Key Dates

Related Announcements

PAR-20-295 - Clinical Translation of Activated Optical Fluorescence Methods and Technologies for Sensitive Cancer Detection in Vivo (R01 Clinical Trial Optional)

Issued by

National Cancer Institute (NCI)

Purpose

The purpose of this Notice of Correction is to add/reinstate missing language to PAR-20-295, “Clinical Translation of Activated Optical Fluorescence Methods and Technologies for Sensitive Cancer Detection In Vivo (Clinical Trial Optional)".

The added text pertains to the recommendations of the Cancer Moonshot Blue Ribbon Panel that PAR-20-295 is associated with.

Given the inadvertent omission of the requisite standard language, the following sections of the FOA are revised:

Part 1. Overview Information, Funding Opportunity Purpose

The following text has been added (as a separate fourth paragraph) to end of the Funding Opportunity Purpose section:

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer Moonshot ^SM Initiative that is intended to accelerate cancer research. Specifically, this FOA falls under the scientific priority designated by the Blue-Ribbon Panel (BRP) as “Developing Cancer Technologies” (see https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/implementation/new-technologies).

Part 2. Full Text of Announcement, Section I. Funding Opportunity Description, Background

The following text replaces the first paragraph

Beau Biden Cancer Moonshot Initiative. NCI convened the Blue Ribbon Panel (BRP) in 2016 to provide recommendations for achieving the Cancer Moonshot's goal of accelerating progress in cancer research, now called the Beau Biden Cancer Moonshot ^SM Initiative. The BRP was charged with assessing the state of the science in specific areas and identifying major research opportunities that could uniquely benefit from the support of the Cancer Moonshot and could lead to significant advances in our understanding of cancer and in how to intervene in its initiation and progression. The recommendations focused on areas in which a coordinated effort could profoundly accelerate the pace of progress in the fight against cancer and were not intended to replace existing cancer programs, initiatives, and policies already underway. The BRP final report was approved by the National Cancer Advisory Board and included a recommendation to “Establish a Network for Direct Patient Engagement”. The 21st Century Cures Act was signed into law in December 2016 dedicating new funds to support efforts associated with the Beau Biden Cancer Moonshot ^SM Initiative, including support for this FOA. In the recommendation to “Develop New Enabling Cancer Technologies” the BRP called NCI to support the development, adaption, and validation of emerging technologies that have the potential to transform cancer research and/or clinical care. Projects aligning with the recommendation will focus on and designing new capabilities for advancing clinical diagnostic measurements in cancer patients, developing new technologies to improve biospecimen and data quality, and improving predictive modeling approaches. Ultimately, the goal is to use these new enabling technologies to improve cancer research across the continuum of care.

Projects supporting these recommendations as part of this FOA will bring a new enabling imaging technology capable of sensitive tumor detection to clinical utility. The goal is to build upon existing development successes with activatable fluorescent probes and translate existing methods into clinical utility and to demonstrate that exceedingly small tumors cell clusters (1-3mm³in volume) can be detected in vivo by optical fluorescence imaging. Clinical studies will focus on first in human protocols and demonstrate small tumor imaging feasibility. Confirmation of detected tumor size sensitivity can be made through biopsy or other methods.

Part 2. Full Text of Announcement, Section III. Eligibility Information, 1. Eligible Applicants, Foreign Institutions

Currently reads:

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Should correctly read (italics):

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

Part 2. Section IV.2: Content and Form of Application Submission, Resource Sharing Plan

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Addressing the Cancer Moonshot Public Access Pilot Program: Utilizing the provision outlined in the 21st Century Cures Act, NCI has established a data sharing policy for projects that are funded as part of the Beau Biden Cancer Moonshot^SM Initiative that requires applicants to submit a Public Access and Data Sharing Plan that: (1) describes their proposed process for making resulting Publications and to the extent possible, the Underlying Primary Data immediately and broadly available to the public and; (2) if applicable, provides a justification to NCI if such sharing is not possible. NCI will give competitive preference and funding priority to applications with a data sharing plan that complies with the strategy described here. The data sharing plan will become a term and condition of award.
• Guiding Principles for Cancer Moonshot Biobanking Activities: The goal in developing these guiding principles is to accelerate research by a) increasing the availability of biospecimens for Cancer Moonshot-related and other biomedical research through facilitation of investigator to investigator sharing of biospecimens, and b) increasing the reproducibility of Cancer Moonshot research through improved biospecimen practices and corresponding annotation. These guiding principles also seek to facilitate, where possible, increased engagement of research participants through researchers' communication of aggregate research results and, in some cases, individual genomic findings that may be medically actionable for research participants. NCI will give competitive preference and funding priority to applications that conform to the "Guiding Principles for Cancer Moonshot Biobanking Activities" (http://biospecimens.cancer.gov/programs/cancermoonshot/principles) and are consistent with the"2016 NCI Best Practices for Biospecimen Resources"

All other aspects of PAR-20-295 are unchanged.

Inquiries

Please direct all inquiries to:

Pushpa Tandon, PhD
National Cancer Institute (NCI)
Telephone: 240 276 5971
Email: tandonp@mail.nih.gov

Christopher Hatch, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6454
Email: hatchc@mail.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov