81_FR_17121 81 FR 17062 - Safety Standard for Portable Hook-On Chairs

81 FR 17062 - Safety Standard for Portable Hook-On Chairs

CONSUMER PRODUCT SAFETY COMMISSION

Federal Register Volume 81, Issue 59 (March 28, 2016)

Page Range17062-17065
FR Document2016-06769

The Danny Keysar Child Product Safety Notification Act, section 104 of the Consumer Product Safety Improvement Act of 2008 (``CPSIA''), requires the United States 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. The Commission is issuing a safety standard for portable hook-on chairs (``hook-on chairs'') in response to the direction of section 104(b) of the CPSIA. In addition, the Commission is amending its regulations regarding third party conformity assessment bodies to include the mandatory standard for hook-on chairs in the list of Notices of Requirements (``NOR'') issued by the Commission.

Federal Register, Volume 81 Issue 59 (Monday, March 28, 2016)
[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Rules and Regulations]
[Pages 17062-17065]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06769]



[[Page 17062]]

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1233

[Docket No. CPSC-2015-0016]


Safety Standard for Portable Hook-On Chairs

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: The Danny Keysar Child Product Safety Notification Act, 
section 104 of the Consumer Product Safety Improvement Act of 2008 
(``CPSIA''), requires the United States 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. The Commission 
is issuing a safety standard for portable hook-on chairs (``hook-on 
chairs'') in response to the direction of section 104(b) of the CPSIA. 
In addition, the Commission is amending its regulations regarding third 
party conformity assessment bodies to include the mandatory standard 
for hook-on chairs in the list of Notices of Requirements (``NOR'') 
issued by the Commission.

DATES: This rule will become effective September 28, 2016. The 
incorporation by reference of the publication listed in this rule is 
approved by the Director of the Federal Register as of September 28, 
2016.

FOR FURTHER INFORMATION CONTACT: Keysha Walker, Compliance Officer, 
U.S. Consumer Product Safety Commission, 4330 East West Highway, 
Bethesda, MD 20814; telephone: 301-504-6820; email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority

    The CPSIA was enacted on August 14, 2008. Section 104(b) of the 
CPSIA, part of the Danny Keysar Child Product Safety Notification Act, 
requires the Commission to: (1) Examine and assess the effectiveness of 
voluntary consumer product safety standards for durable infant or 
toddler products, in consultation with representatives of consumer 
groups, juvenile product manufacturers, and independent child product 
engineers and experts; and (2) promulgate consumer product safety 
standards for durable infant and toddler products. Standards issued 
under section 104 are to be ``substantially the same as'' the 
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.
    The term ``durable infant or toddler product'' is defined in 
section 104(f)(1) of the CPSIA as ``a durable product intended for use, 
or that may be reasonably expected to be used, by children under the 
age of 5 years.'' Section 104(f)(2)(C) of the CPSIA specifically 
identifies ``hook-on chairs'' as a durable infant or toddler product.
    On July 2, 2015, the Commission issued a notice of proposed 
rulemaking (``NPR'') for hook-on chairs. 80 FR 38041. The NPR proposed 
to incorporate by reference the voluntary standard, ASTM F1235-15, 
Standard Consumer Safety Specification for Portable Hook-On Chairs, 
without modification. In this document, the Commission is issuing a 
mandatory safety standard for hook-on chairs. As required by section 
104(b)(1)(A), the Commission consulted with manufacturers, retailers, 
trade organizations, laboratories, consumer advocacy groups, 
consultants, and the public to develop this proposed standard, largely 
through the ASTM process. The rule incorporates by reference the most 
recent voluntary standard, developed by ASTM International, ASTM F1235-
15.
    In addition, the final rule amends the list of NORs issued by the 
Commission in 16 CFR part 1112 to include the standard for hook-on 
chairs. Under section 14 of the Consumer Product Safety Act (``CPSA''), 
the Commission promulgated 16 CFR part 1112 to establish requirements 
for accreditation of third party conformity assessment bodies (or 
testing laboratories) to test for conformity with a children's product 
safety rule. Amending part 1112 adds a NOR for the hook-on chair 
standard to the list of children's product safety rules.

II. Product Description

    The scope section of ASTM F1235-15 defines a ``portable hook-on 
chair'' as ``[u]sually a legless seat constructed to locate the 
occupant at a table in such a position and elevation so that the 
surface of the table can be used as the feeding surface for the 
occupant . . . [s]upported solely by the table on which it is 
mounted.'' The ASTM standard specifies the appropriate ages and weights 
for children using portable hook-on chairs as ``between the ages of six 
months and three years and who weigh no more than 37 lb (16.8 kg) (95th 
percentile male at three years).'' Typical hook-on chairs consist of 
fabric over a lightweight frame, with a device to mount the seat to a 
support surface, such as a table or counter. Some hook-on chairs fold 
for easy storage or transport, and some include a removable tray that 
can be used in conjunction with a table.

III. Market Description

    CPSC staff has identified 10 firms supplying hook-on chairs to the 
U.S. market, typically priced at $40 to $80 each. These 10 firms 
specialize in the manufacture and/or distribution of durable nursery 
products and represent only a small segment of the juvenile products 
industry. Nine of the 10 known firms are domestic (including 3 
manufacturers and 6 importers). The remaining firm is a foreign 
manufacturer. Hook-on chairs represent only a small proportion of each 
firm's overall product line; on average, each firm supplies one hook-on 
chair model to the U.S. market annually.
    Staff expects that the hook-on chairs of nine of the 10 firms are 
compliant with ASTM F1235 because they are either: (1) Certified by the 
Juvenile Products Manufacturers Association (``JPMA'') (three firms); 
or (2) the supplier claims compliance with the voluntary standard (six 
firms). It is unknown whether the hook-on chairs supplied by the 
remaining firm, a foreign manufacturer, comply with the ASTM voluntary 
standard.

IV. Incident Data

    The preamble to the NPR summarized the hook-on chair incident 
data--covering the period between January 1, 2000 and October 31, 
2014--reported to the Commission. 80 FR 38041. In the NPR, CPSC's 
Directorate for Epidemiology, Division of Hazard Analysis, identified 
89 portable hook-on chair-related incidents reported to the CPSC that 
occurred during the covered time period, including 50 incidents 
involving injury, 38 non-injury incidents, and one fatality. Since the 
publication of the NPR, CPSC staff has received 11 new reports (seven 
nonfatal injuries and four incidents without injury) that were 
determined to involve portable hook-on chairs. The seven new injuries 
all involved children between the ages of 6 and 12 months. Among the 11 
new incidents, no ages were reported outside the ASTM-recommended user 
range of 6 months to 3 years. The hazards identified in the new 
incidents are consistent with the hazard patterns

[[Page 17063]]

identified among the incidents present in the NPR briefing package.

V. Overview of ASTM F1235

    The voluntary standard for hook-on chairs was first approved and 
published in 1989, as ASTM F1235-89, Standard Consumer Safety 
Specification for Portable Hook-On Chairs. ASTM has revised the 
voluntary standard seven times since initial publication of the 
standard. The current version, ASTM F1235-15, was approved on May 1, 
2015. In the NPR, the Commission proposed to incorporate ASTM F1235-15, 
which addresses the hazard patterns identified for hook-on chairs, 
without modification.

VI. Response to Comments

    The Commission received two comments in response to the NPR. A 
summary of each comment and a response is provided below.

A. General Support of Standard Adoption

    Comment: A comment from representatives of Kids In Danger, Consumer 
Federation of America, and Consumers Union urged the Commission to 
adopt the proposed rule and agreed with staff's recommendations.
    Response: The Commission is issuing a final rule that is identical 
to the NPR.

B. Hook-On Chair Injuries

    Comment: The second commenter discussed infant fall data, head 
injuries, severed body parts, and installation considerations for hook-
on chairs. In addition, the commenter questioned why ``so many 
injuries, and even on[e] fatality'' occurred before anyone took action 
to implement stringent standards. Additionally, the commenter opined 
that hook-on chairs never should have been released to the market, or 
that they should have been removed immediately after compromised 
attachment incidents surfaced. Lastly, the commenter opined that even 
if injuries and fatalities decrease after implementing this new rule, 
the chances are high that more infants will be killed.
    Response: Section 104 of the CPSIA requires the Commission to 
promulgate consumer product safety standards for durable infant or 
toddler products, including hook-on chairs (specifically identified by 
section 104(f)(2)(C) of the CPSIA). Furthermore, section 104 of the 
CPSIA lays out a broad timeline for promulgation of such durable infant 
and toddler product safety standards. These standards must be 
``substantially the same as'' or more stringent than the relevant 
voluntary standard. Accordingly, through section 104 of the CPSIA, 
Congress has directed the Commission to promulgate safety standards 
relating to hook-on chairs rather than ban their use.
    The current ASTM standard, ASTM F1235-15, incorporates numerous 
changes implemented after hazard patterns emerged under the previous 
version of the standard, ASTM F1235-08. For example, the one fatal 
incident involved an older hook-on chair that did not have a passive 
crotch restraint. Passive crotch restraints are used to prevent 
``submarining'' deaths and are specified in other similar juvenile 
standards, such as the juvenile standard for high chairs. Had the hook-
on chair involved in the fatal incident contained a passive crotch 
restraint, the death would not have occurred. In 2014, ASTM added a 
performance requirement for passive-crotch restraints to ASTM F1235. 
During the ensuing 7 years between adoption of ASTM F1235-08 and ASTM 
F1235-15, the hazard patterns identified in the NPR were all addressed, 
and corresponding requirements were incorporated into the 2015 version 
of the standard. The Commission is confident that these changes in the 
standard (including changes addressing scissoring/shearing, openings, 
and labeling/markings) will reduce injuries associated with hook-on 
chairs.

VII. Final Rule

A. Final Rule for Part 1233 and Incorporation by Reference

    Section 1233.2(a) of the final rule provides that hook-on chairs 
must comply with ASTM F1235-15.
    The Office of the Federal Register (``OFR'') has regulations 
concerning incorporation by reference. 1 CFR part 51. These regulations 
require that, for a final rule, agencies must discuss in the preamble 
of the rule the way that the materials the agency incorporates by 
reference are reasonably available to interested persons and how 
interested parties can obtain the materials. In addition, the preamble 
of the rule must summarize the material. 1 CFR 51.5(b).
    In accordance with the OFR's requirements, the discussion in this 
section summarizes the provisions of ASTM F1235-15. Interested persons 
may purchase a copy of ASTM F1235-15 from ASTM, either through ASTM's 
Web site or by mail at the address provided in the rule. A copy of the 
standard may also be inspected at the CPSC's Office of the Secretary, 
U.S. Consumer Product Safety Commission, or at NARA, as discussed 
above. We note that the Commission and ASTM arranged for commenters to 
have ``read only'' access to ASTM F1235-15 during the NPR's comment 
period.
    ASTM F1235-15 contains requirements covering:
     Sharp points;
     Small parts;
     Lead in paint;
     Wood parts;
     Latching and locking mechanisms;
     Scissoring, shearing, and pinching (including during 
detachment from table support surface);
     Exposed coil springs;
     Openings;
     Labeling; and
     Protective components.
    The standard additionally contains test methods that must be used 
to assess conformity with these requirements.

B. Amendment to 16 CFR Part 1112 To Include NOR for Hook-On Chairs 
Standard

    The final rule amends part 1112 to add a new Sec.  1112.15(b)(40) 
that lists 16 CFR part 1233, Safety Consumer Safety Specification for 
Portable Hook-On Chairs, as a children's products safety rule for which 
the Commission has issued an NOR. Section XIII of the preamble provides 
additional background information regarding certification of hook-on 
chairs and issuance of an NOR.

VIII. Effective Date

    The Administrative Procedure Act (``APA'') generally requires that 
the effective date of a rule be at least 30 days after publication of 
the final rule. 5 U.S.C. 553(d). The safety standard for hook-on chairs 
and the corresponding changes to part 1112 regarding requirements for 
third party conformity assessment bodies will become effective 6 months 
after publication of the final rule in the Federal Register.
    Without evidence to the contrary, CPSC generally considers 6 months 
to be sufficient time for suppliers to come into compliance with a new 
standard, and a 6-month effective date is typical for other CPSIA 
section 104 rules. Six months is also the period that JPMA typically 
allows for products in the JPMA certification program to transition to 
a new standard once that standard is published. The Commission proposed 
a 6-month effective date in the NPR and did not receive any comments 
regarding the effective date.

IX. Regulatory Flexibility Act

A. Introduction

    The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601-612, 
requires that agencies review a proposed rule and a

[[Page 17064]]

final rule for the rule's potential economic impact on small entities, 
including small businesses. Section 604 of the RFA generally requires 
that agencies prepare a final regulatory flexibility analysis 
(``FRFA'') when promulgating final rules, unless the head of the agency 
certifies that the rule will not have a significant economic impact on 
a substantial number of small entities.

B. Impact on Small Businesses

    Approximately 10 firms currently market portable hook-on chairs in 
the United States, nine of which are domestic firms. Under U.S. Small 
Business Administration (``SBA'') guidelines, a manufacturer of hook-on 
chairs is small if it has 500 or fewer employees, and importers and 
wholesalers are considered small if they have 100 or fewer employees.
    In the NPR briefing package, the Commission certified that the 
proposed hook-on chair rule would not have a significant economic 
impact on a substantial number of small entities. That conclusion has 
not changed. All of the domestic hook-on chairs appear to conform to 
the current voluntary standard and are expected to continue to do so. 
Consequently, costs of compliance, if any, are expected to be 
negligible. Third party testing costs are expected to be small and 
economically insignificant (i.e., less than 1 percent of gross revenues 
for the affected firms). Furthermore, we received no comments 
questioning or challenging the certification that the rule would not 
have a significant economic impact on a substantial number of small 
entities.

X. Environmental Considerations

    The Commission's regulations address whether the agency is required 
to prepare an environmental assessment or an environmental impact 
statement. Under these regulations, a rule that has ``little or no 
potential for affecting the human environment,'' is categorically 
exempt from this requirement. 16 CFR 1021.5(c)(1). The final rule falls 
within the categorical exemption.

XI. Paperwork Reduction Act

    This rule contains information collection requirements that are 
subject to public comment and review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521). The preamble to the proposed rule discussed the information 
collection burden of the proposed rule. Sections 8 and 9 of ASTM F1235-
15 contain requirements for marking, labeling, and instructional 
literature. These requirements fall within the definition of 
``collection of information,'' as defined in 44 U.S.C. 3502(3).
    OMB has assigned control number 3041-0170 to this information 
collection. The Commission did not receive any comments regarding the 
information collection burden of this proposal.

XII. Preemption

    Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that when a 
consumer product safety standard is in effect and applies to a product, 
no state or political subdivision of a state may either establish or 
continue in effect a requirement dealing with the same risk of injury 
unless the state requirement is identical to the federal standard. 
Section 26(c) of the CPSA also provides that states or political 
subdivisions of states may apply to the Commission for an exemption 
from this preemption under certain circumstances. Section 104(b) of the 
CPSIA refers to the rules to be issued under that section as ``consumer 
product safety rules.'' Therefore, the preemption provision of section 
26(a) of the CPSA would apply to a rule issued under section 104.

XIII. Amendment to 16 CFR Part 1112 To Include Notice of Requirements 
(NOR) for Hook-On Chair Standard

    Section 14(a) of the CPSA imposes the requirement that products 
subject to a consumer product safety rule under the CPSA, or to a 
similar rule, ban, standard, or regulation under any other Act enforced 
by the Commission, must be certified as complying with all applicable 
CPSC-enforced requirements. 15 U.S.C. 2063(a). Section 14(a)(2) of the 
CPSA requires that certification of children's products subject to a 
children's product safety rule be based on testing conducted by a CPSC-
accepted, third party conformity assessment body. Section 14(a)(3) of 
the CPSA requires the Commission to publish a NOR for the accreditation 
of third party conformity assessment bodies (or laboratories) to assess 
conformity with a children's product safety rule to which a children's 
product is subject. The Standard Consumer Safety Specification for 
Hook-On Chairs, to be codified at 16 CFR part 1233, is a children's 
product safety rule that requires the issuance of an NOR.
    The Commission published a final rule, Requirements Pertaining to 
Third-Party Conformity Assessment Bodies, 78 FR 15836 (March 12, 2013), 
which is codified at 16 CFR part 1112 (referred to here as part 1112). 
This rule became effective on June 10, 2013. Part 1112 establishes 
requirements for accreditation of third-party conformity assessment 
bodies (or laboratories) to test for conformance with a children's 
product safety rule in accordance with section 14(a)(2) of the CPSA. 
Part 1112 also codifies a list of all of the NORs that the CPSC had 
published at the time part 1112 was issued. All NORs issued after the 
Commission published part 1112, such as the standard for hook-on 
chairs, require the Commission to amend part 1112. Accordingly, the 
Commission is now amending part 1112 to include the standard for hook-
on chairs in the list of other children's product safety rules for 
which the CPSC has issued NORs.
    Laboratories applying for acceptance as a CPSC-accepted third-party 
conformity assessment body to test to the new standard for hook-on 
chairs would be required to meet the third-party conformity assessment 
body accreditation requirements in 16 CFR part 1112, Requirements 
Pertaining to Third-Party Conformity Assessment Bodies. When a 
laboratory meets the requirements as a CPSC-accepted third-party 
conformity assessment body, the laboratory can apply to the CPSC to 
have 16 CFR part 1233, Standard Consumer Safety Specification for Hook-
on Chairs, included in its scope of accreditation of CPSC safety rules 
listed for the laboratory on the CPSC Web site at: www.cpsc.gov/labsearch.
    As required by the RFA, staff conducted a FRFA when the Commission 
issued the part 1112 rule (78 FR 15836, 15855-58). Briefly, the FRFA 
concluded that the accreditation requirements would not have a 
significant adverse impact on a substantial number of small test 
laboratories because no requirements were imposed on test laboratories 
that did not intend to provide third-party testing services. The only 
test laboratories that were expected to provide such services were 
those that anticipated receiving sufficient revenue from the mandated 
testing to justify accepting the requirements as a business decision. 
Moreover, a test laboratory would only choose to provide such services 
if it anticipated receiving revenues sufficient to cover the costs of 
the requirements.
    Based on similar reasoning, amending 16 CFR part 1112 to include 
the NOR for the hook-on chairs standard will not have a significant 
adverse impact on small test laboratories. Moreover, based upon the 
number of test laboratories in the United States that have applied for 
CPSC acceptance of accreditation to test for conformance to other 
mandatory juvenile product standards, we expect that only a few test 
laboratories will

[[Page 17065]]

seek CPSC acceptance of their accreditation to test for conformance 
with the hook-on chair standard. Most of these test laboratories will 
have already been accredited to test for conformity to other mandatory 
juvenile product standards, and the only costs to them would be the 
cost of adding the hook-on chairs standard to their scope of 
accreditation. For these reasons, the Commission certifies that the NOR 
amending 16 CFR part 1112 to include the hook-on chairs standard will 
not have a significant impact on a substantial number of small 
entities.

List of Subjects

16 CFR Part 1112

    Administrative practice and procedure, Audit, Consumer protection, 
Reporting and recordkeeping requirements, Third-party conformity 
assessment body.

16 CFR Part 1233

    Consumer protection, Imports, Incorporation by reference, Infants 
and children, Labeling, Law enforcement, Toys.

    For the reasons discussed in the preamble, the Commission amends 
title 16 of the Code of Federal Regulations as follows:

PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY 
ASSESSMENT BODIES

0
1. The authority citation for part 1112 continues to read as follows:

    Authority:  Pub. L. 110-314, section 3, 122 Stat. 3016, 3017 
(2008); 15 U.S.C. 2063.


0
2. Amend Sec.  1112.15 by adding and reserving paragraph (b)(39) and 
adding paragraph (b)(40) to read as follows:


Sec.  1112.15  When can a third party conformity assessment body apply 
for CPSC acceptance for a particular CPSC rule or test method?

* * * * *
    (b) * * *
    (40) 16 CFR part 1233, Safety Standard for Portable Hook-On Chairs.
* * * * *

0
3. Add part 1233 to read as follows:

PART 1233-SAFETY STANDARD FOR PORTABLE HOOK-ON CHAIRS

Sec.
1233.1 Scope.
1233.2 Requirements for portable hook-on chairs.

    Authority: Sec. 104, Pub. L. 110-314, 122 Stat. 3016 (August 14, 
2008); Pub. L. 112-28, 125 Stat. 273 (August 12, 2011).


Sec.  1233.1  Scope.

    This part establishes a consumer product safety standard for 
portable hook-on chairs.


Sec.  1233.2  Requirements for portable hook-on chairs.

    Each portable hook-on chair must comply with all applicable 
provisions of ASTM F1235-15, Standard Consumer Safety Specification for 
Portable Hook-On Chairs, approved on May 1, 2015. The Director of the 
Federal Register approves this incorporation by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM 
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, 
PA 19428; http://www.astm.org/cpsc.htm. You may inspect a copy at the 
Office of the Secretary, U.S. Consumer Product Safety Commission, Room 
820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-
7923, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/code_of_federalregulations/ibr_locations.html.

    Dated: March 22, 2016.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2016-06769 Filed 3-25-16; 8:45 am]
 BILLING CODE 6355-01-P



                                           17062              Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Rules and Regulations

                                           CONSUMER PRODUCT SAFETY                                 standards for durable infant and toddler              hook-on chairs as ‘‘between the ages of
                                           COMMISSION                                              products. Standards issued under                      six months and three years and who
                                                                                                   section 104 are to be ‘‘substantially the             weigh no more than 37 lb (16.8 kg) (95th
                                           16 CFR Parts 1112 and 1233                              same as’’ the applicable voluntary                    percentile male at three years).’’ Typical
                                           [Docket No. CPSC–2015–0016]                             standards or more stringent than the                  hook-on chairs consist of fabric over a
                                                                                                   voluntary standard if the Commission                  lightweight frame, with a device to
                                           Safety Standard for Portable Hook-On                    concludes that more stringent                         mount the seat to a support surface,
                                           Chairs                                                  requirements would further reduce the                 such as a table or counter. Some hook-
                                                                                                   risk of injury associated with the                    on chairs fold for easy storage or
                                           AGENCY:  Consumer Product Safety                        product.                                              transport, and some include a
                                           Commission.                                                The term ‘‘durable infant or toddler               removable tray that can be used in
                                           ACTION: Final rule.                                     product’’ is defined in section 104(f)(1)             conjunction with a table.
                                                                                                   of the CPSIA as ‘‘a durable product
                                           SUMMARY:   The Danny Keysar Child                       intended for use, or that may be                      III. Market Description
                                           Product Safety Notification Act, section                reasonably expected to be used, by                       CPSC staff has identified 10 firms
                                           104 of the Consumer Product Safety                      children under the age of 5 years.’’                  supplying hook-on chairs to the U.S.
                                           Improvement Act of 2008 (‘‘CPSIA’’),                    Section 104(f)(2)(C) of the CPSIA                     market, typically priced at $40 to $80
                                           requires the United States Consumer                     specifically identifies ‘‘hook-on chairs’’            each. These 10 firms specialize in the
                                           Product Safety Commission                               as a durable infant or toddler product.               manufacture and/or distribution of
                                           (‘‘Commission’’ or ‘‘CPSC’’) to                            On July 2, 2015, the Commission                    durable nursery products and represent
                                           promulgate consumer product safety                      issued a notice of proposed rulemaking                only a small segment of the juvenile
                                           standards for durable infant or toddler                 (‘‘NPR’’) for hook-on chairs. 80 FR                   products industry. Nine of the 10
                                           products. These standards are to be                     38041. The NPR proposed to                            known firms are domestic (including 3
                                           ‘‘substantially the same as’’ applicable                incorporate by reference the voluntary                manufacturers and 6 importers). The
                                           voluntary standards, or more stringent                  standard, ASTM F1235–15, Standard                     remaining firm is a foreign
                                           than the voluntary standard if the                      Consumer Safety Specification for                     manufacturer. Hook-on chairs represent
                                           Commission concludes that more                          Portable Hook-On Chairs, without                      only a small proportion of each firm’s
                                           stringent requirements would further                    modification. In this document, the                   overall product line; on average, each
                                           reduce the risk of injury associated with               Commission is issuing a mandatory                     firm supplies one hook-on chair model
                                           the product. The Commission is issuing                  safety standard for hook-on chairs. As                to the U.S. market annually.
                                           a safety standard for portable hook-on                  required by section 104(b)(1)(A), the                    Staff expects that the hook-on chairs
                                           chairs (‘‘hook-on chairs’’) in response to              Commission consulted with                             of nine of the 10 firms are compliant
                                           the direction of section 104(b) of the                  manufacturers, retailers, trade                       with ASTM F1235 because they are
                                           CPSIA. In addition, the Commission is                   organizations, laboratories, consumer                 either: (1) Certified by the Juvenile
                                           amending its regulations regarding third                advocacy groups, consultants, and the                 Products Manufacturers Association
                                           party conformity assessment bodies to                   public to develop this proposed                       (‘‘JPMA’’) (three firms); or (2) the
                                           include the mandatory standard for                      standard, largely through the ASTM                    supplier claims compliance with the
                                           hook-on chairs in the list of Notices of                process. The rule incorporates by                     voluntary standard (six firms). It is
                                           Requirements (‘‘NOR’’) issued by the                    reference the most recent voluntary                   unknown whether the hook-on chairs
                                           Commission.                                             standard, developed by ASTM                           supplied by the remaining firm, a
                                                                                                   International, ASTM F1235–15.                         foreign manufacturer, comply with the
                                           DATES:  This rule will become effective                    In addition, the final rule amends the             ASTM voluntary standard.
                                           September 28, 2016. The incorporation                   list of NORs issued by the Commission
                                           by reference of the publication listed in                                                                     IV. Incident Data
                                                                                                   in 16 CFR part 1112 to include the
                                           this rule is approved by the Director of                standard for hook-on chairs. Under                      The preamble to the NPR summarized
                                           the Federal Register as of September 28,                section 14 of the Consumer Product                    the hook-on chair incident data—
                                           2016.                                                   Safety Act (‘‘CPSA’’), the Commission                 covering the period between January 1,
                                           FOR FURTHER INFORMATION CONTACT:                        promulgated 16 CFR part 1112 to                       2000 and October 31, 2014—reported to
                                           Keysha Walker, Compliance Officer,                      establish requirements for accreditation              the Commission. 80 FR 38041. In the
                                           U.S. Consumer Product Safety                            of third party conformity assessment                  NPR, CPSC’s Directorate for
                                           Commission, 4330 East West Highway,                     bodies (or testing laboratories) to test for          Epidemiology, Division of Hazard
                                           Bethesda, MD 20814; telephone: 301–                     conformity with a children’s product                  Analysis, identified 89 portable hook-on
                                           504–6820; email: kwalker@cpsc.gov.                      safety rule. Amending part 1112 adds a                chair-related incidents reported to the
                                           SUPPLEMENTARY INFORMATION:                              NOR for the hook-on chair standard to                 CPSC that occurred during the covered
                                                                                                   the list of children’s product safety                 time period, including 50 incidents
                                           I. Background and Statutory Authority                                                                         involving injury, 38 non-injury
                                                                                                   rules.
                                             The CPSIA was enacted on August 14,                                                                         incidents, and one fatality. Since the
                                           2008. Section 104(b) of the CPSIA, part                 II. Product Description                               publication of the NPR, CPSC staff has
                                           of the Danny Keysar Child Product                          The scope section of ASTM F1235–15                 received 11 new reports (seven nonfatal
                                           Safety Notification Act, requires the                   defines a ‘‘portable hook-on chair’’ as               injuries and four incidents without
                                           Commission to: (1) Examine and assess                   ‘‘[u]sually a legless seat constructed to             injury) that were determined to involve
                                           the effectiveness of voluntary consumer                 locate the occupant at a table in such a              portable hook-on chairs. The seven new
                                           product safety standards for durable                    position and elevation so that the                    injuries all involved children between
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                                           infant or toddler products, in                          surface of the table can be used as the               the ages of 6 and 12 months. Among the
                                           consultation with representatives of                    feeding surface for the occupant . . .                11 new incidents, no ages were reported
                                           consumer groups, juvenile product                       [s]upported solely by the table on which              outside the ASTM-recommended user
                                           manufacturers, and independent child                    it is mounted.’’ The ASTM standard                    range of 6 months to 3 years. The
                                           product engineers and experts; and (2)                  specifies the appropriate ages and                    hazards identified in the new incidents
                                           promulgate consumer product safety                      weights for children using portable                   are consistent with the hazard patterns


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                                                              Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Rules and Regulations                                          17063

                                           identified among the incidents present                  Accordingly, through section 104 of the               arranged for commenters to have ‘‘read
                                           in the NPR briefing package.                            CPSIA, Congress has directed the                      only’’ access to ASTM F1235–15 during
                                                                                                   Commission to promulgate safety                       the NPR’s comment period.
                                           V. Overview of ASTM F1235
                                                                                                   standards relating to hook-on chairs                     ASTM F1235–15 contains
                                             The voluntary standard for hook-on                    rather than ban their use.                            requirements covering:
                                           chairs was first approved and published                   The current ASTM standard, ASTM                        • Sharp points;
                                           in 1989, as ASTM F1235–89, Standard                     F1235–15, incorporates numerous                          • Small parts;
                                           Consumer Safety Specification for                       changes implemented after hazard                         • Lead in paint;
                                           Portable Hook-On Chairs. ASTM has                       patterns emerged under the previous                      • Wood parts;
                                           revised the voluntary standard seven                    version of the standard, ASTM F1235–                     • Latching and locking mechanisms;
                                           times since initial publication of the                  08. For example, the one fatal incident                  • Scissoring, shearing, and pinching
                                           standard. The current version, ASTM                     involved an older hook-on chair that did              (including during detachment from
                                           F1235–15, was approved on May 1,                        not have a passive crotch restraint.                  table support surface);
                                           2015. In the NPR, the Commission                        Passive crotch restraints are used to                    • Exposed coil springs;
                                           proposed to incorporate ASTM F1235–                     prevent ‘‘submarining’’ deaths and are                   • Openings;
                                           15, which addresses the hazard patterns                 specified in other similar juvenile                      • Labeling; and
                                           identified for hook-on chairs, without                  standards, such as the juvenile standard                 • Protective components.
                                           modification.                                           for high chairs. Had the hook-on chair                   The standard additionally contains
                                           VI. Response to Comments                                involved in the fatal incident contained              test methods that must be used to assess
                                                                                                   a passive crotch restraint, the death                 conformity with these requirements.
                                             The Commission received two                           would not have occurred. In 2014,
                                           comments in response to the NPR. A                                                                            B. Amendment to 16 CFR Part 1112 To
                                                                                                   ASTM added a performance
                                           summary of each comment and a                                                                                 Include NOR for Hook-On Chairs
                                                                                                   requirement for passive-crotch restraints
                                           response is provided below.                                                                                   Standard
                                                                                                   to ASTM F1235. During the ensuing 7
                                           A. General Support of Standard                          years between adoption of ASTM                           The final rule amends part 1112 to
                                           Adoption                                                F1235–08 and ASTM F1235–15, the                       add a new § 1112.15(b)(40) that lists 16
                                                                                                   hazard patterns identified in the NPR                 CFR part 1233, Safety Consumer Safety
                                              Comment: A comment from                                                                                    Specification for Portable Hook-On
                                                                                                   were all addressed, and corresponding
                                           representatives of Kids In Danger,                                                                            Chairs, as a children’s products safety
                                                                                                   requirements were incorporated into the
                                           Consumer Federation of America, and                                                                           rule for which the Commission has
                                                                                                   2015 version of the standard. The
                                           Consumers Union urged the                                                                                     issued an NOR. Section XIII of the
                                                                                                   Commission is confident that these
                                           Commission to adopt the proposed rule                                                                         preamble provides additional
                                                                                                   changes in the standard (including
                                           and agreed with staff’s                                                                                       background information regarding
                                                                                                   changes addressing scissoring/shearing,
                                           recommendations.                                                                                              certification of hook-on chairs and
                                                                                                   openings, and labeling/markings) will
                                              Response: The Commission is issuing
                                                                                                   reduce injuries associated with hook-on               issuance of an NOR.
                                           a final rule that is identical to the NPR.
                                                                                                   chairs.                                               VIII. Effective Date
                                           B. Hook-On Chair Injuries
                                                                                                   VII. Final Rule                                          The Administrative Procedure Act
                                              Comment: The second commenter
                                                                                                   A. Final Rule for Part 1233 and                       (‘‘APA’’) generally requires that the
                                           discussed infant fall data, head injuries,
                                                                                                   Incorporation by Reference                            effective date of a rule be at least 30
                                           severed body parts, and installation
                                                                                                                                                         days after publication of the final rule.
                                           considerations for hook-on chairs. In                      Section 1233.2(a) of the final rule
                                                                                                                                                         5 U.S.C. 553(d). The safety standard for
                                           addition, the commenter questioned                      provides that hook-on chairs must
                                                                                                                                                         hook-on chairs and the corresponding
                                           why ‘‘so many injuries, and even on[e]                  comply with ASTM F1235–15.
                                                                                                                                                         changes to part 1112 regarding
                                           fatality’’ occurred before anyone took                     The Office of the Federal Register
                                                                                                                                                         requirements for third party conformity
                                           action to implement stringent standards.                (‘‘OFR’’) has regulations concerning
                                                                                                                                                         assessment bodies will become effective
                                           Additionally, the commenter opined                      incorporation by reference. 1 CFR part
                                                                                                                                                         6 months after publication of the final
                                           that hook-on chairs never should have                   51. These regulations require that, for a
                                                                                                                                                         rule in the Federal Register.
                                           been released to the market, or that they               final rule, agencies must discuss in the
                                                                                                                                                            Without evidence to the contrary,
                                           should have been removed immediately                    preamble of the rule the way that the
                                                                                                                                                         CPSC generally considers 6 months to
                                           after compromised attachment incidents                  materials the agency incorporates by
                                                                                                                                                         be sufficient time for suppliers to come
                                           surfaced. Lastly, the commenter opined                  reference are reasonably available to
                                                                                                                                                         into compliance with a new standard,
                                           that even if injuries and fatalities                    interested persons and how interested
                                                                                                                                                         and a 6-month effective date is typical
                                           decrease after implementing this new                    parties can obtain the materials. In
                                                                                                                                                         for other CPSIA section 104 rules. Six
                                           rule, the chances are high that more                    addition, the preamble of the rule must
                                                                                                                                                         months is also the period that JPMA
                                           infants will be killed.                                 summarize the material. 1 CFR 51.5(b).
                                              Response: Section 104 of the CPSIA                      In accordance with the OFR’s                       typically allows for products in the
                                           requires the Commission to promulgate                   requirements, the discussion in this                  JPMA certification program to transition
                                           consumer product safety standards for                   section summarizes the provisions of                  to a new standard once that standard is
                                           durable infant or toddler products,                     ASTM F1235–15. Interested persons                     published. The Commission proposed a
                                           including hook-on chairs (specifically                  may purchase a copy of ASTM F1235–                    6-month effective date in the NPR and
                                           identified by section 104(f)(2)(C) of the               15 from ASTM, either through ASTM’s                   did not receive any comments regarding
                                           CPSIA). Furthermore, section 104 of the                 Web site or by mail at the address                    the effective date.
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                                           CPSIA lays out a broad timeline for                     provided in the rule. A copy of the                   IX. Regulatory Flexibility Act
                                           promulgation of such durable infant and                 standard may also be inspected at the
                                           toddler product safety standards. These                 CPSC’s Office of the Secretary, U.S.                  A. Introduction
                                           standards must be ‘‘substantially the                   Consumer Product Safety Commission,                      The Regulatory Flexibility Act
                                           same as’’ or more stringent than the                    or at NARA, as discussed above. We                    (‘‘RFA’’), 5 U.S.C. 601–612, requires that
                                           relevant voluntary standard.                            note that the Commission and ASTM                     agencies review a proposed rule and a


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                                           17064              Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Rules and Regulations

                                           final rule for the rule’s potential                     within the definition of ‘‘collection of              accreditation of third-party conformity
                                           economic impact on small entities,                      information,’’ as defined in 44 U.S.C.                assessment bodies (or laboratories) to
                                           including small businesses. Section 604                 3502(3).                                              test for conformance with a children’s
                                           of the RFA generally requires that                        OMB has assigned control number                     product safety rule in accordance with
                                           agencies prepare a final regulatory                     3041–0170 to this information                         section 14(a)(2) of the CPSA. Part 1112
                                           flexibility analysis (‘‘FRFA’’) when                    collection. The Commission did not                    also codifies a list of all of the NORs
                                           promulgating final rules, unless the                    receive any comments regarding the                    that the CPSC had published at the time
                                           head of the agency certifies that the rule              information collection burden of this                 part 1112 was issued. All NORs issued
                                           will not have a significant economic                    proposal.                                             after the Commission published part
                                           impact on a substantial number of small                 XII. Preemption                                       1112, such as the standard for hook-on
                                           entities.                                                                                                     chairs, require the Commission to
                                                                                                      Section 26(a) of the CPSA, 15 U.S.C.               amend part 1112. Accordingly, the
                                           B. Impact on Small Businesses                           2075(a), provides that when a consumer                Commission is now amending part 1112
                                              Approximately 10 firms currently                     product safety standard is in effect and              to include the standard for hook-on
                                           market portable hook-on chairs in the                   applies to a product, no state or political           chairs in the list of other children’s
                                           United States, nine of which are                        subdivision of a state may either                     product safety rules for which the CPSC
                                           domestic firms. Under U.S. Small                        establish or continue in effect a                     has issued NORs.
                                           Business Administration (‘‘SBA’’)                       requirement dealing with the same risk                   Laboratories applying for acceptance
                                           guidelines, a manufacturer of hook-on                   of injury unless the state requirement is             as a CPSC-accepted third-party
                                           chairs is small if it has 500 or fewer                  identical to the federal standard. Section            conformity assessment body to test to
                                           employees, and importers and                            26(c) of the CPSA also provides that                  the new standard for hook-on chairs
                                           wholesalers are considered small if they                states or political subdivisions of states            would be required to meet the third-
                                           have 100 or fewer employees.                            may apply to the Commission for an                    party conformity assessment body
                                              In the NPR briefing package, the                     exemption from this preemption under                  accreditation requirements in 16 CFR
                                           Commission certified that the proposed                  certain circumstances. Section 104(b) of              part 1112, Requirements Pertaining to
                                           hook-on chair rule would not have a                     the CPSIA refers to the rules to be                   Third-Party Conformity Assessment
                                           significant economic impact on a                        issued under that section as ‘‘consumer               Bodies. When a laboratory meets the
                                           substantial number of small entities.                   product safety rules.’’ Therefore, the                requirements as a CPSC-accepted third-
                                           That conclusion has not changed. All of                 preemption provision of section 26(a) of              party conformity assessment body, the
                                           the domestic hook-on chairs appear to                   the CPSA would apply to a rule issued                 laboratory can apply to the CPSC to
                                           conform to the current voluntary                        under section 104.                                    have 16 CFR part 1233, Standard
                                           standard and are expected to continue                   XIII. Amendment to 16 CFR Part 1112                   Consumer Safety Specification for
                                           to do so. Consequently, costs of                        To Include Notice of Requirements                     Hook-on Chairs, included in its scope of
                                           compliance, if any, are expected to be                  (NOR) for Hook-On Chair Standard                      accreditation of CPSC safety rules listed
                                           negligible. Third party testing costs are                                                                     for the laboratory on the CPSC Web site
                                           expected to be small and economically                      Section 14(a) of the CPSA imposes the              at: www.cpsc.gov/labsearch.
                                           insignificant (i.e., less than 1 percent of             requirement that products subject to a                   As required by the RFA, staff
                                           gross revenues for the affected firms).                 consumer product safety rule under the                conducted a FRFA when the
                                           Furthermore, we received no comments                    CPSA, or to a similar rule, ban,                      Commission issued the part 1112 rule
                                           questioning or challenging the                          standard, or regulation under any other               (78 FR 15836, 15855–58). Briefly, the
                                           certification that the rule would not                   Act enforced by the Commission, must                  FRFA concluded that the accreditation
                                           have a significant economic impact on                   be certified as complying with all                    requirements would not have a
                                           a substantial number of small entities.                 applicable CPSC-enforced requirements.                significant adverse impact on a
                                                                                                   15 U.S.C. 2063(a). Section 14(a)(2) of the            substantial number of small test
                                           X. Environmental Considerations                         CPSA requires that certification of                   laboratories because no requirements
                                              The Commission’s regulations address                 children’s products subject to a                      were imposed on test laboratories that
                                           whether the agency is required to                       children’s product safety rule be based               did not intend to provide third-party
                                           prepare an environmental assessment or                  on testing conducted by a CPSC-                       testing services. The only test
                                           an environmental impact statement.                      accepted, third party conformity                      laboratories that were expected to
                                           Under these regulations, a rule that has                assessment body. Section 14(a)(3) of the              provide such services were those that
                                           ‘‘little or no potential for affecting the              CPSA requires the Commission to                       anticipated receiving sufficient revenue
                                           human environment,’’ is categorically                   publish a NOR for the accreditation of                from the mandated testing to justify
                                           exempt from this requirement. 16 CFR                    third party conformity assessment                     accepting the requirements as a business
                                           1021.5(c)(1). The final rule falls within               bodies (or laboratories) to assess                    decision. Moreover, a test laboratory
                                           the categorical exemption.                              conformity with a children’s product                  would only choose to provide such
                                                                                                   safety rule to which a children’s product             services if it anticipated receiving
                                           XI. Paperwork Reduction Act                             is subject. The Standard Consumer                     revenues sufficient to cover the costs of
                                              This rule contains information                       Safety Specification for Hook-On                      the requirements.
                                           collection requirements that are subject                Chairs, to be codified at 16 CFR part                    Based on similar reasoning, amending
                                           to public comment and review by the                     1233, is a children’s product safety rule             16 CFR part 1112 to include the NOR for
                                           Office of Management and Budget                         that requires the issuance of an NOR.                 the hook-on chairs standard will not
                                           (OMB) under the Paperwork Reduction                        The Commission published a final                   have a significant adverse impact on
                                           Act of 1995 (44 U.S.C. 3501–3521). The                  rule, Requirements Pertaining to Third-               small test laboratories. Moreover, based
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                                           preamble to the proposed rule discussed                 Party Conformity Assessment Bodies, 78                upon the number of test laboratories in
                                           the information collection burden of the                FR 15836 (March 12, 2013), which is                   the United States that have applied for
                                           proposed rule. Sections 8 and 9 of                      codified at 16 CFR part 1112 (referred to             CPSC acceptance of accreditation to test
                                           ASTM F1235–15 contain requirements                      here as part 1112). This rule became                  for conformance to other mandatory
                                           for marking, labeling, and instructional                effective on June 10, 2013. Part 1112                 juvenile product standards, we expect
                                           literature. These requirements fall                     establishes requirements for                          that only a few test laboratories will


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                                                              Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Rules and Regulations                                                17065

                                           seek CPSC acceptance of their                           § 1233.1    Scope.                                    served may respond shall be extended
                                           accreditation to test for conformance                     This part establishes a consumer                    by five (5) days. Service by fax or email
                                           with the hook-on chair standard. Most                   product safety standard for portable                  shall be permitted at the discretion of
                                           of these test laboratories will have                    hook-on chairs.                                       the Presiding Officer, with the parties’
                                           already been accredited to test for                                                                           consent. Signed documents that are
                                           conformity to other mandatory juvenile                  § 1233.2 Requirements for portable hook-              served by email must be in PDF or other
                                                                                                   on chairs.
                                           product standards, and the only costs to                                                                      non-alterable form.
                                           them would be the cost of adding the                       Each portable hook-on chair must
                                                                                                   comply with all applicable provisions of              *     *     *     *    *
                                           hook-on chairs standard to their scope                                                                        [FR Doc. 2016–07017 Filed 3–25–16; 8:45 am]
                                           of accreditation. For these reasons, the                ASTM F1235–15, Standard Consumer
                                                                                                                                                         BILLING CODE 1505–01–D
                                           Commission certifies that the NOR                       Safety Specification for Portable Hook-
                                           amending 16 CFR part 1112 to include                    On Chairs, approved on May 1, 2015.
                                           the hook-on chairs standard will not                    The Director of the Federal Register
                                                                                                   approves this incorporation by reference              DEPARTMENT OF HEALTH AND
                                           have a significant impact on a                                                                                HUMAN SERVICES
                                           substantial number of small entities.                   in accordance with 5 U.S.C. 552(a) and
                                                                                                   1 CFR part 51. You may obtain a copy
                                           List of Subjects                                                                                              Food and Drug Administration
                                                                                                   from ASTM International, 100 Bar
                                           16 CFR Part 1112                                        Harbor Drive, P.O. Box 0700, West
                                                                                                                                                         21 CFR Parts 312 and 320
                                                                                                   Conshohocken, PA 19428; http://
                                             Administrative practice and                           www.astm.org/cpsc.htm. You may                        [Docket No. FDA–2016–N–0011]
                                           procedure, Audit, Consumer protection,                  inspect a copy at the Office of the
                                           Reporting and recordkeeping                             Secretary, U.S. Consumer Product                      Investigational New Drug Applications
                                           requirements, Third-party conformity                    Safety Commission, Room 820, 4330                     for Biological Products;
                                           assessment body.                                        East West Highway, Bethesda, MD                       Bioequivalence Regulations; Technical
                                                                                                   20814, telephone 301–504–7923, or at                  Amendment
                                           16 CFR Part 1233
                                                                                                   the National Archives and Records                     AGENCY:   Food and Drug Administration,
                                             Consumer protection, Imports,                         Administration (NARA). For                            HHS.
                                           Incorporation by reference, Infants and                 information on the availability of this                     Final rule; technical
                                                                                                                                                         ACTION:
                                           children, Labeling, Law enforcement,                    material at NARA, call 202–741–6030,                  amendment.
                                           Toys.                                                   or go to: http://www.archives.gov/
                                             For the reasons discussed in the                      federal_register/code_of_                             SUMMARY:    The Food and Drug
                                           preamble, the Commission amends title                   federalregulations/ibr_locations.html.                Administration (FDA or Agency) is
                                           16 of the Code of Federal Regulations as                  Dated: March 22, 2016.                              amending its regulations to update the
                                           follows:                                                Todd A. Stevenson,                                    address for applicants to submit
                                                                                                   Secretary, Consumer Product Safety                    investigational new drug applications
                                           PART 1112—REQUIREMENTS                                  Commission.                                           (INDs) for biological products regulated
                                           PERTAINING TO THIRD PARTY                               [FR Doc. 2016–06769 Filed 3–25–16; 8:45 am]
                                                                                                                                                         by the Center for Drug Evaluation and
                                           CONFORMITY ASSESSMENT BODIES                            BILLING CODE 6355–01–P
                                                                                                                                                         Research (CDER). FDA is also amending
                                                                                                                                                         its regulations on the criteria and
                                           ■ 1. The authority citation for part 1112                                                                     evidence to assess actual and potential
                                           continues to read as follows:                                                                                 bioequivalence problems
                                                                                                   COMMODITY FUTURES TRADING
                                             Authority: Pub. L. 110–314, section 3, 122                                                                  (bioequivalence regulations) to correct a
                                                                                                   COMMISSION
                                           Stat. 3016, 3017 (2008); 15 U.S.C. 2063.                                                                      typographical error. FDA is taking this
                                                                                                   17 CFR Part 10                                        action to ensure accuracy and clarity in
                                           ■ 2. Amend § 1112.15 by adding and                                                                            the Agency’s regulations.
                                           reserving paragraph (b)(39) and adding                  Rules of Practice                                     DATES: This rule is effective March 28,
                                           paragraph (b)(40) to read as follows:                                                                         2016.
                                                                                                   CFR Correction
                                           § 1112.15 When can a third party                                                                              FOR FURTHER INFORMATION CONTACT:
                                           conformity assessment body apply for                      In Title 17 of the Code of Federal                  Florine Purdie, Center for Drug
                                           CPSC acceptance for a particular CPSC rule              Regulations, Parts 1 to 40, revised as of             Evaluation and Research, Food and
                                           or test method?                                         April 1, 2015, on page 386, in § 10.12,               Drug Administration, 10903 New
                                           *     *    *    *     *                                 paragraph (a)(2)(v) is reinstated to read             Hampshire Ave., Bldg. 51, Rm. 6248,
                                                                                                   as follows:                                           Silver Spring, MD 20993–0002, 301–
                                             (b) * * *
                                             (40) 16 CFR part 1233, Safety                         § 10.12 Service and filing of documents;              796–3601.
                                           Standard for Portable Hook-On Chairs.                   form and execution.                                   SUPPLEMENTARY INFORMATION: FDA is
                                           *     *    *    *     *                                   (a) * * *                                           amending 21 CFR 312.140(a)(2) to
                                                                                                     (2) * * *                                           update the address for applicants to
                                           ■   3. Add part 1233 to read as follows:                  (v) Service shall be complete at the                submit INDs for biological products
                                                                                                   time of personal service; upon deposit                regulated by CDER. FDA is amending 21
                                           PART 1233–SAFETY STANDARD FOR                           in the mail or with a similar commercial              CFR 320.33(f)(3) of its bioequivalence
                                           PORTABLE HOOK-ON CHAIRS                                 package delivery service of a properly                regulations to correct a typographical
                                           Sec.                                                    addressed document for which all                      error by removing the phrase ‘‘(first-
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                                           1233.1 Scope.                                           postage or delivery service fees have                 class metabolism)’’ and adding in its
                                           1233.2 Requirements for portable hook-on                been paid; or upon transmission by fax                place ‘‘(first-pass metabolism).’’
                                                chairs.                                            or email. Where a party effects service                  Publication of this document
                                             Authority: Sec. 104, Pub. L. 110–314, 122             by mail or similar package delivery                   constitutes final action on these changes
                                           Stat. 3016 (August 14, 2008); Pub. L. 112–28,           service (but not by fax or email), the                under the Administrative Procedure Act
                                           125 Stat. 273 (August 12, 2011).                        time within which the party being                     (5 U.S.C. 553). FDA has determined that


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Document Created: 2016-03-26 00:13:11
Document Modified: 2016-03-26 00:13:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule will become effective September 28, 2016. The incorporation by reference of the publication listed in this rule is approved by the Director of the Federal Register as of September 28, 2016.
ContactKeysha Walker, Compliance Officer, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: 301-504-6820; email: [email protected]
FR Citation81 FR 17062 
CFR Citation16 CFR 1112
16 CFR 1233
CFR AssociatedAdministrative Practice and Procedure; Audit; Consumer Protection; Reporting and Recordkeeping Requirements; Third-Party Conformity Assessment Body; Imports; Incorporation by Reference; Infants and Children; Labeling; Law Enforcement and Toys

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