Notice Number: NOT-HL-15-270

Key Dates
Release Date: August 21, 2015

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

Purpose

On July 15, 2015, the NHLBI issued Funding Opportunity Announcement (FOA) RFA-HL-16-010 “Sickle Cell Disease Implementation Consortium (SCDIC):  Using Implementation Science to Optimize Care of Adolescents and Adults with Sickle Cell Disease (U01)". 

This Notice provides details for applicants regarding eligibility requirements for patient recruitment and enrollment into the Sickle Cell Disease (SCD) Registry. The following section of the FOA is revised accordingly:

Part 2. Section I. Funding Opportunity Description

Program Structure

Current Language
Each Clinical Site will be comprised of a group of investigators based in a single contiguous geographic area, such as an entire city, or, in larger cities, a contiguous urban area, a city and adjacent suburbs, or a rural area with regional health facilities. The area must include a sufficient number of adolescent or adult subjects with SCD to permit enrollment, characterization, prospective follow-up, and participation in implementation research studies of a minimum of 300 adolescent or adult subjects with SCD. These subjects will also be consented for enrollment into the SCD Registry. Each Clinical Site will consist of a Research Team and an Advisory Group.

Revised Language
Each Clinical Site will be comprised of a group of investigators based in a single contiguous geographic area, such as an entire city, or, in larger cities, a contiguous urban area, a city and adjacent suburbs, or a rural area with regional health facilities. The area must include a sufficient number of adolescent or adult subjects with SCD to permit enrollment, characterization, prospective follow-up, and participation in implementation research studies of a minimum of 300 adolescent or adult subjects with SCD. These subjects will also be consented for enrollment into the SCD Registry. Patients which respondents should attempt to identify within their catchment area should include subjects with sickle cell disease between 15.0 years of age and 45.0 years of age at the time of enrollment. For the purpose of this FOA, all genotypes (SS, SC, S/beta thalassemia/SC) regardless of clinical severity are considered as sickle cell disease syndromes. Sickle cell trait is not included in this group. Each Clinical Site will consist of a Research Team and an Advisory Group.

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Harvey Luksenburg, MD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-451-6766
Email: luksenburgh@nhlbi.nih.gov