2010-28787. 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 [e-mail].

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 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

Type of respondent	Type of instrument	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Household member 18 years or older	Eligibility Screener	2,500	1	10/60	417
Children ages 5-17	Baseline Assessment	560	1	1.25	700
Parents of children ages 5-17	Baseline Assessment	560	1	1.5	840
Children ages 5--17	6-Month Follow-up Assessment	504	1	50/60	420
Parents of children ages 5-17	6-Month Follow-up Assessment	504	1	1.25	630
Total					3,007

Dated: November 9, 2010.

Carol E. Walker,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.