[Federal Register Volume 75, Number 36 (Wednesday, February 24, 2010)]
[Notices]
[Pages 8367-8368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3754]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; REDS--II--Does Pre-Donation 
Behavioral Deferral Increase the Safety of the Blood Supply?

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Heart, Lung, and 
Blood Institute (NHLBI), the National Institutes of Health (NIH), will 
publish periodic summaries of proposed projects to the Office of 
Management and Budget (OMB) for review and approval.
    Proposed Collection: Title: REDS-II Does Pre-Donation Behavioral 
Deferral Increase the Safety of the Blood Supply?
    Type of Information Collection Request: NEW. Need and Use of 
Information Collection: While it is well-accepted that deferrals, as 
part of the ``layers of safety'' concept, increase the safety of the 
blood supply, studies with sufficiently large sample size to quantify 
HIV infection and other infectious marker rates in deferred donors are 
lacking. Evidence in support of increased safety is frequently inferred 
from studies conducted in other health care settings. For example, a 
small hospital-based case control study conducted in Brazil examined 
the association between infectious markers and body tattoos. Even 
though tattoos are not used as a criteria to determine blood donor 
eligibility in Brazil, having a tattoo was associated with HCV and also 
with having at least one positive infectious marker. (1) Significant 
associations were not independently observed for HIV, HBV, syphilis or 
Chagas. The authors reported an overall sensitivity of 11% and 
specificity of 97% for the presence of a tattoo as indicator of having 
HIV, HCV, HBV, or syphilis infection. The researchers then estimated 
the impact on blood donor selection and disease marker testing using 
the results from their hospital-based case control study. However, the 
assumptions such as disease marker prevalence of as much as 15% in 
donors who are deferred for tattoos and a prevalence of 4% of the 
potential donor base having a tattoo (2) do not represent current 
temporary deferrals in Brazil and do not address the most common 
behavior-related deferrals. A more detailed and targeted assessment of 
the value of relevant deferrals could be used to help inform blood 
donation policies in Brazil.
    In Brazilian blood collection centers, donor deferral is initiated 
either by the blood center staff, based on information disclosed by 
prospective donors, or by the donor through self-deferral. Either type 
of deferral occurs because of the belief that a donor's behavior, 
exposures, or history represents an increased risk to the safety of the 
blood supply
    Although the general eligibility criteria are mandated by the 
Brazilian Ministry of Health, the specific criteria for screening 
potential donors and the procedures for implementing them may vary 
across the regional blood collection centers. This study will focus on 
sexual behavior deferrals and their impact on blood safety. The two 
main study aims are: (1) To assess infectious disease marker prevalence 
in donors who are deferred for higher risk sexual and non-injection 
drug use behavior; and (2) To determine if the different deferral 
classification procedures used by different blood centers in Brazil 
lead to a measurable difference in disease marker prevalence in 
deferred donors. To do this, deferred donors who agree to participate 
in this study will be asked to complete an audio computer assisted self 
interview (ACASI) questionnaire that measures two content areas (1) 
motivations for attempting to donate, (2) additional information on the 
deferral and other potentially undisclosed deferrable behaviors. A 
blood sample will be collected from the deferred donors and tested for 
the panel of infections currently screened for in Brazil (HIV, 
Hepatitis C, Hepatitis B, Human T-lymphotropic virus, syphilis, and 
Trypanosoma cruzi) using the same high-throughput laboratory reagents 
and procedures that are used to screen donations. These deferred donor 
marker rates will be compared to the marker rates among accepted donors 
with the same demographic characteristics. Marker rates in deferred 
donors will also be compared between the blood centers.
    Frequency of Response: Once. Affected Public: Individuals. Type of 
Respondents: Adult Blood Donors. The annual reporting burden is as 
follows: Estimated Number of Respondents: 4,860; Estimated Number of 
Responses per Respondent: 1; Average Burden of Hours per Response: 0.33 
(including administration of the informed consent form and 
questionnaire completion instructions); and Estimated Total Annual 
Burden Hours Requested: 1,620. The annualized cost to respondents is 
estimated at: $10,530 (based on $6.50 per hour). There are no Capital 
Costs to report. There are no Operating or Maintenance Costs to report.

[[Page 8368]]



 
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                                                            Estimated number   Average burden    Estimated total
              Estimated number of respondents               of responses per      hours per       annual burden
                                                               respondent         response       hours requested
----------------------------------------------------------------------------------------------------------------
4,860.....................................................                 1              0.33             1,620
----------------------------------------------------------------------------------------------------------------

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate 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) Evaluate the accuracy of the agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) 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.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Dr. George Nemo, Project Officer, NHLBI, Two 
Rockledge Center, Suite 10042, 6701 Rockledge Drive, Bethesda, MD 
20892-7950, or call 301-435-0075, or E-mail your request to 
<a href="/cdn-cgi/l/email-protection#ddb3b8b0b2ba9db3b4b5f3bab2ab"><span class="__cf_email__" data-cfemail="2d434840424a6d434445034a425b">[email protected]</span></a>.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: February 17, 2010.
Dr. George Nemo,
NHLBI Project Officer, NHLBI, National Institutes of Health.
[FR Doc. 2010-3754 Filed 2-23-10; 8:45 am]
BILLING CODE 4140-01-P


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