Blood Safety and Availability. Like the CFSAC the committee makes
recommendations to the Secretary. Unlike the CFSAC, however, the Committee
receives replies to their recommendations.
http://www.dhhs.gov/ophs/bloodsafety/recommendations/resolutions.html
Non-Voting Ex Officio Members of this committee who presumably would have an
interest regarding the possible presence of XMRV in the blood supply
include:
*Centers for Disease Control & Prevention*
Matthew J. Kuehnert, M.D., FACP
CAPT, US Public Health Service
Director, Office of Blood, Organ, and other Tissue Safety
Division of Healthcare Quality Promotion, NCPDCID, CCID
Centers for Disease Control & Prevention (CDC)
1600 Clifton Road, Building 1, MS A30
Atlanta, GA 30333
*Food and Drug Administration*
Jay S. Epstein, M.D.
Director
Office of Blood Research and Review
Food and Drug Administration
1401 Rockville Pike, HFM-300
Rockville, MD 20852
*jay <goog_1257616079806>*. <goog_1257616079806>*epstein<goog_1257616079806>
*@ <goog_1257616079806>*fda <goog_1257616079806>*.
<goog_1257616079806>*hhs<goog_1257616079806>
*. <goog_1257616079806>*gov <jay.epstein@fda.hhs.gov>*
*National Institutes of Health*
Harvey Klein, M.D.
Director
Division of Transfusion Medicine
National Institutes of Health
Building 10, Room 1C711
10 Center Drive
Bethesda, MD 20892-1184
*Department of Defense*
Monique Hollis-Perry, M.D.
CDR, Medical Corps, US Navy
Medical Director, Blood Bank Division
Staff Pathologist
Naval Medical Center
34800 Bob Wilson Drive
San Diego, CA 92134-5000
*Centers for Medicare and Medicaid Services*
Sheila H. Roman, M.D., M.P.H.
Hospital and Ambulatory Payment Policy Group
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244-1850
*Food and Drug Administration*
Laura St. Martin, M.D., M.P.H.
LCDR, USPHS
FDA/CBER/OCTGT/Division of Human Tissue
1401 Rockville Pike, Suite 200S
Rockville, MD 20852
*Health Resources and Services Administration*
Jim Bowman, M.D., M.S.M., FACS
Division of Transplantation Room 12C-06
Health Resources and Services Administration
5600 Fishers Lane
Rockville, MD 20857
Additionally, Dr. Jerry Holmberg, who testified before the CFSAC on October
30, 2009, stated that investigation into XMRV would be aided by the National
Heart, Lung, and Blood Institute's (NHLBI) Retrovirus Epidemiology Donor
Study (REDS) presumably through the data bank. The Retrovirus Epidemiology
Donor Study (REDS) was initiated in 1989 to provide the NHLBI with a
mechanism for monitoring the incidence of retroviruses and identifying
potential new infectious agents among volunteer blood donors. It compiles
data on the characteristics and test results of blood donors to identify
donors at risk for infection and maintains a serum repository of donor
samples for further study. Contracts for Recipient Epidemiology and Donor
Evaluation Study-III (REDS-III) are now available.
"The REDS-III program will target the following blood banking and
transfusion medicine areas: 1) Donor targeted strategies; 2) blood banking;
3) transfusion practices in adult patients; and 4) education and training.
The program will include survey, epidemiological and laboratory
investigations. Clinical trials in potential recipients of blood products
are NOT within the purview of the REDS-III program. The research portfolios
of the REDS-III Domestic and International programs will be fashioned in
response to contemporary scientific questions that need to be addressed to
advance blood transfusion safety in the U.S. and in countries where REDS-III
international blood centers are located. It is expected that about one third
of the studies conducted in the REDS-III Domestic program will address donor
and/or donation safety and availability issues, and other blood banking
questions; the remaining two thirds of the investigations will address adult
transfusion recipient safety concerns. Comprehensive databases including
information on donors and their donations/components, and on adult patients
considered for, or receiving a transfusion will enable study investigators
with the necessary scientific and analytical expertise to address in a
timely fashion important scientific issues in blood banking and transfusion
medicine."
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