[Federal Register: April 12, 2005 (Volume 70, Number 69)]
[Notices]
[Page 19076-19078]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ap05-70]
[[Page 19076]]
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ENVIRONMENTAL PROTECTION AGENCY
[ORD-2005-0010, FRL-7897-8]
Agency Information Collection Activities: Proposed Collection;
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.
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 EPA is planning to submit a
proposed Information Collection Request (ICR) to the Office of
Management and Budget (OMB). This is a request for a new collection.
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.
DATES: Comments must be submitted on or before June 13, 2005.
ADDRESSES: Submit your comments, referencing docket ID number ORD-2005-
0010, to EPA online using EDOCKET (our preferred method), by email to
oei.docket@epa.gov, or by mail to: EPA Docket Center, Environmental
Protection Agency, Office of Environmental Information Docket, Mail
Code 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: Susan Auby, Environmental Protection
Agency, Office of Information Collection, Office of Environmental
Information, 1200 Pennsylvania Ave., NW., Mail Code 28221T, Washington,
DC 20460; telephone number: (202) 566-1672; fax number: (202) 566-1753;
email address: auby.susan@epa.gov.
SUPPLEMENTARY INFORMATION: EPA has established a public docket for this
ICR under Docket ID number 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 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 obtain a copy of the draft collection of information,
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
60 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, Confidential Business
Information (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.
Affected entities: Entities potentially affected by this action are
women aged 18-40 years, pregnant women, their husbands or partners, and
their children who live in selected areas of North Carolina.
Title: Population-based pilot study of children's environmental
health in support of the National Children's Study.
Abstract: 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. 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). The
purpose of this study is to pilot test protocols, policies and
procedures for the NCS with the goal of improving the efficiency of
study procedures and enhancing the likelihood of successful
implementation in probability-based population study locations across
the US. In particular, this study will test procedures for population-
based sampling and subject recruitment, test proposed study logistics
and estimates of subject burden, and evaluate data collection
strategies including interviews and acquisition of biologic and
environmental samples. Under the Children's Health Act of 2000, NICHD
is charged with leading a cooperative federal effort with EPA and other
agencies of the Department of Health and Human Services to plan and
implement a comprehensive study of children's environmental health.
Further details on the NCS, including the Study Plan, can be found at:
http://www.nationalchildrensstudy.gov. Population-based sampling was a
strong recommendation from the NCS Federal Advisory Committee and an
expert panel workshop on sampling held in March 2004 recommended a
pilot test of sampling strategies. Given the scale and complexity of
the proposed NCS strategy for recruiting pregnant women and women
attempting pregnancy, this pilot study will address uncertainties
related to sampling and recruitment.
Two locations will be selected (one urban and one rural), each of
which approximately corresponds to a NCS Primary Sampling Unit (PSU).
Within each location, two geographic areas will be defined as
``segments.'' The NCS is interested in exploring ways of defining
segments that may lead to more natural communities, so two of the
segments will be drawn based on elementary school catchment areas in
addition to two segments drawn using more traditional census
boundaries. Comparing census-based segments to school-based segments,
we plan to evaluate the time, cost, and efficiency of collecting
community measures; and the impact on recruitment and community
engagement. We plan to evaluate strategies for enumerating the
population such as counting and listing, as well as the use of
commercial postal lists.
Once the segments are enumerated, we plan to visit approximately
10,000 occupied households (approximately
[[Page 19077]]
2,500 per segment) to identify any female occupants who may be eligible
for the pilot study. The initial household visit is expected to take up
to 5 minutes per household, and any adult household member can provide
the necessary information. Each potentially eligible woman in the
household will then be administered a 15-minute screening interview to
determine her eligibility for the study. Like the NCS, this pilot will
recruit women prior to pregnancy who are planning to become pregnant or
who are likely to become pregnant and women who are in the first
trimester of pregnancy at the time of screening. This pilot will also
enroll women at screening who are pregnant but past the first trimester
and a small number of women may be recruited during the birth hospital
stay. The pilot study recruitment and enrollment procedures include up
to five household visits, determining if a lower number of visits would
achieve optimal efficiency. Each segment will have a consistent visit
schedule protocol to avoid confusion. Like the NCS, eligible women who
are planning pregnancy or likely to become pregnant will be aged 18-40
years. For the pilot study, women who are currently pregnant are
eligible if they are 18 years of age or older. Since the sample is
based on residence at delivery, only women who plan to reside in the
same area at delivery (i.e., not move out of the segment before giving
birth) will be eligible. The household screening phase of the project
is expected to take approximately four months to complete.
We plan to follow the visit schedule proposed in the NCS Study
Plan. Women with a high likelihood of pregnancy (i.e., planners) will
be visited in their homes approximately every two months for up to four
visits (or until they conceive) with short telephone interviews in the
intervening months. Women with a moderate likelihood of pregnancy will
have one home visit and short telephone interviews every three months
to update pregnancy status. Women with a low likelihood of pregnancy
will be contacted by telephone twice--at six months and at one year
after enrollment--to determine if their pregnancy status has changed.
(These three groups are defined by the NCS Study Plan as high,
moderate, and low risk of pregnancy, respectively.)
During pregnancy, we plan to make a home visit in the first
trimester and a clinic visit in both the second and third trimester. At
each clinic visit, we plan to complete a brief interview and to conduct
various clinical exams or tests (such as ultrasound exams, venous blood
draw, etc.). In addition to these three pregnancy visits, women who are
enrolled early (before 8-10 weeks of pregnancy) may be invited to an
additional study clinic visit for an oral glucose tolerance test.
As with the NCS, we plan to attempt to collect a number of biologic
specimens at delivery. Many of these specimens (e.g., cord blood,
meconium) will involve minimal or no burden to the mother or infant.
After birth, we plan to visit the family in the home when the child is
1 month, 6 months, 12 months, and 18 months of age. At each home visit
we anticipate collecting interview data; biologic specimens that are
non-invasive (e.g., nails, hair) or minimal risk (such as venous blood
drawn by a trained phlebotomist); and environmental samples (such as
dust wipes).
The content of the interviews and analytic plan for the biologic
and environmental samples collected are focused on factors related to
child growth and development. Questions will be asked about diet and
activity as well as demographic information, medical history,
occupational and other exposures, alcohol and smoking (including
environmental tobacco smoke exposure), mental health and feelings about
pregnancy and parenthood, social support, pets, neighborhood
characteristics, and measures of child health and development. Specific
data elements are intended to capture some of the domains that will be
measured in the NCS which has a broad definition of environment
including biologic, chemical, physical, and psycho-social. We expect to
interview subjects regularly about their feelings about study
participation to capture the qualitative assessments of acceptability
and enhance the lessons that can be learned which may enhance the
successful implementation of the NCS.
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, including 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 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. Women who are not
pregnant at the time of enrollment will have varying burden levels
depending on their time to pregnancy and their likelihood of pregnancy
(as described above). Women who are enrolled in the pilot study while
pregnant or at delivery will be folded into the visit schedule at the
appropriate point. Detailed estimates regarding the number of potential
respondents and burden associated with each visit are provided in the
EDOCKET. Table 1 provides the average burden hours per respondent and
the total cumulative burden hours for the entire study period
(approximately 3 years and 1 month).
Approximately 5 minutes per household is required to determine
potentially eligible occupants. Potentially eligible women are asked to
complete a 15-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 men 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.
[[Page 19078]]
Table 1.--Estimated Average and Total Burden for All Contacts
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Estimated Average burden Estimated
Type of respondent number of hours per total burden Total burden
respondents respondent hours cost
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Household Unit.................................. 10,000 0.1 1,000 \2\ $16,070
Women Screened, Not Enrolled.................... 4,346 0.3 1,303 \2\ 21,070
Women Screened and Enrolled.....................
High likelihood of pregnancy.................... 167 6.2 1,786 \2\ 28,880
Moderate likelihood of pregnancy................ 572 3.7 2,527 \2\ 40,862
Low likelihood of pregnancy..................... 1,797 1.5 3,000 \2\ 48,510
Pregnant at enrollment \1\...................... 169 4.0 1,952 \2\ 31,564
Enrolled at delivery............................ 35 7.1 248 \2\ 4,010
Men............................................. 1,074 0.8 1,286 \2\ 20,795
Children........................................ 406 1.5 603 \3\ 3,105
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\1\ Includes 48 volunteers assumed to be pregnant at enrollment.
\2\ $16.17/hour. Source: Bureau of Labor Statistics, State Wage Data for North Carolina. http://www.bls.gov/oes/
current/oes--nc.htm.
\3\ $5.15/hour (minimum wage).
Dated: March 29, 2005.
Rebecca L. Calderon,
Director, Human Studies Division.
[FR Doc. 05-7334 Filed 4-11-05; 8:45 am]
BILLING CODE 6560-50-P