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.

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 ord.docket@epa.gov, 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: auby.susan@epa.gov.

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.

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 × 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.