Child Strength Study - Supporting Statement A

Child Strength Study - Supporting Statement A.pdf

Child Strength Study

OMB: 3041-0187

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INFORMATION COLLECTION REQUEST (ICR):
OMB supporting statement and privacy impact assessment for:
Child Strength Study

A. JUSTIFICATION
A.1

Circumstances Making the Collection of Information Necessary

This is a request to implement a strength data collection study of children 3 months through 5
years of age. The Consumer Product Safety Commission (CPSC) uses data on human strength
and capabilities to develop product safety standards and inform other CPSC staff activities.
Strength capabilities of children are essential information to develop product performance
requirements in standards to reduce or eliminate the risk such products might pose to a child
(e.g., breaking, collapsing, or liberating a small part). Manufacturers can also use this
information when designing products intended for children. In addition, products not intended
for children, but that can be hazardous to children, can be made safer by adopting performance
requirements that consider children’s ability to interact with product components.
In the 1970s, CPSC sponsored studies to conduct research on human size and strength,
particularly the landmark Snyder et al. (1975 and 1977) studies on child anthropometry and
Owings et al. (1975 and 1977) studies on child strength. 1 Although the research results were
instrumental for many years in developing product safety standards, the information needs an
update, given that these strength studies were conducted more than 40 years ago. CPSC expects
the information collection activity to provide information that reflects more accurately the
strength capabilities of today’s children, and to also provide data that are missing from the
currently available literature, including data for younger children and additional strength
measures. Accordingly, CPSC seeks to update data related to child strength through a new study.

1

Owings, C. L., Chaffin, D. B., Snyder, R. G., & Norcutt, R. H. (1975). Strength Characteristics of U.S. Children
for Product Safety Design. U.S. Consumer Product Safety Commission, Bethesda, MD.
Owings, C.L., Norcutt, R.H., Snyder, R.G., Golomb, D.H. and Lloyd, K.Y. (1977). Gripping Strength
Measurements of Children for Product Safety Design (Contract No. CPSC-C-76-0119).
Snyder, R.G., Spencer, M.L., Owings, C.L., & Schneider, L.W. (1975). The Physical Characteristics of Children as
Related to Death and Injury for Consumer Product Design and Use (Report No. UM-HSRI-BI-75-5). Prepared for
the U.S. Consumer Product Safety Commission. Ann Arbor, MI: The Highway Safety Research Institute,
University of Michigan.
Snyder, R.G., Schneider, L.W., Owings, C.L., Reynolds, H.M., Golomb, D.H., and Schork, M.A.
(1977). Anthropometry of Infants, Children, and Youths to Age 18 for Product Safety Design.
Final Report UM-HSRI-77-17. University of Michigan Transportation Research Institute, Ann
Arbor, MI. Prepared for the U.S. Consumer Product Safety Commission, Washington, D.C. 014926-F.

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A.2

Purpose and Use of the Information Collection

CPSC awarded a contract to the University of Michigan to conduct a study to update and expand
child strength data with a focus on real-world scenarios. The information collected from this
study will provide CPSC updated child strength measures, including upper and lower extremities
and bite strength, with expanded age ranges (strength data for children from 6 months through 5
years of age and bite strength for children from 3 months through 5 years of age). With this
information, CPSC staff will be able to offer more accurate and up-to-date data for voluntary and
mandatory standard development activities. These data will also help staff to analyze injuries
and deaths of children interacting with consumer products and determine whether a product
presents a safety hazard. The study seeks to collect strength information from up to 800 children
within the United States. The contractor will create a customized tool for data collection and
feedback, which will allow the contractor to tailor the interface for each exertion of interest;
check values against expected ranges to identify potential errors; and gather and synchronize
data from multiple sensors simultaneously.
A team of researchers at the University of Michigan Transportation Research Institute (UMTRI),
which has decades of experience in human measurement, including extensive anthropometry and
ergonomics research involving child participants and involving strength measurement, will lead
the study. The research team will obtain an Institutional Review Board (IRB) approval for this
project from the University of Michigan Health Sciences and Behavioral Sciences (IRB HSBS,
FWA00004969). UMTRI has developed a safety protocol to include COVID-related precautions;
the ability to conduct human subjects testing will be based on local conditions and applicable
mandates.
A.2.1 Description of study
The research team at UMTRI conducted pilot studies with children and designed fixtures. For the
actual study, CPSC staff anticipates that, over the 3-year period of this request, the contractor
will collect data from 800 children ranging in age 3 months to 5 years. The study will take up to
2 hours per participant. UMTRI researchers will recruit children via their caregivers through the
University of Michigan Engage site, Craigslist, and with flyers placed at UMTRI. UMTRI will
screen participants via a phone conversation with the caregiver. Inclusion criteria will be based
on age, lack of current illness or injury; age-appropriate cognitive and motor development, as
reported by the caregiver; and the caregiver’s ability to understand written and spoken English
(children in the older age categories should be able to understand spoken English). UMTRI
researchers will assign a subject ID number to each participant. UMTRI researchers will retain
the key file linking the subject ID to identifiable information separately from the data and will
destroy the key file at the conclusion of the testing. The study will be conducted at UMTRI
Laboratories in Ann Arbor, MI. Figure 1 shows the laboratory and a test fixture.

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Figure 1. Test fixture for measuring strength for pushing and pulling tasks in the UMTRI Laboratory.

A research assistant will explain and demonstrate the procedures to the caregiver and child.
Written consent will be obtained from the caregivers, who will remain with the children at all
times. Researchers will obtain verbal assent from the children who are old enough to provide it.
Researchers will obtain several standard anthropometric measurements from each child,
including body weight and standing height. Researchers will record the participant’s body shape
using a whole-body laser scanner (VITUS XXL) and a Microsoft Kinect sensor.
In the laboratory, the children will perform a sequence of tasks to test maximal exertions with
their hands and feet, using the test fixture shown in Figure 1. For standing tasks, they will grip a
padded handle with one or both hands, as instructed, and push or pull as hard as they can. Each
exertion will be targeted for approximately 5 seconds, including the ramp-up and release.
Participants will receive feedback via a graphic display that shows their maximum level
achieved, so that they can be encouraged to go beyond that level, if possible.
For some trials, the participant will be seated in a specially constructed laboratory chair, which is
adjustable, based on the child’s size. Seated exertions will include pushes and pulls with the
hands, and pushes with one foot and both feet. Researchers will vary conditions to avoid exertion
of one part of the body consecutively. For example, a hand pull might be followed by a hand or
foot push.
The research team will use video and images to assess the children’s performance, particularly
their tactics in achieving the requested exertions. The number of trials to be performed will
depend on the capability and attention of the child, but the maximum duration of a child’s
participation will be 2 hours for a single session. Researchers may ask caregivers and children to
return for a second session to collect additional strength measures. Participants will receive a 5minute break at least every 20 minutes, to allow the child to relax and play. The caregiver and
child can take a break or discontinue participation at any time. The caregiver will be paid an
incentive of $40 to $50 per session (up to 2 hours of participation).

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A.2.2 Audiences of data and results
CPSC technical staff will be the primary audience of the data and results. UMTRI researchers
will provide de-identified raw strength and position data, along with a report to CPSC staff. The
report will include an executive summary, background, methods, description of instrumentation
and methodology for each strength measure, including a drawing or picture; description of
validation of instrumentation and method; detailed discussion of the methods used to conduct the
study, including participant selection and recruitment, demographic characteristics, and relevant
anthropometric data, including weight and height; total sample size for each age group and
strength measure; results, including summary of data analysis by age group, including sample
sizes, 5th, 50th, and 95th percentile values, standard deviation, mean, minimum, and maximum
values for males, females, and combined; and data including both anthropometric and strength
measurements.
A.2.3 Methods of dissemination
The Commission will publically release the contractor’s final report, after it has been reviewed
and approved by CPSC staff, by disseminating the report on the agency’s website, and through
staff presentations at meetings and conferences related to the subject matter. The Commission,
its staff, agents and representatives will disseminate the information in accordance with the law
and Commission policy to ensure the information is accurate and not misleading.
To encourage dissemination of the findings, the report will be freely accessible on cpsc.gov. The
work will be prepared in the course of the author’s official contracting duties with CPSC. Thus,
Title 17 U.S.C. Section 105 applies, which provides that there can be no copyright in a United
States government publication.
A.3

Efforts to Identify Duplication and Use of Similar Information

The intent of this data collection is to obtain information that is not readily available elsewhere.
The last time CPSC collected this type of data was more than 40 years ago. Other more recent
studies collected data from a very small number of children, typically fewer than 20 per age
group.
A.4

Impact on Small Businesses or Other Small Entities

None, because the information will not be collected from small businesses or other small entities.
A.5
Consequences to federal program or policy activities if collection is not conducted or is
conducted less frequently
If this collection is not conducted, CPSC staff will have to use outdated strength data for
children, and the voluntary and mandatory standards will not benefit from updated data that more
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accurately reflects the strength capabilities of today’s children. Staff will also continue to lack
child strength data for measures that are relevant to children’s interactions with products,
including bite strength data and strength data for younger children. Lack of updated child
strength data could hinder the analysis of a product involved in a death or injury to a child,
resulting in preventing or delaying CPSC from taking action to remove a dangerous product from
the public.
A.6

Special Circumstances Relating to the Guidelines of 5 CFR §1320.5

No special circumstances exist. This information collection is consistent with the guidelines
prescribed in 5 CFR §1320.5.
A.7

Comments in Response to the Federal Register Notice

CPSC published notice of this proposed collection of information in the Federal Register and
invited comments on the proposal. 85 FR 53800 (Aug. 31, 2020). CPSC received four
comments. After review and consideration of the comments, CPSC did not make any changes to
the supporting statement regarding the study. CPSC’s comment responses will appear in a
separate Federal Register notice, prior to final OMB submission.
A.8

Explanation of any Payment or Gift

The contractor will provide $40 to the caregiver for each participant for up to 2 hours of
participation.
A.9

Assurance of Confidentiality Provided to Respondents

Participation in the study is voluntary, and respondents will be so informed before the screening,
and at the beginning of the study. Participants will be informed of the measures taken to protect
their confidentiality in the introductory language read to sampled persons. Information collected
from respondents will be kept confidential and only used for research purposes.
UMTRI researchers will assign participants a Random ID number not linked to any personal
identifying information. They will take photos and video of the participants in some conditions
to document their exertion postures. UMTRI researchers will de-identify the photos and video by
blurring or obscuring the faces. The data will be examined to assess repeatability and other
aspects of performance, but no generalizable findings will be drawn from the data. UMTRI
researchers will share the data with CPSC only in the form of de-identified information. The data
will be retained indefinitely at UMTRI in de-identified form to document the performance of the
test procedures, for example, the repeatability of certain exertions.

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A.10

Justification for Sensitive Questions

Questions asked in the study typically are not considered sensitive in nature.
A.11

Estimate of Hour Burden to Respondents

Below is a discussion of the burden hours to eventually reach 800 children for the lab study. We
anticipate the response rates shown below, based on previous studies.
Instrument

Hours per
respondent

Total number
of participants

Response
rate

Number of
respondents

Total hours

0.05

4167

30%

1250

63

0.15

1250

80%

1000

150

2

1000

80%

800

1600

3050

1813

Invitation
Invitation for study
Screener
Invitation for study
Study
In-lab study
Total

Total Burden Hours: 1813 hours

The total number of respondents is based on an initial study with 50 participants for each
strength measure for the following age categories:
•
•
•
•
•
•
•
•
•
•

3 – 5 months (bite strength only)
6 – 8 months
9 – 11 months
12 – 17 months
18 – 23 months
24 – 29 months
30 – 35 months
36 – 47 months
48 – 59 months
60 – 71 months

Researchers plan follow-on studies with up to 300 additional participants to collect data for more
strength measures and product-specific interactions.

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A.12

Estimate of Total Annual Cost Burden to Respondents

Respondents have no costs or recordkeeping requirements associated with the study. The
collection has no associated operating, maintenance, or capital costs.
A.13

Estimate of Annualized Costs to the Federal Government

CPSC issued a contract to design and conduct the child strength study to the University of
Michigan under contract number 61320618D0004 for $1,134,502. We estimate salary and
benefits costs for government personnel assigned to this study at $170,356, based on 12 staff
months in 2020, at an average level of GS-13 step 5 in the Washington, D.C. area, effective
January 2020 ($116,353) and a 68.3 percent ratio of wages and salary to total compensation (all
civilian management, professional, and related workers) from Table 2 of the March 2020
Employer Costs for Employee Compensation, published by the Bureau of Labor Statistics.
Therefore, the estimated cost to the government is $1,134,502, plus $170,356 in government
labor costs, for a total of $1,304,858.
A.14

Program Changes or Adjustments

This is not applicable. This is a new request for information collection.
A.15

Publication Plan

The contractor will develop a technical report that will present a description of study design,
research methods, summary of results, and findings and conclusions.
The Commission will release the final technical report by disseminating the report on the
agency’s website and through presentations at meetings and conferences related to the subject
matter. The procedures to disseminate the information by the Commission, its staff, agents, and
representatives will be in accordance with the law and Commission policy to ensure the
information is accurate and not misleading. The agency will disseminate the findings when
appropriate, strictly following the agency’s “Guidelines for Ensuring the Quality of Information
Disseminated to the Public.”
To encourage dissemination of the findings, the report will be freely accessible on cpsc.gov. The
work will be prepared in the course of the author’s official contracting duties with CPSC. Thus,
Title 17 U.S.C. Section 105 applies, which provides that there can be no copyright in a United
States government publication.
A.16

Rationale for Not Displaying the Expiration Date for OMB Approval

No such exception is sought. The OMB data collection number and expiration date will be
displayed on the initial screener and informed consent forms to be used as a reference, if needed.
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A.17

Exception to the Certification Statement

No such exception is sought. These activities comply with the requirements in 5 CFR §1320.9.

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