Submission for OMB Review; Comment Request; The Leukocyte Antibodies Prevalence (LAP) Study, 29652-29653 [06-4790]
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29652
Federal Register / Vol. 71, No. 99 / Tuesday, May 23, 2006 / Notices
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3127.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance outlines FDA’s
current thinking on the use of Bayesian
statistical methods in medical device
clinical trials. Bayesian statistical
methods are currently used in a variety
of medical device applications to FDA.
This draft guidance includes a general
description of Bayesian methods,
discussions on design and analysis of
Bayesian medical device clinical trials,
the benefits and difficulties with the
Bayesian approach, and comparisons
with standard (frequentist) statistical
methods. Finally, the draft guidance
presents some ideas on using Bayesian
methods in postmarket studies.
rmajette on PROD1PC67 with NOTICES
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on use of Bayesian statistics in medical
device clinical trials. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
To receive ‘‘Guidance for the Use of
Bayesian Statistics in Medical Device
Clinical Trials’’ by fax, call the CDRH
Facts-On-Demand system at 800–899–
0381 or 301–827–0111 from a touchtone telephone. Press 1 to enter the
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The CDRH Web site may be accessed at
VerDate Aug<31>2005
15:14 May 22, 2006
Jkt 208001
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 807 have
been approved under 0910–0120; the
collections of information in 21 CFR
part 812 have been approved under
0910–0078; the collections of
information in 21 CFR part 814 have
been approved under 0910–0231; and
the collections of information in 21 CFR
part 822 have been approved under
0910–0449.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Comments
received may be seen in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–7855 Filed 5–22–06; 8:45 am]
BILLING CODE 4160–01–S
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.
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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
E:\FR\FM\23MYN1.SGM
23MYN1
29653
Federal Register / Vol. 71, No. 99 / Tuesday, May 23, 2006 / Notices
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.
Estimated
number of
respondents
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
Adult Blood Donors ..........................................................................................
rmajette on PROD1PC67 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.
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 nemog@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
VerDate Aug<31>2005
15:14 May 22, 2006
Jkt 208001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; ActiGraph Accelerometer
Validation Study
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on January 23,
2006, page 3312 and allowed 60-days
for public comment. One public
comment was received. 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
currently valid OMB control number.
Proposed Collection: Title: Actigraph
Accelerometer Validation Study Type of
Information Collection Request: New.
Need and Use of Information Collection:
The NCI is collaborating with other NIH
Institutes on a proposed longitudinal
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
study of Hispanic subpopulations in the
United States referred to as the Hispanic
Community Health Study. The Hispanic
population is now the largest minority
population in the U.S. with a projected
three-fold growth by 2050. Hispanic
subgroups are influenced by a number
of chronic disease risk factors associated
with immigration from different cultural
settings and environments. These
factors include diet, physical activity,
community support, working
conditions, and access to health care.
Hispanic groups have higher rates of
obesity and diabetes than non-Hispanic
groups, but have lower coronary disease
and cancer (all sites) mortality. There
are also observed differences in health
outcomes between Hispanic subgroups.
For example, Puerto Ricans have a fourfold higher asthma prevalence than
Mexican-Americans. Hispanic
populations are understudied with
respect to many diseases and risk
factors. Their projected population
growth underscores the need for
accurate evaluation of their disease
burden and risk. A vast amount of
research suggests that the level of
physical activity influences many of the
chronic diseases and conditions of
interest, including obesity, diabetes,
cardiovascular disease, and cancer. To
better understand the relationship
between physical activity and chronic
disease, and to make specific activity
prescriptions, it is necessary to be able
to accurately assess levels and types of
activity. In particular, better methods
are needed to improve the validity and
reliability of physical activity
assessment instruments to better assess
the frequency, duration, and intensity of
physical activity. For that reason, NCI
plans to evaluate the use of a new type
of accelerometer, a small device worn
on a belt at the waist that measures and
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[Federal Register Volume 71, Number 99 (Tuesday, May 23, 2006)]
[Notices]
[Pages 29652-29653]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4790]
-----------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
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 nemog@nih.gov.
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
