[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14801-14804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6091]


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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.

ACTION: Notice.

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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 
(MSM).
    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

[[Page 14802]]

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, 
MD 20852.

SUPPLEMENTARY INFORMATION:

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 
deferral.
     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.
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    \1\ http://www.cdc.gov/hiv/surveillance/resources/reports/2009report/index.htm.
    \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.
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    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.
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    \3\ Blood Products Advisory Committee held September 14, 2000 
http://www.fda.gov/ohrms/dockets/ac/cber00.htm#Blood%20Prducts.
    Advisory Committee on Blood Safety and Availability held June 
10-11, 2010 http://www.hhs.gov/ash/bloodsafety/advisorycommittee/recommendations/msm-deferral_qa_20110722-final.pdf.
    \4\ FDA Workshop on Behavior-Based Donor Deferrals in the NAT 
Era held March 8, 2006 http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/UCM054430.pdf.
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    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

[[Page 14803]]

Secretary for Health charged relevant agencies to develop and carry out 
such studies, including a pilot operational study of revised deferral 
criteria for MSM.
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    \5\ Advisory Committee on Blood Safety and Availability held 
June 10-11, 2010 http://www.hhs.gov/ash/bloodsafety/advisorycommittee/recommendations/msm-deferral_qa_20110722-final.pdf.
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    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 
Questionnaire (DHQ):
    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.

Information Requested

    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.
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    \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.
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    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 
inventory.
    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

[[Page 14804]]

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 
be considered
 Impact on blood establishment operations
 Staff training and staff perceptions
 Tracking of pre-donation and/or post- donation test results
 Inventory management
 Donor perceptions regarding the possible changes in deferral 
policy within the operational study scenarios (including both MSM and 
non-MSM donors)
 Public reaction, if any, and impact on blood drives
 Potential venues where the study could be conducted
 Study costs
 Willingness of blood organizations to participate in a pilot 
study
 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.
Richard Henry,
Deputy Director, Blood Safety & Availability.
[FR Doc. 2012-6091 Filed 3-12-12; 8:45 am]
BILLING CODE 4150-41-P