13 March 2012
Blood Donor Deferral Criteria for Men Who Have Had Sex With Other Men
[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6091]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information (RFI) on Design of a Pilot Operational
Study To Assess Alternative Blood Donor Deferral Criteria for Men Who
Have Had Sex With Other Men (MSM)
AGENCY: Office of the Secretary, Office of the Assistant Secretary for
Health, Department of Health and Human Services.
SUMMARY: The Department of Health and Human Services (HHS) is seeking
to identify interest and obtain information relevant to the design of a
pilot operational study (or studies) on alternative donor deferral
criteria that would permit blood and plasma donations (subsequently
termed ``blood donations'') by men who have had sex with other men
Based upon documented higher levels of certain transfusion-
transmissible infections (e.g. Human Immunodeficiency Virus (HIV) and
Hepatitis B Virus (HBV)) in some groups of men who have had sex with
men, all men with a history of this behavior since 1977 are currently
deferred from donating blood. However, the increased effectiveness of
donor testing for HIV, HBV, syphilis and other infectious agents has
greatly enhanced blood safety. As a result, questions have been raised
about the need to continue an indefinite deferral of all MSM and
whether there could be blood donation by MSM who may not be at
increased risk. In June 2010, HHS sought advice from its Advisory
Committee for Blood Safety and Availability (ACBSA) on the issue of the
current MSM deferral policy. The Advisory Committee noted that the
existing policy is suboptimal, but recommended that the policy should
be retained pending the completion of targeted research studies that
might support a safe alternative policy.
HHS and the agencies responsible for blood safety are committed to
efforts to maintain and enhance the safety of the nation's blood
supply, taking into account all new and emerging scientific
information. Consistent with the June 2010 recommendations of the
ACBSA, HHS seeks to determine through appropriate studies whether blood
safety can be maintained or enhanced under revised blood donor
screening criteria that would permit donation by some MSM. This request
for information (RFI) is being issued in recognition of the challenges
of designing such studies.
This RFI seeks information from interested parties regarding the
design, logistics and feasibility of a pilot operational study (or
studies) to assess alternative blood donor eligibility criteria for
MSM. Responses to this RFI will inform HHS on the design, logistics and
feasibility of such a study, which, if feasible, could result in
identifying potential pathways toward future alternate policies that
will maintain or enhance the current very high levels of blood safety.
The concept is to conduct a pilot operational study, in which MSM who
meet specified criteria would
be permitted to donate blood, with additional safeguards in place to
protect blood recipients during the course of the study. Data would be
gathered to assess the effectiveness of the specified criteria to
select low risk donors among MSM. Upon completing all data collection
activities, there will be a transparent and evidence-based evaluation
of current and possible future MSM blood donation policies.
This RFI is for information and planning purposes only and should
not be construed as a solicitation or as an obligation on the part of
HHS. HHS does not intend to award a grant or contract to pay for the
preparation of any information submitted or for the use of such
information by HHS. Whereas all responses to this notice will be
carefully considered, acknowledgment of receipt of responses will not
be made, nor will respondents be notified of the evaluation by HHS of
the information received. No basis for claims against HHS shall arise
as a result of a response to this request for information or to the use
of such information by HHS as either part of our evaluation process or
in developing specifications for any subsequent announcement.
DATES: All responses must be received no later than 4 p.m. EDT on June
11, 2012 at the address listed below.
ADDRESSES: You may submit comments identified by docket ID number HHS-
OPHS-2012-0003, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Enter the above docket ID number in the ``Enter Keyword or ID field and
click on ``Search.'' On the next page, click the ``Submit a Comment''
action and follow the instructions.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Richard Henry, M.L., M.P.H., Office of the Assistant
Secretary for Health, U.S. Department of Health and Human Services,
1101 Wootton Parkway, Tower Building, Suite 250, Rockville, MD 20852.
Comments received, including any personal information, will be
posted without change to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: James Berger, Acting Director for
Blood Safety and Availability, Office of the Assistant Secretary for
Health, Office of the Secretary, U.S. Department of Health and Human
Services, 1101 Wootton Parkway, Tower Building, Suite 250, Rockville,
General Blood Safety Strategy
Current high levels of safety of the U.S. blood supply are provided
by five overlapping layers of protection. These include:
First, potential donors are provided educational materials
and also asked specific questions about their health, and about risk
factors for certain transfusion-transmissible diseases (i.e., medical,
behavioral and travel-related risks), as a basis for acceptance or
Second, the donated blood is tested for evidence of
transfusion transmissible infections by highly sensitive laboratory
assays. These include tests for infections which can be acquired
through high risk sexual behaviors including HIV, HBV, and/or syphilis.
Third, blood establishments must keep a current list of
individuals who have been deferred as donors in order to prevent future
collection or use of their blood.
Fourth, blood products are quarantined until the testing
is completed and the donation records have been verified for
suitability of the collections.
Fifth, blood establishments must investigate any breaches
of these safeguards, correct system deficiencies, and maintain records
for FDA review.
Rationale for Current Deferral Policy for MSM
Deferral of potential donors prior to donation combined with highly
sophisticated and sensitive laboratory testing of donated blood are
among the multiple overlapping safeguards currently in place to protect
the blood supply. Of particular concern for blood safety are infections
known to be transmissible by blood transfusion, including HIV and HBV.
Deferral of MSM from donation of blood is based on well-documented
observations of a markedly higher prevalence \1\ (current infection)
and incidence \2\ (newly acquired infection) of these transmissible
agents among some MSM than in the non-MSM general population.
Additionally, there is a theoretical concern that persons at increased
risk for known sexually transmitted diseases might also be at increased
risk to acquire sexually and blood transmitted infections that may
emerge in the future and for which no donor screening tests exist.
\2\ Prejean J, Song R, Hernandez A, Ziebell R, Green T, Walker
F, Lin LS, An Q, Mermin J, Lansky A, Hall HI; HIV Incidence
Surveillance Group. Estimated HIV Incidence in the United States,
2006-2009. PLoS One. 2011;6(8):e17502. Epub 2011 Aug 3.
The risk of infection from a blood transfusion is now extremely low
(less than one in one million units transfused for HIV and less than
one in 280,000 units transfused for HBV). These risks have diminished
dramatically in the past three decades as a result of the overlapping
safeguards. From recently published modeling studies, transfusion-
transmitted infections, while rare, are now generally attributed to the
interplay of three factors: (1) Failure of donor selection measures to
accurately defer an at-risk donor, either by deficiencies in the donor
screening process or failure of a donor to provide accurate answers;
(2) donation by an infected individual during the ``window period''
when early infection cannot yet be detected by current testing; and (3)
inadvertent release of a donated unit of blood (a) before all testing
is known to be negative; (b) before other criteria affecting blood
safety and quality are determined to have been met; or (c) despite a
positive screening test or other finding of unsuitability (Quarantine
Release Errors or QRE).
Reconsideration of MSM Deferral Policy
There have been advisory committee meetings \3\ and a public
workshop \4\ over the past decade, which have reexamined the deferral
policy, taking into account existing scientific evidence related to
deferral of MSM from blood donation. In addition, there has been
increased interest in changing this policy from some members of the
U.S. Congress, the public and interested advocacy groups.
\3\ Blood Products Advisory Committee held September 14, 2000
Advisory Committee on Blood Safety and Availability held June
10-11, 2010 http://www.hhs.gov/ash/bloodsafety/advisorycommittee/
\4\ FDA Workshop on Behavior-Based Donor Deferrals in the NAT
Era held March 8, 2006 http://www.fda.gov/downloads/BiologicsBloodVaccines/
Most recently, in June 2010, the HHS ACBSA \5\ heard presentations
of currently available scientific data and recommended to the HHS
Secretary that the current MSM deferral policy, while suboptimal,
should be retained pending the completion of targeted research studies
that might support a safe alternative policy. Based on these
recommendations, the Assistant
Secretary for Health charged relevant agencies to develop and carry out
such studies, including a pilot operational study of revised deferral
criteria for MSM.
\5\ Advisory Committee on Blood Safety and Availability held
June 10-11, 2010 http://www.hhs.gov/ash/bloodsafety/advisorycommittee/
A public workshop was conducted and three funded studies are in
progress to help re-evaluate the MSM deferral policy:
(1) Workshop on Quarantine Release Errors (QREs):
FDA convened a workshop in September 2011 to better understand and
find ways to prevent errors in quarantine management that could lead to
inappropriate release of blood (QREs). While only a very low proportion
of QREs present serious health threats, QREs continue to occur, both in
community based and hospital based blood collection establishments. It
was determined that human error during non-computerized operations
frequently contributes to the QREs that occur. As a result of the
workshop, AABB is establishing an industry-led task force to study the
QRE issue, to identify best practices, and to propose additional
interventions. In particular, application of human factor engineering
will be brought to bear in a review of blood banking practices to
better optimize the interface between human and automated steps as a
way to improve process controls. The output of the task force will be
used by government agencies to establish guidance on best practices in
quarantine control of blood components.
(2) Study on the Epidemiology of Transfusion-Transmissible
Infections in U.S. Blood Donors:
An analysis of data on the prevalence and incidence of certain
major transfusion-transmissible infections (e.g. HIV, HBV, and
Hepatitis C Virus (HCV)) obtained from routine donation testing of
blood donors was initiated in 2011. This study will provide baseline
estimates of the current risks of transfusion-transmitted viral
infections in the U.S. blood supply. Additionally, the current risk
factors (including heterosexual) reported by infected donors and their
relative prevalence compared to other donors as controls will be
determined, thus providing information as to which risk factor(s)
should be targeted by optimized donor screening strategies. This study
is supported by the National Heart, Lung, and Blood Institute (NHLBI)
of the National Institutes of Health (NIH) and is being conducted as
part of the second Retrovirus Epidemiology Donor Study (REDS-II). This
study includes the American Red Cross, Blood Systems, Inc., and the New
York Blood Center which together are responsible for collecting
approximately 60 percent of the U.S. blood supply.
(3) Study on Evaluation of the current Blood Donation History
Several factors, including culture, social conditions, and language
fluency, contribute to different interpretations of the questions that
comprise the current blood donation screening questionnaire. A study to
assess donor understanding and interpretation of the DHQ screening
questions (cognitive evaluation) was conducted approximately ten years
ago by the National Center for Health Statistics of the Centers for
Disease Control and Prevention (NCHS, CDC). Because techniques for
questionnaire evaluation have advanced considerably over the past
decade, the HHS Office of the Assistant Secretary for Health funded
NCHS, CDC to re-evaluate the DHQ, with particular emphasis on donor
understanding of the behavioral risk questions intended to prevent
transmissible infections. This study will help determine whether the
existing MSM deferral questions are understood and properly interpreted
by donors. It may also determine more effective ways to communicate
with at-risk populations through donor questions.
(4) Study on the Attitudes and Behaviors of MSM Toward the Blood
Donation Screening Process:
Blood donors must accurately assess their individual risk(s), and
then self-defer from donation or disclose their risk(s) for the current
screening process to effectively maintain blood safety. Failure to
self-defer or disclose risk after a potential exposure to a
transfusion-transmissible infection may result in the collection and
release of an infectious blood donation, which may be associated with a
false negative laboratory test during early infection (the ``window
period''). For this reason, it is important to evaluate whether MSM
with increased risk would reliably self-defer or disclose risks if
permitted to donate under revised selection criteria. A study funded by
the Food and Drug Administration (FDA) and being carried out by the
NHLBI REDS-III program will assess attitudes and behaviors of MSM
toward current and possible future blood donation policies. This study
is specifically designed to examine whether MSM comply with the current
deferral criteria and whether MSM would be likely to comply with
potential different deferral criteria.
HHS is interested in obtaining information about the design,
logistics and feasibility of a pilot operational study to assess
alternative blood donor acceptance criteria for MSM. Specifically, HHS
requests information from private and public sector stakeholders
regarding potential pilot operational study designs, including
innovative and cost effective approaches to evaluate alternative blood
donor acceptance criteria for MSM.
Input is requested for the following:
(1) Candidate acceptance criteria for a pilot operational study
that would permit blood donation by MSM. For example, MSM with one year
or five years of abstinence from sex with other men, or other criteria,
subject to study designs with additional safeguards.
(2) Possible study designs that would generate useful information
regarding the safety of candidate acceptance criteria while maintaining
current levels of blood safety during the pilot study. Possibilities
might include but are not limited to the following:
(a) Pre-donation Donor Testing
In a pre-donation testing strategy, MSM who are presently deferred,
but who would be eligible to donate during the pilot operational study
under modified acceptance criteria would be screened for donation with
the candidate modified criteria and have a blood sample drawn for
standard donor screening,\6\ and potentially, additional tests at their
first session in a blood collection center. They would not be permitted
to donate a unit of blood at that time. MSM donors who meet all other
donor eligibility criteria, and have negative pre-donation test
results, would be invited to return within a defined period, at which
time standard donor screening and testing would be performed and blood
for use in transfusion would then be collected.
\6\ Current tests include Antibody to HIV-1 and -2 (Anti-HIV-1,
-2), HIV-1 RNA (HIV-1 NAT), Antibody to HCV (anti-HCV), HCV RNA (HCV
NAT), Antibody to HTLV-I and -II (Anti-HTLV-I/II), Hepatitis B
Surface Antigen (HBsAg), Antibody to Hepatitis B Core Antigen (Anti-
HBc), West Nile Virus RNA (WNV NAT), Antibody to Trypanosoma cruzi
(Chagas' disease), and a serologic test for syphilis.
A pre-donation testing strategy would focus on the prevalence of
HIV and other transfusion-transmissible infections in the MSM
population. Infected donors would be identified and deferred based on
prescreening results. Quarantine release errors (QREs) would be
avoided, because infectious units would not be drawn and entered into
Unanswered questions regarding a pre-donation testing option
include: (1) the added costs of donor testing if provided by the
collection center; (2) the added cost and complexity of
tracking the results of pre-donation testing; (3) the period within
which a potential MSM donor would need to return to complete an actual
blood donation; (4) concern that pre-donation testing of only MSM could
be seen as discriminatory; and (5) the residual impact on safety due to
window period donations that would not be reduced by pre-testing.
(b) Post-Donation Testing
In a post-donation testing strategy, MSM who are presently
deferred, but who would be eligible to donate during the pilot under
modified deferral criteria would have a unit of blood drawn. This unit
would be segregated from other units and placed in a separate
quarantine. The donor would be asked to return for ``post-donation
testing'' within a specified period following the donation that would
exceed the ``window period'' for transfusion-transmissible infections
but be within the expiration dating period of the unit of blood (i.e.,
within 14 to 42 days post-donation for red blood cells or from 14 days
to within one year for plasma for transfusion). For donors who continue
to meet acceptance criteria and have negative ``post-donation test''
results, the unit would be released for transfusion. Such collections
would be most applicable to repeat plasma donations given the longer
shelf life of frozen plasma, providing greater flexibility for the time
of ``post-donation testing'' of the donor. Also, plasma for transfusion
could be collected at the time of ``post-donation testing'' initiating
a new quarantine for a new collection.
Placing units drawn from MSM donors in quarantine until qualifying
``post-donation testing'' results are obtained would address the issue
of recent (i.e. ``incident'') infections. Infectious units would be
entered into a quarantine portion of the blood bank inventory prior to
the availability of screening test results. However, if more infectious
units are drawn and placed in inventory, these units would be subject
to quarantine release errors.
There could be the same or similar unanswered questions for the
post-donation testing strategy as are outlined above under the pre-
donation testing strategy. In addition, blood establishments would need
to maintain stratified and potentially larger quarantine inventories
and would incur the costs of discarding all units in quarantine for
which a donor failed to return for ``post-donation testing.''
(c) Combined Pre-Donation and Post-Donation Testing
Under this scenario, an MSM donor seeking to donate under modified
deferral criteria would be screened with a questionnaire and asked to
give a pre-donation testing sample. Assuming the blood sample is
negative for infectious markers, and the donor meets all other
eligibility criteria, the donor would be invited to return within a
defined period to donate a unit of blood. This unit would be placed in
quarantine and the donor again would be asked to return, this time for
post-donation testing also within a specified time period.
This strategy would provide the strictest control over any increase
in risk to the blood supply. Both incident and prevalent infection
concerns would be addressed. However, this scenario would require a
potential donor meeting the candidate MSM acceptability criteria to
make three appearances at a blood collection facility within specified
time periods in order to have a donation released for transfusion.
Blood establishments would face challenging logistic issues in
conducting such a study concurrently with normal, highly standardized
blood collection operations.
(3) Input is requested on the data that should be gathered and the
criteria used to evaluate the results of the pilot operational study.
For example, should MSM donors and non-MSM donors be asked to
participate in surveys on their understanding of the donor screening
questions, their specific sexual behaviors and their motivations to
donate blood? Should the study outcome be based on observed markers of
transfusion-transmitted infections in MSM donors compared with other
donors? Should MSM donors with positive screening tests be interviewed
to better understand their risk factors, their understanding of the
donor questionnaire and their motivations to donate if they did not
appropriately self-defer or disclose their risk?
Requested RFI Responses:
Please comment on each of the above scenarios, or propose
additional pilot operational study designs for consideration. In your
response, please address each of the following:
Revised criteria that should be considered to permit blood
donation by MSM
Blood safety considerations and safety mitigations that should
Impact on blood establishment operations
Staff training and staff perceptions
Tracking of pre-donation and/or post- donation test results
Donor perceptions regarding the possible changes in deferral
policy within the operational study scenarios (including both MSM and
Public reaction, if any, and impact on blood drives
Potential venues where the study could be conducted
Willingness of blood organizations to participate in a pilot
Data elements that should be gathered during the study,
including those that may be associated with future emerging infections
Criteria for evaluation of the study results and conclusions
Expected timeframe for each proposed study.
Dated: March 8, 2012.
Deputy Director, Blood Safety & Availability.
[FR Doc. 2012-6091 Filed 3-12-12; 8:45 am]
BILLING CODE 4150-41-P