[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Notices]
[Pages 55393-55394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22788]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-11-11AO]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 days of this 
notice.

Proposed Project

    Children's Health After the Storms (CHATS)--New--National Center 
for Environmental Health (NCEH) and Agency for Toxic Substances and 
Disease Registry (ATSDR)/Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    This project involves research to assess the potential adverse 
health effects among children who resided in Federal Emergency 
Management Agency (FEMA)-provided temporary housing units deployed in 
the Gulf Coast region following hurricanes Katrina and Rita. The title 
of this study has changed since publication of the initial 60-day 
Federal Register Notice (FRN) (previous title ``The Gulf Coast 
Children's Health Study''); however, the goals remain the same.
    The Children's Health Study After the Storms (CHATS) addresses an 
important public health need to assess the potential short-term and 
long-term health effects among children who lived in FEMA-provided 
temporary housing units 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 may include adverse acute and 
chronic health conditions, primarily respiratory and dermal, that may 
be associated with their exposures. 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 3-
15 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 2,236 
households in order to identify 625 eligible children. Of these, it is 
expected that 80%, or 500 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, and each assessment is divided into 
two sessions. 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 450 children. If a 
determination is made to conduct the Full Study, these 450 children 
will be part of the Full Study and continue to participate in the rest 
of follow-up assessments.
    There is no cost to the participants except their time. The total 
estimated annual burden hours are 1,310.

[[Page 55394]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
              Respondent                   Form name or module      respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Household member 18 yrs or older......  Eligibility Screener....           1,118               1           10/60
Children ages 3-15....................  Baseline: Session 1.....             250               1           15/60
                                        (Child Modules).........
Parents of children ages 3-15.........  Baseline: Session 1                  250               1               1
                                         (Parent Modules).
Children ages 3-15....................  Baseline: Session 2.....             250               1               1
                                        (Child Modules).........
Parents of children ages 3-15.........  Baseline: Session 2.....             250               1           30/60
                                        (Parent Modules)........
Children ages 3-15....................  6-month Follow-up:                   225               1            7/60
                                         Session 1 (Child
                                         Modules).
Parents of children ages 3-15.........  6-month Follow-up:                   225               1           40/60
                                         Session 1 (Parent
                                         Modules).
Children ages 3-15....................  6-month Follow-up:                   225               1           37/60
                                         Session 2 (Child
                                         Modules).
Parents of children ages 3-15.........  6-month Follow-up:                   225               1           30/60
                                         Session 2 (Parent
                                         Modules).
Household member 18 yrs or older......  Verification                         112               1            2/60
                                         Questionnaire for
                                         Eligibility Screener
                                         (10% subsample).
Household member 18 yrs or older......  Verification                          43               1            5/60
                                         Questionnaire for
                                         Baseline and 6-month
                                         Follow-up Visits (9%
                                         subsample).
Household member 18 yrs or older......  Mail Verification Form                 5               1            5/60
                                         for Baseline and 6-
                                         month Follow-up Visits
                                         (1% subsample).
----------------------------------------------------------------------------------------------------------------


    Dated: August 30, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-22788 Filed 9-6-11; 8:45 am]
BILLING CODE 4163-18-P