Notice of Clarification for RFA-DK-11-010: Clinical Trial Planning Grants in Type 1 Diabetes (R34)

Notice Number: NOT-DK-11-012

Release Date: June 23, 2011

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Neurological Disorders and Stroke (NINDS))

The purpose of this Notice is to clarify the funding of applications submitted to RFA-DK11-010: Clinical Trial Planning Grants in Type I Diabetes (R34) and of future clinical trials that may be conducted by awardees of an R34 Clinical Trial Planning Grant under this FOA.

OLD LANGUAGE

Section I (Funding Opportunity Description)

This FOA will utilize the NIH Clinical Trial Planning Grant (R34) to support the development of clinical trials in individuals with type 1 diabetes. Contingent on the merit of the proposed trials and the availability of funds, NIH anticipates funding of up to three full scale trials from the funded R34 planning grants.  During the early funding period of the R34 grant, the investigators will have the opportunity to revise the protocol based on considerations raised in peer review.  NIH will then seek external input that will guide priorities for the support of a limited number of full clinical trials selected from the funded R34 protocols.  Those clinical trials will be conducted in collaboration with a single data coordinating center that will be awarded through a future FOA. The data coordinating center will work with R34 awardees to finalize the protocol and budget, complete administrative tasks and recruit clinical sites.  The data coordinating center award will provide support for the conduct of the selected trials.  Clinical trials developed under R34 grants that are not prioritized for implementation through this data coordinating center may be appropriate for support through other funding sources or mechanisms.

NIDDK is amending Section I, paragraph four to add the following: Depending on the merit and cost of the clinical trials proposed in the applications, only a single award may be made, should the most meritorious application for a clinical trial utilize all available funds.

NIDDK is also deleting the following sentences: Those clinical trials will be conducted in collaboration with a single data coordinating center that will be awarded through a future FOA. The data coordinating center will work with R34 awardees to finalize the protocol and budget, complete administrative tasks and recruit clinical sites.  The data coordinating center award will provide support for the conduct of the selected trials.

NIDDK is adding this sentence: These trials will be funded through a future FOA.

NEW LANGUAGE

Section I. Funding Opportunity Description, paragraph four

This FOA will utilize the NIH Clinical Trial Planning Grant (R34) to support the development of clinical trials in individuals with type 1 diabetes. Contingent on the merit of the proposed trials and the availability of funds, NIH anticipates funding of up to three full scale trials from the funded R34 planning grants. Depending on the merit and cost of the clinical trials proposed in the applications, only a single award may be made, should the most meritorious application for a clinical trial utilize all available funds. During the early funding period of the R34 grant, the investigators will have the opportunity to revise the protocol based on considerations raised in peer review.  NIH will then seek external input that will guide priorities for the support of a limited number of full clinical trials selected from the funded R34 protocols.  These trials will be funded through a future FOA. Clinical trials developed under R34 grants that are not prioritized for implementation may be appropriate for support through other funding sources or mechanisms.

All other aspects of this FOA remain unchanged.

Please direct all inquiries to:

Teresa Jones, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 435-2996
FAX: (301) 480-3503
E-mail: jonester@mail.nih.gov