[Federal Register: September 20, 2005 (Volume 70, Number 181)]
[Notices]
[Page 55127-55128]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se05-55]
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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 ord.docket@epa.gov, 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:
mendola.pauline@epa.gov.
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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