[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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent             Type of         Number of     responses per   per  response   Total burden
                                   instrument       respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
    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]
BILLING CODE 4163-18-P