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Agency Information Collection Activities; Submission of EPA ICR No. 2109.01 to OMB for Review and Approval; Comment Request

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 the following Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval: Seven County Study of Air Quality and Birth Defects: Computer-Assisted Telephone Questionnaire for Subset of Study Population (EPA ICR No. 2109.01) The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.


Additional comments may be submitted on or before May 5, 2003.


Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section.

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Dr. Pauline Mendola, U.S. EPA/NHEERL, Human Studies Division, MD 58 A, Research Triangle Park, NC 27711; telephone number: (919) 966-6953; fax (919) 966-7584; e-mail address:

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EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On December 23, 2002 (67 FR 78227) EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.

EPA has established a public docket for this ICR under Docket ID No. ORD-2003-0001 which is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Office of Environmental Information Docket is (202) 566-1753. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at​edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified above.

Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: (1) Submit your comments to EPA online using EDOCKET (our preferred method), by e-mail to, or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not Start Printed Page 16507be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 (May 31, 2002), or go to​edocket.

Title: Seven County Study of Air Quality and Birth Defects: Computer-Assisted Telephone Questionnaire for Subset of Study Population (EPA ICR Number 2109.01). This is a request for a new collection. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB.

Abstract: The 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 are the mothers of babies born with and without birth defects in 1999 in seven Texas counties and will be randomly selected from a larger case-control study of air pollution and birth defects in the state. Potential participants will be first contacted by mail to provide basic information about the questionnaire. Within two weeks of receipt of the letter, they will be telephoned and invited to complete the questionnaire over the telephone. Participation in the telephone interview is completely voluntary. The study investigators will use this data to help estimate the association between air pollution exposure and the risk of selected birth defects. The questionnaire seeks to gather information on individual-level behaviors that have never been collected in studies published in this area of research. If it proves useful, it will indicate a need for such supplemental data collection in future studies. Confidentiality of the participants will be maintained by keeping all electronic forms and datasets on password protected computers, and any CDs or floppy disks in locked filing cabinets of the study investigators. No participant will be identifiable through any publications including EPA reports, dissertation manuscripts and journal articles.

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, and are identified on the form and/or instrument, if applicable.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 10 minutes per response. 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.

Respondents/Affected Entities: Individuals or households.

Estimated Number of Respondents: 1000.

Frequency of Response: Once.

Estimated Total Annual Hour Burden: 167.

Estimated Total Annual Cost: $2,458.24.

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Dated: March 27, 2003.

Oscar Morales,

Director, Collection Strategies Division.

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[FR Doc. 03-8256 Filed 4-3-03; 8:45 am]