Applicant Resources about RFA-AG-24-004

Q: What is involved in stakeholder engagement?

A: From the RFA:

• Principal Investigators must propose their approach for two engagement panels. The first panel, a family and people living with dementia (FPLWD) engagement panel, hereafter FPLWD Engagement Panel, will include a multifarious group of people, families, and caregivers with various perspectives on living with and supporting those living with AD/ADRD. The second panel, which will be called a Technical Monitoring Committee, will be comprised of economists, data scientists, and modeling experts to provide guidance to the study team on developing estimates of the cost of illness. It is not anticipated that there will be a significant overlap between the activities of the FPLWD Engagement Panel and the Technical Monitoring Committee.

  • The Principal Investigator is to propose their team’s approach to engagement. Potential applicants who are new to this topic are encouraged to familiarize themselves with the Patient-Centered Outcomes Research Institute’s stakeholder engagement information .
• FPLWD Engagement Panel: The goal of engaging FPLWD is to ensure that the challenges of finding, paying for, and maintaining treatment and care for AD/ADRD are adequately captured. Through the FPLWD Engagement Panel, FPLWD provides input on the services, treatments, and processes that cost them time and money to navigate, regardless of whether the care and treatment are paid for out of pocket or by other payers. FPLWD will have the opportunity to ground the study in lived experience. This Patient-Centered Outcomes Research Institute's webpage is a possible source of patient and family engagement information.
• Technical Monitoring Committee: The goal of the Technical Monitoring Committee is to provide critical feedback to the study team on data sources, data access, data analysis, development of analytic models, and content of scientific manuscripts. The Technical Monitoring Committee supports the scientific rigor of the project. Potential Technical Monitoring Committee members must not be named or contacted during the application period, rather applicants are invited to describe their approach to establishing and engaging with the Technical Monitoring Committee.”

Q: Are family caregivers expected to be compensated for their time as a stakeholder?

A: This is at the Principal Investigator’s discretion.

Q: Do the panels be held one time or reoccurring?

A: The Principal Investigator should propose their plan and approach.

Q: Is it preferred that individuals on the data analysis panel come from more than one institution, not just from the awardee institution?

A: One of the evaluation criteria is: “How well-described is the [Panel] Technical Experts on data sources, data access, data analysis, development of analytic models (Technical Monitoring Committee)?” Therefore, the Principal Investigator should propose their plan and approach.

Q: Can we use Medicare data as a data source?

A: Yes.

Q: What about private proprietary data that can give us valuable estimates of cost elements but not allow to share individual-level data?

A: The Principal Investigator should propose their plan and approach.

Q: Do all project datasets need to be shared or only the primary dataset? What about CMS data that might typically be accessed through the VRDC? What about proprietary datasets, e.g., EHR data?

A: Datasets whose data rights and data use agreements allow for sharing should be shared.

Q: Does the requirement for an annual update of data rule out Health and Retirement Study as the backbone data set?

A: No. The Principal Investigator should propose which data elements can be updated annually to provide annually updated estimates of the cost of AD/ADRD.

Q: Would MedRIC datasets, which include all CMS data, be available for free through VRDC under this agreement?

A: Standard policies apply. The Principal Investigator will need to fill out the required forms to access data through the MedRIC enclave. Potential applicants are encouraged to familiarize themselves with:

• NIA Data Linkage Program
• NIA’s CMS Data Policy
• MedRIC- Information for potential new partners
• MedRIC list of currently linked studies
• NIA Blog About MedRIC Enclave

Q: Does the documentation accompany the code?

A: The sharing of analytic code should be done in such a way that it supports the scientific objectives of the project. Potential applicants are encouraged to consider the code repository of the Medical Expenditure Panel Survey as an exemplar.

Q: What is involved in a pilot study? Can the awarded team apply for the pilot awards? Can pilot studies be conducted at the awardee or other outside institutions? Is there a minimum number of pilot projects that need to be funded? What is the target scope and budget for the pilot projects?

A: From the RFA: “The Cooperative Agreement must support pilot studies to conduct policy simulations and model enhancements. The study shall ensure that the tasks needed to invite, select, and mentor pilot investigators are undertaken. Any proposed approach must include the involvement of the NIA Program Official in the review and selection of pilot projects.”

The evaluation criteria state that applications should describe an approach to conducting nationwide outreach to solicit pilot project applications. Applications should explain how pilot awardees would be selected and engaged. Applications should explain the plan for inviting, reviewing, and prioritizing pilots. The Principal Investigator should propose the approach in the application.

Q: The definition of ADRD provided in the RFA is broad and more inclusive of conditions that are not typically considered within the umbrella of ADRD (e.g., delirium). Is the NIA interested in this broader definition of ADRD and all associated costs?

A: Principal investigators are encouraged to limit the scope of the project to align with the published support level and to be responsive to the scored review criteria listed in the RFA.

Q: How much will NIA intend to commit to funding an awardee in FY 2024?

A: The annual direct costs are 1 million dollars, and the work will be supported for 5 years. (Total of 5 million dollars over 5 years).

Q: Is MedRIC.info the same or different from the MedRIC enclave?

A: MedRIC.info is the website URL. The ‘enclave’ is the FedRAMP compliant virtual cloud space where MedRIC hosts NIA’s CMS data as authorized under the NIA DUA.

Q: The RFA says that Technical Monitoring Committee members need not be named in the proposal, what about the FPLWD?

A: Neither the members of the Technical Monitoring Committee nor the Families and People Living with Dementia need to be named in the application.

Q: Who should I contact if I have further questions?

A: Point of Contact

Application Submission Contacts

• eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues), Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact) & Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
• General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources): Email: GrantsInfo@nih.gov (preferred method of contact &Telephone: 301-637-3015
• Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace): Contact Center Telephone: 800-518-4726 & Email: support@grants.gov

Scientific/Research Contact(s)

Priscilla Novak, PhD, MPH
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: Priscilla.Novak@nih.gov

Peer Review Contact(s)

Ramesh Vemuri, PhD
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: Ramesh.Vemuri@nih.gov

Financial/Grants Management Contact(s)

Jeni Smits
National Institute on Aging (NIA)
E-mail: Jeni.smits@nih.gov

DBSR