Notice of Clarification of NIDDK Budget Policy for Clinical Trial Applications

Notice Number: NOT-DK-18-012

Key Dates
Release Date: April 19, 2018

Related Announcements
None

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

Purpose

The purpose of this Notice is to clarify the NIDDK funding policy regarding investigator-initiated therapeutic clinical trial applications that request budgets $500,000 or greater in direct costs in any year. General NIDDK funding policy is that R01 applications requesting $500,000 or more in direct costs for any year (exclusive of subcontract F&A) will be held to a more stringent pay line.   It is expected that annual budgets will vary between years in therapeutic clinical trials, based on the timeline for study initiation, recruitment, implementation of the intervention, participant follow-up and study close-out/data analysis. It is NIDDK's intent that the annual budget requested should match the timeline proposed for the project. The PD/PI should request a yearly budget that matches planned activities and should not artificially spread dollars into a different year to keep the annual budget below $500,000.   NIDDK will not apply a more stringent pay line for R01 applications for therapeutic clinical trials where the total direct costs (exclusive of F&A on subcontracts) for five years do not exceed $2.5 million direct costs (or $2 million for four years), even if the direct costs equal or exceed $500,000 in some years. The more stringent pay line will continue to be applied for all other R01 applications (i.e., all applications that do not have a therapeutic clinical trial as the primary focus of the research plan).   This Notice does not change the requirement for prior approval for such applications. Applicants requesting $500,000 or more in direct costs in any year must contact the appropriate NIDDK program director at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide and the NIH Grants Policy Statement 2.3.7.2 Acceptance for Review of Unsolicited Applications Requesting $500,000 or More in Direct Costs.

Inquiries

Please direct all inquiries to:

Barbara Linder, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-0021
Email: linderb@mail.nih.gov  

Tracy Rankin, Ph.D., M.P.H.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4748
Email: rankint@mail.nih.gov     

Aynur Unalp-Arida, MD, MSc, PhD
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8879
Email: aynur.unalp-arida@nih.gov