[Federal Register Volume 75, Number 98 (Friday, May 21, 2010)]
[Notices]
[Pages 28619-28620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12326]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


 Meeting of the Advisory Committee on Blood Safety and 
Availability

AGENCY: Department of Health and Human Services, Office of the 
Secretary.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. 
Department of Health and Human Services is hereby giving notice that 
the Advisory Committee on Blood Safety and Availability (ACBSA) will 
hold a meeting. The meeting will be open to the public.

DATES: The meeting will take place Thursday, June 10 and Friday, June 
11, 2010, from 8:30 a.m. to 5 p.m.

ADDRESSES: The Universities at Shady Grove, 9630 Gudelsky Drive, 
Rockville, Maryland 20850, Phone: 301-738-6000.

FOR FURTHER INFORMATION CONTACT: Jerry A. Holmberg, PhD, Executive 
Secretary, Advisory Committee on Blood Safety and Availability, Office 
of Public Health and Science, Department of Health and Human Services, 
1101 Wootton Parkway, Suite 250, Rockville, MD 20852, (240) 453-8803, 
FAX (240) 453-8456, e-mail ACBSA@hhs.gov.

SUPPLEMENTARY INFORMATION: The Advisory Committee on Blood Safety and 
Availability (ACBSA) provides advice to the Secretary and the Assistant 
Secretary for Health on a range of policy issues that impact (1) 
Definition of public health parameters around safety and availability 
of the blood supply and blood products, (2) broad public health, 
ethical and legal issues related to transfusion and transplantation 
safety, and (3) the implications for safety and the availability of 
various economic factors affecting product cost and supply.
    Current Food and Drug Administration (FDA) policy recommends that 
men who have had sex with another man (MSM) even one time since 1977 
should be deferred indefinitely from donating blood. The deferral of 
MSM began prior to the availability of tests for HIV in early 1985. The 
deferral has existed in its current form since September 1985. This and 
other related FDA policies are designed to address the major sources of 
known risk to the blood supply as well as the theoretical risk of 
emerging infectious disease (EID) transmission. FDA has reviewed the 
policy periodically, most recently at a meeting of the FDA Blood 
Products Advisory Committee in 2000 and in an FDA-sponsored public 
scientific workshop in 2006. After considering both public discussions 
FDA retained its policy. FDA has noted its commitment to continue to 
review its donor deferral recommendations.
    Data from the Centers for Disease Control and Prevention (CDC) 
indicate that HIV and other blood borne pathogens are not randomly 
distributed in the population, but are concentrated within specific 
subgroups, including those whose sex partners have risk behavior(s) 
associated with a higher prevalence of transfusion transmitted diseases 
(TTDs). MSM have an increased incidence and prevalence of several 
currently recognized transfusion-transmitted diseases (e.g. HBV, HIV, 
syphilis, and CMV). There is a theoretical concern that MSM populations 
may also be at increased risk for other unrecognized transfusion-
transmitted agents.
    Although today's blood supply is screened using highly sensitive 
tests, screening tests can be falsely negative during the ``window 
period,'' defined as the interval between the time when an infected 
individual may transmit the disease and the time when screening tests 
become positive. A period of deferral is needed after high-risk 
exposure to prevent false negative tests from ``window period'' 
collections. Deferral of donors with high-risk exposure depends upon 
reliable responses to a donor questionnaire, which are never 100 
percent accurate. Therefore, despite highly sensitive testing and 
current deferral policies, failures to identify infected donors may 
occur.
    In addition, unsuitable blood may be released inadvertently through 
inventory control errors. This increased risk is believed to be 
primarily related to human errors resulting in the release of infected 
units from quarantine. This is based on the assumption that due to 
higher infectious disease prevalence in MSM, greater numbers of 
infected units would be collected, leading to a small overall increase 
in quarantine release errors. These quarantine release errors would 
likely be reduced if computerized inventory controls were in place in 
all blood facilities.
    At the June 10-11, 2010 meeting, the HHS ACBSA will hear 
presentations and engage in deliberations on the current MSM deferral 
policy. Specifically, the ACBSA will be asked to discuss the following: 
what are the most important factors (e.g. societal, scientific, and 
economic) to consider in making a policy change; is the currently 
available scientific information including risk assessments sufficient 
to support a policy change at this time;

[[Page 28620]]

what studies, if any, are needed before implementing a policy change; 
what monitoring tools or surveillance activities would need to be in 
place before implementing a policy change; what additional safety 
measures, if any, are needed to assure blood safety under a revised 
deferral policy?
    The public will have opportunity to present their views to the 
Committee on the second day. A public comment session has been 
scheduled for June 11, 2010. Comments will be limited to five minutes 
per speaker and must be pertinent to the discussion. Pre-registration 
is required for participation in the public comment session. Any member 
of the public who would like to participate in this session should 
contact the Executive Secretary no later than June 8, 2010. It is 
requested that those who wish to have printed material distributed to 
the Committee provide thirty (30) copies of the document to be 
distributed to the Executive Secretary, ACBSA, prior to close of 
business June 8, 2010. If it is not possible to provide 30 copies of 
the material to be distributed, then individuals are requested to 
provide at a minimum one (1) copy of the document(s) to be distributed 
prior to the close of business June 8, 2010. It also is requested that 
any member of the public who wishes to provide comments to the 
Committee utilizing electronic data projection submit the necessary 
material to the Executive Secretary prior to close of business June 8, 
2010. Electronic comments must adhere to disability accessibility 
guidelines (Section 508 compliance).

    Dated: May 4, 2010.
Jerry A. Holmberg,
Executive Secretary, Advisory Committee on Blood Safety and 
Availability.
[FR Doc. 2010-12326 Filed 5-20-10; 8:45 am]
BILLING CODE 4150-41-P