06-4790. 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 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.

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

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 [e-mail].

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.