[Federal Register Volume 70, Number 69 (Tuesday, April 12, 2005)]
[Notices]
[Pages 19076-19078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7334]



[[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 
[email protected], 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: [email protected].

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

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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.

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                          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