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Agency Information Collection Activities: Proposed Collection; Comment Request; Seven-County Study of Air Quality and Birth Defects: Computer-Assisted Telephone Questionnaire for Subset of Study Population

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Information about this document as published in the Federal Register.

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Environmental Protection Agency (EPA).




In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit the following proposed Information Collection Request (ICR) to the Office of Management and Budget (OMB). Title: Seven-County Study of Air Quality and Birth Defects: Computer-Assisted Telephone Questionnaire for Subset of Study Population. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.


Comments must be submitted on or before February 21, 2003.


Public comments should be submitted to: Dr. Pauline Mendola, US EPA (MD 58A) Research Triangle Park, NC 27711.

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Interested persons may obtain technical information or a copy of the ICR without charge by contacting: Dr. Pauline Mendola, (919) 966-6953; FAX: (919) 966-7584; E-mail:, or by mailing a request to the address above.

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Affected entities: Entities potentially affected by this action are women who delivered a live-born or stillborn infant or who experienced a recorded fetal death in seven Texas counties in 1999 already enrolled in the record-linkage component of the Seven-County Study of Air Quality and Birth Defects.

Title: Seven-County Study of Air Quality and Birth Defects: Computer-Assisted Telephone Questionnaire for Subset of Study Population.

Abstract: Previous U.S. studies examining the relationship between air pollution and adverse reproductive outcomes have not used data beyond the Environmental Protection Agency's stationary ambient monitors to estimate exposure. The proposed computer-assisted questionnaire contains a maximum of 28 questions categorized into 6 sections: Residential History, Work History, Time Spent Outside the Home (Weekdays), Time Spent Outside the Home (Weekends), Multivitamin Use, and Tobacco Use. Study participants will be the mothers of infants born with and without birth defects in 1999 in seven Texas counties. These women will be selected from a larger records-linkage-based case-control study of air pollution and birth defects in the state.

Obtaining questionnaire information on maternal residence at conception will allow us to more precisely estimate exposure during the critical window of gestational weeks three through eight. Maternal work history, outdoor activities, and time spent outside the home will be used to refine exposure estimates for outdoor air pollution. The sections on maternal vitamin use and smoking during pregnancy will provide relevant data on potential confounders of the association between air pollution and birth defects.

The study investigators will use this data to help estimate the association between air pollution exposure and risk of selected birth defects. This will be the first study in this research area to collect this type of data, and if it proves useful, will indicate a need for such supplemental data collection in future studies.

The information will appear in the form of final EPA reports, dissertation manuscripts, and journal articles, and will also be made publicly available.

The total cost of this study is estimated to be approximately $150,000.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

The EPA would like to solicit comments to:

(i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(ii) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, Start Printed Page 78228including the validity of the methodology and assumptions used;

(iii) Enhance the quality, utility, and clarity of the information to be collected; and

(iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Burden Statement: The computer-assisted telephone questionnaire will be administered to mothers previously contacted via mail. Each interview will last approximately 10 minutes, including the time spent eliciting informed consent. A maximum of 1000 mothers will be invited to participate (10,000 total minutes or 167 total hours), we estimate that approximately 700 mothers will respond, resulting in a total time of 7000 minutes, or 117 hours. The data collection will be scheduled over approximately 3 months. There are no direct respondent costs for this data collection. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

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Dated: December 4, 2002.

John Vandenberg,

Director, Human Studies Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development.

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[FR Doc. 02-32262 Filed 12-20-02; 8:45 am]