Notice Number: NOT-HL-06-137

Key Dates
Release Date: November 8, 2006

Issued by
National Heart, Lung, and Blood Institute (NHLBI), ( http://www.nhlbi.nih.gov/ )

The National Heart, Lung, and Blood Institute (NHLBI) issued a Funding Opportunity Announcement (FOA) entitled Comprehensive Sickle Cell Centers (U54) RFA-HL-06-008 on July 21, 2006 .

The purpose of this Notice is to clarify several inconsistencies, make one correction, and provide two brief addenda to this FOA.

Number and duration of patient services research projects . On page 5 of the RFA it is stated that at least one project is required. However, on page 11 it is stated that at least two projects are required. The correct requirement is that at least one project is required, and five years of funding must be requested for patient services research.

Scope of patient services research projects versus patient services cores . In the application, these two components should be described separately. The project involves research while the Core includes services only (no research).

Definition of translational research . On page 6 of the RFA it is stated that both pre-clinical (basic) and clinical research are required during the five-year duration of the project. However, on page 15 it states that a translational project may include only patient-oriented (clinical) research. The correct requirement is that both pre-clinical and clinical research are required. A project with only clinical research is equivalent to an intra-Center clinical research project.

Budget caps- total costs versus direct costs . Please note that the $500,000 annual cap on the Clinical Core and the $400,000 annual cap on an Inter-Center project is expressed in terms of total costs (direct costs plus facilities and administrative costs). All other budget caps (e.g. per-CSCC, and Scholar) are expressed in terms of annual direct costs only.

Requirement for a basic research project . On page 17 of the RFA it states in the fifth bullet, line 2, under Format that a basic research project is required. This is not correct. It is correct that at least one basic or clinical research project is required.

References to NHLBI Advisory Council dates . In several places in the RFA the NHLBI Advisory Council date pertinent to this RFA is listed. These multiple listings are not consistent. Some list September 2007 while others list February 2008. The correct NHLBI Advisory Council date for this RFA is February 2008.

Definition of minimum funding requirements . On page 29 of the RFA it is stated that to be considered for funding, CSCC applications must have both a clinical research project and a basic research project with priority scores fundable at the time of the September 2007 NHLBI Advisory Council meeting. The correct statement is that in order to be considered for funding, CSCC applications must have at least two research projects (from any two of the five classes listed below) with priority scores fundable at the time of the February 2008 NHLBI Advisory Council meeting. The five classes of research projects are:

• inter-Center clinical project
• intra-Center clinical
• basic research project
• translational project
• patient services research project

Correction: Cutoff Dates for Clinical Trial Participation and Enrollment Performance Information for Renewal Applications . On page 18 of the RFA under Center Overview, requirements are listed for submitting in the Center Overview section of renewal applications the number of collaborative trials participated in, and the number of research subjects enrolled in those trials. The time period covered for these requirements is specified as April 2004 through October 2006. The end of the time period should be December 2006, not October 2006.

Addendum: Availability of New Instrument for Patient Services Research. On page 6 of the RFA, examples for patient services research are listed. In addition, these projects may make use of an instrument currently under development and expected to be available in the first year of funding.. The NHLBI has a contract with a survey research organization to develop, validate and field- test a sickle cell disease-specific health-related quality of life questionnaire ( Schre-QOL ) for use among patients aged 18 and older. The beta-version of the questionnaire and related materials (e.g., codebook), will be available in February 2008. The final version of the questionnaire and related materials will be available September 2008. The questionnaire will be available to all interested researchers, both in paper form and for computerized administration. Data on the psychometric properties of the instrument will be available.

Addendum: Expanded Scope for Scholar Research. On page 7 of the RFA, the types of research projects for Scholars are listed, and they include basic and clinical research. Scholars may also propose translational or patient services research.

All other aspects of the RFA remain unchanged. The full text of the RFA, which was published on July 21, 2006 , can be found at: http://grants1.nih.gov/grants/guide/rfa-files/RFA-HL-06-008.html

Inquiries

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Please direct questions to:

Greg Evans, Ph.D.
Leader, Hemoglobinopathies and Genetics Scientific Research Group
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Two Rockledge Center , Suite 10042 , MSC 7950
6701 Rockledge Drive
Bethesda , MD 20892-7950
Telephone: (301) 435-0056
FAX: (301) 480-0868
Email: evansgl@mail.nih.gov

For questions concerning patient services research projects and patient services cores, please contact:

Ellen Werner, Ph.D.
Health Scientist Administrator
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Two Rockledge Center , Suite 10042 , MSC 7950
6701 Rockledge Drive
Bethesda , MD 20892-7950
Telephone: (301) 435-0077
FAX: (301) 480-0868
Email: wernere@nhlbi.nih.gov