2011-22788. 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 [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to [phone]. 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.

Estimated Annualized Burden Hours

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

Dated: August 30, 2011.

Daniel Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.