National Institute of Child Health and Human Development; Revision to Proposed Collection; Comment Request; the National Children's Study, Vanguard (Pilot) Study, 69680-69681 [2010-28701]
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Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development; Revision to
Proposed Collection; Comment
Request; the National Children’s
Study, Vanguard (Pilot) Study
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 Institute of Child Health and
Human Development (NICHD), 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.
SUMMARY:
srobinson on DSKHWCL6B1PROD with NOTICES
Proposed Collection
Title: The National Children’s Study,
Vanguard (pilot) Study.
Type of Information Collection
Request: Revision.
Need and Use of Information
Collection:
The purpose of the proposed data
collection is to continue the Vanguard
phase of the National Children’s Study
(NCS), to evaluate the feasibility,
acceptability, and cost of recruitment
strategies and study design elements for
a prospective, national longitudinal
study of child health and development.
In combination, the substudies
encompassed by the Vanguard phase
will be used to inform the design of the
Main Study of the National Children’s
Study.
Background
The National Children’s Study is a
prospective, national longitudinal study
of the interaction between environment,
genetics, and biological factors on child
health and development. The Study
defines ‘‘environment’’ broadly, taking a
number of natural and man-made
environmental, biological, genetic, and
psychosocial factors into account. By
studying children through their
different phases of growth and
development, researchers will be better
able to understand the role these factors
have on health and disease. Findings
from the Study will be made available
as the research progresses, making
potential benefits known to the public
as soon as possible. The National
Children’s Study is led by a consortium
of federal partners: the U.S. Department
of Health and Human Services
(including the Eunice Kennedy Shriver
National Institute of Child Health and
Human Development and the National
VerDate Mar<15>2010
18:04 Nov 12, 2010
Jkt 223001
Institute of Environmental Health
Sciences of the National Institutes of
Health and the Centers for Disease
Control and Prevention), and the U.S.
Environmental Protection Agency.
To conduct the detailed preparation
needed for a study of this size and
complexity, the NCS includes a
preliminary pilot study known as the
Vanguard Study. The purpose of the
Vanguard Study is to assess the
feasibility, acceptability, and cost of the
recruitment strategies, study logistics,
and study visit measures that are to be
used in the design of the NCS Main
Study. The Vanguard Study begins prior
to the NCS Main Study and will run in
parallel with the Main Study. At every
phase of the NCS, the multiple
methodological studies conducted
during the Vanguard phase will inform
the implementation and analysis plan
for the Main Study.
The Vanguard Study is conducted
through study locations across the
United States. Seven of these locations
began recruitment in the winter and
spring of 2009, and an additional 30
locations will begin recruiting in late
2010. These 30 sites were added to the
Vanguard Study to evaluate the
feasibility, acceptability and cost of
three separate recruitment strategies for
enrollment of pregnant women into the
NCS; additional study locations were
established to yield greater precision in
statistical analyses. The original seven
sites used a household enumeration and
screening strategy to identify eligible
women for recruitment into the study.
The 30 sites that entered the study in
2010 are recruiting pregnant women as
participants using three methods: (a) A
provider-based recruitment method,
where women are recruited via their
health care providers; (b) an enhanced
household enumeration method; and
(c) a two-tiered recruitment procedure
where women are offered participation
in a lower-intensity data collection and
then may be able to convert to a higherintensity data collection. These sites
have been collecting data relating to the
pre-pregnancy, pregnancy, and birth
periods. The original seven Vanguard
sites have been collecting data relating
to the pre-pregnancy, pregnancy, and
birth periods, as well as postnatal data
collection points at 3-, 6-, 9- and 12months of age.
Methods
We propose to continue data
collection during this phase of the
Vanguard Study among the 37 study
locations up to and including the visit
planned to take place when the sample
children have reached 24 months of age.
This would align study visits approved
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
for the initial 7 Vanguard Study
locations (which extend past the birth
visit to include a 3-, 6-, 9-, 12-, 18- and
24-month visit) with the study visits
approved for the 30 additional
Vanguard Study locations (which were
initially proposed and approved up to
and including the birth visit). Extending
the data collection of the 30 additional
Vanguard Study locations to 24 months
of age would support rigorous,
empirical evaluation of participant
retention as it may relate to recruitment
strategy. A strong understanding of how
to encourage retention of study
participants, particularly during the
infancy and early childhood years, will
be essential to planning the Main Study.
Additionally, continuing data collection
post-birth among the alternate
recruitment strategy study locations
allows us to generate additional data to
inform the development of study visit
procedures, both for future Vanguard
study efforts and the Main Study.
We will evaluate the feasibility
(technical performance), acceptability
(respondent tolerance and impact on
study infrastructure), and cost
(operations, time, and effort) of each
recruitment and retention strategy using
pre-determined measures. We will
compare these findings and use them as
a basis to inform the strategies, or
combinations of strategies, that might be
used in the Main Study of the NCS.
Frequency of Response: See above
descriptions.
Affected Public: Pregnant women and
their children.
The additional annualized cost to
respondents over the two-year data
collection period for all three
recruitment strategies combined is
estimated at annualized respondent cost
of $75,000 (based on $10 per hour). This
is calculated as estimating 15,000
respondents across all three recruitment
strategies, contacted once per visit, at an
estimated average of .5 hours per
response, for a total estimated annual
respondent burden as 7,500 hours.
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
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 minimize
E:\FR\FM\15NON1.SGM
15NON1
69681
Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Notices
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.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Sarah L.
Glavin, Deputy Director, Office of
Science Policy, Analysis and
Communication, National Institute of
Child Health and Human Development,
31 Center Drive Room 2A18, Bethesda,
Maryland 20892, or call non-toll free
number (301) 496–1877 or E-mail your
request, including your address, to
glavins@mail.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.
FOR FURTHER INFORMATION CONTACT:
Dated: November 5, 2010.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communications, National
Institute of Child Health and Human
Development, National Institutes of Health.
[FR Doc. 2010–28701 Filed 11–12–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; California Health Interview
Survey Cancer Control Module (CHIS–
CCM) 2011 (NCI)
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 Cancer Institute (NCI), 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: California
Health Interview Survey Cancer Control
Module (CHIS–CCM) 2010. Type of
Information Collection Request:
Revision. Need and Use of Information
Collection: The NCI has sponsored five
Cancer Control Modules in the
California Health Interview Survey
(CHIS), and will be sponsoring a sixth
to be administered in 2011. CHIS is a
telephone survey that collects
population-based, standardized healthrelated data to assess California’s
progress in meeting Healthy People
2010 objectives for the nation and the
State. The CHIS sample is designed to
provide statistically reliable estimates
statewide, for California counties, and
for California’s ethnically and racially
SUMMARY:
diverse population. Initiated by the
UCLA Center for Health Policy
Research, the California Department of
Health Services, and the California
Public Health Institute, the survey is
funded by a number of public and
private sources. It was first administered
in 2001 to 55,428 adults and
subsequently in 2003 to 42,043 adults,
in 2005 to 43,020 adults, and in 2007 to
48,150 adults. These adults are a
representative sample of California’s
non-institutionalized population living
in households. CHIS 2011 is planned for
continual administration to 48,150
adults and 3,316 adolescent
Californians. This study will allow NCI
to examine patterns and trends in
cancer screening and follow-up, as well
as to study other cancer-related topics
such as tobacco control, diet, physical
activity, obesity, and human
papillomavirus. Additionally, CHIS is
designed to be comparable to the
National Health Interview Survey
(NHIS) data in order to conduct
comparative analyses. CHIS provides
enhanced estimates for cancer risk
factors and screening among racial/
ethnic minority populations. Frequency
of Response: Once. Affected public:
Individuals. Types of Respondents: U.S.
adults and adolescents (persons 12 years
of age and older). The total annual
burden hours requested are 2,177 (see
Table 1). There are no Capital Costs,
Operating Costs, and/or Maintenance
Costs to report.
TABLE 1—ESTIMATES OF ANNUALIZED HOUR BURDEN
Number of
respondents
Form type
Adults ................................................
Adult Pilot .........................................
50
1
Adult Survey .....................................
16,000
1
Adolescent Pilot ...............................
6
1
Adolescent Survey ...........................
1,100
1
...........................................................
17,156
........................
Adolescents .......................................
Total ...........................................
srobinson on DSKHWCL6B1PROD with NOTICES
Average time
per response—minutes/hours
Frequency of
response
Type of respondent
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
proposed 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
VerDate Mar<15>2010
18:04 Nov 12, 2010
Jkt 223001
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
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
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
8/60
(0.133)
8/60
(0.133)
2/60
(0.033)
2/60
(0.033)
........................
Annual hour
burden
6.67
2,133.33
0.20
36.67
2,176.87
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 Nancy Breen, PhD,
Project Officer, National Cancer
Institute, EPN 4094, 6130 Executive
Boulevard MSC 7344, Bethesda,
Maryland 20852–7344, or call non-toll
E:\FR\FM\15NON1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Notices]
[Pages 69680-69681]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28701]
[[Page 69680]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development;
Revision to Proposed Collection; Comment Request; the National
Children's Study, Vanguard (Pilot) 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 Institute of Child
Health and Human Development (NICHD), 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 National Children's Study, Vanguard (pilot) Study.
Type of Information Collection Request: Revision.
Need and Use of Information Collection:
The purpose of the proposed data collection is to continue the
Vanguard phase of the National Children's Study (NCS), to evaluate the
feasibility, acceptability, and cost of recruitment strategies and
study design elements for a prospective, national longitudinal study of
child health and development. In combination, the substudies
encompassed by the Vanguard phase will be used to inform the design of
the Main Study of the National Children's Study.
Background
The National Children's Study is a prospective, national
longitudinal study of the interaction between environment, genetics,
and biological factors on child health and development. The Study
defines ``environment'' broadly, taking a number of natural and man-
made environmental, biological, genetic, and psychosocial factors into
account. By studying children through their different phases of growth
and development, researchers will be better able to understand the role
these factors have on health and disease. Findings from the Study will
be made available as the research progresses, making potential benefits
known to the public as soon as possible. The National Children's Study
is led by a consortium of federal partners: the U.S. Department of
Health and Human Services (including the Eunice Kennedy Shriver
National Institute of Child Health and Human Development and the
National Institute of Environmental Health Sciences of the National
Institutes of Health and the Centers for Disease Control and
Prevention), and the U.S. Environmental Protection Agency.
To conduct the detailed preparation needed for a study of this size
and complexity, the NCS includes a preliminary pilot study known as the
Vanguard Study. The purpose of the Vanguard Study is to assess the
feasibility, acceptability, and cost of the recruitment strategies,
study logistics, and study visit measures that are to be used in the
design of the NCS Main Study. The Vanguard Study begins prior to the
NCS Main Study and will run in parallel with the Main Study. At every
phase of the NCS, the multiple methodological studies conducted during
the Vanguard phase will inform the implementation and analysis plan for
the Main Study.
The Vanguard Study is conducted through study locations across the
United States. Seven of these locations began recruitment in the winter
and spring of 2009, and an additional 30 locations will begin
recruiting in late 2010. These 30 sites were added to the Vanguard
Study to evaluate the feasibility, acceptability and cost of three
separate recruitment strategies for enrollment of pregnant women into
the NCS; additional study locations were established to yield greater
precision in statistical analyses. The original seven sites used a
household enumeration and screening strategy to identify eligible women
for recruitment into the study. The 30 sites that entered the study in
2010 are recruiting pregnant women as participants using three methods:
(a) A provider-based recruitment method, where women are recruited via
their health care providers; (b) an enhanced household enumeration
method; and (c) a two-tiered recruitment procedure where women are
offered participation in a lower-intensity data collection and then may
be able to convert to a higher-intensity data collection. These sites
have been collecting data relating to the pre-pregnancy, pregnancy, and
birth periods. The original seven Vanguard sites have been collecting
data relating to the pre-pregnancy, pregnancy, and birth periods, as
well as postnatal data collection points at 3-, 6-, 9- and 12- months
of age.
Methods
We propose to continue data collection during this phase of the
Vanguard Study among the 37 study locations up to and including the
visit planned to take place when the sample children have reached 24
months of age. This would align study visits approved for the initial 7
Vanguard Study locations (which extend past the birth visit to include
a 3-, 6-, 9-, 12-, 18- and 24-month visit) with the study visits
approved for the 30 additional Vanguard Study locations (which were
initially proposed and approved up to and including the birth visit).
Extending the data collection of the 30 additional Vanguard Study
locations to 24 months of age would support rigorous, empirical
evaluation of participant retention as it may relate to recruitment
strategy. A strong understanding of how to encourage retention of study
participants, particularly during the infancy and early childhood
years, will be essential to planning the Main Study. Additionally,
continuing data collection post-birth among the alternate recruitment
strategy study locations allows us to generate additional data to
inform the development of study visit procedures, both for future
Vanguard study efforts and the Main Study.
We will evaluate the feasibility (technical performance),
acceptability (respondent tolerance and impact on study
infrastructure), and cost (operations, time, and effort) of each
recruitment and retention strategy using pre-determined measures. We
will compare these findings and use them as a basis to inform the
strategies, or combinations of strategies, that might be used in the
Main Study of the NCS.
Frequency of Response: See above descriptions.
Affected Public: Pregnant women and their children.
The additional annualized cost to respondents over the two-year
data collection period for all three recruitment strategies combined is
estimated at annualized respondent cost of $75,000 (based on $10 per
hour). This is calculated as estimating 15,000 respondents across all
three recruitment strategies, contacted once per visit, at an estimated
average of .5 hours per response, for a total estimated annual
respondent burden as 7,500 hours. There are no Capital Costs to report.
There are no Operating or Maintenance Costs to report.
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 minimize
[[Page 69681]]
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. Sarah L. Glavin, Deputy Director, Office of
Science Policy, Analysis and Communication, National Institute of Child
Health and Human Development, 31 Center Drive Room 2A18, Bethesda,
Maryland 20892, or call non-toll free number (301) 496-1877 or E-mail
your request, including your address, to glavins@mail.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: November 5, 2010.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications,
National Institute of Child Health and Human Development, National
Institutes of Health.
[FR Doc. 2010-28701 Filed 11-12-10; 8:45 am]
BILLING CODE 4140-01-P
