Proposed Collection; Comment Request; The Leukocyte Antibodies Prevalence (LAP) Study, 5344-5345 [E6-1269]

Download as PDF 5344 Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices ‘‘Psychopharmacologic Drugs Advisory Committee’’ meeting. Agenda: The committee will discuss new drug application (NDA) 20–717, S– 019, PROVIGIL (100 milligrams (mg), 200 mg, 85 mg, 170 mg, 255 mg, 340 mg, and 425 mg) Tablets, Cephalon, Inc.; the proposed indication is for the treatment of attention deficit hyperactivity disorder (ADHD). Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by March 15, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 15, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Cicely Reese at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 24, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–1222 Filed 1–31–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee; Notice of Meeting cchase on PROD1PC60 with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration VerDate Aug<31>2005 17:49 Jan 31, 2006 Jkt 208001 (FDA). The meeting will be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held via teleconference on February 17, 2006, from 1 p.m. to 5:30 p.m. Location: National Institutes of Health (NIH) campus, Food and Drug Administration, Bldg. 29B, conference rooms A and B, 8800 Rockville Pike, Bethesda, MD. This meeting will be held by teleconference. The public is welcome to attend. A speakerphone will be provided at the specified location for public participation in this meeting. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the internet at https://www.nih.gov/about/visitor/ index.htm. (FDA has verified the Web site addresses, but we are not responsible for subsequent changes to the Web sites after this document publishes in the Federal Register.) Visitors must show two forms of identification such as a Federal employee badge, driver’s license, passport, green card, etc. If you are planning to drive to and park on the NIH campus, you must enter at the South Dr. entrance of the campus which is located on Wisconsin Ave. (the medical center metro entrance), and allow extra time for vehicle inspection. Detailed information about security procedures is located at https:// www.nih.gov/about/visitorsecurity.htm. Due to the limited available parking, visitors are encouraged to use public transportation. Contact Person: Christine Walsh or Denise Royster, Food and Drug Administration, Center for Biologics Evaluation and Research (HFM–71), 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will review and discuss the selection of strains to be included in the influenza virus vaccine for the 2006–2007 season. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by February 10, 2006. Oral PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 presentations from the public will be scheduled between approximately 3:30 p.m. and 4:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 10, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 24, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–1224 Filed 1–31–06; 8:45 am] BILLING CODE 4160–01–S 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 E:\FR\FM\01FEN1.SGM 01FEN1 5345 Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices 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. Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours requested Adult Blood Donors .......................................................................................... cchase on PROD1PC60 with NOTICES Type of respondents 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. 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 nemog@nih.gov. VerDate Aug<31>2005 17:49 Jan 31, 2006 Jkt 208001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: FDA Approvable Human DNA Diagnostic Test for Endometriosis National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in U.S. Patent PO 00000 Frm 00114 Fmt 4703 Sfmt 4703 Application Number 60/654,331 filed February 18, 2005, entitled ‘‘Identification of Molecular Markers for Endometriosis in Blood Lymphocytes Using DNA Microarrays,’’ to OrthoClinical Diagnostics, having a place of business in Raritan, NJ 08869. The contemplated exclusive license may be limited to an FDA approvable human DNA diagnostic test for endometriosis. The United States of America is the assignee of the patent rights in this invention. Only written comments and/or application for a license which are received by the National Institutes of Health on or before April 3, 2006 will be considered. ADDRESSES: Requests for a copy of the patent, inquires, comments, and other materials relating to the contemplated license should be directed to: Marlene Astor, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: 301–435–4426; Facsimile: 301–402–0220; e-mail: ms482m@nih.gov. DATES: SUPPLEMENTARY INFORMATION: Endometriosis is a common, nonmalignant gynecological disease that E:\FR\FM\01FEN1.SGM 01FEN1

Agencies

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


-----------------------------------------------------------------------

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.

----------------------------------------------------------------------------------------------------------------
                                                                  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
----------------------------------------------------------------------------------------------------------------

    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 
nemog@nih.gov.
    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
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