Amendment: RFA-AI-08-015 Clinical Trials in Organ Transplantation (CTOT) (U01)

Notice Number: NOT-AI-09-003

Key Dates

The National Institute of Allergy and Infectious Diseases (NIAID) has amended RFA number AI-08-015 (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-08-015.html), entitled “Clinical Trials in Organ Transplantation (CTOT) (U01)” due to the need to clarify language in the Research Objectives and Scope (see Description below).  Because this clarification is being posted so close to the original receipt date NIAID is extending the receipt date to allow applicants additional time to address this clarification. The following key dates are changed to:

Application Due Date(s):  November 7, 2008
Peer Review Date(s):  February, 2009
Council Review Date(s):  May 2009
Earliest Anticipated Start Date(s): July 2009
Additional Information to be Available Date (Activation Date):  Not Applicable
Expiration Date:  November 8, 2008

This schedule also applies to all dates listed in Section IV 3.A. Receipt, Review, and Anticipated Start Dates.

Issued by
National Institutes of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

Description

NIAID has amended the RFA with regard to language under (1) Section I, Item 1, Research Objectives and Scope; as well as Section IV, Application and Submission Information, Item 6.2, Research Plan.

(1) Specifically, in Section I, Item 1, Research Objectives and Scope, the RFA states:

“The objective of this FOA is to support multi-center interventional clinical trials and/or observational studies in pediatric and adult candidates for and recipients of organ transplantation. Studies involving children will be carried out in collaboration with the NIAID-funded Clinical Trials in Organ Transplantation in Children (CTOT-C) consortium (see below).”

And

“The CTOT consortium will work collaboratively with the Clinical Trials in Organ Transplantation in Children (CTOT-C) consortium (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-07-006.html), a similar clinical studies program in pediatric organ transplantation. CTOT-C investigators will provide pediatric expertise and help to identify pediatric subjects for clinical trials.”

For further clarification NIAID is adding the following language:

“While NIH encourages the inclusion of children in research, this initiative will support clinical trials in which the majority of study subjects are adults. Studies may include a minority of pediatric subjects, in which case the investigator will collaborate with the NIAID-funded Clinical Trials in Organ Transplantation in Children (CTOT-C) consortium.”

(2) Under section IV, Item 6.2, Research Plan, the RFA states:
“Research Plan (Items 2-5 - 35 Pages)”

This is changed to read “Research Plan (35 Pages). The requirements listed in IV.6.2 a and b must be described in not more than 35 pages.

Inquiries

For questions or further information, contact:

Nancy D. Bridges, M.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Disease
Room 3035, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 451-4406
FAX: (301)480-0693
Email: nbridges@niaid.nih.gov


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