Proposed Collection; Comment Request; The Atherosclerosis Risk in Communities Study (ARIC), 50924-50925 [E6-14185]
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50924
Federal Register / Vol. 71, No. 166 / Monday, August 28, 2006 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Assisted Household Report-Long Form ..........................................................
Assisted Household Report-Short Form ..........................................................
Applicant Household Report ............................................................................
Estimated Total Annual Burden
Hours: 2,636.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, attn: ACF Reports Clearance
Officer. E-mail address:
rsargis@acf.hhs.gov. All requests should
be identified by the title of the
information collection.
The Department specifically requests
comments on (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
Number of
responses per
respondent
Average burden hours per
response
1
1
1
35
1
13
52
140
52
comments and suggestions submitted
within 60 days of this publication.
Dated: August 22, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–7190 Filed 8–25–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; The Atherosclerosis Risk in
Communities Study (ARIC)
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 be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection:
Title: The Atherosclerosis Risk in
Communities Study (ARIC).
Type of Information Collection
Request: Revision of a currently
approved collection (OMB No. 0925–
0281).
Need and Use of Information
Collection: This project involves annual
Total burden
hours
1,820
140
676
follow-up by telephone of participants
in the ARIC study, review of their
medical records, and interviews with
doctors and family to identify disease
occurrence. Interviewers will contact
doctors and hospitals to ascertain
participants’ cardiovascular events.
Information gathered will be used to
further describe the risk factors,
occurrence rates, and consequences of
cardiovascular disease in middle aged
and older men and women.
Frequency of Response: The
participants will be contacted annually.
Affected Public: Individuals or
households; businesses or other for
profit; small businesses or
organizations.
Type of Respondents: Individuals or
households; doctors and staff of
hospitals and nursing homes.
The annual reporting burden is as
follows:
Estimated Number of Respondents:
12,845.
Estimated Number of Responses per
Respondent: 1.0.
Average Burden Hours Per Response:
0.242.
Estimated Total Annual Burden
Hours Requested: 3,108.
The annualized cost to respondents is
estimated at $60,525, assuming
respondents time at the rate of $16.5 per
hour and physician time at the rate of
$75 per hour. There are no Capital Costs
to report. There are no Operating or
Maintenance Costs to report.
ESTIMATE OF ANNUAL HOUR BURDEN (2007–2010)
No. of respondents
Type of response
Frequency of
response
Average hours
per response
Annual hour
burden
Participant Follow-up .......................................................................................
Physician (or coroner)1 ....................................................................................
Participant’s next-of-kin1 ..................................................................................
11,500
945
450
1.0
1.0
1.0
0.2500
0.1667
0.1667
2,875
158
75
Total ..........................................................................................................
12,845
1.0
0.2420
3,108
1 Annual
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burden is placed on doctors, hospitals, and respondent relatives/informants through requests for information which will help in the
compilation of the number and nature of new fatal and nonfatal events.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
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15:09 Aug 25, 2006
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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
PO 00000
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Fmt 4703
Sfmt 4703
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
E:\FR\FM\28AUN1.SGM
28AUN1
Federal Register / Vol. 71, No. 166 / Monday, August 28, 2006 / Notices
information to be 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. Hanyu Ni,
Project Officer, NIH, NHLBI, 6701
Rockledge Drive, MSC 7934, Bethesda,
MD 20892–7934, or call non-toll-free
number 301–435–0448 or e-mail your
request, including your address to:
NiHanyu@nhlbi.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: August 21, 2006.
Meg Scofield,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E6–14185 Filed 8–25–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; The REDS–II Donor Iron
Study: Predicting Hemoglobin Deferral
and Development of Iron Depletion in
Blood Donors
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.
mstockstill on PROD1PC61 with NOTICES
Proposed Collection
Title: The REDS–II Donor Iron Study:
Predicting Hemoglobin Deferral and
Development of Iron Depletion in Blood
Donors.
Type of Information Collection
Request: New.
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15:09 Aug 25, 2006
Jkt 208001
Need and Use of Information
Collection: Although the overall health
significance of iron depletion in blood
donors is uncertain, iron depletion
leading to iron deficient erythropoiesis
and lowered hemoglobin levels results
in donor deferral and, occasionally, in
mild iron deficiency anemia.
Hemoglobin deferrals represent more
than half of all donor deferral, deferring
16% of women. Several cross sectional
studies of blood donors, using older
measures of iron status in blood donors
have indicated that female sex, frequent
donation and not taking iron
supplements are predictors of iron
depletion. However, none of these
studies have included racial/ethnic,
anthropomorphic, or behavioral factors
and none have evaluated the impact of
newly discovered iron protein
polymorphisms. The REDS–II Donor
Iron Study is a longitudinal study of
iron status in two cohorts of blood
donors: A first-time/reactivated donor
cohort in which baseline iron and
hemoglobin status can be assessed
without the influence of previous
donations, and a frequent donor cohort,
where the cumulative effect of
additional frequent blood donations can
be assessed. Each cohort’s donors will
donate blood and provide evaluation
samples during the study period. We
also propose to assess the baseline
status of a group of first-time donors
who are deferred for low hemoglobin on
their first visit.
The primary goal of the study is to
evaluate the effects of blood donation
intensity on iron and hemoglobin status
and assess how these are modified as a
function of baseline iron/hemoglobin
measures, demographic factors, and
reproductive and behavioral factors.
Hemoglobin levels, a panel of iron
protein, red cell and reticulocyte indices
will be measured at baseline and at a
final follow-up visit 15–24 months after
the baseline visit. A DNA sample will be
obtained once at the baseline visit to
assess three key iron protein
polymorphisms. Donors will also
complete a self-administered survey
assessing past blood donation, smoking
history, use of vitamin/mineral
supplements, iron supplements, aspirin,
frequency of heme rich food intake, and,
for females, menstrual status and
pregnancy history at these two time
points. This study aims to identify the
optimal laboratory measures that would
predict the development of iron
depletion, hemoglobin deferral, and/or
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Fmt 4703
Sfmt 4703
50925
iron deficient hemoglobin deferral in
active whole blood and double red cell
donors at subsequent blood donations.
The data collected will help evaluate
hemoglobin distributions in the blood
donor population (eligible and deferred
donors) and compare them with
NHANES data. Other secondary
objectives include elucidating key
genetic influences on hemoglobin levels
and iron status in a donor population as
a function of donation history; and
establishing a serum and DNA archive
to evaluate the potential utility of future
iron studies and genetic
polymorphisms.
This study will develop better
predictive models for iron depletion and
hemoglobin deferral (with or without
iron deficiency) in blood donors; allow
for the development of improved donor
screening strategies and open the
possibility for customized donation
frequency guidelines for individuals or
classes of donors; provide important
baseline information for the design of
targeted iron supplementation strategies
in blood donors, and improved
counseling messages to blood donors
regarding diet or supplements; and by
elucidating the effect of genetic iron
protein polymorphisms on the
development of iron depletion, enhance
the understanding of the role of these
proteins in states of iron stress, using
frequent blood donation as a model.
Frequency of Response: Twice.
Affected Public: Individuals.
Type of Respondents: Adult blood
donors.
The annual reporting burden is as
follows:
Estimated Number of Respondents:
Baseline Visit: 3,750.
Follow-up Visit: 1720.
Estimated Number of Responses per
Respondent: 1.
Average Burden of Hours per
Response:
Baseline Visit: 0.12.
Follow-up Visit: 0.1.
Estimated Total Annual Burden
Hours Requested:
Baseline Visit: 450.
Follow-up Visit: 172.
The annualized cost to respondents is
estimated at:
Baseline Visit: $8,100.
Follow-up Visit: $3,096 (based on $18
per hour).
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
E:\FR\FM\28AUN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 166 (Monday, August 28, 2006)]
[Notices]
[Pages 50924-50925]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14185]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; The Atherosclerosis Risk in
Communities Study (ARIC)
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 be submitted to the
Office of Management and Budget (OMB) for review and approval.
Proposed Collection:
Title: The Atherosclerosis Risk in Communities Study (ARIC).
Type of Information Collection Request: Revision of a currently
approved collection (OMB No. 0925-0281).
Need and Use of Information Collection: This project involves
annual follow-up by telephone of participants in the ARIC study, review
of their medical records, and interviews with doctors and family to
identify disease occurrence. Interviewers will contact doctors and
hospitals to ascertain participants' cardiovascular events. Information
gathered will be used to further describe the risk factors, occurrence
rates, and consequences of cardiovascular disease in middle aged and
older men and women.
Frequency of Response: The participants will be contacted annually.
Affected Public: Individuals or households; businesses or other for
profit; small businesses or organizations.
Type of Respondents: Individuals or households; doctors and staff
of hospitals and nursing homes.
The annual reporting burden is as follows:
Estimated Number of Respondents: 12,845.
Estimated Number of Responses per Respondent: 1.0.
Average Burden Hours Per Response: 0.242.
Estimated Total Annual Burden Hours Requested: 3,108.
The annualized cost to respondents is estimated at $60,525,
assuming respondents time at the rate of $16.5 per hour and physician
time at the rate of $75 per hour. There are no Capital Costs to report.
There are no Operating or Maintenance Costs to report.
Estimate of Annual Hour Burden (2007-2010)
----------------------------------------------------------------------------------------------------------------
No. of Frequency of Average hours Annual hour
Type of response respondents response per response burden
----------------------------------------------------------------------------------------------------------------
Participant Follow-up........................... 11,500 1.0 0.2500 2,875
Physician (or coroner)\1\....................... 945 1.0 0.1667 158
Participant's next-of-kin\1\.................... 450 1.0 0.1667 75
---------------------------------------------------------------
Total....................................... 12,845 1.0 0.2420 3,108
----------------------------------------------------------------------------------------------------------------
\1\ Annual burden is placed on doctors, hospitals, and respondent relatives/informants through requests for
information which will help in the compilation of the number and nature of new fatal and nonfatal events.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on 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 assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the
[[Page 50925]]
information to be 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. Hanyu Ni, Project Officer, NIH, NHLBI, 6701
Rockledge Drive, MSC 7934, Bethesda, MD 20892-7934, or call non-toll-
free number 301-435-0448 or e-mail your request, including your address
to: NiHanyu@nhlbi.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: August 21, 2006.
Meg Scofield,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E6-14185 Filed 8-25-06; 8:45 am]
BILLING CODE 4140-01-P
