[Federal Register Volume 70, Number 181 (Tuesday, September 20, 2005)]
[Notices]
[Pages 55127-55128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18711]


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ENVIRONMENTAL PROTECTION AGENCY

[ORD-2005-0010; FRL-7971-1]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: 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.

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

ADDRESSES: Submit your comments, referencing docket ID No. ORD-2005-
0010, to (1) EPA online using EDOCKET (our preferred method), by e-mail 
to [email protected], 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.

FOR FURTHER INFORMATION CONTACT: 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: 
[email protected].

SUPPLEMENTARY INFORMATION: 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

[[Page 55128]]

Reading 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 http://www.epa.gov/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 http://www.epa.gov/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 http://www.nationalchildrensstudy.gov.
    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.

    Dated: September 6, 2005.
Oscar Morales,
Director, Collection Strategies Division.
[FR Doc. 05-18711 Filed 9-19-05; 8:45 am]
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