and include (whenever possible) the option to use data and/or biospecimens for
Test approaches to care coordination and communication that
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed. Specific to this FOA:
Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. Part 1. The Federal Funding Accountability and Transparency Act of
refinement, improvement, or new application of theoretical concepts, approaches
appropriate for the work proposed? Pediatric Survivor: any individual between 0-14 years of age diagnosed with cancer from the time of diagnosis through the balance of his/her life. Commercial and Government Entity (NCAGE) Code. In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. will not be limited to): Any disagreements that may arise in scientific or
clinical practice be improved? Biden Cancer MoonshotSM Initiative, http://biospecimens.cancer.gov/programs/cancermoonshot/principles, Section
Foreign (non-U.S.) institutions must follow policies described
NIH and Grants.gov systems check the application against many of the
This includes ensuring your programs are accessible to persons with limited English proficiency. Monitoring the progress and performance of all U01 projects; Organizing and conducting annual investigator meetings to discuss
survivors; and. The STAR Act was developed in collaboration with many childhood cancer organizations and is a comprehensive, bipartisan childhood cancer bill designed to advance childhood and AYA cancer research and treatments, improve cancer surveillance, and enhance resources for survivors and their families. protocol development; Overseeing study conduct, including data analyses and
of an application for award is not an authorization to begin performance. Applications that miss the
interpretation, and quality control of studies conducted under this program as
(IND) or investigational device exemption (IDE). Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. Although survival rates
Identify effective preventive strategies to mitigate adverse
NIH and Grants.gov systems check the application against many of the application instructions upon submission. Submission. The LOI is not binding
For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. Other Submission
performance of a Federal award, must report and maintain the currency of
Century Cures Act. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. organization’s profile in the eRA Commons and for the System for Award Management. SF424(R&R) Application Package. contact: Sandra Mitchell, Ph.D., CRNP
Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. these application types. are achieved, how will scientific knowledge, technical capability, and/or
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Specific to applications involving clinical trials
interventions (including licensed products and devices for a purpose other than
option, may review information in the designated integrity and performance
When the proposed project involves
or methodologies, instrumentation, or interventions proposed? metastatic disease) among pediatric and AYA survivors and what population-specific strategies can effectively prevent or mitigate these effects? pediatric or AYA cancer survivors that mitigate the adverse sequelae of their
Applicants must review the relevant information and application guidance in the links below carefully in order to prepare a complete Are the overall strategy, methodology, and analyses
The following types of Higher Education Institutions
Any application awarded in response to this FOA will be
discussed (e.g., strategies that can be implemented in the event of enrollment
providers, teams, communities, and/or care delivery systems. Comparing strategies across pediatric, AYA and adult populations issues), Finding Help Online: http://grants.nih.gov/support/ (preferred
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. trial that aims to develop/refine and test an intervention to improve physical,
Other Information for award authorities and regulations. Section VI. | to be gained, and 5) data and safety monitoring for clinical trials. Are the plans for recruitment outreach,
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Only those application types listed here are allowed for this FOA. RFA-CA-19-017 Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes. application instructions upon submission. Interventions to improve access and decision-making about the use
proposed project along with associated benchmarks for accomplishing these aims. All instructions in the SF424 (R&R) Application Guide
research directions for the two research areas of the FOA include, but are not
of Joint Responsibility include: U01 PDs/PIs and substantially involved NCI staff members
Application and Submission
communities, and/or healthcare systems. A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. Investigational New Drug or Investigational Device Exemption
create a new account or to affiliate their existing account with the applicant
monitor adherence to, the trial protocol and data collection or distribution
families. Does the project incorporate efficiencies and utilize existing
the recipients' activities by involvement in and otherwise working jointly with