Frequently Asked Questions for RFA-AG-23-032
The frequently asked questions below are related to RFA-AG-23-032: Network for Personalization of Diagnostic Tests for Alzheimer’s Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) in Older Adults with Multiple Chronic Conditions (MCCs) (U24 Clinical Trial Optional).
Q: Does this funding opportunity have non-responsiveness criteria, or will all applications received under RFA-AG-23-032 be peer-reviewed?
A: Yes, there are non-responsiveness criteria. Applicants are strongly encouraged to reach out to scientific contacts to discuss their applications. Applications that are not responsive to this FOA, and will be withdrawn prior to review, include:
- Applications that propose activities that only serve investigators at a single institution, or a small number of institutions, rather than the field at large
- Applications that include plans to conduct definitive multicenter randomized clinical trials
- Applications that do not include all of the following components:
- Plans to assemble existing data and acquire real-world data to ensure a large sample with adequate representation of older adults living with well-characterized MCCs and incorporate pre-specified subgroup analyses
- Plans to analyze data for performance and accuracy of biomarkers, including blood, CSF, and/or imaging, in real-world older patients living with MCCs
- Plans to conduct pilot studies of specific AD/ADRD imaging and/or biomarkers in persons living with MCCs
Q: Are there any special review criteria that will be applied to applications submitted under RFA-AG-23-032?
A: Yes. There are additional review criteria listed in the FOA under the following peer review criteria: Section V. Application Review Information; Significance, Innovation, Approach and Environment.
Q: Are there any special instructions for this FOA?
A: Yes, the following FOA sections contain additional instructions:
Section IV. Application and Submission Information.
- Letter of Intent
- SF424 (R&R) Senior/Key Person Profile
- Research Plan
- Resource Sharing Plan
Q. RFA-AG-23-032 states that the budget is limited to $1,150,000 in direct costs for five years. Is special permission still required to submit a budget requesting more than $500,000 in direct costs?
A. No, you are not required to request permission to submit the application. But applicants are encouraged to submit a letter of intent as outlined in the FOA.