[Federal Register Volume 78, Number 114 (Thursday, June 13, 2013)]
[Rules and Regulations]
[Pages 35559-35567]
[FR Doc No: 2013-13909]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1910 and 1926

[Docket No. OSHA-2013-0005]
RIN 1218-AC77

Updating OSHA Standards Based on National Consensus Standards;
Signage

AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.

ACTION: Direct final rule; request for comments.

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SUMMARY: The Occupational Safety and Health Administration (``OSHA'' or
``the Agency'') is issuing this direct final rule to update its general
industry and construction signage standards by adding references to the
latest versions of the American National Standards Institute (``ANSI'')
standards on specifications for accident prevention signs and tags,
ANSI Z535.1-2006(R2011), Z535.2-2011 and Z535.5-2011. In this
rulemaking, OSHA is retaining the existing references to the earlier
ANSI standards, ANSI Z53.1-1967, Z35.1-1968 and Z35.2-1968, in its
signage standards, thereby providing employers an option to comply with
the updated or earlier standards. OSHA also is incorporating by
reference Part VI of the Manual of Uniform Traffic Control Devices
(``MUTCD''), 1988 Edition, Revision 3, into the incorporation-by-
reference section of the construction standards having inadvertently
omitted this edition of the MUTCD from this section during an earlier
rulemaking, and amending citations in two provisions of the
construction standards to show the correct incorporation-by-reference
section. In addition, OSHA is publishing a notice of proposed
rulemaking in today's Federal Register adding the same references.

DATES: This direct final rule will become effective on September 11,
2013 unless OSHA receives a significant adverse comment to this direct
final rule or the companion proposal by July 15, 2013. If OSHA receives
a significant adverse comment, the Agency will publish a timely
withdrawal of the direct final rule in the Federal Register.
    Submit comments on this direct final rule (including comments on
the information-collection (paperwork) determination described under
the section titled Procedural Determinations, hearing requests, and
other information by July 15, 2013. All submissions must bear a
postmark or provide other evidence of the submission date (the
following section titled ADDRESSES describes the available methods of
making submissions).
    The Director of the Federal Register approved the incorporation by
reference of specific publications listed in this direct final rule as
of September 11, 2013.

ADDRESSES: Submit comments, hearing requests, and other information as
follows:
     Electronic. Submit comments electronically to http://www.regulations.gov, which is the Federal eRulemaking Portal. Follow
the instructions online for submitting comments.
     Facsimile. OSHA allows facsimile transmission of comments
and hearing requests that are 10 pages or fewer in length (including
attachments). Send these documents to the OSHA Docket Office at (202)
693-1648; OSHA does not require hard copies of these documents. Instead
of transmitting facsimile copies of attachments that supplement these
documents (e.g., studies, journal articles), commenters must submit
these attachments to the OSHA Docket Office, Technical Data Center,
Room N-2625, OSHA, U.S. Department of Labor, 200 Constitution Ave. NW.,
Washington, DC 20210. These attachments must clearly identify the
sender's name, date, subject, and docket number (i.e., OSHA-2013-0005)
so that the Agency can attach them to the appropriate document.
     Regular mail, express delivery, hand delivery, and
messenger (courier) service. Submit comments and any additional
material (e.g., studies, journal articles) to the OSHA Docket Office,
Docket No. OSHA-2013-0005 or RIN 1218-AC77, Technical Data Center, Room
N-2625, OSHA, U.S. Department of Labor, 200 Constitution Ave. NW.,
Washington, DC 20210; telephone:<PHONE_NUMBER>. (OSHA's TTY number is
(877) 889-5627.) Note that security procedures may result in
significant delays in receiving comments and other written materials by
regular mail. Contact the OSHA Docket Office for information about
security procedures for delivery of materials by express delivery, hand
delivery, and messenger service. The hours of operation for the OSHA
Docket Office are 8:15 a.m. to 4:45 p.m., e.t.
     Instructions. All submissions must include the Agency name
and the OSHA docket number (i.e., OSHA Docket No. OSHA-2013-0005). OSHA
will place comments and other material, including any personal
information, in the public docket without revision, and these materials
will be available online at http://www.regulations.gov. Therefore, the
Agency cautions commenters about submitting statements they do not want
made public, or submitting comments that contain personal information
(either about themselves or others) such as Social Security numbers,
birth dates, and medical data.
    OSHA invites comments on all issues related to this direct final
rule. The Agency also welcomes comments on its findings that this
direct final rule would have no negative economic, paperwork, or other
regulatory impacts on the regulated community. This direct final rule
is the companion document of a notice of proposed rulemaking published
in the ``Proposed Rules'' section of today's Federal Register. If OSHA
receives no significant adverse comment on this direct final rule, the
Agency will publish a Federal Register notice confirming the effective
date of the final rule and withdrawing the companion proposed rule. The
final rule may include minor stylistic or technical corrections of the
direct final rule. For the purpose of judicial review, OSHA considers
the date that the Agency confirms the effective date of the final rule
to be the date of issuance. If, however, OSHA receives a significant
adverse comment on the direct final rule or proposal, the Agency will
publish a timely withdrawal of this direct final rule and proceed with
the proposed rule, which addresses the same revisions of its signage
standards.
     Docket. The electronic docket for this direct final rule
established at http://www.regulations.gov lists most of the documents
in the docket. Some information (e.g., copyrighted material), however,
cannot be read or downloaded through this Web site. All submissions,
including copyrighted material, are accessible at the OSHA Docket
Office. Contact the OSHA Docket Office for assistance in locating
docket submissions.

FOR FURTHER INFORMATION CONTACT: General information and press
inquiries: Contact Frank Meilinger, OSHA Office of Communications, Room
N-3647, U.S. Department of Labor, 200 Constitution Ave. NW.,
Washington, DC 20210; telephone:<PHONE_NUMBER>.
    Technical inquiries: Contact Kenneth Stevanus, Directorate of
Standards and Guidance, Room N-3609, OSHA, U.S. Department of Labor,
200 Constitution Ave. NW., Washington, DC 20210; telephone: (202) 693-
2260; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of this Federal Register notice.
Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This Federal Register notice, as well as
news releases and other relevant information, also are available at
OSHA's Web page at http://www.osha.gov.
    Availability of Incorporated Standards. With the approval of the
Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part
51, OSHA incorporates by reference under 29 CFR 1910.6, and 1926.6 the
American National Standards Institute (``ANSI'') standards cited in 29
CFR 1910.97(a)(3)(ii); 1910.145(d)(2), (d)(4), and (d)(6);
1910.261(c)(16); and 1926.200(b)(1), (c)(1), (c)(3), (g)(2), (h)(2),
and (i). OSHA also is incorporating by reference under 29 CFR 1926.6
Part VI of the MUTCD, 1988 Edition, Revision 3. To enforce any other
version of the cited ANSI standards other than the editions specified
by 29 CFR 1910.97(a)(3)(ii); 1910.145(d)(2), (d)(4), and (d)(6);
1910.261(c)(16); and 1926.200(b)(1), (c)(1), (c)(3), (g)(2), (h)(2) and
(i), or to enforce any other version of the cited edition of the MUTCD
specified by 29 CFR 1926.200(g)(2); 1926.201(a); and 1926.202, OSHA
must publish a notice of change in the Federal Register, and must make
the material available to the public. All approved material is
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, telephone<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Also, the material is available for inspection at any
OSHA Regional Office or the OSHA Docket Office (U.S. Department of
Labor, 200 Constitution Ave. NW., Room N-2625, Washington, DC 20210;
telephone:<PHONE_NUMBER> (TTY number:<PHONE_NUMBER>)).

Table of Contents

I. Direct Final Rulemaking
II. Background
III. Summary and Explanation of Revisions to the Signage Standards
IV. Procedural Determinations
    A. Legal Considerations
    B. Final Economic Analysis and Regulatory Flexibility Act
Certification
    C. OMB Review Under the Paperwork Reduction Act of 1995
    D. Federalism
    E. State-Plan States
    F. Unfunded Mandates Reform Act of 1995
    G. Consultation and Coordination with Indian Tribal Governments
    H. Consultation with the Advisory Committee on Construction
Safety and Health
V. Authority and Signature

I. Direct Final Rulemaking

    In a direct final rulemaking, an agency publishes a direct final
rule in the Federal Register along with a statement that the rule will
become effective unless the agency receives a significant adverse
comment within a specified period. The agency also publishes
concurrently with the direct final rule an identical proposed rule. If
the agency receives no significant adverse comment, the direct final
rule will become effective. However, should the agency receive a
significant adverse comment, the agency will withdraw the direct final
rule and treat the comments as submissions on the proposed rule.
    OSHA uses direct final rules because it expects the rulemaking to
be noncontroversial; provide protection to employees that is at least
equivalent to the protection afforded to them by the previous standard-
development organization standard; and impose no significant new
compliance costs on employers (69 FR 68283, 68285 (2004)). OSHA used
direct final rules previously to update or, when appropriate, revoke
references to previous national consensus standards in OSHA rules (see,
e.g., 69 FR 68283 (2004); 70 FR 76979 (2006); 76 FR 75782 (2011); and
77 FR 37587 (2012)).
    For the purposes of this direct final rule, a significant adverse
comment is one that ``explains why the rule would be inappropriate,
including challenges to the rule's underlying premise or approach, or
why it would be ineffective or unacceptable without a change'' (see 60
FR 43108, 43111(1995)). In determining whether a comment necessitates
withdrawal of the direct final rule, OSHA will consider whether the
comment raises an issue serious enough to warrant a substantive
response in a notice-and-comment process. OSHA will not consider a
comment recommending additional revisions to a rule to be a significant
adverse comment unless the comment states why the direct final rule
would be ineffective without the revisions. If OSHA receives a timely
significant adverse comment, it will publish a Federal Register notice
withdrawing the direct final rule no later than 90 days after the
publication date of this current notice.
    This direct final rulemaking furthers the objectives of Executive
Order 13563, which requires that the regulatory process ``promote
predictability and reduce uncertainty'' and ``identify and use the
best, most innovative and least burdensome tools for achieving
regulatory ends.'' As described below, the revisions will make the
requirements of OSHA's signage standards consistent with the most
recent national consensus standards, thereby eliminating confusion and
clarifying employers' obligations (for the purposes of this rulemaking,
the term ``signage standards'' refers to standards that regulate both
signs and tags). Therefore, OSHA believes that these revisions will not
compromise the safety of employees, but will instead enhance employee
protection. Accordingly, the Agency concludes that updating the
references to the national consensus standards in its signage standards
is consistent with, and promotes the objectives of, Executive Order
13563.

II. Background

    In June 2009, the National Electrical Manufacturers Association
(NEMA) contacted OSHA and, based on a letter from ANSI, requested that
the Agency add references to the latest versions of ANSI's Z535 series
of standards to OSHA's signage standards. Letter dated June 2, 2009,
from Kyle Pitsor, Vice President, Government Relations, NEMA, to
Richard Fairfax, Director, Directorate of Enforcement Programs, OSHA
(Ex. OSHA-2013-0005-0003, p. 1), attaching a letter dated May 28, 2009,
from Geoffrey Peckham, Chair, ANSI Z535.2 Subcommittee, to Mr. Fairfax
(Ex. OSHA-2013-0005-0003, p. 3). NEMA specifically advocated
incorporating by reference ANSI Z535.2, ``Environmental and Facility
Safety Signs,'' in OSHA standards that refer to old\1\ versions of this
ANSI standard. Pitsor letter (Ex. OSHA-2013-0005-0003, p. 1); accord
Peckham letter (Ex. OSHA-2013-0005-0003, p. 3).
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    \1\ The terms ``old'' and ``older,'' as used in this Federal
Register notice, refer specifically to signs or tags that comply
with ANSI Z53.1-1967, Z35.1-1968 and Z35.2-1968.
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    Over the next few years, OSHA staff met with NEMA several times to
discuss the association's request that OSHA adopt ANSI's Z535 series of
standards. Besides urging OSHA to incorporate ANSI Z535.2 by reference,
NEMA also asked the Agency to update its standards' references to ANSI
Z53.1-67, ``Safety Color Code for Marking Physical Hazards and the
Identification of Certain Equipment,'' by citing the current version of
this standard, ANSI Z535.1, ``Safety Colors.'' As a result of these
meetings and as recorded in a second letter to OSHA, NEMA provided the
Agency with side-by-side comparisons of ANSI Z35.1-68, Z535.2-2007, and
Z535.2-2011, and ANSI Z53.1-67, Z535.1-2006, and Z535.1-2006(R2011),
and other relevant materials such as signs, which OSHA evaluated.
Letter dated March 30, 2011, from Evan Gaddis, President and CEO, NEMA,
to Dr. David Michaels, Assistant Secretary of Labor for Occupational
Safety and Health; Side-by-Side Comparisons of ANSI standards; NEMA
Signage Materials (Exs. OSHA-2013-0005-0004 through -0006). OSHA also
subsequently considered whether it should also incorporate by reference
ANSI Z535.5, ``Safety Tags and Barricade Tapes (for Temporary
Hazards),'' into those OSHA standards that refer to a much older
version of this ANSI standard.
    At present, employers continue to use the old signs and tags not
only because they are long-lasting and rarely need replacing, but also
because they comply with OSHA's current signage standards, which
incorporate the old ANSI standards by reference. Both NEMA and ANSI
contend that incorporating the new ANSI standards by reference is
necessary to encourage employers to buy and use signs and tags that
comply with these standards without receiving a de minimis notice for
failure to comply with the old ANSI standards.\2\ Pitsor letter (Ex.
OSHA-2013-0005-0003, p. 1); Peckham letter (Ex. OSHA-2013-0005-0003, p.
3).
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    \2\ According to OSHA's Field Operations Manual (FOM), a de
minimis condition occurs when ``[a]n employer has implemented a
measure different than the one specified in a standard, that has no
direct or immediate relationship to safety or health.'' FOM, CPL 02-
00-150, Ch. 4, Sec.  VIII, pp. 4-36 to 4-37 (Apr. 22, 2011),
available on OSHA's Web page. OSHA issues no citations or penalties
for these conditions, but compliance officers will document the
condition during an inspection. Id. at 4-36. See, also, Letter of
Interpretation dated February 22, 2011, from Thomas Galassi,
Director, Directorate of Enforcement Programs, OSHA, to Richard A.
Eichel, ATA Safety, describing OSHA's de minimis enforcement policy
with regard to ANSI signs; available at http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=27641.
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    NEMA and ANSI further assert that signs and tags meeting the latest
version

of the ANSI standards, the Z535 series, provide an equal or greater
level of protection than the currently required signs that comply with
the old ANSI standards, Z35.1, Z35.2, and Z53.1, cited in OSHA's
standards. Pitsor letter (Ex. OSHA-2013-0005-0003, p. 1); Peckham
letter (Ex. OSHA-2013-0005-0003, p. 3). In its letter, ANSI provides an
exhibit demonstrating why it believes the new Z535.2-2007 signs are at
least as protective as the old Z35.1 signs (Peckham letter, Ex. OSHA-
2013-0005-0003, p. 10 (Peckham's Ex. 6).\3\ The exhibit, which compares
the information contained in the two sets of signs, shows that the new
Z535.2 signs typically have at least as much information as the Z35.1
signs. Moreover, the new ANSI safety-color standard, ANSI Z535.1-
2006(2011), includes two safety colors, brown and gray, that were not
in Z53.1-1967. See ANSI Z535.1-2006(2011), pp. v-vi (ANSI also added
safety blue in the 1979 revision after deleting this color in the 1971
revision).
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    \3\ This exhibit is actually Exhibit 6 of the Peckham letter,
but is mislabeled as Exhibit 5.
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    ANSI and NEMA also claim that the new signs provide additional
information, including the specific identity of the hazard, a
description of how serious the hazard is, how to avoid the hazard, and
the probable consequences of not avoiding the hazard. Peckham letter
(Exs. OSHA-2013-0005-0003, pp. 7-9, and OSHA-2013-0005-0006, pp. 9-11).
ANSI further argues that, the old sign formats ``lack the ability to
contain [the] symbols, more extensive word messages, multiple messages,
and additional languages'' necessary to communicate critical safety
information to an increasingly multicultural work force. Id., pp. 6 and
9-10. NEMA also submitted an ANSI timeline of the institute's
standards, and the safety signs that complied with those standards, for
the years 1914 to 2011; this timeline illustrates additions made to the
information contained in these signs during this period. NEMA Signage
Materials, pp. 6-8 (Ex. OSHA-2013-0005-0006). Based on the available
record, OSHA believes that the new signs are at least as protective as
the old ones. Therefore, this direct final rule is incorporating the
ANSI Z535 series by reference in the applicable OSHA signage standards
so that employers will be able to buy and use the new signs without the
prospect of receiving de minimis notices for using noncompliant signs.
OSHA invites the public to comment on its conclusion that the new signs
are as effective as the old ones.

III. Summary and Explanation of Revisions to the Signage Standards

    As discussed in a previous Federal Register notice (69 FR 68283
(2004)), OSHA is undertaking a series of projects to update its
standards to incorporate the latest versions of national consensus and
industry standards. These projects include updating or removing
national consensus and industry standards cited in existing OSHA
standards, updating the text of standards that OSHA adopted directly
from previous national consensus standards, and, when appropriate,
replacing specific references to previous national consensus and
industry standards with performance requirements.
    This direct final rule updates the references to ANSI consensus
standards in four provisions of OSHA's general industry and
construction standards: 29 CFR 1910.97, Nonionizing radiation; Sec.
1910.145, Specifications for accident prevention signs and tags; Sec.
1910.261, Pulp, paper, and paper board mills; and Sec.  1926.200,
Accident prevention signs and tags. These provisions incorporate by
reference ANSI consensus standards Z53.1-1967, ``Safety Color Code for
Marking Physical Hazards and the Identification of Certain Equipment'';
Z35.1-1968, ``Specifications for Accident Prevention Signs''; and
Z35.2-1968, ``Specifications for Accident Prevention Tags.'' The direct
final rule will allow employers to comply with either these ANSI
standards or the latest versions of them, Z535.1-2006(R2011), Z535.2-
2011, and Z535.5-2011. The latter compliance option will allow
employers to update their signage based on the newest ANSI consensus
standards without violating OSHA's requirements. In addition, since
employers will not have to update their signage, there is no additional
compliance cost or burden resulting from this rulemaking. The direct
final rule will revise the above four provisions in the following ways:
    (1) OSHA's general industry standard on nonionizing radiation at
Sec.  1910.97(a)(3)(ii) requires employers to use the color
specification provided by ANSI 53.1-1953, ``Safety Color Code for
Marking Physical Hazards,'' which OSHA incorporated by reference under
Sec.  1910.6 in 1974 (39 FR 23502 (1974)). Currently, Sec.  1910.6
refers to ANSI Z53.1-1967, ``Safety Color Code for Marking Physical
Hazards and the Identification of Certain Equipment'' because, on March
7, 1996, OSHA incorporated ANSI Z53.1-1967 by reference under Sec.
1910.6 without revising the reference to ANSI Z53.1-1953 in Sec.
1910.97(a)(3)(ii) (see 61 FR 9228, 9232 (1996)). In addition, OSHA did
not obtain approval from the Office of the Federal Register during the
1996 rulemaking to incorporate ANSI Z53.1-1967 by reference under Sec.
1910.6. With this direct final rule, OSHA is correcting this oversight
by incorporating ANSI Z53.1-1967 by reference under Sec.  1910.6 after
obtaining approval to do so from the Office of the Federal Register. In
addition, this direct final rule will update the nonionizing radiation
provision by incorporating ANSI Z535.1-2006(R2011), ``Safety Colors,''
by reference. This addition will allow employers to comply with the
1967 version or the 2006(R2011) version of the cited ANSI standard.
    (2) OSHA's general industry standard on specifications for
accident-prevention signs and tags at Sec.  1910.145 refers to ANSI
standard Z53.1-1967, ``Safety Colors for Marking Physical Hazards and
the Identification of Certain Equipment,'' which Sec.  1910.6
incorporated by reference in three places: Sec. Sec.  1910.145(d)(2),
Danger signs; 1910.145(d)(4), Caution signs; and 1910.145(d)(6), Safety
instruction signs. However, as noted above, the Office of the Federal
Register did not approve ANSI Z53.1-1967 for incorporation by reference
under Sec.  1910.6. Therefore, this direct final rule is correcting
this oversight by incorporating that ANSI standard by reference under
Sec.  1910.6 after receiving approval from the Office of the Federal
Register to do so.
    Each of the three cited provisions of Sec.  1910.145(d) specifies
the colors employers must use for each type of sign, and requires that
the signs meet the specifications in Table 1, ``Fundamental
Specification of Safety Colors for CIE Standard Source `C,' '' of ANSI
Z53.1-1967. The direct final rule will update each of these sections by
referencing Table 1, ``Specification of the Safety Colors for CIE
Illuminate C and the CIE 1931, 2[deg] Standard Observer,'' of ANSI
Z535.1-2006(R2011), ``Safety Colors,'' which it incorporates by
reference. This addition will allow employers to comply with the 1967
version or the 2006(R2011) version of the cited ANSI standard.
    (3) OSHA's general industry standard on pulp, paper, and paper
board mills at Sec.  1910.261 refers to ANSI Z35.1-1968,
``Specifications for Accident Prevention Signs,'' which Sec.
1910.6(e)(59) incorporates by reference in two places. First, Sec.
1910.261(c)(16) refers to this 1968 ANSI standard. The direct final
rule will update Sec.  1910.261(c)(16) by incorporating ANSI Z535.2-
2011, ``Environmental and Facility Safety Signs,'' by reference in
Sec.  1910.6(e)(60). This addition will allow

employers to comply with the 1968 version or the 2011 version of the
cited ANSI standard.
    Second, Sec.  1910.6(e)(59) incorporates Z35.1-1968,
``Specifications for Accident Prevention Signs,'' by reference in Sec.
1910.261(a)(3)(xxiv). However, on June 18, 1998, as part of an OSHA
rulemaking, the Agency removed subsection Sec.  1910.261(a)(3)(xxiv)
from the pulp, paper, and paper board mills standard, but did not
remove the reference to Sec.  1910.261(a)(3)(xxiv) in Sec.
1910.6(e)(59). The direct final rule will correct this oversight.
    (4) OSHA's construction standard on accident prevention signs and
tags, Sec.  1926.200, refers to ANSI standards Z35.1-1968,
``Specifications for Accident Prevention Signs''; Z35.2-1968,
``Specifications for Accident Prevention Tags''; or Z53.1-1967,
``Safety Color Code for Marking Physical Hazards and the Identification
of Certain Equipment,'' in five places discussed below.\4\ In addition,
as discussed below, Sec.  1926.200 is incorporating by reference Part
VI of the MUTCD, 1988 Edition, Revision 3.
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    \4\ Although Sec.  1926.200(c)(3) currently refers to ANSI
Z53.1-1967, OSHA did not incorporate that ANSI standard by reference
under Sec.  1926.6. This direct final rule, therefore, is correcting
this oversight by incorporating ANSI Z53.1-1967 by reference under
Sec.  1926.6.
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    The first reference to one of these old ANSI standards is in Sec.
1926.200(b)(1), Danger signs, which refers to Figure G-1, which is
identical to Figure 1 in ANSI Z35.1-1968, ``Specifications for Accident
Prevention Signs.'' The second reference is in Sec.  1926.200(c)(1),
Caution signs, which refers to Figure G-2, which is identical to Figure
4 in the same ANSI standard. The direct final rule will remove Figures
G-1 and G-2 from Sec.  1926.200(b)(1) and (c)(1), and update these
provisions by referencing the appropriate figures from ANSI Z35.1-1968
and ANSI Z535.2-2011, ``Environmental and Facility Safety Signs.''
These revisions, therefore, will give employers the option of using the
figures from either ANSI standard.
    The third reference to an old ANSI standard is in Sec.
1926.200(c)(3), which refers to ANSI Z53.1-1967, ``Safety Color Code
for Marking Physical Hazards and the Identification of Certain
Equipment.'' This OSHA provision specifies the colors employers must
use in caution signs, and requires that the signs meet the
specifications in Table 1 of ANSI Z53.1-1967. This direct final rule
will update Sec.  1926.200(c)(3) by adding a reference to Table 1 of
ANSI Z535.1-2006(R2011), ``Safety Colors,'' the latest version of
Z53.1-1967. This addition, therefore, will allow employers to use
either Table 1 of Z53.1-1967 or Table 1 of Z535.1-2006(R2011).
    The fourth reference to an old ANSI standard is in Sec.
1926.200(h)(2), Accident prevention tags, which says that
specifications for accident-prevention tags similar to the
specifications in Table G-1 apply; OSHA based Table G-1 on Figures 1 to
4 in ANSI Z35.2-1968, ``Specifications for Accident Prevention Tags.''
The direct final rule will remove Table G-1 from Sec.  1926.200(h)(2),
and update this provision by referencing Figures 1 to 4 of ANSI Z35.2-
1968 and Figures 1 to 8 of Z535.5-2011, ``Safety Tags and Barricade
Tapes (for Temporary Hazards).'' These revisions, therefore, will give
employers the option of using the figures from either ANSI standard.
    The fifth reference to the old ANSI standards is in Sec.
1926.200(i), which refers to ANSI Z35.1-1968, ``Specifications for
Accident Prevention Signs,'' and Z35.2-1968, ``Specifications for
Accident Prevention Tags.'' Section 1926.200(i) requires employers to
follow these two ANSI standards with respect to OSHA rules not
specifically prescribed in 29 CFR 1926, subpart G. This direct final
rule will update Sec.  1926.200(i) by adding Z535.2-2011,
``Environmental and Facility Safety Signs,'' and Z535.5-2011, ``Safety
Tags and Barricade Tapes (for Temporary Hazards),'' the latest versions
of the cited ANSI standards, as references. These additions will allow
employers to comply with Z35.1-1968 or Z535.2-11 for signs, and Z35.2-
1968 or Z535.5-11 for tags.
    This direct final rule also will update paragraph (g)(2) of Sec.
1926.200 by removing the language referring to the Director of the
Federal Register's approval for incorporation by reference of Part VI
of the 1988 Edition, Revision 3, of the MUTCD, and adding a reference
to Sec.  1926.6 instead (i.e., this reference indicates such approval).
Additionally, in an earlier rulemaking (see 75 FR 47906, 48132 (2010)),
OSHA inadvertently removed Part VI of the MUTCD from Sec.  1926.6. This
direct final rule will correct this oversight by returning the
reference to Part VI of the MUTCD to Sec.  1926.6; it also will remove
the reference to Sec.  1926.200(g)(2) as the incorporation-by-reference
provision in Sec.  1926.201(a) and Sec.  1926.202, and replace it with
a reference to Sec.  1926.6.
    In summary, OSHA believes, based on the discussion above under
Background, that many general industry and construction employers
currently comply with the ANSI signage requirements incorporated by
reference in its existing signage standards, i.e., ANSI Z35.1-1968,
Z35.2-1968, and Z53.1-1967. Therefore, OSHA is retaining these
requirements in its signage standards. OSHA also determined that the
latest editions of the ANSI signage standards, i.e., Z535.1-
2006(R2011), Z535.2-2011, and Z535.5-2011, provide at least as
effective protection to employees as the old ANSI standards
incorporated by reference in the Agency's signage standards.
Accordingly, OSHA is giving employers the option of complying with the
old or the new ANSI standards. Since employers can choose to comply
with OSHA's existing signage standards, incorporating the new ANSI
standards by reference will not increase the cost or burden of
compliance.

IV. Procedural Determinations

A. Legal Considerations

    The purpose of the Occupational Safety and Health Act of 1970 (OSH
Act), 29 U.S.C. 65-78, is to achieve to the extent possible safe and
healthful working conditions for all employees. 29 U.S.C. 651(b). To
achieve this goal, Congress authorized the Secretary of Labor to
promulgate and enforce occupational safety and health standards. 29
U.S.C. 654(b), 655(b). A safety or health standard is a standard that
``requires conditions, or the adoption or use of one or more practices,
means, methods, operations, or processes reasonably necessary or
appropriate to provide safe or healthful employment and places of
employment.'' 29 U.S.C. 652(8). A standard is reasonably necessary or
appropriate within the meaning of Section 652(8) of the OSH Act when a
significant risk of material harm exists in the workplace and the
standard would substantially reduce or eliminate that workplace risk.
See Industrial Union Department, AFL-CIO v. American Petroleum
Institute, 448 U.S. 607 (1980). OSHA already determined that
requirements specified by signage standards, including design
requirements, are reasonably necessary or appropriate within the
meaning of Section 652(8) (see, e.g., 49 FR 49726, 49737 (1978); 51 FR
33251, 33251-33259 (1986)).
    This direct final rule neither reduces employee protection nor
alters an employer's obligations under the existing standards. Under
this direct final rule, employers will be able to continue to use the
same signs and tags they are using currently to meet their compliance
obligations under the existing standards' design-criteria requirements.
This direct final rule provides employers with additional

options for meeting the design-criteria requirements for signage
protection. Therefore, this direct final rule does not alter the
substantive protection that employers must provide to employees or
impose a new compliance burden on employers. Accordingly, OSHA need
not, in this rulemaking, determine significant risk or the extent to
which this direct final rule will reduce that risk, as typically
required by Industrial Union Department.

B. Final Economic Analysis and Regulatory Flexibility Act Certification

    This direct final rule is not economically significant within the
context of Executive Order 12866, or a major rule under the Unfunded
Mandates Reform Act or Section 801 of the Small Business Regulatory
Enforcement Fairness Act. In addition, this direct final rule complies
with Executive Order 13563. The rulemaking imposes no additional costs
on any private-sector or public-sector entity, and does not meet any of
the criteria for an economically significant or major rule specified by
the Executive Order or relevant statutes.
    This rulemaking allows employers increased flexibility in choosing
signage for the protection of their employees. This direct final rule,
however, does not require an employer to update or replace its signage
solely as a result of this rule if the employer's current signage
protection meets the revised standards. Because the rule imposes no
costs, OSHA certifies that it will not have a significant economic
impact on a substantial number of small entities.

C. OMB Review Under the Paperwork Reduction Act of 1995

    This rulemaking does not impose new information-collection
requirements for purposes of the Paperwork Reduction Act of 1995, 44
U.S.C. 3501-30. Accordingly, the Agency does not have to prepare an
Information Collection Request in association with this rulemaking.
    Members of the public may respond to this paperwork determination
by sending their written comments to the Office of Information and
Regulatory Affairs, Attn: OSHA Desk Officer (RIN 1218-AC77), Office of
Management and Budget, Room 10235, 725 17th Street NW., Washington, DC
20503. The Agency encourages commenters to submit these comments to the
rulemaking docket, along with their comments on other parts of this
direct final rule. For instructions on submitting these comments and
accessing the docket, see the sections of this Federal Register notice
titled DATES and ADDRESSES. OSHA, however, will not consider any
comment received on this paperwork determination to be a ``significant
adverse comment'' as specified above under the section titled Direct
Final Rulemaking.
    To make inquiries, or to request other information, contact Mr.
Todd Owen, Directorate of Standards and Guidance, OSHA, Room N-3609,
U.S. Department of Labor, 200 Constitution Ave. NW., Washington, DC
20210; telephone<PHONE_NUMBER>.

D. Federalism

    OSHA reviewed this direct final rule in accordance with the
Executive Order on Federalism (Executive Order 13132, 64 FR 43255,
August 10, 1999), which requires that agencies, to the extent possible,
refrain from limiting state policy options, consult with states prior
to taking any actions that would restrict state policy options, and
take such actions only when clear constitutional authority exists and
the problem is national in scope. Executive Order 13132 provides for
preemption of state law only with the expressed consent of Congress.
Agencies must limit any such preemption to the extent possible.
    Under Section 18 of the OSH Act, 29 U.S.C. 667, Congress expressly
provides that states may adopt, with Federal approval, a plan for the
development and enforcement of occupational safety and health standards
(29 U.S.C. 667); OSHA refers to states that obtain Federal approval for
such a plan as ``State-Plan states.'' Occupational safety and health
standards developed by State-Plan states must be at least as effective
in providing safe and healthful employment and places of employment as
the Federal standards. Subject to these requirements, State-Plan states
are free to develop and enforce under state law their own requirements
for occupational safety and health standards.
    While OSHA drafted this direct final rule to protect employees in
every state, Section 18(c)(2) of the OSH Act permits State-Plan states
and U.S. territories to develop and enforce their own standards for
signage protection provided these requirements are at least as
effective in providing safe and healthful employment and places of
employment as the requirements specified in this direct final rule.
    In summary, this direct final rule complies with Executive Order
13132. In states without OSHA-approved state plans, this rulemaking
limits state policy options in the same manner as other OSHA standards.
In State-Plan states, this rulemaking does not significantly limit
state policy options because, as explained in the following section,
State-Plan states do not have to adopt this direct final rule.

E. State-Plan States

    When Federal OSHA promulgates a new standard or amends an existing
standard to be more stringent than it was previously, the 27 states or
U.S. territories with their own OSHA-approved occupational safety and
health plans must revise their standards to reflect the new standard or
amendment, or show OSHA why such action is unnecessary, e.g., because
an existing state standard covering this area is at least as effective
in protecting workers as the new Federal standard or amendment. 29 CFR
1953.5(a). In this regard, the state standard must be at least as
effective as the final Federal rule. State-Plan states must adopt the
Federal standard or complete their own standard within six months of
the publication date of the final Federal rule. When OSHA promulgates a
new standard or amendment that does not impose additional or more
stringent requirements than the existing standard, State-Plan states
need not amend their standards, although OSHA may encourage them to do
so. The following 21 states and 1 U.S. territory have OSHA-approved
occupational safety and health plans that apply only to private-sector
employers: Alaska, Arizona, California, Hawaii, Indiana, Iowa,
Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North
Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah,
Vermont, Virginia, Washington, and Wyoming. In addition, Connecticut,
Illinois, New Jersey, New York, and the Virgin Islands have OSHA-
approved State Plans that apply only to state and local government
employees.
    This direct final rule will not impose any additional or more
stringent requirements on employers compared to existing OSHA
standards. Through this rulemaking, OSHA is incorporating by reference
three recent editions of the applicable national consensus standards in
its existing signage protection standards. This direct final rule does
not require employers to update or replace their signage solely as a
result of this rulemaking if their current signage meets the
requirements of this direct final rule. OSHA believes that adding the
new references to ANSI Z535.1-2006(R2011), ANSI Z535.2-2011, and ANSI
Z535.5-2011, while retaining the current references to ANSI Z35.1-1968,
Z35.2-1968, and Z53.1-1967, will impose no additional compliance
obligations on employers because employers can continue using their

existing signage and, when necessary, update their signage and not be
out of compliance.
    Therefore, this direct final rule does not require action under 29
CFR 1953.5(a), and State-Plan states do not need to adopt this rule or
show OSHA why such action is unnecessary. However, to the extent these
State-Plan states have the same standards as the OSHA standards
affected by this direct final rule, OSHA encourages them to adopt the
amendments.

F. Unfunded Mandates Reform Act of 1995

    OSHA reviewed this direct final rule according to the Unfunded
Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501-1571, and Executive
Order 12875, 58 FR 58093 (1993). 75 FR 48130; 2010. As discussed above
in Section IV.B (``Final Economic Analysis and Regulatory Flexibility
Certification'') of this preamble, OSHA determined that this direct
final rule imposes no additional costs on any private-sector or public-
sector entity. Accordingly, this direct final rule requires no
additional expenditures by either public or private employers.
    As noted above under Section IV.E (``State-Plan States'') of this
preamble, OSHA standards do not apply to state or local governments
except in states that elected voluntarily to adopt an OSHA-approved
state plan. Consequently, this direct final rule does not meet the
definition of a ``Federal intergovernmental mandate'' (see Section
421(5) of the UMRA, 2 U.S.C. 658(5). Therefore, for the purposes of the
UMRA, OSHA certifies that this direct final rule does not mandate that
state, local, or tribal governments adopt new, unfunded regulatory
obligations, or increase expenditures by the private sector of more
than $100 million in any year.

G. Consultation and Coordination With Indian Tribal Governments

    OSHA reviewed this direct final rule in accordance with Executive
Order 13175, 65 FR 67249 (2000), and determined that it does not have
``tribal implications'' as defined in that order. This direct final
rule does not have substantial direct effects on one or more Indian
tribes, on the relationship between the Federal government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal government and Indian tribes.

H. Consultation With the Advisory Committee on Construction Safety and
Health

    Under 29 CFR parts 1911 and 1912, OSHA must consult with the
Advisory Committee on Construction Safety and Health (``ACCSH'' or
``the Committee''), established pursuant to Section 107 of the Contract
Work Hours and Safety Standards Act, 40 U.S.C. 3701-3708, in setting
standards for construction work. Specifically, Sec.  1911.10(a)
requires the Assistant Secretary to provide ACCSH with a draft proposed
rule (along with pertinent factual information) and give the Committee
an opportunity to submit recommendations. See, also, Sec.  1912.3(a)
(``[W]henever occupational safety or health standards for construction
activities are proposed, the Assistant Secretary [for Occupational
Safety and Health] shall consult the Advisory Committee'').
    On March 18, 2013, OSHA presented to the ACCSH a draft of the
proposed rule accompanying this direct final rule, as well as a table
comparing the current regulatory text with the proposed regulatory text
for the provisions of 29 CFR 1926.200 subject to this rulemaking. OSHA
explained that it was proposing to update these provisions by allowing
employers to comply with either the older ANSI standards, Z35.1-1968,
Z35.2-1968, and Z53.1-1967, or the latest ANSI standards, Z535.1-
006(R2011), Z535.2-2011, and Z535.5-2011. The ACCSH subsequently
recommended that OSHA proceed with the proposed rule to update Sec.
1926.200 (a transcript of these proceedings is available at Docket No.
OSHA-2013-0005-0007, pp. 41-46). ACCSH members also suggested that OSHA
consider replacing the illustrations of the old signs and tags it is
removing from Sec.  1926.200(b)(1), (c)(1), and (h)(2) with the new
ones, or a combination of the old ones and the new ones. Id. at 21-23.
OSHA will consider this suggestion.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Ave. NW., Washington, DC 20210, authorized the preparation
of this direct final rule. OSHA is issuing this direct final rule
pursuant to 29 U.S.C. 653, 655, and 657; 5 U.S.C. 553; 40 U.S.C. 3701-
3708; Secretary of Labor's Order 1-2012, 77 FR 3912 (2012); and 29 CFR
part 1911.

List of Subjects in 29 CFR Parts 1910 and 1926

    Construction, General industry, Incorporation by reference,
Occupational safety and health, Safety, Signs, Tags.

    Signed at Washington, DC, on June 5, 2013.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.

Amendments to Standards

    For the reasons stated above in the preamble, the Occupational
Safety and Health Administration is amending 29 CFR parts 1910 and 1926
as follows:

PART 1910--[AMENDED]

Subpart A--[Amended]

0
1. The authority citation for subpart A of part 1910 continues to read
as follows:

    Authority: 29 U.S.C. 653, 655, 657; Secretary of Labor's Order
No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90
(55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR
65008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR
3912), as applicable.
    Sections 1910.6, 1910.7, 1910.8 and 1910.9 also issued under 29
CFR 1911. Section 1910.7(f) also issued under 31 U.S.C. 9701, 29
U.S.C. 9a, 5 U.S.C. 553; Public Law 106-113 (113 Stat. 1501A-222);
Pub. L. 11-8 and 111-317; and OMB Circular A-25 (dated July 8, 1993)
(58 FR 38142, July 15, 1993).

0
2. Amend Sec.  1910.6 as follows:
0
a. Revise paragraphs (e)(59) and (e)(65);
0
b. Redesignate paragraphs (e)(66) through (e)(77) as paragraphs (e)(68)
through (e)(79); and
0
c. Add paragraphs (e)(66) and (e)(67).

Sec.  1910.6  Incorporation by reference.

* * * * *
    (e) * * *
    (59) ANSI Z35.1-1968, Specifications for Accident Prevention Signs;
IBR approved for Sec.  1910.261(c). Copies available for purchase from
the IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112;
telephone: 1-877-413-5184; Web site: www.global.ihs.com.
* * * * *
    (65) USAS Z53.1-1967 (also referred to as ANSI Z53.1-1967), Safety
Color Code for Marking Physical Hazards, ANSI approved October 9, 1967;
IBR approved for Sec.  1910.97(a) and 1910.145(d). Copies available for
purchase from the IHS Standards Store, 15 Inverness Way East,
Englewood, CO 80112; telephone: 1-877-413-5184; Web site:
www.global.ihs.com.
    (66) ANSI Z535.1-2006(R2011), Safety Colors, reaffirmed July 19,
2011;

IBR approved for Sec. Sec.  1910.97(a) and 1910.145(d). Copies
available for purchase from the International Safety Equipment
Association, 1901 North Moore Street, Arlington, VA 22209-1762;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Web site:
www.safetyequipment.org.
    (67) ANSI Z535.2-2011, Environmental and Facility Safety Signs,
published September 15, 2011; IBR approved for Sec.  1910.261(c).
Copies available for purchase from the International Safety Equipment
Association, 1901 North Moore Street, Arlington, VA 22209-1762;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Web site:
www.safetyequipment.org.
* * * * *

Subpart G--[Amended]

0
3. Revise the authority citation for subpart G of part 1910 to read as
follows:

    Authority:  29 U.S.C. 653, 655, 657; Secretary of Labor's Order
No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90
(55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR
50017), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR
3912), as applicable; and 29 CFR part 1911.

0
4. Amend Sec.  1910.97 by revising paragraph (a)(3)(ii) to read as
follows:

Sec.  1910.97  Nonionizing radiation.

* * * * *
    (a) * * *
    (3) * * *
    (ii) ANSI Z53.1-1967 or ANSI Z535.1-2006(R2011), incorporated by
reference in Sec.  1910.6, is for use for color specification. All
lettering and the border shall be of aluminum color.
* * * * *

Subpart J--[Amended]

0
5. Revise the authority citation for subpart J of part 1910 to read as
follows:

    Authority:  29 U.S.C. 653, 655, 657; Secretary of Labor's Order
No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90
(55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2007 (72 FR
31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable.

    Sections 1910.141, 1910.142, 1910.145, 1910.146, and 1910.147
also issued under 29 CFR part 1911.

0
6. Amend Sec.  1910.145 by revising paragraphs (d)(2), (d)(4), and
(d)(6) to read as follows:

Sec.  1910.145  Specifications for accident prevention signs and tags.

* * * * *
    (d) * * *
    (2) Danger signs. The colors red, black, and white shall be those
of opaque glossy samples as specified in Table 1, ``Fundamental
Specification of Safety Colors for CIE Standard Source `C,' '' of ANSI
Z53.1-1967 or in Table 1, ``Specification of the Safety Colors for CIE
Illuminate C and the CIE 1931, 2[ordm] Standard Observer,'' of ANSI
Z535.1-2006(R2011), incorporated by reference in Sec.  1910.6.
* * * * *
    (4) Caution signs. The standard color of the background shall be
yellow; and the panel, black with yellow letters. Any letters used
against the yellow background shall be black. The colors shall be those
of opaque glossy samples as specified in Table 1 of ANSI Z53.1-1967 or
Table 1 of ANSI Z535.1-2006(R2011), incorporated by reference in Sec.
1910.6.
* * * * *
    (6) Safety instruction signs. The standard color of the background
shall be white; and the panel, green with white letters. Any letters
used against the white background shall be black. The colors shall be
those of opaque glossy samples as specified in Table 1 of ANSI Z53.1-
1967 or in Table 1 of ANSI Z535.1-2006(R2011), incorporated by
reference in Sec.  1910.6.
* * * * *

Subpart R--[Amended]

0
7. Revise the authority citation for subpart R of part 1910 to read as
follows:

    Authority: 29 U.S.C. 653, 655, 657; Secretary of Labor's Order
No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90
(55 FR 9033), 6-96 (62 FR 111), 5-2007 (72 FR 31159)), 4-2010 (75 FR
55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.

0
8. Amend Sec.  1910.261 by revising paragraph (c)(16) to read as
follows:

Sec.  1910.261  Pulp, paper, and paperboard mills.

* * * * *
    (c) * * *
    (16) Signs. When conveyors cross walkways or roadways in the yards,
the employer must erect signs reading ``Danger--Overhead Conveyor'' or
an equivalent warning, in accordance with ANSI Z35.1-1968 or ANSI
Z535.2-2011, incorporated by reference in Sec.  1910.6.
* * * * *

PART 1926--[AMENDED]

Subpart A--[Amended]

0
9. The authority citation for subpart A of part 1926 continues to read
as follows:

    Authority: 40 U.S.C. 333; 29 U.S.C. 653, 655, 657; Secretary of
Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48
FR 35736), 6-96 (62 FR 111), 5-2007 (72 FR 31160), 4-2010 (75 FR
55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.

0
10. Amend Sec.  1926.6 as follows:
0
a. Revise paragraph (h)(24);
0
b. Redesignate paragraphs (h)(27) through (h)(30) as (h)(31) through
(h)(34) and paragraph (u)(1) as (u)(2);
0
c. Add paragraphs (h)(27) through (h)(30), and (u)(1); and
0
d. Revise newly redesignated paragraph (u)(2).

Sec.  1926.6  Incorporation by reference.

* * * * *
    (h) * * *
    (24) ANSI Z35.1-1968, Specifications for Accident Prevention Signs;
IBR approved for Sec.  1926.200(b), (c), and 1 (i). Copies available
for purchase from the IHS Standards Store, 15 Inverness Way East,
Englewood, CO 80112; telephone: 1-877-413-5184; Web site:
www.global.ihs.com.
* * * * *
    (27) USA Z53.1-1967 (also referred to as ANSI Z53.1-1967), Safety
Color Code for Marking Physical Hazards, ANSI approved October 9, 1967;
IBR approved for Sec.  1926.200(c). Copies available for purchase from
the IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112;
telephone: 1-877-413-5184; Web site: www.global.ihs.com.
    (28) ANSI Z535.1-2006(R2011), Safety Colors, reaffirmed July 19,
2011; IBR approved for Sec.  1926.200(c). Copies available for purchase
from the International Safety Equipment Association, 1901 North Moore
Street, Arlington, VA 22209-1762; telephone:<PHONE_NUMBER>; fax: 703-
528-2148; Web site: www.safetyequipment.org.
    (29) ANSI Z535.2-2011, Environmental and Facility Safety Signs,
published September 15, 2011; IBR approved for Sec.  1926.200(b), (c),
and (i). Copies available for purchase from the International Safety
Equipment Association, 1901 North Moore Street, Arlington, VA 22209-
1762; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Web site:
www.safetyequipment.org.
    (30) ANSI Z535.5-2011, Safety Tags and Barricade Tapes (for
Temporary Hazards), published September 15, 2011, including Errata,
November 14, 2011; IBR approved for Sec.  1926.200(h)

and (i). Copies available for purchase from the International Safety
Equipment Association, 1901 North Moore Street, Arlington, VA 22209-
1762; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Web site:
www.safetyequipment.org.
* * * * *
    (u) * * *
    (1) Manual on Uniform Traffic Control Devices (MUTCD), Part VI,
Standards and Guides for Traffic Controls for Street and Highway
Construction, Maintenance, Utility, and Incident Management Operation,
1988 Edition, Revision 3, September 3, 1993; IBR approved for
Sec. Sec.  1926.200(g), 1926.201(a), and 1926.202. Electronic copies of
the MUTCD, 1988 Edition, Revision 3, are available for downloading at
http://www.osha.gov/doc/highway_workzones/mutcd/index.html.
    (2) Manual on Uniform Traffic Control Devices (MUTCD), Millennium
Edition, Dec. 2000; IBR approved for Sec. Sec.  1926.200(g)),
1926.201(a), and 1926.202. Electronic copies of the MUTCD 2000 are
available for downloading at http://mutcd.fhwa.dot.gov/kno-millennium_12.18.00.htm.
* * * * *

Subpart G--[Amended]

0
11. Revise the authority citation for subpart G of part 1926 to read as
follows:

    Authority: 40 U.S.C. 333; 29 U.S.C. 653, 655, 657; Secretary of
Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48
FR 35736), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR
31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable;
and 29 CFR part 1911.

0
12. Amend Sec.  1926.200 by revising paragraphs (b)(1), (c)(1), (c)(3),
(g)(2), (h)(2), and (i) to read as follows:

Sec.  1926.200  Accident prevention signs and tags.

* * * * *
    (b) Danger signs. (1) Danger signs shall be used only where an
immediate hazard exists, and shall follow the specifications provided
in Figure 1 of ANSI Z35.1-1968 or in Figure 2 of ANSI Z535.2-2011,
incorporated by reference in Sec.  1926.6.
* * * * *
    (c) Caution signs. (1) Caution signs shall be used only to warn
against potential hazards or to caution against unsafe practices, and
shall follow the specifications provided in Figure 4 of ANSI Z35.1-1968
or in Figure 2 of ANSI Z535.2-2011, incorporated by reference for the
sections specified in Sec.  1926.6.
* * * * *
    (3) The standard color of the background shall be yellow; and the
panel, black with yellow letters. Any letters used against the yellow
background shall be black. The colors shall be those of opaque glossy
samples as specified in Table 1 of ANSI Z53.1-1967 or in Table 1 of
ANSI Z535.1-2006(R2011), incorporated by reference in Sec.  1926.6.
* * * * *
    (g) * * *
    (2) All traffic control signs or devices used for protection of
construction workers shall conform to Part VI of the MUTCD, 1988
Edition, Revision 3, or Part VI of the MUTCD, Millennium Edition,
incorporated by reference in Sec.  1926.6.
    (h) * * *
    (2) For accident prevention tags, employers shall follow
specifications that are similar to those in Figures 1 to 4 of ANSI
Z35.2-1968 or Figures 1 to 8 of ANSI Z535.5-2011, incorporated by
reference in Sec.  1926.6.
    (i) Additional rules. ANSI Z35.1-1968, ANSI Z535.2-2011, ANSI
Z35.2-1968, and ANSI Z535.5-2011, incorporated by reference in Sec.
1926.6, contain rules in addition to those specifically prescribed in
this subpart. The employer shall comply with ANSI Z35.1-1968 or ANSI
Z535.2-2011, and ANSI Z35.2-1968 or Z535.5-2011, with respect to such
additional rules.

0
13. Amend Sec.  1926.201 by revising paragraph (a) to read as follows:

Sec.  1926.201  Signaling.

    (a) Flaggers. Signaling by flaggers and the use of flaggers,
including warning garments worn by flaggers, shall conform to Part VI
of the Manual on Uniform Traffic Control Devices (1988 Edition,
Revision 3, or the Millennium Edition), incorporated by reference in
Sec.  1926.6.
* * * * *

0
14. Revise Sec.  1926.202 to read as follows:

Sec.  1926.202  Barricades.

    Barricades for protection of employees shall conform to Part VI of
the Manual on Uniform Traffic Control Devices (1988 Edition, Revision
3, or the Millennium Edition), incorporated by reference in Sec.
1926.6.
[FR Doc. 2013-13909 Filed 6-12-13; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: August 24, 2007 (Volume 72, Number 164)]
[Notices]
[Page 48627-48628]
[DOCID:fr24au07-50]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. RP07-520-001; RP07-537-001; RP96-272-067; RP96-272-068]

Northern Natural Gas Company; Notice of Compliance Filing

August 20, 2007.
    Take notice that on August 14, 2007, Northern Natural Gas Company
(Northern), tendered for filing as part of its FERC Gas Tariff, Fifth
Revised Volume No. 1, the following tariff sheets:

Substitute 41 Revised Sheet No. 66A
Substitute 42 Revised Sheet No. 66A
Substitute 43 Revised Sheet No. 66A
Substitute 44 Revised Sheet No. 66A

    Northern states that it is filing the above referenced tariff
sheets to make corrections to the negotiated rate Sheet No. 66A.
    Northern further states that copies of the filing have been mailed
to each of its customers and interested State Commissions.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-16746 Filed 8-23-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)]
[Notices]
[Pages 37462-37463]
[FR Doc No: 2017-16871]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2017-0106]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0073

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Requests
(ICRs) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0073,
Alteration of Unreasonably Obstructive Bridges without change. Our ICR
describes the information we seek to collect from the public. Before
submitting this ICR to OIRA, the Coast Guard is inviting comments as
described below.

DATES: Comments must reach the Coast Guard on or before October 10,
2017.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2017-0106] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr. Ave. SE., Stop 7710, Washington, DC
20593-7710.

FOR FURTHER INFORMATION:  Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek an
extension of approval for the Collection. We will

consider all comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2017-0106], and
must be received by October 10, 2017.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Alteration of Unreasonably Obstructive Bridges.
    OMB Control Number: 1625-0073.
    Summary: The collection of information is a request to determine if
the bridge is unreasonably obstructive.
    Need: 33 U.S.C. 494, 502, 511, 513, 514, 515, 516, 517, 521, 522,
523 and 524 authorize the Coast Guard to remove or alter bridges and
causeways over the navigable waters of the United States that the Coast
Guard deems to be unreasonably obstructive.
    Forms: Not applicable.
    Respondents: Public and private owners of bridges over navigable
waters of the United States.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has decreased from 240
hours to 160 hours a year. There are six additional engineering
projects that have been added to this information collection since
2014. Two of the four previous projects have been completed since 2014;
making a total of eight current projects. The reduction in burden is
based on having previously completed the majority of the review for
each study.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: August 3, 2017.
Marilyn L. Scott-Perez,
U.S. Coast Guard, Chief, Office of Information Management.
[FR Doc. 2017-16871 Filed 8-9-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: June 4, 2009 (Volume 74, Number 106)]
[Notices]
[Page 26915-26916]
[DOCID:fr04jn09-127]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2009-0001-N-12]

Notice of Request for Comments on Information Collection
Requirements

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice and request for comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Requirements (ICRs) abstracted below have been forwarded to
the Office of Management and Budget (OMB) for review and comment. The
ICRs describe the nature of the information collections and their
expected burdens. The Federal Register notice with a 60-day comment
period soliciting comments on the following collections of information
was published on March 24, 2009 (74 FR 12443).

DATES: Comments must be submitted on or before July 6, 2009.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Safety,
Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC
20590 (telephone:<PHONE_NUMBER>), or Ms. Nakia Jackson, Office of
Information Technology, RAD-20, Federal Railroad Administration, 1200
New Jersey Ave., SE., Mail Stop 35, Washington, DC 20590 (telephone:
(202) 493-6073). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law No. 104-13, Section 2, 109 Stat. 163 (1995) (codified as
revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5
CFR part 1320, require Federal agencies to issue two notices seeking
public comment on information collection activities before OMB may
approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5,
1320.8(d)(1), 1320.12. On March 24, 2009, FRA published a 60-day notice
in the Federal Register soliciting comment on ICRs that the agency was
seeking OMB approval. 74 FR 12443. FRA received no comments after
issuing this 60-day notice. Accordingly, DOT announces that these
information collection activities have been re-evaluated and certified
under 5 CFR 1320.5(a) and forwarded to OMB for review and approval
pursuant to 5 CFR 1320.12(c).
    Before OMB decides whether to approve these proposed collections of
information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30 day
notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. OMB believes that the 30 day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should
submit their respective comments to OMB within 30 days of publication
to best ensure having their full effect. 5 CFR 1320.12(c); see also 60
FR 44983, Aug. 29, 1995.
    The summaries below describe the nature of the information
collection requirements (ICRs) and the expected burden. The revised
requirements are being submitted for clearance by OMB as required by
the PRA.
    Title: Filing of Dedicated Cars
    OMB Control Number: 2130-0502
    Type of Request: Extension of a currently approved collection.
    Affected Public: Railroads.
    Abstract: Title 49, Part 215 of the Code of Federal Regulations,
prescribes certain conditions to be followed for the movement of
freight cars that are not in compliance with this Part. These cars must
be identified in a written report to FRA before they are assigned to
dedicated service, and the words ``Dedicated Service'' must be
stenciled on each side of the freight car body. FRA uses the
information to determine whether the equipment is safe to operate and
that the operation qualifies for dedicated service. See 49 CFR 215.5
(c) (2), 215.5 (d).
    Form Number(s): N/A.
    Annual Estimated Burden Hours: 4 hours.

    Title: Remotely Controlled Switch Operations.
    OMB Control Number: 2130-0516.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Railroads.
    Abstract: Title 49, Section 218.30 of the Code of Federal
Regulations (CFR), ensures that remotely controlled switches are lined
to protect workers who are vulnerable to being struck by moving cars as
they inspect or service equipment on a particular track or,
alternatively, occupy camp cars. FRA believes that production of
notification requests promotes safety by minimizing mental lapses of
workers who are simultaneously handling several tasks. Sections 218.30
and 218.67 require the operator of remotely controlled switches to
maintain a record of each notification requesting blue signal
protection for 15 days. Operators of remotely controlled switches use
the information as a record documenting blue signal protection of
workers or camp cars. This record also serves as a valuable resource
for railroad supervisors and FRA inspectors monitoring regulatory
compliance.
    Form Number(s): N/A.
    Annual Estimated Burden Hours: 60,038 hours.

    Title: Bad Order and Home Shop Card.
    OMB Control Number: 2130-0519.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Railroads.
    Abstract: Under 49 CFR part 215, each railroad is required to
inspect freight cars placed in service and take the necessary remedial
action when defects are identified. Part 215 defects are specific in
nature and relate to items that have or could have caused accidents or
incidents. Section 215.9 sets forth specific procedures that railroads
must follow when it is necessary to move defective cars for repair
purposes. For example, railroads must affix a ``bad order'' tag
describing each defect to each side of the freight car. It is
imperative that a defective freight car be tagged ``bad order'' so that
it may be readily identified and moved to another location for repair
purposes only. At the repair point, the ``bad order'' tag serves as a
repair record. Railroads must retain each tag for 90 days to verify
that proper repairs were made at the designated location. FRA and State
inspectors review all pertinent records to determine whether defective
cars presenting an immediate hazard are being moved in transportation.
    Form Number(s): N/A.
    Annual Estimated Burden Hours: 15,750 hours.
    Addressee: Send comments regarding these information collections to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 Seventeenth Street, NW., Washington, DC 20503,
Attention: FRA Desk Officer. Alternatively, comments may be sent via e-
mail to the Office of Information and Regulatory Affairs (OIRA), Office
of Management and Budget, at the following address: oira_
<EMAIL_ADDRESS>    Comments are invited on the following: Whether the proposed
collections of information are necessary for the proper performance of
the functions of the Department, including

whether the information will have practical utility; the accuracy of
the Department's estimates of the burden of the proposed information
collections; ways to enhance the quality, utility, and clarity of the
information to be collected; and ways to minimize the burden of the
collections of information on respondents, including the use of
automated collection techniques or other forms of information
technology.
    A comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication of this notice in the Federal
Register.

    Authority:  44 U.S.C. 3501-3520.

    Issued in Washington, DC, on May 29, 2009.
Kimberly Orben,
Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. E9-13042 Filed 6-3-09; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Rules and Regulations]
[Pages 977-979]
[FR Doc No: 2023-00008]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2022-N-3171]

Medical Devices; Ear, Nose, and Throat Devices; Classification of
the Powered Insertion System for a Cochlear Implant Electrode Array

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the powered insertion system for a cochlear implant
electrode array into class II (special controls). The special controls
that apply to the device type are identified in this order and will be
part of the codified language for the powered insertion system for a
cochlear implant electrode array's classification. We are taking this
action because we have determined that classifying the device into
class II (special controls) will provide a reasonable assurance of
safety and effectiveness of the device. We believe this action will
also enhance patients' access to beneficial innovative devices.

DATES: This order is effective January 6, 2023. The classification was
applicable on October 1, 2021.

FOR FURTHER INFORMATION CONTACT: Vasant Dasika, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1206, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the powered insertion system for a
cochlear implant electrode array as class II (special controls), which
we have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On December 18, 2019, FDA received iotaMotion, Inc.'s request for
De Novo classification of the iotaSOFT Insertion System--Drive Unit,
Controller and Accessories. FDA reviewed the request in order to
classify the device under the criteria for classification set forth in
section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable

assurance of safety and effectiveness, but there is sufficient
information to establish special controls that, in combination with the
general controls, provide reasonable assurance of the safety and
effectiveness of the device for its intended use (see 21 U.S.C.
360c(a)(1)(B)). After review of the information submitted in the
request, we determined that the device can be classified into class II
with the establishment of special controls. FDA has determined that
these special controls, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of the
device.
    Therefore, on October 1, 2021, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
874.4450.\1\ We have named the generic type of device powered insertion
system for a cochlear implant electrode array, and it is identified as
a prescription device used to assist in placing an electrode array into
the cochlea.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

Table 1--Powered Insertion System for a Cochlear Implant Electrode Risks
                         and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Risks to health relating to device       Clinical performance testing,
 interface with patient anatomy,          Usability testing, Non-
 including:                               clinical performance testing,
 Damage to skull tissue.          and Labeling.
 Damage to dura mater.
 Bone damage.
 Cerebrospinal fluid leak.
 Damage to cochlea; hearing
 loss, tinnitus, vertigo.
Cochlear implant insertion failure       Clinical performance testing,
 leading to:.                             Non-clinical performance
 Trauma to cochlear structures    testing, Usability testing,
 resulting in residual hearing loss or    Cochlear implant compatibility
 nerve degeneration..                     validation, Software
 Suboptimal array placement       verification, validation, and
 (including array rotation) leading to    hazard analysis, and Labeling.
 poor hearing performance..
 Failure to disengage from
 cochlear implant at end of procedure,
 leading to manual correction and
 insertion..
Damage to cochlear implant during        Non-clinical performance
 insertion leading to poor cochlear       testing, Usability testing,
 implant performance and/or compromised   Cochlear implant compatibility
 implant reliability.                     validation, Shelf life
                                          testing, Software
                                          verification, validation, and
                                          hazard analysis, and Labeling.
Adverse tissue reaction, including       Biocompatibility evaluation.
 irritation/inflammation of surgical
 site.
Electromagnetic interference, thermal    Electrical safety testing,
 injury, or electric shock.               Electromagnetic compatibility
                                          testing, and Labeling.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Excessive operation time leading to      Clinical performance testing,
 increased exposure to anesthesia.        Usability testing, and
                                          Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, powered insertion systems for a
cochlear implant electrode array are for prescription use only.
Prescription devices are exempt from the requirement for adequate
directions for use for the layperson under section 502(f)(1) of the
FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the
conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 874

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for part 874 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  874.4450 to subpart E to read as follows:

Sec.  874.4450   Powered insertion system for a cochlear implant
electrode array.

    (a) Identification. A powered insertion system for a cochlear
implant electrode array is a prescription device used to assist in
placing an electrode array into the cochlea.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device
performs as intended under anticipated conditions of use, including
evaluation of all adverse events.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use.
Testing must include:
    (i) Verification of cochlear implant attachment force, release
force, and insertion speed;
    (ii) Testing to demonstrate the device does not damage or degrade
the cochlear implant (including the lead and array portions of the
cochlear implant); and
    (iii) Comparison testing with manual insertion to evaluate:
    (A) Differences in cochlear implant array insertion force
associated with use of the device; and
    (B) Intracochlear placement of the cochlear implant array (intended
scala placement and array insertion depth, together with minimal array
tip foldover and cochlear scala translocation).
    (3) Usability testing in a simulated hospital environment with an
anatomically relevant model (e.g., cadaver testing) that evaluates the
following:
    (i) Successful use to aid in placement of the electrode array into
the cochlea; and
    (ii) Harms caused by use errors observed.
    (4) Changes in cochlear implant compatibility are determined to
significantly affect the safety or effectiveness of the device and must
be validated through performance testing or a rationale for omission of
any testing.
    (5) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (6) Performance testing must demonstrate the electromagnetic
compatibility, electrical safety, and thermal safety of the device.
    (7) The patient-contacting components of the device must be
demonstrated to be sterile and non-pyrogenic.
    (8) Performance testing must support the shelf life of device
components provided sterile by demonstrating continued sterility,
package integrity, and device functionality over the labeled shelf
life.
    (9) Software verification, validation, and hazard analysis must be
performed for any software components of the device.
    (10) Labeling must include:
    (i) The recommended training for the safe use of the device;
    (ii) Summary of the relevant clinical and non-clinical testing
pertinent to use of the device with compatible electrode arrays; and
    (iii) A shelf life.

    Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00008 Filed 1-5-23; 8:45 am]
BILLING CODE 4164-01-P