[Federal Register Volume 69, Number 211 (Tuesday, November 2, 2004)]
[Notices]
[Pages 63527-63528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24416]


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ENVIRONMENTAL PROTECTION AGENCY

[ORD-2004-0016, FRL-7832-9]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Application of Measures of Spontaneous Motor Activity 
for Behavioral Assessment in Human Infants, EPA ICR Number: 2166.01

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 January 3, 2005.

ADDRESSES: Submit your comments, referencing docket ID number ORD-2004-
0016, to EPA online using EDOCKET (our preferred method), by e-mail to 
[email protected], or by mail to: EPA Docket Center, Environmental 
Protection Agency, ORD Docket 28221-T, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: Susan Auby, Environmental Protection 
Agency, Office of Information Collection, Mail Code 28221T, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 
566-1672; fax number: (202) 566-1753; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA has established a public docket for this 
ICR under Docket ID number ORD-2004-0016, 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 1752XXXX. 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, 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 
families with children between 4 and 14 months of age residing in the 
Research Triangle Park, NC area.

[[Page 63528]]

    Title: Application of Measures of Spontaneous Motor Activity for 
Behavioral Assessment in Human Infants.
    Abstract: The goal of the proposed information collection is to 
test a method to collect data that would be used to quantitatively 
characterize spontaneous motor activity in young children between the 
ages of 4 and 24 months. Data from the study will be used to (1) 
identify sources of variance in infants' and toddlers' daily activity 
levels, (2) estimate the number of days of activity measurement that 
would be necessary to reliably measure these activities, and (3) 
investigate the potential association between activity measures 
averaged over long periods of time (e.g., days) and activity measures 
averaged over the duration of a specific event. Data will be analyzed 
and used to help EPA determine the best way to gather reliable data to 
further examine the effects of exposure to neurotoxicants on 
development in young children. The information will appear in the form 
of final EPA reports and journal articles and will be made publically 
available. 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 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: Two hundred and twenty parent-child dyads will be 
invited to a laboratory for an initial visit, where the study examiner 
will obtain consent and place small, lightweight device called an 
accelerometer on the child's ankle or wrist. This will take 
approximately 30 minutes per dyad and result in a burden of 110 hours. 
Children will wear the accelerometer, which produces activity measures, 
for a 7-day monitoring period (day and night). After the accelerometer 
has been placed, the parent will complete either the Infant Behavioral 
Questionnaire Revised (IBQ-R) (for children under the age of 12 months) 
of the Infant Toddler Social and Emotional Assessment (ITSEA) (for 
children over the age of 12 months), and results will be used to assess 
the child's temperament. Administration of either the IBQ-R or the 
ITSEA takes on average 30 minutes, resulting in a burden of 110 hours. 
During the lab visit, the study examiner will administer the Peabody 
Developmental Motor Scale, 2nd Edition (PMDS-2) to the child; any child 
not falling into the normal range of motor activity will not be asked 
to continue in the study. Administration of the PMDS-2 takes, on 
average, 45 minutes. This corresponds to a burden of 165 hours for the 
study population. Children continuing in the study will participate in 
a brief unstructured play activity before leaving the lab.
    If a child is in the normal range of motor development, the parent 
will be provided with a 7-day Time Activity Diary on which the parent 
will record the beginning and ending time of each activity, using a 
list of coded responses. Each parent will spend approximately 45 
minutes per day for each of the 7 study days completing the Time 
Activity Diary. This corresponds to 5.25 hours per individual or 1,155 
hours for the study population (5.25 x 220). At 48 hour intervals the 
study examiner will visit the child's home to retrieve accelerometer 
data. At the end of the 7-day data collection period, the study 
examiner will visit the home of each dyad to collect the accelerometer 
and Time Activity Diary. Each of these visits will take approximately 
30 minutes, resulting in 198 hours of response burden. Thus, the total 
burden for 220 parent-child dyads is estimated to be 1,738 hours. The 
data collection will be scheduled over 12 months. There are no direct 
respondent costs for this data collection. 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.

    Dated: October 19, 2004.
Rebecca Calderon,
Director, Human Studies Division, National Health and Environmental 
Effects Research Laboratory, Office of Research and Development.
[FR Doc. 04-24416 Filed 11-1-04; 8:45 am]
BILLING CODE 6560-50-P