[Federal Register Volume 71, Number 21 (Wednesday, February 1, 2006)]
[Notices]
[Pages 5344-5345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; The Leukocyte Antibodies 
Prevalence (LAP) Study

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: The Leukocyte Antibodies Prevalence 
(LAP) Study. Type of Information Collection Request: NEW. Need and Use 
of Information Collection: The two current hypotheses for pathogenesis 
of transfusion-related acute lung injury (TRALI) include the 
development of acute pulmonary insufficiency from immune and non-immune 
causes. The immune mediated mechanism

[[Page 5345]]

postulates that passively transferred anti-leukocyte antibodies from 
blood donors are responsible for TRALI. The donor antibodies implicated 
in TRALI include antibodies directed towards HLA class I and class II 
antigens, and anti-neutrophil antibodies. The LAP Study is a cross-
sectional multi-center study to measure the prevalence of HLA and 
neutrophil antibodies in blood donors with or without a history of 
blood transfusion or pregnancy, and the development of a repository of 
blood samples obtained from these donors. Specifically, 7,900 adult 
blood donors across six blood centers participating in the Retrovirus 
Epidemiology Donor Study II (REDS-II) will be enrolled in the study. 
Eligible donors will be asked to complete a short questionnaire on 
their transfusion history (ever, and date of last transfusion) and, for 
female donors, questions on pregnancy history (ever, number and outcome 
of pregnancies, last pregnancy). Each donor will also be asked to 
provide a sample of blood which will be tested for the presence of HLA 
class I and class II antibodies. This data will help us evaluate 
variations in HLA antibody prevalence based on blood transfusion and 
pregnancy history and time since the last immunizing event. Further, 
neutrophil specific antibodies will be measured in those blood donors 
who have HLA antibodies. Also, donors with neutrophil antibodies will 
be tested to determine their neutrophil phenotype using routine 
serologic and DNA methods, since individuals homozygous for certain 
neutrophil antigens are more prone to develop certain neutrophil 
antibodies. The results from testing HLA positive donors for neutrophil 
antibodies in this primary study could be used to develop an optimal 
testing strategy for large number of donors using the stored repository 
samples. These data will provide the basis for calculating donor loss 
in the event that a TRALI prevention strategy is implemented that 
includes deferring donors with a history of transfusion or pregnancy or 
those with HLA or neutrophil antibodies. The second major goal of this 
study is to develop a repository of blood samples from well 
characterized blood donors whose detailed transfusion and pregnancy 
histories are known. Repository samples will be stored indefinitely. 
Although future research on repository samples is yet to be determined, 
they may be tested for studies designed to help transfusion safety and 
transfusion biology. Frequency of Response: Once. Affected Public: 
Individuals. Type of Respondents: Adult Blood Donors. The annual 
reporting burden is a follows: Estimated Number of Respondents: 7,900; 
Estimated Number of Responses per Respondent: 1; Average Burden of 
Hours per Response: 0.17; and Estimated Total Annual Burden Hours 
Requested: 1343. The annualized cost to respondents is estimated at: 
$24,174 (based on $18 per hour). There are no Capital Costs to report. 
There are no Operating or Maintenance Costs to report.

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                                                                  Estimated                      Estimated total
                                                 Estimated        number of     Average  burden   annual burden
             Type of respondents                 number of      responses per      hours  per         hours
                                                respondents       respondent        response        requested
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Adult Blood Donors..........................           7,900                1             0.17             1343
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    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.

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, Room 10142, 6701 Rockledge Drive, MSC 7950, Bethesda, 
MD 20892-7950, or call 301-435-0075, or e-mail your request to 
[email protected].
    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: January 20, 2006.
Charles M. Peterson,
Director, DBDR, National Institutes of Health.
[FR Doc. E6-1269 Filed 1-31-06; 8:45 am]
BILLING CODE 4140-01-P