Key Dates

Related Announcements

RFA-DK-21-505 - Limited Competition for the Continuation of the Data Coordinating Center for the Diabetic Foot Consortium (U24 Clinical Trial Optional)

Issued by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

This Notice informs the applicant community of an extension in the Application Due Date and a correction to the award amounts for RFA-DK-21-505, "Limited Competition for the Continuation of the Data Coordinating Center for the Diabetic Foot Consortium (U24 Clinical Trial Optional)" . The Application Due Date is changed from May 23, 2022 to August 17, 2022. The Award Information and the Application and Submission Information Sections have also been updated to more accurately reflect funds available and the level of effort required under this FOA.

The following sections of RFA-DK-21-505 have been modified to reflect these changes:

Part I. Overview Information

Key Dates

Currently Reads:

Open Date (Earliest Submission Date): April 23, 2022

Letter of Intent Due Date(s): April 23, 2022

Expiration Date: May 24, 2022

Modified to Read (changes shown in bolded italics):

Open Date (Earliest Submission Date): July 17, 2022

Letter of Intent Due Date(s): July 17, 2022

Expiration Date: August 18, 2022

Under Section II. Award Information, Funds Available and Anticipated Number of Awards (changes in bolded italics):

Currently reads:

The NIDDK intends to commit up to $3,000,000 in FY 2023 to fund one award.

Modified to read:

NIDDK expects to commit up to $4,256,000 to fund one award in FY 2023.

Under Section II. Award Information, Award Budgets, (changes in bolded italics):

Currently reads:

The application budget should not exceed $2,240,000 in direct costs for the first year. The application budget should accurately reflect the needs of the DCC.

Modified to read:

The application budget should not exceed $2.73 million in direct costs in year one; $2.94 million in years two and three, $2.64 million in year four and $1.93 million in year 5 (exclusive of Facilities & Administrative costs for subawards). The applications budget should accurately reflect the needs of the DCC and it subawards.

Under Section IV. Application and Submission Information, R&R Budget (changes in bolded italics):

Currently reads:

The PD/PI must include at least 35% effort. The budget for the DCC activities should be based on a continuous biorepository protocol with an enrollment to meet the goals of "No DFU Patient Goes Unstudied" and the initiation in the first and third years of a large biomarker validation or social determinants of health (SDH) study lasting about two years each. The protocols would include the collection of longitudinal clinical data, images, biosamples, patient reported outcomes and specific biomarker tests and the budget should include the statistical, bioinformatics and manuscript support for studies using this data. The budget should include the DCC administrative costs for the initiation and maintenance of four clinical sites with the possibility of turnover of some sites based on the needs of the DFC.

Modified to read:

The PD/PI must include at least 50% effort. The budget for the DCC activities should be based on DFC biomarker, biorepository and social determinants of health (SDH) protocols. The protocols would include the collection of longitudinal clinical data, images, biosamples, patient reported outcomes and specific biomarker tests and the budget should include the statistical, bioinformatics and manuscript support for studies using this data. The budget should include the DCC administrative costs for the maintenance of up to twelve clinical sites with the possibility of turnover of some sites based on the needs of the DFC.

Under Section IV. Application and Submission Information, R&R Subaward Budget (changes in bolded italics):

Currently reads:

The budget should allocate $750,000 per year for subawards to clinical sites, BAUs, and other DFC activities to meet the goals of the DFC as determined by the DFC Steering Committee and with approval of NIDDK. The application should not allocate those funds, but only state that they will be used for subawards.

Modified to read:

The budget should allocate $1,070,000 in year one, $1,390,000 in years two-four and $750,000 in year five for subawards to clinical sites, BAUs, and other DFC activities to meet the goals of the DFC as determined by the DFC Steering Committee and with approval of NIDDK. The application should not allocate those funds, but only state that they will be used for subawards and entered on the budget page Section F, Line 5

All other aspects of this Funding Opportunity Announcement remain unchanged.

Inquiries

Please direct all inquiries to:

Teresa L. Z. Jones, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-2996
Email: [email protected]