2010-12326. 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: [phone].

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, [phone], FAX [phone], e-mail [e-mail].

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; 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.