Notice Number: NOT-HL-13-182

Key Dates
Release Date: June 3, 2013

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

On May 15, 2013, the NHLBI issued Funding Opportunity Announcement (FOA) RFA-HL-14-014 "Clinical Centers (CC) for the NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network (U01)". This Notice corrects the allowable number of satellite recruiting sites.

The following sections of the FOA are revised accordingly:

Part 2. Section I. Funding Opportunity Description

Research Approach

Current Language:
The CCs will each include 1 (and only 1) other satellite recruiting institution that will participate in enrollment and study conduct but not on the Steering Committee (SC).

Modified Language:
CC applicants must propose at least one satellite recruiting institution that will participate in enrollment and study conduct but not on the Steering Committee (SC).

Part 2. Section IV. Application and Submission Information

R and R Budget

Current Language:
A budget may be proposed for the satellite recruiting center including 1.2 person months (10% full-time professional effort) and up to 3.6 person months (30% full-time professional coordinator effort).

As each CC application requires one (and only one) satellite recruiting site, the application should use the traditional subcontract model.

Modified Language:
A budget may be proposed for the satellite recruiting center(s) that includes a total of no more than 1.2 person months (10% full-time professional effort) and up to 3.6 person months (30% full-time professional coordinator effort) beginning in year 2. In the case of more than one satellite recruiting site, these suggested core costs may be distributed as the PD/PI sees fit.

As each CC application requires at least one satellite recruiting site, the application should use the traditional subcontract model.

Part 2. Section IV. Application and Submission Information

PHS 398 Research Plan

Current Language:
(b) A description of the one satellite site including leadership and research nurse coordinator support.

Modified Language:
(b) A description of the satellite recruiting site(s) including leadership and research coordinator support. Previous collaborations/interactions should be described. CC plans for coordination and communication are review criteria and complex clinical centers may be found to be unwieldy and could adversely affect merit scores assigned by peer reviewers.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Andrea L. Harabin, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0222
Email: andrea.harabin@nih.gov