RFA-DP-24-031 Q&A Document for grants.gov posting.pdf

RFA-DP-24-031 NOFO

Questions from Potential Applicants and CDC Responses

Question 1: The RFA references two previously funded NOFOs: #DP15-010 (The Epidemiological Study of

Interstitial Cystitis) and #DP-21-002 (Epidemiologic Cohort Study of Interstitial Cystitis) in the “Relevant

Work” section on page 6. Could CDC confirm whether this RFA is intended as a follow-on to one of those two previously funded NOFOs, or if an entirely different IC cohort previously funded by NIH is eligible?

Answer: This Notice of Funding Opportunity (NOFO) is NEW, therefore an application that is submitted for funding for the first time will be considered (Section II. Award Information).

As stated in the NOFO, Section III.5 States, 5: Responsiveness: Applicants must have access to an existing and established baseline cohort of at least 200 IC participants that has been followed previously or will be followed in 2024, and that the applicant can follow over time to accomplish the goals and objectives of this NOFO. Applicants must provide evidence such as a letter of commitment, memorandum of agreement, memorandum of understanding, or other documentation providing evidence of access to the established cohort that can be followed over time. This evidence should be placed in Appendix A of the application. The applicant does not have to have collected data on IC previously.

Question 2: We had a question about the nature of “existing IC cohorts” mentioned in the RFA. The

NOFO mentions …applicants should have access to a cohort of IC participants who are eligible for follow-up or have been followed up. Because IC is a rare condition with little existing epidemiologic information, it is beneficial and efficient in terms of both cost and data collection to continue collecting information on an already existing cohort for which epidemiologic data has already been collected.

We have a cohort of participants that have been characterized in terms of medical diagnosis given as part of standard of care, combined with medical record data that are captured as part of routine care.

Would this be eligible for this NOFO as a group that is “eligible for follow up”?

Answer: This is a new, open competition Notice of Funding Opportunity (NOFO) and all applications that meet the eligibility detailed in Section III of the NOFO will be accepted.

As stated in the NOFO, Section III.5 States, 5: Responsiveness:

Applicants must have access to an existing and established baseline cohort of at least 200 IC participants that has been followed previously or will be followed in 2024, and that the applicant can follow over time to accomplish the goals and objectives of this NOFO. Applicants must provide evidence such as a letter of commitment, memorandum of agreement, memorandum of understanding, or other documentation providing evidence of access to the established cohort that can be followed over time.

This evidence should be placed in Appendix A of the application. The applicant does not have to have collected data on IC previously.

Question 3 Part 1: Page 31 of the RFA states that “Indirect costs on training grants are limited to a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and sub-awards in excess of $25,000. If requesting indirect costs in the budget based on a federally negotiated rate, a copy of the indirect cost rate agreement is required. Include a copy of the current negotiated federal indirect cost rate agreement or cost allocation plan approval letter." As page 2 indicates a U01 Cooperative Agreement activity code, as opposed to a training grant, can CDC confirm this language is applicable?

Answer: Yes, the language in this section is applicable to this Notice of Funding Opportunity (NOFO).

Question 3 Part 2: Further, our current rate agreement expired. We have submitted our incurred cost proposals and are awaiting the new letter however, we have been informed that, due to volume and delays the new rate approval letter will be delayed and may not be received prior to the application deadline. May we submit copies of our incurred cost proposal to support our proposed fringe and indirect rates, and provide the final approved letter once received?

Answer: As stated in Section V.3. Budget and Period of Support of the NOFO, “You can obtain budget preparation guidance for completing a detailed justified budget on the CDC website, at the following Internet address: https://www.cdc.gov/grants/applying/application-resources.html “ Please be sure to review the pdf entitled, “CDC Budget Preparation Guidelines”. A copy of the most recent indirect cost rate agreement or a cost allocation plan must be provided with the application.

END OF Q&A

Updated Guidance Regarding This NOFO:

- If requesting indirect costs in the budget based on a federally negotiated rate, a copy of the indirect cost rate agreement is required. Include a copy of the current negotiated federal indirect cost rate agreement or cost allocation plan approval letter in the R&R Budget Form as part of the Budget Justification attachment.

- CDC has retired the Risk Assessment Questionnaire Requirement and applicants are no longer required to submit the CDC Risk Questionnaire as part of their NOFO application. This instruction supersedes instructions under Section IV, 11: Other submission requirements and information. Risk Questionnaires that are submitted will not be reviewed. CDC continues to conduct the review of risk posed by applicants and we may ask for additional information prior to the award based on the results of the review.

https://www.cdc.gov/grants/applying/application-resources.html