[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]



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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