QandA_document 4.11.24.docx

Surveillance of Congenital Heart Defects Among Children, Adolescents, and Adults

Notice of Funding Opportunity number CDC-RFA-DD-24-0051 Federal Assistance Listing: 93.073

National Center on Birth Defects and Developmental Disabilities Division of Birth Defects and Infant Disorders Centers for Disease Control (CDC)

Question and Answer

Last Updated: 04/11/2024 9:00 am 1 Q1. What is the deadline for the requested letter of intent (optional but recommended)?

A1. The deadline for the LOI is April 12, 2024.

Q2. For Component B, are multi-PI permitted for this funding opportunity?

A2. Only one designated PI is allowed on cooperative agreements. One or more Co-Investigators are allowable.

Q3. Are applicants for this opportunity allowed to use 10-pt font for tables in the Project Narrative (including the Work Plan)?

A3. 10 point font is allowable within tables in the project narrative. Outside of tables, applicants should use 12 point font.

Q4. Is surveillance/data through age 64 required? Would an application that focused on age 0-1 be non-responsive?

A4. Applicants that meet eligibility requirements listed on pages 31-36 of the NOFO and that submit a responsive application are eligible to apply to the grant. Eligible applications will be scored with respect to, among other considerations described in the NOFO, 1) the extent the methods will accomplish the program goals, 2) the extent that the applicant described the estimated number of individuals aged 0-64 years with CHD during the 2021-2023 period, 3) the extent that the activities describe the proposed intent to conduct comprehensive population-based surveillance among individuals aged 0-64 years with CHD, and 4) the organization’s capacity to either create a new or enhance an existing surveillance system ensuring that individuals aged 0-64 years with CHD are included.

Q5. Is it okay if we can’t get/share a small number of the required data elements?

A5. Applicants must indicate any restrictions (e.g., IRB, HIPAA) to provide all required data elements as indicated in Appendix. Applicants will be evaluated on the extent to which the proposed methods address the procedures for generation of the standardized data elements.

Q6. Do applications need to hit every item on the below list or is it sufficient to target only some of these items:

Improved understanding of: age-specific mortality in individuals with CHD; healthcare use, comorbidities, and outcomes of individuals with CHD; health equity among individuals with CHD; racial, ethnic, and socioeconomic patterns in healthcare use and long-term outcomes in individuals with CHD; respiratory viruses (including COVID-19, influenza, and RSV) and immunizations among individuals with CHD; healthcare use during the COVID-19 pandemic among individuals with CHD o the potential impact of state and national healthcare policies on individuals with CHD A6. The goals of the project are captured in the logic model (pages 6-10) and on pages 21-22 (component A) and page 24 (Component B); all listed outcomes are expected outcomes of this NOFO. Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement section of the NOFO.

Eligible applications will be scored with respect to, among other considerations described in the NOFO, 1) the extent to which the methods accomplish program goals 2) if the outcome measures are clear and measurable to address the need and the main activities of the NOFO.

Q7. I want to make sure that my understanding of eligible CHDs described in the NOFO DD24-0051 is correct. It looks like you could select just one code among ICD codes (at a minimum) to be eligible for applying this grant.

NOFO stating “Have one or more of the following ICD-10-CM (or equivalent ICD-9-CM or BPA) CHD codes in a case finding data source (birth defects registry data, clinical and administrative data).”

A7. Applicants that meet eligibility requirements listed on pages 31-36 of the NOFO and that submit a responsive application are eligible to apply to the grant. Eligible applications will be scored with respect to, among other considerations described in the NOFO, 1) the extent the methods will accomplish the program goals, 2) the extent that the applicant described the estimated number of individuals aged 0-64 years with CHD during the 2021-2023 period, and 3) the extent that the activities describe the proposed intent to conduct comprehensive population-based surveillance among individuals aged 0-64 years with CHD.

Applicants should name and describe each data source that will be used to identify individuals with CHD. Data sources can include, but not be limited to clinic data, vital records, immunization systems, hospital discharge, payor data; and the use of birth defect registry data is strongly encouraged. Eligible cases will be ages 0-64 years at any time between 2021-2023, reside in the source population geographic area at any time during 2021-2023, have one or more CHD ICD-10-CM, or equivalent ICD-9-CM or BPA codes, in a case finding data source.

Q8. Within the context of this single application, how should budgets and budget narratives be handled? As separate documents labelled by Component, or as a combined document?

A8. Applicants should include a detailed budget justification by budget category for Year 1 for Component A only or Component B only (as appropriate) and estimated total amounts by budget category for Years 2-5 (Component A) and Years 2-5 (Component B). As long as submitted documents clearly distinguish between components, there is no preference for combined versus separate documents.

Q9. Can the narrative for Component B refer back to information in the Component A section (for instance for organization capabilities), or should this section of the narrative be written as a standalone document?

A9. The narrative for Component B can refer back to information in the Component A section. Organizations applying for both components have an additional 4 pages for the project narrative to ensure there is enough space to adequately describe the unique requirements for Component B that are not included within Component A requirements.

Q10. Should the work plan for Component B be combined with that for Component A? Or should it be created as a standalone work plan within the 4-page limit?

A10. Applicants applying to both Component A and Component B should have corresponding work plans for each component. As long as the described activities are clearly distinguished between components, there is no preference for combined versus separate work plans.

Q11. Are publication references to be included in the narrative? Or only in the biosketch?

A11. Applications will be scored with respect to, among other considerations described in the NOFO, the organization's capacity to lead and publish original manuscripts in a timely manner, as evidenced by citations of recent first- or senior-author publications. Applications will be scored during Phase II by objective reviewers who may be external to the federal government (non-federal personnel), federal personnel, or a mix of federal and non-federal personnel; elements of Phase II review can be found on pages 44-49 in the NOFO.

Q12. For key personnel, can an NIH format biosketch be submitted, or does it need to be a CV?

A12. There is no specific preference for staff CV versus NIH biosketch format. The application should describe organization's capacity to achieve the program goals; applications will be scored with respect to, among other considerations described the NOFO, whether the applicant identified appropriate staff for and that the identified staff members have relevant experience and expertise in their respective areas.

Q13. If an applicant applies only for Component A, would the limit be 15 pages? If an applicant applies for Components A and B, would the limit be 19 pages?

A13. If applying for Component A only, then the project narrative has a limit of 15 pages. If applying for Components A and B then the project narrative has a limit of 19 pages.

Q14. Just wanted to be sure that non-governmental organizations outside the US but registered with NIH can submit proposals.

A14. If the applicant's address is not domestic (to the U.S.) then they are considered foreign and therefore they are ineligible to apply.

Q15. UPDATED: I was on the informational call and wanted to get the slide deck. Could you share that with me?

Slides from the informational webinar were made available as a PDF document on grants.gov as of April 2, 2024.

Q16. Are citations lists an allowable appendix? If so, what the filename should be and where should it be uploaded?

A16. Applicants can include, as attachments, a list of citations for relevant first- or senior-author publications. Applicants should name the citations “Citations_CompA” and upload as a PDF file under “Other Attachment Forms” at www.grants.gov Q17. Can you please clarify whether sites are responsible for creating a site-specific database to collect and store the surveillance data or will we have access to a common database (e.g. REDCap project, SQL database) provided by CDC?

A17. Recipients will have access to a common database provided by CDC.

Q18. Can you clarify if individual sites would be responsible for linking to the NDI or would this activity be coordinated by CDC/the Network?

A18. Recipients will be responsible for linking to state death records and/or NDI.

Q19. It is not clear how much/if any data abstraction is required from medical records. Do sites need to plan and budget for staff that would review and abstract data from medical records?

A19. For sites not previously funded under DD19-1902, there is no expectation for medical record abstraction. Sites previously funded under DD19-1902 will validate 200-300 randomly selected cases through abstraction of detailed medical records to complement work of Component B of DD24-0051.

Q20. Is it possible to provide recommendations for % FTE for various positions/activities (e.g. project coordinator, data manager, etc.)?

A20. Applicants should determine the necessary positions and appropriate level of effort needed to accomplish the activities of the NOFO. The level of effort (either billed to the award or cost-shared) associated with positions listed in the budget narrative should align with the proposed activities each position will support.

Q21. CHD STAR went from 2010-2019 and CHD STAR2 goes from 2021-20. Why the surveillance gap? Won’t this create some analytic issues for the gap years?

A21. CDC and recipients will define surveillance years once the project begins. For planning purposes, the three-year time period of 2021-2023 (calendar years) should be used.

Q22. Does the 15-page limit (if you’re only applying for Component A) for the Project Narrative include abstract, TOC, or references?

A22. The Table of Contents has no page limit and is not included in the Project Narrative. The project abstract is a self-contained, brief summary of the proposed project and is not included in the Project Narrative. References may be part of the Project Narrative. Additionally, applicants can include, as attachments, a list of citations for relevant first- or senior-author publications. Applicants should name the citations "Citations_CompA" and upload as a PDF file under "Other Attachment Forms" at www.grants.gov. For a list of acceptable attachments, please see Section H. Other Information in the NOFO.

Q23. Can you confirm that the LOI is in fact optional?

A23. Please see Section F. (Dates) of the NOFO. Letter of intent is recommended but not required.

Q24. Is there a minimum FTE requirement for Project Management support?

A24. No. Applicants should determine the necessary positions and appropriate level of effort needed to accomplish the activities of the NOFO. The level of effort (either billed to the award or cost-shared) associated with positions listed in the budget narrative should align with the proposed activities each position will support.