[Federal Register Volume 71, Number 99 (Tuesday, May 23, 2006)]
[Notices]
[Pages 29652-29653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National institutes of Health


Submission for OMB Review; Comment Request; The Leukocyte 
Antibodies Prevalence (LAP) Study

    Summary: Under the provisions of section 3507(a)(1)(D) of the 
Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood 
Institute (NHLBI), the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on February 1, 2006, pages 5344-5355 and allowed 60 days for 
public comment. No comments were received in response to this notice. 
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 current valid OMB control number.
    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 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

[[Page 29653]]

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 dat 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 as 
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
----------------------------------------------------------------------------------------------------------------
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.
    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, New Executive Office Building, Room 10235, Washington, DC 
20503, 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 Dr. George Nemo, Project Officer, NHLBI, Two 
Rockledge Center, Suite 361, 6700 Rockledge Drive, Bethesda, MD 20892, 
or call non-toll free number 301-435-0075, or e-mail your request, 
including your address 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 12, 2006.
Charles M. Peterson,
Director, DBDR, National Institutes of Health.
[FR Doc. 06-4790 Filed 5-22-06; 8:45 am]
BILLING CODE 4140-01-M