[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Notices]
[Pages 69680-69681]
From the Federal Register Online via the Government Publishing 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 [email protected].
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