[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Notices]
[Pages 70006-70007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28787]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-11-11AO]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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 Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Carol E. Walker, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to [email protected].
Comments are invited 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) ways to enhance 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. Written comments should be received
within 60 days of this notice.
Proposed Project
Gulf Coast Children's Health Study--NEW--National Center for
Environmental Health (NCEH), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The Gulf Coast Children's Health Study addresses an important
public health need to assess the potential short-term and long-term
health effects among children who lived in Federal Emergency Management
Agency (FEMA)-provided temporary housing units (THU) deployed in the
Gulf Coast region following hurricanes Katrina and Rita and who were
potentially exposed to higher levels of indoor air pollutants such as
formaldehyde and other volatile organic compounds compared to other
types of housing. These health effects
[[Page 70007]]
may include adverse acute and chronic health conditions, primarily
respiratory and dermal, that may be associated with their exposures.
CDC plans to conduct a scientifically valid environmental epidemiologic
study to assess the potential adverse health effects among children.
Plans involve a two-year Feasibility Study to investigate the
association between exposure to temporary housing units and health
conditions and to assess the practicality of conducting a larger
longitudinal study. If certain feasibility objectives are met, such as
identifying a sufficient number of eligible participants, a 6-year Full
Study will be conducted following the same study design as the
Feasibility Study.
The Feasibility Study will be conducted in the states of Louisiana
and Mississippi. The study will assess the potential health impacts
from exposures to various indoor pollutants (e.g., formaldehyde and
other volatile organic compounds and plasticizers, including
phthalates) commonly found in higher concentrations in the temporary
housing units compared with other types of housing.
In the study, a 1:1 ratio of exposed and unexposed children age 5-
17 years will be recruited. Children who resided in temporary housing
units will be categorized into the ``exposed'' group and children who
did not reside in temporary housing units will be categorized into the
``unexposed'' group. A screening questionnaire will be used to assess
eligibility and exposure to temporary housing units. The screening
questionnaire will be conducted with one adult resident of each
selected household. Based on responses to the screening questions, one
eligible child will be selected for the study from each participating
household. To obtain the desired sample size, we plan to screen 2,500
households in order to identify 700 eligible children. Of these, it is
expected that 80%, or 560 children, will agree to participate in the
study.
The Feasibility Study will involve a baseline and a 6-month follow-
up assessment for each participant. The baseline assessment will
include a health questionnaire, clinical assessment including
biological sample collection, and environmental exposure measurement.
The environmental exposure assessment will be collecting biomarkers of
exposure and measuring exposures to environmental pollutants using
personal and indoor sampling devices over a 7-day period. In the 6-
month follow-up assessment, a shorter version of the health
questionnaire and the same clinical and environmental exposure
assessments will be conducted.
Accounting for a 10% loss to follow-up, the sample size for the 6-
month follow-up assessment is projected to be 504 children. If a
determination is made to conduct the Full Study, these 504 children
will be part of the Full Study and continue to participate in the rest
of five follow-up assessments occurring at 9-month intervals.
There is no cost to the participants except their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Type of Number of responses per per response Total burden
instrument respondents respondent (in hours) (in hours)
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Household member 18 years or Eligibility 2,500 1 10/60 417
older. Screener.
Children ages 5-17............ Baseline 560 1 1.25 700
Assessment.
Parents of children ages 5-17. Baseline 560 1 1.5 840
Assessment.
Children ages 5--17........... 6-Month Follow- 504 1 50/60 420
up Assessment.
Parents of children ages 5-17. 6-Month Follow- 504 1 1.25 630
up Assessment.
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Total..................... 3,007
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Dated: November 9, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2010-28787 Filed 11-15-10; 8:45 am]
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