[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Notices]
[Pages 35408-35410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14462]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request: Opinions and Perspectives 
About the Current Blood Donation Policy for Men Who Have Sex With Men

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Heart, Lung, and Blood Institute

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(NHLBI), the National Institutes of Health (NIH) has submitted to the 
Office of Management and Budget (OMB) a request for review and approval 
of the information collection listed below. This proposed information 
collection was previously published in the Federal Register in Volume 
77 on February 23, 2012, page 10756, and allowed 60-days for public 
comment. Six written comments were received, one of which was shared by 
two signatories. One comment was a personal opinion regarding the 
current federal blood donation policy for men who have sex with men. 
Two of the written comments supported the study goals and design as 
proposed. Three of the written comments suggested changes to some of 
the questions, or asked whether the scope of the study could be 
expanded. As a result, content pertaining to the sexual histories of 
survey respondents was expanded to inform the broader context for the 
current policy for men who have sex with men. The purpose of this 
notice is to allow an additional 30 days for public comment. The 
National Institutes of Health may not conduct or sponsor, and the 
respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid OMB control number.
    Proposed Collection: Title: Opinions and Perspectives about the 
Current Blood Donation Policy for Men Who Have Sex with Men. Type of 
Information Collection Request: New. Need and Use of Information 
Collection: The current policy for blood donation in the U.S. with 
respect to men who have sex with men (MSM) is that any man who 
discloses having had sex with another man since 1977 is deferred 
indefinitely from donating. However, data from donors who have tested 
disease marker positive and were interviewed regarding potential risk 
factors suggest that some individuals continue to donate blood without 
disclosing MSM activity in contravention of the policy. In the 1980s 
there were surveillance studies of risk factors among donors who were 
determined to be HIV positive in pre-donation testing: Results 
indicated MSM behavior to be a risk factor for 56% of male donors. In 
addition, as part of the Retrovirus Epidemiology Donor Study (REDS), 
when anonymously surveyed by paper and pencil mailed surveys, 1.2% of 
male blood donors reported MSM behavior.
    In a 2007 study conducted in Sweden, 19% of 334 MSM who responded 
to a survey that was included in a monthly publication targeted to the 
Lesbian, Gay, Bisexual and Transgender (LGBT) community reported 
donating blood at least one-time since 1985. The authors suggested that 
MSM donors may be motivated by perceived discrimination, particularly 
younger MSM.
    Recent publications from the United Kingdom have reported what are 
likely the only population-based assessment of non-compliance with a 
similar restriction on blood donation for the MSM population as in the 
U.S.; this study was conducted in 2009 and 2010 and also estimated 
opinions about and self-reported intended compliance with the MSM 
deferral policy in place in the United Kingdom at that time. Note, the 
policy in the United Kingdom was modified in November 2011 and MSM in 
the United Kingdom are now allowed to donate if they have not been 
sexually active for a one-year period before donation.
    Data similar to those collected in Sweden and the United Kingdom 
are not available for the U.S. Potential changes to the current MSM 
policy for blood donation requires additional data, including 
information about motivating factors and compliance with the current 
MSM policy or a modified policy in the MSM population and in current 
blood donors. Speculative analyses have been conducted but do not 
directly address important considerations related to this policy such 
as the current level of compliance (in the MSM population) and non-
compliance (in the blood donor population). While many scientists and 
ethicists have expressed opinions in support or against modification of 
the current MSM policy for blood donation, there is a lack of data that 
directly addresses important aspects of this policy debate. The 
proposed study will build off the studies conducted in Sweden and the 
United Kingdom and will collect directly relevant information on this 
topic by estimating the prevalence of compliance and non-compliance 
with the current MSM policy and assessing motivations for blood 
donation in the U.S. MSM population. Three research aims drive this 
study's protocols to provide valuable evidence on the motivations and 
compliance behaviors in the MSM and blood donor populations. The four 
geographic areas where the study will be conducted include the State of 
Connecticut, Western Pennsylvania, Southern Wisconsin, and the Bay Area 
of California.
    The first aim seeks to assess opinions about and common themes 
within the MSM population with respect to blood donation and the 
current MSM policy. Specifically, within a population of self-
identified MSM in the U.S., what common themes can be identified 
regarding knowledge and opinions of current blood donation eligibility, 
and would opinions, including self-reported intended compliance, 
improve if the current MSM policy were changed to a deferral of a 
defined shorter duration? Another objective is to use what is learned 
in the focus groups to help select proper venues for identifying MSM 
who might be interested in participating in a comprehensive survey to 
assess compliance and non-compliance with the current MSM policy (see 
second aim).
    The second aim seeks to assess compliance and non-compliance in the 
MSM population with the current MSM blood donation policy by 
confidentially surveying two populations. One survey will be conducted 
in the MSM community to provide better estimates of compliance and non-
compliance with the current policy and a second survey will be 
conducted in male blood donors to evaluate how frequently men who have 
had sex with another man since 1977 are donating blood. The surveys 
will be conducted using an instrument that includes common content to 
maximize the comparability of the responses. Both surveys will be 
conducted using Internet-based techniques and currently available 
software (SurveyGizmo, www.surveygizmo.com).
    The third aim seeks to assess motivations for donating in the group 
of self-identified MSM who are active blood donors in the U.S. 
Participants from the four geographic areas who report donating blood 
or the intention to donate will be asked to participate in confidential 
qualitative telephone interviews to identify their reasons for donating 
or wanting to donate blood.
    Frequency of Response: Once. Affected Public: Individuals. Type of 
Respondents: Males 18 years old or older. The annual reporting burden 
is as follows: Estimated Number of Respondents: 4864; Estimated Number 
of Responses per Respondent: 1 per respondent for 4844 respondents and 
2 per respondent for 20 respondents; Average Burden of Hours per 
Response: 1.5 hours for Aim 1, 0.33 hour for Aim 2, and 1.0 hour for 
Aim 3; and Estimated Total Annual Burden Hours Requested: 1,700. The 
annualized total cost to all respondents is estimated at: $13,600 
(based on $8.00 per hour). There are no Capital Costs to report. There 
are no Operating or Maintenance Costs to report.

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                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total annual
                   Study aims                      annual number   responses per     hours per     burden hours
                                                  of respondents    respondent       response        requested
----------------------------------------------------------------------------------------------------------------
Aim 1--Focus Groups.............................              64               1             1.5              96
Aim 2.1--Web interview..........................           1,600               1            0.33             528
Aim 2.2--Web interview..........................           3,200               1            0.33            1056
Aim 3...........................................             20*               1               1              20
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* Aim 3 respondents are a subset of the respondents included in Aim 2.

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Whether the proposed collection of information is 
necessary for the proper performance of the function of the agency, 
including whether the information will have practical utility; (2) The 
accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and the assumptions used; (3) Ways to enhance the quality, utility, and 
clarity of the information collected; and (4) Ways to minimize the 
burden of the collection of information on those who are to respond, 
including the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to 202-395-6974, 
Attention: Desk Officer for NIH. To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Simone Glynn, MD, Project Officer/ICD Contact, 
Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 
20892, or call 301-435-0065, or Email your request to: 
[email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

    Dated: May 29, 2012.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart, 
Lung, and Blood Institute, NIH.
    Dated: June 4, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-14462 Filed 6-12-12; 8:45 am]
BILLING CODE 4140-01-P