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Agency Information Collection Activities: Submission to OMB for Review and Approval; Comment Request; Population-Based Pilot Study of Children's Environmental Health in Support of The National Children's Study, EPA ICR Number 2187.01

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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 an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request for a new collection. This ICR describes the nature of the information collection and its estimated burden and cost.


Comments must be submitted on or before October 20, 2005.


Submit your comments, referencing docket ID No. ORD-2005-0010, to (1) EPA online using EDOCKET (our preferred method), by e-mail to, or by mail to: EPA Docket Center, Environmental Protection Agency, Office of Research and Development Docket, Mail Code 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

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Pauline Mendola, Office of Research and Development, National Health and Environmental Effects Research Library, Human Studies Division, Environmental Protection Agency, Mail Code MD 58 A, Research Triangle Park, NC 27711; telephone number: (919) 966-6953; fax number: (919) 966-7584; e-mail address:

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EPA has submitted the following ICR to OMB for review and approval according to procedures prescribed in 5 CFR 1320.12. On April 12, 2005 (70 FR 19076), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA has addressed the comments received.

EPA has established a public docket for this ICR under Docket ID No. ORD-2005-0010, which is available for public viewing at the Office of Research and Development 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 Start Printed Page 55128Reading Room is (202) 566-1744, and the telephone number for the Office of Research and Development Docket is (202) 566-1752. 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 within 30 days of this notice. 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 be 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: Population-based Pilot Study of Children's Environmental Health in Support of The National Children's Study.

Abstract: The proposed study will be conducted by the Epidemiology and Biomarkers Branch, Human Studies Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development, U.S. EPA. The U.S. EPA will conduct this research in partnership with the National Children's Study (NCS) Program Office at the National Institute of Child Health and Human Development (NICHD) as well as the other lead agencies of the NCS: the Centers for Disease Control and Prevention (CDC) and the National Institute of Environmental Health Sciences (NIEHS). This proposed data collection will pilot test logistics, protocols and procedures for the NCS, a long term study of the influence of environmental factors on child health and development. The goal is to improve the efficiency of the implementation of NCS by testing procedures for population-based sampling and subject recruitment, proposed study logistics and estimates of subject burden, and evaluating data collection strategies including interviews and acquisition of biologic and environmental samples. Further details on the NCS, including the Study Plan, can be found at

Approximately 10,000 households will be screened and 2,740 women will be enrolled who meet eligibility criteria, primarily defined by age and likelihood of pregnancy. The schedule of visits follows the proposed NCS Study Plan. Briefly, women who are planning pregnancy will be visited bimonthly, women with lower likelihood of pregnancy will be visited once; pregnant women will have a home visit in the first trimester and a clinic visit in the second and third trimester. A hospital visit at birth is planned as well as home visits to follow-up with the mother and infant at 1, 6, 12, and 18 months of age. Data from interviews as well as biologic and environmental samples will address the relationship between common environmental factors and the physical and developmental growth of children. Qualitative assessments of the participants' perceptions about the study will be gathered at each visit to enhance the lessons that can be learned to aid the successful implementation of the NCS.

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 in 40 CFR are listed in 40 CFR part 9 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 varies depending on the eligibility and pregnancy status of women at the time of enrollment. Detailed estimates regarding the number of potential respondents and burden associated with each visit are provided in the EDOCKET. Approximately 10 minutes per household is required to determine potentially eligible occupants. Potentially eligible women are asked to complete a 10-minute screening interview. The estimated total burden for a fully participating woman ranges from 8 hours (for a woman enrolled at delivery) to 21 hours (for a “high likelihood” woman who receives all contacts in the preconception period) over a three year period. The burden for husbands/partners is somewhat more consistent because they only receive one visit in each of the preconception, pregnancy, and childhood visit periods; each visit is approximately 1 hour. The burden for children ranges from 10 minutes at the birth visit to approximately 2 hours for full participation up to 18 months of age. 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: Women aged 18-40 years, pregnant women, their husbands or partners, and their children who live in selected areas of North Carolina.

Estimated Number of Respondents: 10,000.

Frequency of Response: On occasion.

Estimated Total Annual Hour Burden: 4,585.

Estimated Total Annual Cost: $82,728. There are no annualized capital costs or O&M costs.

Changes in the Estimates: Not applicable; this is a new information collection.

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Dated: September 6, 2005.

Oscar Morales,

Director, Collection Strategies Division.

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[FR Doc. 05-18711 Filed 9-19-05; 8:45 am]