CDC-RFA-DD-24-0083_NOFO_Questions_and_Answers_April 12_2024_Final.docx

CDC-RFA-DD-24-0083

“Documenting outcomes associated with Persistent Tic Disorders (including Tourette Syndrome) in Children, Adolescents, and Young Adults through Surveillance” Questions and Answers Questions originally posted and responded to as received here: Notice of Funding Opportunity (NOFO) CDC-RFA-DD-24-0083 | CDC Note: The deadline to submit questions was April 5, 2024.

Application Information Q: Is CDC specifying a type of database that all funded entities use across the board to facilitate data sharing and the ability to analyze all the data together? Is there a specific type of database that CDC would like to see?

A: CDC did not specify a type of database for this project.

Q: Will CDC use a data warehouse for dissemination of the database after this project concludes?

A: Generally, CDC does not take responsibility for the dissemination of grantees’ data and long-term archiving of data after the project concludes. Grantees may use their own sites, privately owned repositories, or government-based sites (e.g., NIH Repositories) to share and archive project data.

Q: It states in the NOFO that the funds should not be used for research—what specifically is the meaning of that as far as specific data use? The data that is collected—part of the expectation is that this data should be shared with other entities as well, could it then be used as part of research?

A: The Office for Human Research Protections (OHRP) states that, “The difference between public health surveillance and research in this context is that the purpose of the surveillance is to inform the decisions or actions that must be made by a public health authority.” Read more: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-activities-deemed-not-be-research-public-health-surveillance/index.html.

The definition of research is “A means of systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The purpose of research is to generate or contribute to generalizable knowledge.” Read more: Additional Requirement – 31 | Grants | CDC.

Data from this project can be used for reports, presentations, and scientific publications.

Q: Is it a priority to include multiple sampling sites (e.g., different settings in order to capture a more diverse sample and/or to replicate/test the sampling/analytical approaches in alternative settings) or rather, is the intent that alignment/comparisons and this will be done across awardees?

A: Either option is acceptable. Page 18 of the NOFO states, “If recipient uses a sub-recipient for all or part of the workplan activities, the recipient must demonstrate adequate staffing and capacity to supervise sub-recipient’s activities and products.” If multiple sites apply together, one site must be the primary applicant (and recipient, if awarded).

Q: Given that the recruitment is in a TS/CTD patient population, and the downstream focus appears to be on establishing a mechanism for tracking key associations with TS/CTD/sequela, is diagnostic confirmation/clinician-rated objective measure of tic clinical severity either recommended or required?

A: Applicants should describe the recruitment population and how a diagnosis has been documented or will be documented as part of the project.

Q: What are the procedures to conduct the study?

A: This is a non-research NOFO. Page 2 of the NOFO states, the applicant needs to propose a methodology to recruit participants and collect and share data. Final procedures will be determined across recipients with coordination by CDC.

Q: Can an award recipient advertise online for participants?

A: Yes. Page 9 of the NOFO, under Strategy 2 states that successful applicants will have to show plans to recruit the target population from clinic populations.

Q: On page 43 under Phase II review section, the rubric is broken down into three categories that do not align directly with the order of the sections in the narrative. They are Approach, Evaluation, and Org. Capacity. Under Approach, it says “Present a workplan aligned with the strategies/activities, outcomes, and performance measures and consistent with the content and format of the CDC template” is worth 3/25 points awarded for that section. Is this the same work plan that is outlined on page 36 where it reads, ” “Applicants must prepare a work plan consistent with the CDC Project Description Work Plan section. The work plan integrates and delineates more specifically how the recipient plans to carry out achieving the period of performance outcomes, strategies and activities, evaluation, and performance measurement. The applicant must provide a detailed work plan for the first year of the project and a high-level work plan for subsequent years to track and monitor implementation of activities and progress on period of performance outcomes. The recommended work plan format is a table listing the strategies and activities, outcomes, and evaluation and performance measures as presented in the logic model and the narrative sections of the NOFO”?

Our interpretation is that the work plan that comes at the end of the narrative will be scored under the Approach section and that these two sections refer to the same item, but I just want to make sure this is the case.

A: Yes, these two sections refer to the same workplan.

Q: On page 55 of the notice, it lists the supplemental documents that we can include.” Are the items listed there the only acceptable submissions in this section? Could we also include, for instance, a list of references or endnotes in the “other documents” section?

A: Please follow the guidance on page 55, which states, “Applicants may not attach documents other than those listed; if other documents are attached, applications will not be reviewed.”

Eligibility Q: Does every business have to file the Lobbyists form or only those who are Lobbyists?

A: Yes, the “Disclosure of Lobbying Activities” (SFLLL) is required as part of the submission.

Programmatic Information Q: If they work in a clinic, do they collect data on each patient once during a 5-year period?

A: The NOFO project objective is to collect cross-sectional data on priority outcomes for diverse populations of children, adolescents, and young adults with PTD/TS as well as data on selected impacts (e.g., employment) for caregivers of children and adolescents. The applicant should include a data management plan with a description of the data to be collected or generated in the proposed project. Data collection procedures will be standardized across sites post-award.

Q: What end date of the 5 years of the application period?

A: The end date of the 5-year award period is August 31, 2029 Q: Is the Intermediate to Long term Outcome of continued surveillance envisioned as part of an ongoing data collection infrastructure (i.e., embedded in the clinical process/medical record) or creation of a patient registry? In other words, is the goal to create and evaluate the infrastructure to collect data “locally” but with the ability coordinate/share/census-track or rather to collaboratively design/develop a single collection infrastructure (akin to a registry)?

A: The goal of this NOFO is to collaboratively develop a standard survey and data collection protocol that can be implemented at multiple sites.

Page 4 of the NOFO states, “Recipients will collaborate with CDC and other NOFO recipients to finalize measures for priority outcomes, to develop a standard survey and surveillance data collection protocol across sites, to establish a data sharing approach, and to analyze, summarize, and disseminate multi-site findings.”

Page 9 of the NOFO indicates recipients may implement “a limited number (e.g., 1-3) of measures for non-priority outcomes can be proposed) minimizing participant burden.”

Budget Q: Does the funding amount represent direct and indirect?

A: Yes, the funding amount listed on page 21 of the NOFO includes both direct and indirect costs