Notice Number: NOT-DK-16-003

Key Dates
Release Date: December 4, 2015

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

Purpose

The purpose of this Notice is to amend the award budget and project period limits and clarify the eligible clinical studies for RFA-DK-15-019 "Research Using Biosamples and Subjects from Type 1 Diabetes Clinical Studies - Complications (DP3)" as shown below:

Part. 2. Section II, Award Information

Award Budget

Current language
The maximum direct costs are $1 million for the entire project period. Facilities and Administrative (F&A) costs to be determined at the time of award. F&A costs requested by consortium participants are not included in the direct cost limitation.

Revised Language
The maximum direct costs are $1.6 million for the entire project period. Facilities and Administrative (F&A) costs are to be determined at the time of award. F&A costs requested by consortium participants are not included in the direct cost limitation.

Part. 2. Section II, Award Information

Award Project Period

Current language
The scope of the proposed project should determine the project period. The maximum project period is 3 years.

Revised language
The scope of the proposed project should determine the project period. The maximum project period is 3 years. The project period of the DP3 award may extend beyond the current funding period of a parent study.

Part. 2. Section I. Funding Opportunity Description

The current language of the second paragraph in this section reads as follows:

The clinical studies should have well-characterized subjects with type 1 diabetes of the appropriate number and clinical characteristics for the proposed research. Other groups of subjects can be studied, only if their findings will be used for comparison to findings in the subjects with type 1 diabetes. The focus of the research should be on type 1 diabetes. The research could include new measurements on stored biosamples; new collections of biosamples; or new clinical evaluations of subjects, such as imaging measurements or the use of continuous glucose monitors.

The language has been revised within the second paragraph to clarify eligible clinical studies:

For the purpose of this FOA, the clinical studies should have well-characterized subjects with type 1 diabetes of the appropriate number and clinical characteristics for the proposed research. In most cases, the clinical study will be the result of a research grant and the characterization of the cohort will be part of the standardized assessments of the clinical study. However, this is not required if the applicant can document that the proposed cohort consists of well-characterized individuals with type 1 diabetes. All applicants should document the methods used to characterize the subjects for the parameters relevant to the proposed research project. Other groups of subjects can be studied, only if their findings will be used for comparison to findings in the subjects with type 1 diabetes. The focus of the research should be on type 1 diabetes. The research could include new measurements on stored biosamples; new collections of biosamples; or new clinical evaluations of subjects, such as imaging measurements or the use of continuous glucose monitors.

All other aspects of this Funding Opportunity Announcement (FOA) 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]