RFA-DP-25-038 Question and Answer Document. Final. V2.pdf

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Epilepsy Incidence Among Children in the United States
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RFA-DP-25-038
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This is a Questions and Answers document for RFA-DP-25-038, "Epilepsy Incidence Among Children in the United States" Notice of Funding Opportunity from the CDC. The document clarifies key application requirements including: international entities with US registration are not eligible; letter of intent should include basic information like institution name, project title, and key personnel; multiple PIs are allowed with a leadership plan; AI/machine learning approaches are encouraged but not required; and both a total multi-year budget and detailed Year 1 budget must be submitted.

The Q&A provides additional guidance that the research strategy should cover the entire project period, not just Year 1; community stakeholder involvement is expected for informing research approaches and dissemination; evaluation plans should follow CDC templates; and applicants should consider both existing risk factors and potential new risk factors related to epilepsy diagnosis. The study allows examination of pathological/molecular factors and factors recordable at birth, with emphasis on using available data sets and ensuring generalizability of findings.

RFA-DP-25-038 Question and Answer Document. Final. V2.pdf

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RFA-DP-25-038

Epilepsy Incidence Among Children in the United States Notice of Funding Opportunity

(NOFO)

Questions from Potential Applicants and CDC Responses

Question 1: We are an international headquartered company but have a US registered entity. May we be eligible to apply as a US entity?

Answer: Upon review, we have determined that even with a US registered entity, your entity would still not be eligible to apply for this NOFO. Please note that CDC does publish other funding opportunities where foreign entities are eligible. Please subscribe to www.grants.gov and search for others.

Question 2: Could you please share the expectations for the letter of intent? Is this similar to NIH LOI’s where we typically provide a short synopsis and list of investigators or is something more extensive required?

Answer: We don’t need anything extensive for the letter of intent. Please see Section IV. Application and Submission Information; #3 of the NOFO:

Although a letter of intent is not required, is not binding, nor enters into the review of a subsequent application, the information allows CDC to plan the review. By the date listed above, prospective applicants are asked to email their intent to apply and include the following information: applicant institution, descriptive title of the proposed research, name and direct telephone number of the PD(s)/PI(s), names of other key personnel, and a list of proposed participating institutions.

Email the info to Natalie Brown, Scientific Program Official, at researchnofo@cdc.gov. Place the number and title of this NOFO in the subject line: RFA CDC DP25-038, Epilepsy Incidence Among Children in the United States.

Question 3: Is an MPI submission allowed for this U01 funding mechanism, RFA-DP-25-038, Epilepsy Incidence Among Children in the United States?

Answer: Yes, the NOFO allows multiple PIs. If multiple PIs are proposed, applicants must provide a multiple leadership plan.

Question 4: Can you discuss the importance placed on including AI or machine learning?

Answer: As stated in the NOFO we encourage use of these strategies, it is not a requirement. We refer potential applicants to the wording that is stated in the NOFO. Applicants are encouraged to consider those types of methods potentially as an innovation.

Question 5: For the risk factors component of the NOFO - are applicants expected to focus on exploring the relationship between known risk factors and epilepsy diagnosis or using data to identify new potential risk factors?

http://www.grants.gov/ mailto:researchnofo@cdc.gov

Answer: Potential applicants should consider their approaches relative to any innovation and your available data

Question 6: Is there a specific format for the Year 1 evaluation plan?

Answer: We would encourage potential applicants to visit the www.cdc.gov evaluation website. Consider templates for logic models and other examples that are available online. Potential applicants may want to engage evaluators who have programmatic expertise because it’s a unique expertise.

Question 7: It wasn't clear whether we are to submit a multi-year budget for the total amount requested in addition to a detailed year 1 budget or just the Year 1 budget.

Answer: Both will need to be provided. Applicants should provide a total budget, but also a detailed budget for year one with their application. We need the cumulative as well as a detailed broken-down budget for year one.

Question 8: For the fetal brain development, are you interested in things that can be determined pathologically or molecularly, or are you interested in anything that’s recordable as a diagnosis at birth?

Answer: At a minimum we are certainly interested in factors that are recordable as a diagnosis at birth relative to available data sets, again. This (i.e., pathological, or molecular risk factors) is certainly not a requirement, and may be something that is considered, within the scope of an innovation. Potential applicants are also encouraged to consider any approach relative to the generalizability of findings and also relative to available data.

Question 9: Does the research strategy need to address a four year plan or only year 1?

Answer: The research strategy should be a description of your entire plan for the project.

Question 10: To what degree do you expect community stakeholder involvement in an incidence study of existing data?

Answer: As indicated in the NOFO we do expect community stakeholder involvement, collaboration, and partnerships with different groups. Potential applicants can consider collaboration with local epilepsy, social service agencies, healthcare systems, other organizations that represent people with epilepsy and or their caregivers to help inform the research approaches, and most importantly, the dissemination strategies.

http://www.cdc.gov/

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