Proposed Collection; Comment Request; The Leukocyte Antibodies Prevalence (LAP) Study, 5344-5345 [E6-1269]
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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
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orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
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presentations from the public will be
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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]
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DEPARTMENT OF HEALTH AND
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Food and Drug Administration
Vaccines and Related Biological
Products Advisory Committee; Notice
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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
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General Function of the Committee:
To provide advice and
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FDA’s regulatory issues.
Date and Time: The meeting will be
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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,
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Due to the limited available parking,
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Contact Person: Christine Walsh or
Denise Royster, Food and Drug
Administration, Center for Biologics
Evaluation and Research (HFM–71),
1401 Rockville Pike, Rockville, MD
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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
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Fmt 4703
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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]
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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
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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
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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
