[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 [email protected].
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