Supplemental Supporting statement for Infant Sleep Products - NPR - 102819

Information Collection Request (ICR)
Safety Standard for Infant Sleep Products
Supporting Statement
OMB Control #3041-0177

A.

Justification

1.
Information to be collected and circumstances that make the collection of information
necessary
Section 104(b) of the Consumer Product Safety Improvement Act of 2008 (CPSIA),
Public Law 110-314, 122 Stat. 3016 (August 14, 2008), requires the Consumer Product Safety
Commission (“Commission” or “CPSC”) to promulgate consumer product safety standards for
durable infant or toddler products. These standards are to be “substantially the same as”
applicable voluntary standards or more stringent than the voluntary standard if the Commission
concludes that more stringent requirements would further reduce the risk of injury associated
with the product. Although a number of sleep products were specifically mentioned as a durable
infant or toddler products in section 104(f)(2), inclined sleep products and the other infant sleep
products included in this collection were not. The Commission is proposing a safety standard for
infant sleepers incorporating by reference the voluntary standard for infant inclined sleep
products issued by ASTM International, ASTM F3118-17a, with significant changes. The
modifications include a change of the title and scope and deleting large portions of the standard,
including sections 8 and 9, which contain requirements for marking, labeling, and instructional
literature. This submission supplants the earlier submission for inclined sleep products, and we
have submitted it under the same control number, as the rulemaking has been published as a
supplemental proposed rule.
However, products covered by the scope of the proposed safety standard for infant sleep
products would need to meet the requirements of the mandatory Safety Standard for Bassinets
and Cradles (16 CFR 1218), including its marking, labeling, and instructional requirements. The
mandatory Safety Standard for Bassinets and Cradles (16 CFR 1218) incorporates by reference
the voluntary standard for bassinets and cradles issued by ASTM International, ASTM F219416ε1, with no modifications to the marking, labeling, or instructional requirements. Therefore,
ASTM F2194-16ε1 is the relevant standard to refer to for this information collection.
Sections 8 and 9 of ASTM F2194-16ε1 contain requirements for marking, labeling, and
instructional literature that are disclosure requirements, thus falling within the definition of
“collections of information” at 5 C.F.R. § 1320.3(c).
Section 8 of ASTM F2194-16ε1 requires that the name of the manufacturer, distributor, or
seller and either the place of business (city, state, and mailing address, including zip code), or
telephone number, or both appear on each bassinet/cradle (and therefore, each infant sleep
product) and its retail packaging. Section 8 also requires a code mark or other means on each

product and retail package that indicates the date (month and year as a minimum) of
manufacture.
Section 9 of ASTM F2194-16ε1 requires easy-to-read and understandable instructions to
be supplied with bassinets and cradles (and therefore, each infant sleep product). The instructions
should include all applicable warning statements, as well as instructions on assembly,
adjustment, operating, maintenance, and cleaning, as applicable.
This ICR will be incorporated into the ICR for Third Party Testing of Children’s Products
(OMB Control No. 3041–0159) the next time it is updated.
2.

Use and sharing of collected information

The information required in sections 8 and 9 of ASTM F2194-16ε1 is intended to address
safety issues that might arise with the product. The information required in section 8 of ASTM
F2194-16ε1 is intended to help the CPSC and the consumer identify the firm and the product,
should a safety issue arise. The instructional literature required by section 9 of ASTM F219416ε1 is meant to prevent safety problems by providing assembly, adjustment, operating,
maintenance, and cleaning information to consumers.
3.

Use of information technology (IT) in information collection

Information technology will not be used in these requirements. In the proposed rule,
suppliers are required to provide labeling, marking, and instructional literature according to
ASTM F2194-16ε1. This disclosure is provided with the purchase of the product.
4.

Efforts to identify duplication

Information being disclosed is manufacturer and product specific. To the extent that firms
do not already comply with the voluntary standard, information provided by these requirements
is not available through any other agency, organization, or individual.
5.

Impact on small businesses

The costs of marking, labeling, and instructional literature associated with the standard
for infant sleep products is expected to impact small firms. However, the statute requiring this
action does not contain an exemption for small firms.
As described in section 12 below, there are 19 firms known currently to be marketing
infant sleep products in the United States. Based on U.S. Small Business Administration
guidelines, 9 are small (3 small domestic importers and 6 small domestic manufacturers, 2 of
which are very small home-based manufacturers).
In regard to the burden associated with sections 8 and 9 of ASTM F2194-16ε1, it is
expected that the 2 very small home-based manufacturers may need to create warning labels and
instructional literature for their infant sleep products, as they may not have already developed

either. The time commitment necessary for these firms could be considerable, as discussed in
section 12. For the remaining small firms, even those whose warning labels and/or instructional
literature are not in compliance with the voluntary standard, this is unlikely to be the case, as
changes to existing labels, markings, and instructional literature do not typically impose a large
time requirement.
6.
Consequences to federal program or policy activities if collection is not conducted or is
conducted less frequently
Without the marking, labeling, and instructional literature requirements, the level of
noncompliance and consumer misuse could increase significantly, resulting in an increase in the
number of product-related deaths and injuries.
The lack of marking and labeling could complicate CPSC efforts to locate and recall
noncomplying products and result in an increase in the number of product-related deaths and
injuries.
7.
Special circumstances requiring respondents to report information more often than
quarterly or to prepare responses in fewer than 30 days
There are no special circumstances that will require respondents to produce labels or
instructional material more often than quarterly or in fewer than 30 days.
8.

Consultation outside the agency

The CPSC consulted several manufacturers to obtain their views on the information
collection burden associated with the marking and label requirements. Additionally, the Federal
Register (FR) notice for the proposed rule discusses the information collection burden and
invites public comment on the CPSC’s estimates. Notice 84 FR 60949 was published on
November 12, 2019.
9.

Decision to provide payment or gift
There is no payment or gift provided to respondents.

10.

Assurance of confidentiality

There is no assurance of confidentiality. The information in the marking, labeling, and
instructional literature is not confidential.
11.

Questions of a sensitive nature
There are no questions of a sensitive nature.

12.

Estimate of hour burden to respondents

Section 8 of ASTM F2194-16ε1 requires that the name of the manufacturer, distributor, or
seller and either the place of business (city, state, and mailing address, including zip code), or
telephone number, or both appear on each product and its retail packaging. Section 8 also
requires a code mark or other means on each product and retail package that indicates the date
(month and year as a minimum) of manufacture.
Nineteen known entities supply infant sleep products to the U.S. market and may need to
modify existing, or create new, labels to comply with ASTM F2194-16ε1. CPSC estimates that
the time required to make modifications is about 1 hour per model, but the time required to
create a label from scratch is about 7 hours per model. Based on an evaluation of supplier
product lines, all entities supply an average of one infant sleep product.
Therefore, the estimated burden associated with labels for small home-based
manufacturers is 7 hours per model × 6 entities × 1 models per entity = 42 hours, the estimated
burden associated with labels for other suppliers is 1 hour per model × 13 entities × 1 model per
entity = 13 hours, and the total estimated burden associated with labels is 55 (42 + 13). CPSC
estimates the hourly compensation for the time required to create and update labels is $34.61
(U.S. Bureau of Labor Statistics, ‘‘Employer Costs for Employee Compensation,’’ March 2019,
total compensation for all sales and office workers in goods-producing private industries, series
id CMU201G000200000D: http://www.bls.gov/ncs/). Therefore, the estimated annual cost
associated with the proposed labeling requirements is $1,904 ($34.61per hour × 55 hours =
$1,904). No operating, maintenance, or capital costs are associated with the collection.
Section 9 of ASTM F2194-16ε1 requires instructions to be supplied with bassinets and
cradles (and therefore, each infant sleep product). Under OMB’s regulations, the time, effort, and
financial resources necessary to comply with a collection of information incurred by parties in
the ‘‘normal course of their activities’’ are excluded from a burden estimate when an agency
demonstrates that the disclosure activities required are ‘‘usual and customary.’’ 5 CFR
1320.3(b)(2). As with the warning labels, the reporting burden of this requirement differs for
home-based and non-home-based suppliers. We are not aware of any non-home-based
manufacturers or importers that generally require use instructions but lack such instructions.
However, it is believed that home-based infant sleep product manufacturers supplying on
a very small scale may provide either no instructions or only limited instructions with their
products as part of their “normal course of activities.” Based on information collected for the
infant slings rulemaking, CPSC staff tentatively estimates that each home-based entity supplying
homemade sleep products might require 50 hours to develop an instruction manual to accompany
their products. While the number of home-based suppliers of infant sleep products is likely to
vary over time, it appears that at the present time there are approximately 6 home-based suppliers
of infant sleep products operating in the U.S. market. Therefore, the costs of designing an
instruction manual for these firms could be as high as $10,383 (50 hours per model x 6 entities x
1 model per entity = 300 hours x $34.61 per hour = $10,383). Not all firms would incur these
costs every year, but new firms that enter the market would and this may be a fluctuating market.
As already noted, the other 13 firms are estimated to have no burden hours associated with
section 9 of ASTM F2194-16ε1, because any burden associated with supplying instructions with

infant sleep products would be “usual and customary” and not within the definition of “burden”
under the OMB’s regulations.
Based on this analysis, the proposed standard for infant sleep products would impose a
burden to industry of 355 hours at a cost of $12,287 annually.
13.

Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no costs to respondents beyond those presented in Section A.12. There are no
further operating, maintenance, or capital costs associated with the collection.
14.

Estimate of annualized costs to the federal government

The estimated annual cost of the information collection requirements to the federal
government is approximately $3,992, which includes 60 staff hours to examine and evaluate the
information as needed for Compliance activities. This is based on a GS-12 level salaried
employee. The average wage rate for a mid-level salaried GS-12 employee in the Washington,
DC metropolitan area (effective as of April 2019) is $94,520 (GS-12, step 5). This represents
68.3 percent of total compensation (U.S. Bureau of Labor Statistics, “Employer Costs for
Employee Compensation,” March 2019, Table 2, percentage of wages and salaries for all civilian
management, professional, and related employees: http://www.bls.gov/ncs/). Adding an
additional 31.7 percent for benefits brings average annual compensation for a mid-level salaried
GS-12 employee to $138,389 or $66.53 per hour. Assuming that approximately 60 hours will be
required annually, this results in an annual cost of $3,992.
15.

Program changes or adjustments
This is a new information request.

16.

Plans for tabulation and publication
Not applicable.

17.

Rationale for not displaying the expiration date for OMB approval
Not applicable.

B.

Collection of Information Employing Statistical Methods
Not applicable.