will be asked to apply for separate administrative supplement funding not to exceed $120,000 total costs for their collaborative research efforts.

Submitting Applications:

• For administrative supplements to grants and cooperative agreements, supplement requests must be submitted in accordance with the parent program announcement, PA-20-272. NOTE: Administrative supplement requests (applications) for support of clinical trials will not be accepted and/or considered in response to this NOSI.
• 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-21-009.”
•  Supplement requests should be submitted electronically.
• For funding consideration, applicants must include “NOT-CA-21-009” (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.
• In order to facilitate efficient processing of the request applicants are strongly encouraged to notify Kim Witherspoon (kw265c@nih.gov), as well as the assigned NCI Program Official for the parent award that a request has been submitted in response to this NOSI.
• A letter of support written and signed by the Principal Investigator of the PDXNet or Minority PDXNet collaborating U54 PDTC or U24 PDCCC award 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 PDTC group or U24 PDCCC.
• Page Limits – These sections have the following limits:
  • Project Summary/Abstract: 30 lines of text
  • Project Narrative: 3 sentences
  • Research Strategy: 12 pages
  • Biographical Sketch: for Senior/Key Personnel and Significant Contributors only
• The application submitted in response to this NOSI (i.e., the administrative supplement request/application) should include a figure or table in the Research Strategy section that outlines the plans for work to be performed by the applicant/awardee and work to be performed by the PDXNet or Minority PDXNet collaborating U54 or U24 award. 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 or PDCCC. (Note: The collaboration can include any one of the four U54 PDTCs funded through RFA-CA-17-003, two U54 Minority-PDTCs funded through RFA-CA-17-032, or the U24 PDCCC in the PDXNet.) The application should 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. Applicants should discuss their application with the NCI Program Official of the parent award prior to submission of an administrative supplement application in order to ensure that the content area of the supplement fits within the scientific priorities of the NCI and is within the scope of the parent award. In addition to contacting the NCI Program Official for the parent award, applicants are strongly encouraged to include the Scientific/Research Contact person listed below in these communications.

Review and Selection Process

NCI will conduct administrative reviews of applications and will support the most meritorious applications submitted for consideration, based upon availability of funds. Additionally, Program staff will evaluate applications using the following selection factors.

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;
• Identifies underlying genetic or epigenetic variations that could explain different therapeutic responses between racial/ethnic minority patient populations (if applying for a Minority-PDTC collaboration);
• Outlines an interactive collaboration between the applicant and the PDXNet investigator.

Inquiries

Please direct all inquiries to

Kim Witherspoon
National Cancer Institute (NCI)
Telephone: 240-276-6141
Email: Kim.Witherspoon@nih.gov

Jeffrey Moscow, M.D.
PDXNet Program Official
National Cancer Institute (NCI)
Telephone: 240-276-6565
Email: jeffrey.moscow@nih.gov
 

Tiffany Wallace, Ph.D.
M-PDTC Program Officer
National Cancer Institute (NCI)
Telephone: 240-276-5114
Email: Tiffany.Wallace@nih.gov