This notice informs the current National Cancer Institute (NCI) U24 awardees of NCI’s special interest in administrative supplement applications that seek to support a NCI Moonshot-associated U24 Coordinating Center to help integrate and manage ongoing and future activities of the Cancer Moonshot-funded Mechanisms of Cancer Drug Resistance and Sensitivity Network (DRSN) formed by RFA-CA-17-009 along with DRSN collaborations formed by administrative supplements PAR-18-752 and NOT-CA-19-032. The DRSN Coordinating Center should work to integrate the activities of additional Moonshot investigators funded to research mechanisms of cancer resistance through RFA-CA-19-049, -050, -051, -052, & -053. This Notice of Special Interest (NOSI) intends to provide funding for one year to an existing Moonshot-associated U24 Coordinating Center to bring DRSN activities up to par with Cancer Moonshot-related policies and guidelines, facilitate DRSN collaborative research by providing analytic and organizational infrastructure and expertise, provide data integration methods and data analysis support, and coordinate DRSN activities with other Cancer Moonshot networks and NCI programs.

Background

The DRSN Coordinating Center oversees DRSN activities, manages and harmonizes data generated across the DRSN, and maximizes the optimal utilization of unique resources. Support includes access to NCI Cancer Therapy Evaluation Program (CTEP), Investigational New Drug (IND) agents within the DRSN, and other Cancer Moonshot Coordinating Centers. The U24 Coordinating Center will promote exchange of scientific findings and potential collaborations between the DRSN investigator teams and across the NCI portfolio.

The DRSN Coordinating Center facilitates data sharing within the DRSN, as well as, between the DRSN and with other Moonshot networks, which will be included in the terms and conditions of the administrative supplement award. The DRSN Coordinating Center and the NCI Center for Biomedical Informatics & Information Technology (CBIIT) team would deposit underlying, primary data for DRSN publications into a repository under the NCI Cancer Research Data Commons.

Specific Research Objectives

The goals of the Coordinating Center to be supported through this administrative supplement are to:
A. Provide a centralized administrative infrastructure to coordinate DRSN activities, which includes organizational, biostatistical, data curation, and collaborative support for basic cancer research studies.
B. Strengthen collaborations within the DRSN and promote DRSN interaction and collaboration with other Cancer Moonshot-funded researchers and networks.
C. Provide multidisciplinary analytic expertise to support DRSN collaborative research.
D. Develop improved data integration methods to enhance DRSN research capacity.
E. Ensure DRSN compliance with NCI Cancer Moonshot policies.

The DRSN Coordinating Center must have expertise and capabilities in biostatistics, information technology, study design, data management, protocol development, and logistical support.

Areas of expertise under consideration for this NOSI include (but are not limited to):

I. Network Coordination.

• Provide logistical and administrative assistance in arranging DRSN meetings and conference calls, including 1 to 2 annual face-to-face meetings.
• Develop and maintain a DRSN intranet, as well as, a forward-facing central web portal.
• Implement a network-wide data and resource sharing infrastructure that conforms to the guiding principles and expectations of the NCI Cancer Moonshot initiative(s).

II. Statistical support and computational analysis. The DRSN Coordinating Center supports application of statistical and computational tools for DRSN studies. Areas of interest may include, but are not limited to:

• Develop and implement standard procedures for data collection, storage, and sharing by the DRSN.
• Develop instruction manuals for data collection from discovery work and interact with the participating institutions to resolve data errors.
• In response to requests from the NCI Program Official, design interfacing modules with commercially available software necessary to support discovery related research activities.
• Pre-processing of high dimensional data deriving from proteomic-, genomic-, epigenomic-, and metabolomic-based assays.
• Development/application of bioinformatic and analytical tools for analyzing expression data (from DNA, RNA, or protein array expression) with respect to biologic or clinical endpoints.
• Perform data analysis, harmonization, and formatting on data sets across DRSN centers.

III. Data Management. The DRSN Coordinating Center, under the direction of the DRSN and NCI Program:

• Supports the development, coordination, implementation, and conduct of DRSN collaborative research projects.
• Coordinates with DRSN awardees and the NCI Center for Biomedical Informatics & Information Technology (CBIIT) team to deposit the underlying primary data for DRSN publications into an appropriate data repository under the NCI Cancer Research Data Commons.
• Assists in data analysis, quality assurance for a central database, and distribution of specimens stored at sites participating in the DRSN.
• Supports the formation and distribution of DRSN biospecimen sets and analyzes data that result from the use of these specimens.
• Provides a mechanism for rapid and routine (to be decided by the DRSN Steering Committee in coordination with NCI Program staff) transmittal of materials (e.g., computer output, reports, etc.) among the DRSN participants and the NCI Program.

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:

Eligible Individuals (Program Director/Principal Investigator)

Awardee/Applicant(s) must hold an active grant or cooperative agreement from the NCI for supporting a Cancer Moonshot program as a Coordinating Center. The project period for the parent award must be active, and cannot be in a no cost extension, for the 1 year of this administrative supplement project.

The parent award must be active when the supplement application is submitted (e.g. within the originally reviewed and approved project period), regardless of the time remaining on the current project.

NCI awardees that are currently funded as Coordinating Centers for other Moonshot programs will be prioritized for this award. Ongoing and demonstrable service coordination of Moonshot network activities will be essential for NCI staff to ascertain the applicant’s expertise in network coordination, statistical and computational analysis, and data management and protocol development as specified in the work scope section above and in accordance with NCI Moonshot data and resource sharing principles.

Budget

One Cancer Moonshot-associated U24 Coordinating Center will be awarded a single year award with a maximum total cost of $825,000 per year (maximum direct cost is $500,000 per year). Support for future years of funding may be possible, depending on the availability of funds.

FY 2020 supplement budget requests cannot exceed $500,000 in direct costs exclusive of Facilities and Administrative (F&A) costs on sub-awards, and the budget cannot exceed the direct costs of the current parent award.

The administrative supplement request is permitted for 1 year of support only. The earliest anticipated start date is September 1, 2020.

Submitting Applications

• For administrative supplements to grants and cooperative agreements, requests must be submitted in accordance with the parent program announcement PA-18-591. NOTE: Administrative supplement requests (applications) for support of clinical trials will not be accepted and/or considered in response to this funding opportunity announcement.
• 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-20-052.”
• Supplement requests should be submitted electronically if allowed by the parent mechanism.
• Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains “FORMS-F-ADMINSUPP”. In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• In order to facilitate efficient processing of the request, applicants are strongly encouraged to notify Kim Witherspoon ([email protected]), Dr. Percy Ivy ([email protected]), as well as, the assigned NCI Program Official for the parent award that a request has been submitted in response to this NOSI.
• Page Limits: All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed.
• Due Date: All requests, regardless of the parent award funding mechanism, must be received by 5:00 PM local time on June 1, 2020, for possible funding in FY 2020.

Evaluation Process:

NCI will conduct administrative reviews of applications and will support the most meritorious application submitted for consideration that can best support the DRSN as its coordinating center.

NOTE: For funding consideration, applicants must include “NOT-CA-20-052” (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.