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###### Consumer Product Safety Commission

          - [CPSC Docket No. 2023-0031]

# AGENCY:

Consumer Product Safety Commission.

# ACTION:

Notice.

# SUMMARY:

Pursuant to the Paperwork Reduction Act of 1995 (PRA), this is the Consumer Product Safety Commission's (CPSC or Commission) second notice inviting public comment about a request for approval from the Office of Management and Budget (OMB) for a new information collection. The proposed collection is associated with CPSC's investigation, through child observations and caregiver questionnaires, of smart toys and additional toys (take-apart vehicles, musical instruments, figurines, plush toys with electronic components, and manipulatives) to consider children's ability to interact with toys as the manufacturer intended and assist in updating CPSC's age determination guidelines. We received one comment on the first notice, which we address in this notice, and again describe the proposed collection of information.  By publication of this notice, the Commission announces that CPSC has submitted to the OMB a request for approval of the collection of information, as proposed.

# DATES:

Submit written or electronic comments on the collection of information by January 2, 2024.

# ADDRESSES:

                        Submit comments about this request by email:                         *OIRA_submission@omb.eop.gov*                         or fax: 202-395-6881. Comments by mail should be sent to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the CPSC, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503. In addition, written comments that are sent to OMB, also should be submitted electronically at:                         *http://www.regulations.gov,*                         under Docket No. CPSC-2023-0031, by any of the following methods:                    

*Electronic Submissions:*                         CPSC encourages you to submit electronic comments to the Federal eRulemaking Portal at:                         *https://www.regulations.gov.*                         Follow the instructions for submitting comments. CPSC typically does not accept comments submitted by electronic mail (email), except as described below.                    

*Mail/Hand Delivery/Courier/Confidential Written Submissions:*                         Submit comments by mail, hand delivery, or courier to: Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: (301) 504-7479. If you wish to submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public, you may submit such comments by mail, hand delivery, or courier, or you may email them to:                         *cpsc-os@cpsc.gov.*

*Instructions:*                         All submissions must include the agency name and docket number. CPSC may post all comments without change, including any personal                               ( print page 83534)                            identifiers, contact information, or other personal information provided, to:                         *https://www.regulations.gov.*                         Do not submit through this website: confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If you wish to submit such information, please submit it according to the instructions for mail/hand delivery/courier/confidential written submissions.                    

*Docket:*                         For access to the docket to read background documents or comments received, go to:                         *https://www.regulations.gov;*                         insert the docket number, CPSC-2023-0031, into the “Search” box; and follow the prompts.                    

# FOR FURTHER INFORMATION CONTACT:

                        Cynthia Gillham, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; (301)504-7791, or by email to:                         *CGillham@cpsc.gov.*

# SUPPLEMENTARY INFORMATION:

                    Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521), before an agency submits a proposed collection of information to OMB for approval, it must first publish a document in the                     **Federal Register**                     providing a 60-day comment period and otherwise consult with members of the public and affected agencies concerning the proposed collection of information. CPSC published notice of this collection on August 7, 2023, and received one comment. 88 FR 52142. CPSC has not made any changes in the study based on that comment.                

## I. Burden Description

                    Under the PRA, CPSC is publishing the following information: [1] 

 A title for the collection of information;

 A summary of the collection of information;

 A brief description of the need for the information and the proposed use of the information;

 A description of the likely respondents and proposed frequency of response to the collection of information;

 An estimate of the burden that will result from the collection of information; and

 Notice that comments may be submitted to the agency and OMB.

44 U.S.C. 3507(a)(1)(D). Specifically, the Commission provides the following information:

*Title:*                     Investigation of Smart Toys and Additional Toys Through Child Observations.                

*OMB Control Number:*                     New.                

*Type of Request:*                     New information collection requirement.                

*Type of Review Requested:*                     Regular.                

*Requested Expiration Date of Approval:*                     1 year from date of approval.                

*Summary of the Collection of Information:*                     CPSC proposes to conduct individual in-person data collection sessions with up to 60 children aged 2 to 4 years old and their caregivers, for a total of 120 participants. Caregivers will answer a series of screening questions to determine if the caregiver and child meet the criteria for enrollment in the study. CPSC will enroll in the data collection study children and caregivers who meet the screening criteria and are willing to participate.                

                    Over 2 in-person sessions, researchers will collect data primarily through direct human observations of children's interactions with toys and caregivers' responses to questionnaires. In each session, researchers will introduce children to 4 or 5 toys chosen from 6 toy categories (smart toys, take-apart vehicles, musical instruments, figurines, plush toys with electronic components, and manipulatives). The researcher will demonstrate for the child how to use each toy and then document the child's play patterns with the toy, noting the child's ability to interact with each toy consistent with the manufacturer's instructions. Researchers will use coding checklists to document real-time observations of the child's interactions with the toys, in the form of concrete behaviors across different modalities, such as gross motor (                    *e.g.,*                     turns figurines head), fine motor (                    *e.g.,*                     slides switch on/off), and behavioral (                    *e.g.,*                     feeds an animal, engages in pretend play with one or multiple figurines), which demonstrate the child's ability to use the toy as intended.                

Caregivers will respond to researcher questions about the caregiver's perception of their child's ability to interact with the selected toys as intended, potential purchasing decisions for the specific toys, and whether the caregiver would demonstrate how to play with the toys or some of the components as the manufacturer intends. Researchers will record on paper forms their observations of children's interactions and caregiver's responses to questions about the toys.

Researchers will randomize the presentation order of the toys for each caregiver/child pair to preclude any effects of sequence and control for learning or fatigue that might take place. Also, researchers will use video cameras to record each child's interaction with a toy. Researchers will use the video as a backup reference for real time coding.

Researchers will separate out all personally identifiable information from data collected. Also, researchers will separate out from collected information all identifying information from the initial screening, as well as scheduling. This information will be kept on a secure server in password protected files and discarded by researchers when no longer needed. At the end of each session, researchers will save the video data onto a secure server. Researchers will enter data recorded on the paper forms into a secure database, which also will be kept on a secure server. Researchers will limit access to this information and will summarize all information collected during the sessions using generic categories and summary statistics.

*Description of the Need for the Information and Proposed Use of the Information:*                     Created in 1972, the CPSC is an independent federal regulatory agency with a public health and safety mission to protect the public from unreasonable risks of injury and death from consumer products used in and around the home, in recreation, and in schools. As part of this statutory mandate, CPSC is authorized to conduct research on consumer products and behavior to identify and address product safety hazards, as well as to develop efficient and effective means of bringing about safety improvements. This information collection supports the Commission's strategic goal of safety.                

                    Age-appropriate toys are important for the physical, intellectual, and socioemotional development of children. Age-appropriate toys can help children learn, develop imaginative capacities, and refine motor coordination. However, interacting with toys intended for older children poses a potential risk for a child to be seriously or fatally injured. In 2021, an estimated 206,400 toy-related injuries were treated in U.S. hospital emergency rooms.[2]                                          Of the 206,400 toy-related injuries, an estimated 74% happened to children 14 years of age or younger; 69% occurred to children 12 years of age or younger; and 37% happened to children 4 years of age or younger.                

                    To identify a toy's safety hazards, the CPSC Division of Human Factors first determines the intended age group of potential users. CPSC considers age determinations for toys to be of                           ( print page 83535)                        paramount importance because age-grading and labeling can be used to assist consumers in making purchasing decisions, and also serve as the basis for the toy's regulatory requirements and the associated testing parameters. For example, toys intended for children under 8 years of age are required to undergo use and abuse tests based on actual use and misuse by children of that age. Test specifications vary for different age groups (                    *i.e.,*                     children 18 months and younger, 19-36 months, and 37-95 months). Toys intended for children younger than 3 years old cannot contain small parts. Additionally, since 2008, CPSC regulations establish lead and phthalates limitations for many products intended for children 12 years of age.                

                    CPSC staff consider numerous toy characteristics when determining the intended age, including the physical characteristics of the toy (                    *e.g.,*                     size and weight of the toy and its components), the cognitive requirements for using the toy as intended, the fine motor or other physical skills required to use the toy as the manufacturer intended, and the toy's theme and appearance. The CPSC's                     *Age Determination Guidelines: Relating Consumer Product Characteristics to the Skills, Play Behaviors, and Interests of Children (Guidelines),*                     available at                     *https://www.cpsc.gov/​content/​2020-Age-Determination-Guidelines,*                     provide details and examples for each of these characteristics for different age groups. Manufacturers can use the                     *Guidelines*                     to generate an intended age during a toy's design phase. Manufacturers can also use the                     *Guidelines*                     to accurately age label a product, which promotes safety by informing consumer purchasing and toy-safety decisions (meaning which toys are appropriate to allow a child to play with).                

                    Although the                     *Guidelines*                     include extensive information about a large variety of toys, some toy categories are not well covered in the                     *Guidelines*                     because they include toys that are new to the U.S. market since the research that went into the 2020 version of the                     *Guidelines.*                     While smart toys are discussed in the                     *Guidelines,*                     this category of toys evolves rapidly, so the                     *Guidelines*                     may not represent what is currently in the market. Other toys such as figurines, interlocking building sets, and musical toys are discussed in the                     *Guidelines,*                     though not extensively. This data collection will add to the information about selected toys in six toy categories (smart toys, take-apart vehicles, musical instruments, figurines, plush toys with electronic components, and manipulatives), and enrich CPSC's understanding regarding the ages of children who are interested in these toys and who possess the skills and cognitive ability to use them as intended. This data collection will provide information to help CPSC determine the developmentally appropriate ages for selected toys. Ultimately, the data collection will inform the various stakeholders who use the information contained in the                     *Guidelines.*

*Affected Public:*                     Children between 2 and 4 years of age and their caregivers.                

*Estimated Number of Respondents:*                     60 children and 60 caregivers, totaling 120 individuals.                

*Frequency:*                     One-time data collection that will take place over 2 in-person sessions. The first session will last up to 80 minutes, and the second session will last up to 80 minutes.                

*Estimated Total Annual Burden Hours:*                     CPSC plans to pilot test the study with 4 participants (2 caregivers and 2 children) with a maximum time burden of 2.67 hours per person (10.68 hours). CPSC also assumes a 15-minute completion time for the recruitment screener questionnaire to be filled out by a maximum of 100 people, to select 60 adult participants (25 hours).                

                    CPSC estimates that the total time for each selected respondent pair (caregiver/child) to participate in the data collection will likely not be more than 160 minutes. Therefore, each participant has a maximum time burden of 2.67 hours. Data collection duration for each respondent will be 2.67 hours, or a total of 160 hours for 60 respondent pairs. Respondent pairs will not incur any reporting costs from the information collection. The pairs also will not incur a record keeping burden or record keeping costs from this information collection. We will assume an hourly wage rate of $31.54 for each respondent pair (caregiver and child).[3] 

Accordingly, the total burden hours to recruit participants and for selected respondents to participate is 356 hours (recruitment screening time (25 hours), pilot study (10.68 hours), and the main study (2.67 hours × 120 participants)).

                    The total cost of this collection to the federal government is $93,345 annually. This represents 6 months of staff time. This amount includes federal employee salaries and benefits. No travel costs are associated with the collection. This estimate uses an annual salary of $126,949 (the equivalent of a GS-13, Step 5 employee, in the Washington DC area in 2023) [4]                                          which represents 68.0 percent of the employer costs for employee compensation. The remaining 32.0 percent of employer costs are added for benefits (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” March 2023, percentage of wages and salaries for all civilian management, professional, and related employees),[5]                                          for a total annual compensation per FTE of $186,690.                

*Estimated Total Annual Burden Cost:*                     $104,573.24 (Respondents: $11,228.24 (31.54/hr. × 356 hours) + Federal Government: $93,345).                

## II. Comment Response

*Comment Summary:*                     The National Center for Health Research submitted a comment on the proposal, supporting CPSC's research but concerned that the study design will not provide the needed information. The commenter suggests that CPSC may need at least twice as many as the 60 children and 60 caregivers in the study to determine products appropriate for children ages 2 to 4. The commenter believes that the study should include more children to represent the diversity of U.S. children in the 3-year age group for cognitive and social development, socio-economic status, and social and cultural differences, because these differences could influence the ability to use toys safely and effectively. The commenter states that even 120 children may not be an adequate sample size because each child would only be evaluated regarding 4 of the 6 different toy categories, opining that more children are necessary to study appropriate labeling for children under 3 years old, and that increasing the number and diversity of children and caregivers that engage with each toy category is essential to provide information that will be reliable and generalizable for families across the country.                

*CPSC's Response:*                     The proposed data collection is not intended to provide nationally representative data; this research is exploratory. Further, as this is largely a descriptive study, CPSC does not plan on conducting inferential statistics and doing hypothesis testing. Researchers will gather information by documenting children's play patterns with selected toys from each of six toy categories that are not addressed in CPSC's                     *Guidelines*                     (                    *i.e.,*                     smart toys, take-apart vehicles, musical instruments, figurines, plush toys with electronic components, and manipulatives). Given                           ( print page 83536)                        that children's play behaviors with these toy categories have not been thoroughly examined, this research is an initial exploration of the types of play behaviors children of different age groups exhibit when interacting with the selected toys. Researchers will gather information by observing children's play patterns in a laboratory setting and noting how they interact with selected toys. The controlled laboratory setting will allow researchers to explore developmental differences in play patterns among the age groups.                

Additionally, the duration of each session provides the researchers an opportunity to observe naturalistic play behaviors without rushing the child through interacting with the toy. Researchers will code and summarize observation data while the child is interacting with the toy. Researchers will tabulate descriptive statistics to identify the universe of behaviors for each age group and toy, and, when possible, compare children's play with toys that are intended for their age, versus toys that are intended for children either older or younger. Collecting this data will add to the available information about toys in six toy categories and inform potential next steps in the age-grading process.

Because pilot testing per pair could be up to a maximum of 80 minutes for each session, CPSC is calculating the overall possible information collection participant burden based upon a 160-minute maximum burden. Researchers determined the duration of sessions to balance adequate time for observation, needed breaks for the child, and not overburdening the child.

The commenter expressed concern that “Each child would only be evaluated regarding 4 of the 6 different toy categories.” In fact, the researchers will introduce children to selected toys from 6 toy categories (smart toys, take-apart vehicles, musical instruments, figurines, plush toys with electronic components, and manipulatives) in each of the sessions. During the first session they will be introduced to 4 toys and during the second session they will be introduced to 5 toys, for a total of 9 toys. The order in which the toys are presented will be randomized to preclude the effects of fatigue and learning from one toy to the next.

Elina Lingappa,

Paralegal Specialist, Consumer Product Safety Commission.

# Footnotes

1.                             On November 21, 2023, the Commission voted (4-0) to publish this notice.                    
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2.                             Consumer Product Safety Commission: Toy-Related Deaths and Injuries, Calendar Year 2021. November, 2022: Toy-Related Deaths and Injuries, Calendar Year 2021; available at:                         *https://www.cpsc.gov/​Research--Statistics/​Toys-and-Childrens-Products.*
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3.                             Average hourly wage across all occupations from                         *https://www.bls.gov/​oes/​current/​oes_​va.htm#00-0000.*                         CPSC uses occupational wage estimates for Virginia because the study will be conducted in the area.                    
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4.                                                     *https://www.opm.gov/​policy-data-oversight/​pay-leave/​salaries-wages/​salary-tables/​pdf/​2023/​DCB.pdf.*
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5.                                                     *https://www.bls.gov/​news.release/​archives/​ecec_​06162023.pdf.*
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[FR Doc. 2023-26364 Filed 11-29-23; 8:45 am]

BILLING CODE 6355-01-P