Notice Number: NOT-HL-08-117

Key Dates
Release Date:  April 10, 2008

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

This notice is to alert investigators of a change to an NHLBI FOA, RFA-HL-08-005 (“Immunomodulatory, Inflammatory, and Vasoregulatory Properties of Transfused Red Blood Cell Units as a Function of Preparation and Storage (R01)”) regarding the use of animal blood models.

For the purposes of this FOA, Applications will be accepted that propose animal model research with animal blood if that work is considered necessary to support studies using human red blood cells within the project.  Thus, if studies using animal blood are proposed, the animal work must be a minor component of the project with the majority of the effort being devoted to studies on human red blood cells.

Thus the responsiveness statement, the last paragraph in Section I. Funding Opportunity Description , is changed to:

“Areas of research that will not be considered responsive to this FOA include applications that do not primarily focus on the characterization and effect of elements in red blood cell units that are collected and stored according to methods approved by the U.S. FDA and are suitable for transfusion in the U.S. Thus, the in vitro and/or in vivo study of human red blood cell products must be the primary focus of the applications.  Applicants are permitted to propose animal model research using animal blood if the work is considered necessary to inform subsequent studies with human red blood cells within the project.  If animal studies using animal blood are proposed, the animal work must only represent a minority of the project with the majority of the effort being devoted to studies on human red blood cells. Research on human whole blood products, platelet units, or plasma units and plasma derivatives will not be considered responsive. Research on oxygen carrying red blood cell substitutes, enzymatic treatment of red blood cells, and in vitro production of red blood cells or other blood components would not be responsive to this FOA. Studies of infectious agents and Phase III clinical trials are not responsive. Studies that evaluate the effectiveness/efficacy of various blood component preparation or manipulation techniques also would not be responsive to this FOA. For example, a study that proposes to evaluate if leukoreduction is achieved using an established or proposed novel filtration method would not be responsive to this FOA.”

Inquiries

Simone Glynn, M.D, M.P.H., Branch Chief
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD  20892-7950
Telephone:  (301) 435-0065
Email:  glynnsa@nhlbi.nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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