2015-10542. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection entitled The Green Housing Pilot Study (New Orleans).

DATES:

Written comments must be received on or before July 6, 2015.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2015-0027 by any of the following methods:

• Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.
• Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

Please note:

All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

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; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

Proposed Project

The Green Housing Pilot Study (New Orleans)—New—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC) is seeking a new three-year regular OMB approval for a pilot study of additional components to be tested in a single study site (New Orleans) for the Green Housing Study (OMB No. 0920-0906, Expiration Date 10/31/2017). The goal of the Green Housing pilot study (New Orleans) is to apply environmental sample collection methods and novel approaches to study exposures to various indoor pollutants (both chemical and biological agents) in children (0-12 yrs.).

The information collected will help scientists better understand time-activity patterns of young children (0-12 years) that affect exposures to chemical and biological agents in their residential environments. This knowledge will improve estimates of exposure for children. Results from this pilot study will also inform future Green Housing Study sites and will potentially reduce participant time burden by collecting some questionnaires electronically.

This study directly supports the Healthy People 2020 Healthy Homes' health protection goal of the Centers for Disease Control and Prevention (CDC). This investigation is also consistent with CDC's Health Protection Research Agenda, which calls for research to identify the major environmental causes of disease and disability and related risk factors.

In 2011, CDC funded the first two study sites for the Green Housing Study; one location was in Boston and the other was in Cincinnati. In these two cities, renovations sponsored by the Department of Housing and Urban Development (HUD) had already been scheduled. By selecting sites in which renovations were already schedule to occur, the CDC leveraged the opportunity to collect survey and biomarker data from residents and to collect environmental measurements in homes in order to evaluate associations between green housing and health. The biomarker measurements of the children (such as those from urine, feces, toenails) reflects exposures that are in body, thus improving assessment of how environmental exposures can influence what enters the body.

The third study is in New Orleans. With the New Orleans study site, CDC and Environmental Protection Agency (EPA) investigators propose a pilot study of other sampling and analysis methodologies to improve exposure assessment for future study sites. Several objectives will be evaluated in the EPA pilot study add-on to the third study site:

(1) Identify and characterize factors affecting children's exposures to chemical ingredients from consumer products found in their everyday environment in order to support the data and modeling needs of the exposure components of EPA's national research programs;

(2) Evaluate the pilot study data metrics for incorporation in and enhancement of CDC's ability to understand the relationship between environmental exposures and asthma in green versus traditional low-income housing;

(3) Compare multimedia measurements and survey data between pre- and post-renovation time points in green and traditional low-income housing to assess exposure related changes in the residence and participants due to renovation activities.

This pilot study of additional environmental exposure assessment methodologies is only for the New Orleans study site. Each study site only has 64 households (32 green renovated homes and 32 comparison homes) so this will be the maximum number of households in this pilot study. Like the previous study sites, participants for the New Orleans study site will continue to include children with asthma, their mothers/primary caregivers living in HUD-subsidized housing that has either received a green renovation or is a comparison home (i.e., no renovation). In addition, younger children (newborns through age 12 years, with a focus on newborns to age 3 years) will be enrolled for the New Orleans study site. Having a larger age range of children in the pilot study will improve the estimate of how environmental exposures inside and outside of their homes can occur during different life stages of childhood, a critical period of life when the immune system and other organ systems are still developing.

The Pilot study will be implemented by incorporating it into the Green Housing study schedule for approximately 12 months. Data collection methods proposed for the pilot include: (1) A questionnaire regarding time-activity patterns of their children which will be administered to mothers/primary caregivers (i.e., the respondents), (2) collection of air, soil, dust samples from the respondent's home; and (3) collection of blood, urine, toenails clippings, and feces from the respondent's eligible children. We hypothesize that a better estimation of exposure pathways will improve exposure modeling for the current Green Housing Study site (New Orleans), future Green Housing Study sites, and future research in environmental health. Although children are considered participants (by giving biological samples and providing some clinical measurements), the respondents to all questionnaires are the mothers/primary caregivers.

The number and type of respondents that will complete the questionnaires are 64 mothers/primary caregivers of enrolled children. All health and environmental exposure information about children will be provided by their mothers/primary caregivers (i.e., no children will fill out questionnaires).

There is no cost to the respondents other than their time to participate in the study. The total estimated annual burden hours for the pilot study in New Orleans study site of the Green Housing Study is 171 hrs.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
Mothers/Primary Caregivers of Enrolled Children	Time/Activity Questionnaire	64	4	40/60	171
Total					171

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.