May 19, 2023
- March 13, 2023 - Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Real-World Data Platform (U54 Clinical Trial Optional). See NOFO RFA-AG-24-009.
National Institute on Aging (NIA)
The purpose of this Notice is to inform potential applicants of three modifications to notice of funding opportunity (NOFO) RFA-AG-24-009, “Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Real-World Data Platform (U54 Clinical Trial Optional).”
The following sections of RFA-AG-24-009 were modified:
The information below outlines the changes made in each section.
Section IV. Application and Submission Information
2. Content and Form of Application Submission
Overall Component
PHS 398 Research Plan (Overall)
Other Plan(s):
Summary of Change:
The word “deidentification” was changed to “reidentification” in the sixth bullet under “Applications must address the following items:”
Currently Reads:
- For studies involving human participants, describe how the investigators will mitigate deidentification risk with the data, and generally how they will secure the personal and private information of the participants; this includes a condition on the end-user certifying that no attempts to identify participants from the de-identified data will be made.
Modified to Read (in bold italics):
- For studies involving human participants, describe how the investigators will mitigate reidentification risk with the data, and generally how they will secure the personal and private information of the participants; this includes a condition on the end-user certifying that no attempts to identify participants from the de-identified data will be made.
Incubator Core
Budget (Incubator Core)
Summary of Change:
A paragraph was added to inform of the required budget allocation for the Incubator Core.
Currently Reads:
Budget forms appropriate for the specific component will be included in the application package.
While the Incubator Core should support research on both AD/ADRD and general aging topics, no more than 15% of Incubator funds can be allocated to non-AD/ADRD projects each year.
NIA intends to commit $4 million in Y1, $6 million in Y2, $10 million in Y3, $10 million in Y4, $14 million in Y5, and $14 million in Y6 to fund research through the Incubator Core. NINDS intends to commit $2 million in each year of the award to fund research through the Incubator Core.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Modified to Read (in bold italics):
Budget forms appropriate for the specific component will be included in the application package.
While the Incubator Core should support research on both AD/ADRD and general aging topics, no more than 15% of Incubator funds can be allocated to non-AD/ADRD projects each year.
NIA intends to commit $4 million in Y1, $6 million in Y2, $10 million in Y3, $10 million in Y4, $14 million in Y5, and $14 million in Y6 to fund research through the Incubator Core. NINDS intends to commit $2 million in each year of the award to fund research through the Incubator Core.
Applications must allocate $6 million in Y1, $8 million in Y2, $12 million in Y3, $12 million in Y4, $16 million in Y5, and $16 million in Y6 to fund research through the Incubator Core. Potential Incubator Core projects can range in scope and specific goals but must address milestones specified in the NIH AD/ADRD Research Implementation Database. The AD/ADRD registry must be funded from the NIA allocation. The incubator core budget should reflect the actual needs of the proposed AD/ADRD registry across all years.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Section VI. Award Administration Information
3. Data Management and Sharing
Summary of Change:
The word “deidentification” was changed to “reidentification” in the eighth bullet under “Applications must address the following items:”
Currently Reads:
- For studies involving human participants, describe how the investigators will mitigate deidentification risk with the data, whether that procedure is one following HIPAA, IRB, or other Institutional guidance, and generally how they will secure the personal and private information of the participants; this includes a condition on the end-user certifying that no attempts to identify participants from the de-identified data will be made and specified cell sizes; and review of outputs.
Modified to Read (in bold italics):
- For studies involving human participants, describe how the investigators will mitigate reidentification risk with the data, whether that procedure is one following HIPAA, IRB, or other Institutional guidance, and generally how they will secure the personal and private information of the participants; this includes a condition on the end-user certifying that no attempts to identify participants from the de-identified data will be made and specified cell sizes; and review of outputs.
All other aspects of the NOFO remain unchanged.
For programmatic inquiries:
Partha Bhattacharyya
National Institute on Aging (NIA)
Phone: 301-496-3131
Email: NIARWD@nih.gov
For administrative inquiries:
Megan Hancock
National Institute on Aging (NIA)
Phone: 301-451-9802
Email: megan.hancock@nih.gov
and Human Services (HHS)
