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61302 Federal Register / Vol. 80, No.

197 / Tuesday, October 13, 2015 / Rules and Regulations

we are revoking the requirements in shortwave therapy is a prescription date of this reclassification must submit
§ 890.5290(b) related to the device that applies to the body pulsed an amendment to their previously
classification of SWT as class III devices electromagnetic energy in the RF bands cleared premarket notification (510(k))
and codifying the reclassification of of 13.56 MHz or 27.12 MHz and that is demonstrating compliance with these
SWT into class II (special controls). intended for adjunctive use in the special controls.
VIII. Reference palliative treatment of postoperative Dated: October 6, 2015.
pain and edema of soft tissue by means Leslie Kux,
FDA has placed the following other than the generation of deep heat
reference on display in the Division of Associate Commissioner for Policy.
within body tissues as described in
Dockets Management (HFA–305) Food paragraph (a) of this section. [FR Doc. 2015–25923 Filed 10–9–15; 8:45 am]
and Drug Administration, 5630 Fishers (2) Classification: Class II (special BILLING CODE 4164–01–P
Lane, Rm. 1061, Rockville, MD 20852. controls). The device is classified as
Interested persons may see it between 9 class II. The special controls for this
a.m. and 4 p.m., Monday through device are: DEPARTMENT OF TRANSPORTATION
Friday, and online at http:// (i) Components of the device that
www.regulations.gov. come into human contact must be Federal Highway Administration
1. FDA’s Orthopedic and demonstrated to be biocompatible.
Rehabilitation Devices Panel transcript (ii) Appropriate analysis/testing must 23 CFR Part 625
and other meeting materials are demonstrate that the device is [Docket No. FHWA–2015–0003]
available on FDA’s Web site at http:// electrically safe and electromagnetically
www.fda.gov/AdvisoryCommittees/ compatible in its intended use RIN 2125–AF67
CommitteesMeetingMaterials/ environment.
MedicalDevices/ Design Standards for Highways
(iii) Non-clinical performance testing
MedicalDevicesAdvisoryCommittee/ must demonstrate that the device AGENCY: Federal Highway
Orthopaedicand performs as intended under anticipated Administration (FHWA), Department of
RehabilitationDevicesPanel/ conditions of use. Non-clinical Transportation (DOT).
ucm352525.htm. performance testing must characterize ACTION: Final rule.
List of Subjects in 21 CFR Part 890 the output waveform of the device and
demonstrate that the device meets SUMMARY: This rule updates the
Medical devices, Physical medicine appropriate output performance regulations governing the required
devices. specifications. The output design standards to be utilized on
Therefore, under the Federal Food, characteristics and the methods used to Federal-aid highway program (FAHP)
Drug, and Cosmetic Act and under determine these characteristics, projects. In issuing the final rule, FHWA
authority delegated to the Commissioner including the following, must be incorporates by reference the latest
of Food and Drugs, 21 CFR part 890 is determined: versions of design standards and
amended as follows: (A) Peak output power; standard specifications previously
(B) Pulse width; adopted and incorporated by reference,
PART 890—PHYSICAL MEDICINE (C) Pulse frequency; and removes the corresponding
DEVICES (D) Duty cycle; outdated or superseded versions of
■ 1. The authority citation for 21 CFR (E) Characteristics of other types of these standards and specifications. This
part 890 continues to read as follows: modulation that may be used; rule also makes technical changes to the
(F) Average measured output powered regulatory text consistent with updated
Authority: 21 U.S.C. 351, 360, 360c, 360e, into the RF antenna/applicator;
360j, 371.
Federal Register procedures.
(G) Specific absorption rates in saline DATES: This final rule is effective
■ 2. Section 890.5290 is amended by gel test load or other appropriate model; November 12, 2015. The incorporation
revising paragraphs (a)(1) and (b) and (H) Characterization of the electrical
by reference of certain publications
removing paragraph (c). and magnetic fields in saline gel test
listed in the rule is approved by the
The revisions read as follows: load or other appropriate model for each
Director of the Federal Register as of
RF antenna and prescribed RF antenna
§ 890.5290 Shortwave diathermy. November 12, 2015.
orientation/position; and
(a) Shortwave diathermy for use in (I) Characterization of the deposited FOR FURTHER INFORMATION CONTACT: Mr.
applying therapeutic deep heat for energy density in saline gel test load or Michael Matzke, Office of Program
selected medical conditions—(1) other appropriate model. Administration (HIPA–20), (202) 366–
Identification. A shortwave diathermy (iv) A detailed summary of the 4658, or via email at
for use in applying therapeutic deep clinical testing pertinent to use of the michael.matzke@dot.gov, or Mr. Robert
heat for selected medical conditions is device to demonstrate the effectiveness Black, Office of the Chief Counsel
a device that applies to specific areas of of the device in its intended use. (HCC–30), (202) 366–1373, or via email
the body electromagnetic energy in the (v) Labeling must include the at robert.black@dot.gov. Office hours are
radiofrequency (RF) bands of 13.56 following: from 8:00 a.m. to 4:30 p.m., e.t., Monday
megahertz (MHz) or 27.12 MHz and that (A) Output characteristics of the through Friday, except Federal holidays.
is intended to generate deep heat within device; SUPPLEMENTARY INFORMATION:
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body tissues for the treatment of (B) Recommended treatment regimes,


selected medical conditions such as Electronic Access and Filing
including duration of use; and
relief of pain, muscle spasms, and joint (C) A detailed summary of the clinical This document, the notice of
contractures, but not for the treatment of testing pertinent to the use of the device proposed rulemaking (NPRM), and all
malignancies. and a summary of the adverse events comments received may be viewed
* * * * * and complications. online through the Federal eRulemaking
(b) Nonthermal shortwave therapy— (vi) Nonthermal shortwave therapy portal at: http://www.regulations.gov.
(1) Identification. A nonthermal devices marketed prior to the effective The Web site is available 24 hours each

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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations 61303

day, 365 days each year. Please follow the States for highway projects. Many of titled Mitigation Strategies for Design
the instructions. An electronic copy of the standards, policies, and standard Exceptions available at http://
this document may also be downloaded specifications that were approved by safety.fhwa.dot.gov/geometric/pubs/
by accessing the Office of Federal FHWA and incorporated into 23 CFR mitigationstrategies/fhwa_sa_07011.pdf.
Register’s home page at: http:// part 625 were developed and issued by In addition, FHWA supports using
www.archives.gov/federal-register/, or AASHTO. design guides that national
the Government Printing Office’s Web The revisions also include updated organizations develop from peer-
page at: http://www.gpo.gov/fdsys. versions of welding codes published by reviewed research, or equivalent guides
AWS. The AWS is a nonprofit developed in cooperation with State or
Background organization known for its code and local officials, when such guides are not
This rulemaking updates existing certification procedures, providing in conflict with Federal laws and
regulations governing new construction, industry standards for welding, regulations.
reconstruction, resurfacing (except for including in the transportation field. The rule also makes technical changes
maintenance resurfacing), restoration, The AWS reports about 66,000 members to the regulatory text consistent with
and rehabilitation projects on the worldwide and develops updated updated Federal Register procedures,
National Highway System (NHS), materials for welding professionals and including updating mailing addresses
including the Interstate System, by other interested parties, including those and including telephone and Web site
incorporating by reference the current related to bridge welding and structural addresses in 23 CFR 625.4(d) pertaining
versions of design standards and welding. to the availability of documents
standard specifications previously While these adopted standards and incorporated by reference.
adopted and incorporated by reference specifications apply to all projects on
under 23 CFR 625.4, and removing the Discussion Under 1 CFR Part 51
the NHS (including the Interstate
outdated or superseded versions of System), FHWA encourages the use of The documents FHWA is
these standards and specifications. flexibility and a context-sensitive incorporating by reference are
Several of these design standards and approach to consider a full range of reasonably available to interested
standard specifications were established project and user needs and the impacts parties, primarily STAs and local
by the American Association of State to the community and natural and agencies carrying out Federal-aid
Highway and Transportation Officials human environment. The STA and local highway projects. These documents
(AASHTO) and the American Welding agencies may consider using design represent the most recent refinements
Society (AWS) and were previously exceptions to achieve a design that that professional organizations have
adopted by FHWA through rulemaking. balances project and user needs, formally accepted and are currently in
The updated standards or specifications performance, cost, environmental use by the transportation industry. The
replace previous versions of these implications, and community values. documents are also available for review
documents and represent the most These adopted design standards provide at the U.S. Department of
recent refinements that professional a range of acceptable values for highway Transportation’s National
organizations have formally accepted. features, and FHWA encourages the use Transportation Library, the National
The FHWA formally adopts them for of this flexibility to achieve a design Archives and Records Administration,
NHS projects. that best suits the desires of the or may be obtained from AASHTO or
The revisions include referencing the community while satisfying the purpose AWS.
2011 edition of the AASHTO A Policy for the project and needs of its users. The documents incorporated by
on Geometric Design of Highways and At a minimum, STAs and local reference in this final rule are:
Streets, commonly referred to as the agencies should select design values (1) A Policy on Geometric Design of
Green Book. The revisions also include based on an evaluation of the context of Highways and Streets, 6th Edition,
referencing the current version of the facility, needs of all the various AASHTO 2011. The AASHTO, 2011
AASHTO’s Load and Resistance Factor project users, safety, mobility, human edition incorporates the latest research
Design (LRFD) Bridge Design and natural environmental impacts, and and current industry practices, with the
Specifications; LRFD Movable Highway project costs. For most situations, there basic criteria identified for geometric
Bridge Design Specifications; and is sufficient flexibility within the range design standards remaining essentially
Standard Specifications for Structural of acceptable values to achieve a the same. This Policy is a
Supports of Highway Signs, Luminaires balanced design. However, when this is comprehensive manual to assist STAs
and Traffic Signals. In addition, the not possible, STAs and local agencies and local agencies in administrative,
revisions reference the current version may consider designs that deviate from planning, and educational efforts
of the AWS Bridge Welding Code and the design standards when warranted pertaining to design formulation. The
the Structural Welding Code— based on the project’s impact on the Policy includes design guidelines for
Reinforcing Steel. environment (natural and built), freeways, arterials, collectors, and local
The AASHTO is an organization that historical and recreational facilities, and roads in both urban and rural locations.
represents 52 State transportation other factors. In instances where design (2) A Policy on Design Standards
agencies (STA) (including the District of standards for a particular element Interstate System, AASHTO, January
Columbia and Puerto Rico). Its members cannot be attained, a design exception, 2005. This Policy complements A Policy
consist of the duly constituted heads subject to approval by FHWA, or on on Geometric Design of Highways and
and other chief officials of those behalf of FHWA if an STA has assumed Streets and Standard Specifications for
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agencies. The Secretary of the responsibility through a Highway Bridges. Topics include design
Transportation is an ex-officio member, Stewardship and Oversight agreement, traffic, right-of-way, geometric controls
and DOT staff participates in various is required for projects on the NHS. and criteria, cross section elements,
AASHTO activities as nonvoting Additional information on FHWA’s interchanges, and bridges and other
representatives. Among other functions, adopted design standards and design structures.
AASHTO develops and issues exceptions is available electronically at (3) Standard Specifications for
standards, specifications, policies, http://www.fhwa.dot.gov/design/ Highway Bridges, 17th Edition,
guides, and related materials for use by standards and in FHWA’s publication AASHTO, 2002. This document details

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61304 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations

the design standards for the serve as a standard and guide for the The Oklahoma DOT and California
maintenance and rehabilitation of older, design, fabrication, and erection of these DOT support was noted. No change was
existing structures. For new bridge types of supports. made to the regulation.
designs, it is superseded by the (9) D1.4/D1.4M: 2011 Structural Individual’s Comments
AASHTO LRFD Bridge Design Welding Code—Reinforcing Steel, 7th
Specifications (see related item). Edition, American Welding Society, An individual commenter advised
(4) AASHTO LRFD Bridge 2011. This manual covers welding of that the address shown in the NPRM 23
Construction Specifications, 3rd reinforcing steel in most reinforced CFR 625.4(d)(2) was incorrect and
Edition, AASHTO 2010, with 2010, concrete applications. It includes should be: American Welding Society,
2011, 2012, and 2014 Interim Revisions. sections on allowable stresses, structural 8869 NW 36 Street, #130, Miami, FL
This new edition has been revised to be details, workmanship requirements, 33166–6672.
consistent with its companion, the technique, procedure and performance The FHWA agrees and the final rule
recently updated AASHTO LRFD Bridge qualification, and inspection. was revised accordingly.
Design Specifications (see related item). The individual also noted that in July
Among the revisions are improved Summary Discussion of Comments 2015, the AASHTO Standard in 23 CFR
testing and acceptance criteria, updated Received in Response to the NPRM 625.4(c)(2) (Standard Specifications for
material references, and recommended Transportation Materials and Methods
On June 2, 2015, FHWA published an
guidelines for construction loads. of Sampling and Testing, parts I and II,
NPRM in the Federal Register at 80 FR
(5) AASHTO LRFD Bridge Design AASHTO 1995), was superseded by the
31327 soliciting public comments on its
Specifications, 7th Edition, AASHTO, latest edition of the manual (Standard
proposal to update the existing
2014, with 2015 Interim Revisions. The Specifications for Transportation
regulations. The following presents an
AASHTO LRFD Bridge Design Materials and Methods of Sampling and
overview of the comments received to
Specifications are intended for use in Testing, 35th Edition and AASHTO
the NPRM. The docket contained
the design, evaluation, and Provisional Standards, 2015 Edition).
comments from 11 different parties
rehabilitation of bridges, and are Furthermore, the Standard
including 3 STAs, 4 industry
mandated by the FHWA for use on all Specifications for Structural Supports
organizations, and 4 individuals. The
bridges using Federal funding. These for Highway Signs, Luminaires and
FHWA appreciates the feedback the
Specifications employ the LRFD Traffic Signals, 6th Edition, AASHTO
commenters provided, carefully
methodology using factors developing 2013 was superseded by LRFD
reviewed and analyzed all the
from current statistical knowledge of Specifications for Structural Supports
comments that were submitted, and
loads and structural performance. for Highway Signs, Luminaires and
(6) AASHTO LRFD Moveable made revisions to the NPRM to
Traffic Signals, 1st Edition, AASHTO
Highway Bridge Design Specifications, incorporate suggestions where
2015 in August of 2015.
2nd Edition, AASHTO, 2007, including necessary. The timing of the updates for the
2008, 2010, 2011, 2012, 2014, and 2015 Summary of STA Comments AASHTO materials and structural
Interim Revisions. This guide includes support publications did not allow for
information on design of bridge spans, The Pennsylvania DOT was FHWA to propose the adoption of them
mechanical systems (motors, hydraulics, concerned that the NPRM lacked in the NPRM. The FHWA will consider
etc.), electrical systems, and bridge implementation timeframes for the adopting these two manuals in a future
protection systems. The guidelines also updated standards. As an example, they update to the regulations. No change
cover seismic analysis and vessel stated that STAs will need to update was made to the final rule.
impact analysis. Several types of standard designs for structural support The individual also recommend
movable bridges as discussed, including for overhead signs and traffic signals several other documents for
Bascule span, Swing span, and Vertical and estimated that it may take 3 years incorporation by reference including a
Lift bridges. to accomplish this. Pennsylvania DOT specification for bridge and parking
(7) AASHTO/AWS D1.5M/D1.5: 2010 went on to suggest implementation garage deck overlays and several
Bridge Welding Code, 6th Edition, timeframes of 1–2 years for standards 23 roadway lighting guides and
AASHTO, 2010, with 2011 and 2012 CFR 625.4(b)(1), (2), (3), (4), (5), and (6); specifications. Generally, the guides and
Interim Revisions. This document and 3–4 years for standard 23 CFR specifications suggested by the
covers AASHTO welding requirements 625.4(b)(7). commenter refer to specific roadway
for welded highway bridges made from The FHWA believes that the materials and appurtenances and are left
carbon and low-alloy construction standards and manuals incorporated by up to STAs to reference as necessary for
steels. Chapters cover design of welded reference under this rulemaking, where projects. No changes were made to the
connections, workmanship, technique, not in conflict with standards and final rule to adopt the additional
procedure and performance manuals under the previous regulation, documents suggested by the commenter.
qualification, inspection, and stud have been used by STAs for projects on Another individual commenter
welding. This document features the the NHS. This final rule is effective for suggested that the time period for
latest AASHTO revisions and all NHS projects authorized to proceed adopting newer versions of the Green
nondestructive examination with design activities on or after the Book can be shortened or eliminated by
requirements, as well as a section effective date of this rule. While FHWA not including specific edition
providing a ‘‘Fracture Control Plan for will not establish any extended information in the regulation, and that
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Nonredundant Bridge Members.’’ implementation timeframes within the by doing so, FHWA could avoid a
(8) Standards for Structural Supports regulation, STAs should work closely formal rulemaking process and adopt
for Highway Signs, Luminaires and with their FHWA division office in newer editions of the Green Book by
Traffic Signals, 6th Edition, AASHTO, implementing the final rule. only issuing a memo or policy paper.
2013. These Standards are applicable to Both Oklahoma DOT and California Procedures and requirements for
the structural design of supports for DOT expressed support for the update incorporation by reference are covered
highway signs, luminaires, and traffic of the standards, specifications, and in 1 CFR part 51. This regulation
signals. The Standards are intended to text. requires that the language incorporating

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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations 61305

a publication by reference be precise consider the publication entitled encourages the use of flexibility and a
and complete and must clearly state the Flexibility in Highway Design and the context-sensitive approach to consider
title, date, edition, author, publisher and context-sensitive design approach in the the full range of project and user needs
identification number of the development of design criteria. The and the impacts to the community and
publication. Therefore, no change was NACTO also points out that many city- natural and human environment. The
made to the final rule. owned arterial streets were added to the 2011 edition, adopted under this
An individual expressed support for NHS under the Moving Ahead for rulemaking, strengthens such language
the update as long as it eliminates Progress in the 21st Century Act (Pub. and incorporates many of the principles
outdated options for road and road- L. 112–141), known as MAP–21, and contained in the materials referenced in
related infrastructure. A review of the that a context-sensitive design approach
23 U.S.C. 109(c)(2). For most situations,
list of outdated options provided by the is critical to achieving a balanced design
there is sufficient flexibility within the
commenter showed that they mainly on these roadways. The Smart Growth
America and People For Bikes range of acceptable values contained in
related to signing and striping issues
and therefore fall under the purview of additionally urge FHWA to include; the the standards to achieve a balanced
the Manual on Uniform Traffic Control NACTO Urban Bikeway Design Guide,3 design for a variety of roadway
Devices, or are based on specific design and the FHWA Separated Bike Lane classification types. However, when this
decisions that are made on a project-by- Planning and Design Guide.4 is not possible, a design exception may
project basis by STAs and local Part 625, Design Standards for be appropriate.
agencies. No change was made to the Highways, contains a listing of The FHWA does not intend to adopt
final rule. documents that define specific criteria the guides as standards for the NHS but
An individual commented that the and controls for the design of NHS will continue to recommend the use of
regulation needs to contain timeline projects. Such documents are referred to a wide array of design resources to
limits for highway projects and that it as standards. The FHWA and other achieve context-sensitive urban street
must require that more time is spent on organizations produce many other
designs. Instead, language has been
drainage design since rework after documents that serve to complement the
added to the rule to recognize that
completion of construction can be design standards. These documents are
often referred to as guides, references, or FHWA supports the use of guides that
costly. In addition, the individual
best practices. Non-regulatory national organizations develop from
suggested that all cloverleaf on and off
information, such as guides and peer-reviewed research, or equivalent
ramps be replaced to provide for
references that serve to complement or guides developed in cooperation with
smoother operations on the highway
system. supplement design standards need not State or local officials, when such
Establishing design and construction be included within the Code of Federal guides are not in conflict with other
schedules and timelines for highway Regulations. Instead, FHWA typically Federal laws or regulations.
projects is left to STAs and/or local recognizes guidance through policy In addition, FHWA will consider
agencies and will depend on many memoranda or development of separate including a similar statement about
factors such as project complexity, FHWA publications. FHWA support of other guides that
engineering and environmental issues, As an example, on August 20, 2013, serve as supplements to the regulatory
and agency staffing and resources, to FHWA issued a memorandum 5 standards in future updates to 23 CFR
name a few. Similarly, as the owners of expressing its support for taking a
part 652.
the highway system, STAs and/or local flexible approach to bicycle and
agencies are responsible for setting pedestrian facility design. The The Public Resource.org asserted that
highway improvement priorities memorandum listed several good the documents to be incorporated by
according to local needs. As such, it is resources that can be referenced to reference into the rule are not
outside the scope of this rulemaking to develop non-motorized transportation reasonably available to the public.
set or otherwise require timelines for networks, particularly in urban areas. As stated earlier, when proposing to
design and construction of projects. The The memorandum references the incorporate a document by reference in
standards adopted by this regulation NACTO Urban Bikeway Design Guide the regulations, FHWA follows the
address the need for proper drainage and ITE Designing Walkable Urban policies and procedures under 1 CFR
design and interchange geometrics, Thoroughfares guide. Subsequent to the part 51 to ensure that the materials
including cloverleaf on and off ramps. date of the memorandum, NACTO proposed to be incorporated are
No change was made to the final rule. published the Urban Street Design
reasonably available to interested
Guide. The FHWA expressed support
Industry Organization Comments parties and usable by the class of
for using the new guide in Frequently
The National Association of City Asked Questions available on the persons affected. The NPRM describes
Transportation Officials (NACTO), internet at http://www.fhwa.dot.gov/ where the materials can be obtained by
Smart Growth America, and People For environment/bicycle_pedestrian/ members of the public, including in-
Bikes all recommended amending 23 guidance/design_guidance/design_ person at the Department of
CFR 625 to include the NACTO Urban flexibility_qa.cfm. Transportation headquarters office. The
Street Design Guide 1 and an ITE While adopted standards and materials have been formally adopted by
Recommended Practice/Designing specifications apply to all projects on professional organizations and have
Walkable Urban Thoroughfares: A the NHS, the AASHTO Green Book been in use by the community for some
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Context-Sensitive Approach 2 as design time. The FHWA believes these


guidance or as standards for urban 3 http://nacto.org/publication/urban-bikeway-
documents to be in use by the STAs and
design-guide/. local agencies affected by this
streets. The NACTO points out that 23 4 http://www.fhwa.dot.gov/environment/bicycle_
U.S.C. 109(c)(2) requires the Secretary to pedestrian/publications/separated_bikelane_pdg/ rulemaking and thus are reasonably
page00.cfm. available.
1 http://nacto.org/publication/urban-street- 5 http://www.fhwa.dot.gov/environment/bicycle_
design-guide/. pedestrian/guidance/design_guidance/design_
2 http://www.ite.org/css/online/. flexibility.cfm.

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61306 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations

Rulemaking Analyses and Notices Unfunded Mandates Reform Act of 1995 National Environmental Policy Act
Executive Order 12866 (Regulatory This final rule does not impose The FHWA analyzed this rule for the
Planning and Review), Executive Order unfunded mandates as defined by the purposes of the National Environmental
13563 (Improving Regulation and Unfunded Mandates Reform Act of 1995 Policy Act (NEPA) (42 U.S.C. 4321 et
Regulatory Review), and DOT (Pub. L. 104–4, March 22, 1995, 109 seq.) and determined that this action
Regulatory Policies and Procedures Stat. 48). Furthermore, in compliance would not have any effect on the quality
with the Unfunded Mandates Reform of the human and natural environment
The FHWA determined that this Act of 1995, FHWA evaluated this rule because it only makes technical changes
action does not constitute a significant to assess the effects on State, local, and and incorporates by reference the latest
regulatory action within the meaning of tribal governments and the private versions of design standards and
Executive Order 12866 or within the sector. This rule does not result in the standard specifications previously
meaning of DOT regulatory policies and expenditure by State, local, and tribal adopted and incorporated by reference
procedures. The amendments update governments, in the aggregate, or by the under 23 CFR part 625 and removes the
several industry design standards and private sector, of $143.1 million or more corresponding outdated or superseded
standard specifications adopted and in any one year (2 U.S.C. 1532). In versions of these standards and
incorporated by reference under 23 CFR addition, the definition of ‘‘Federal specifications. The rule qualifies as a
part 625 and remove the corresponding Mandate’’ in the Unfunded Mandates categorical exclusion to NEPA under 23
outdated or superseded versions of Reform Act excludes financial CFR 771.117(c)(20).
these standards and specifications. This assistance of the type in which State,
rule makes technical changes to the Executive Order 13175 (Tribal
local, or tribal governments have Consultation)
regulatory text consistent with updated authority to adjust their participation in
Federal Register procedures. The FHWA analyzed this rule under
the program in accordance with changes
In addition, this action complies with Executive Order 13175, dated November
made in the program by the Federal
the principles of Executive Order 13563. 6, 2000, and believes that this action
Government. The Federal-aid highway
After evaluating the costs and benefits would not have substantial direct effects
program permits this type of flexibility.
of these amendments, FHWA on one or more Indian tribes, would not
determined that the economic impact of Executive Order 13132 (Federalism impose substantial direct compliance
this rulemaking would be minimal. Assessment) costs on Indian tribal governments, and
These changes are not anticipated to would not preempt tribal law. This rule
This rule was analyzed in accordance
adversely affect, in any material way, establishes the requirements for the
with the principles and criteria
any sector of the economy. In addition, procurement, management, and
contained in Executive Order 13132,
these changes will not create a serious administration of engineering and
dated August 4, 1999, and it was
inconsistency with any other agency’s design related services using FAHP
determined that this rule does not have
action or materially alter the budgetary funding and directly related to a
a substantial direct effect or sufficient
impact of any entitlements, grants, user construction project. As such, this rule
federalism implications on States that would not impose any direct
fees, or loan programs. These updated would limit the policymaking discretion
standards and specifications represent compliance requirements on Indian
of the States. Nothing in this rule tribal governments nor would it have
the most recent refinements that directly preempts any State law or
professional organizations have formally any economic or other impacts on the
regulation or affects the States’ ability to viability of Indian tribes. Therefore, a
accepted, and are currently in use by the discharge traditional State governmental
transportation industry. The FHWA tribal summary impact statement is not
functions. required.
anticipates that the economic impact of
this rulemaking will be minimal; Executive Order 12372 Executive Order 13211 (Energy Effects)
therefore, a full regulatory evaluation is (Intergovernmental Review)
The FHWA analyzed this rule under
not necessary. The regulations implementing Executive Order 13211, Actions
Regulatory Flexibility Act Executive Order 12372 regarding Concerning Regulations that
intergovernmental consultation on Significantly Affect Energy Supply,
In compliance with the Regulatory Federal programs and activities apply to Distribution, or Use. We determined
Flexibility Act (Pub. L. 96–354, 5 U.S.C. this program. This Executive Order that this action would not be a
601–612), FHWA evaluated the effects applies because State and local significant energy action under that
of this rule on small entities, such as governments would be directly affected order because any action contemplated
local governments and businesses. The by the proposed regulation, which is a would not be likely to have a significant
FHWA determined that this action condition on Federal highway funding. adverse effect on the supply,
would not have a significant economic Local entities should refer to the Catalog distribution, or use of energy. Therefore,
impact on a substantial number of small of Federal Domestic Assistance Program FHWA certifies that a Statement of
entities. The amendments would update Number 20.205, Highway Planning and Energy Effects under Executive Order
several industry design standards and Construction, for further information. 13211 is not required.
standard specifications adopted and
incorporated by reference under 23 CFR Paperwork Reduction Act Executive Order 12630 (Taking of
part 625. The FHWA believes the Federal agencies must obtain approval Private Property)
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projected impact upon small entities from the Office of Management and The FHWA analyzed this rule and
that utilize Federal-aid highway Budget for each collection of determined that this action would not
program funding for the development of information they conduct, sponsor, or affect a taking of private property or
highway improvement projects on the require through regulations. This rule otherwise have taking implications
NHS would be negligible. Therefore, does not contain a collection of under Executive Order 12630,
FHWA certifies that the rule would not information requirement for the purpose Governmental Actions and Interference
have a significant economic impact on of the Paperwork Reduction Act of 1995 with Constitutionally Protected Property
a substantial number of small entities. (44 U.S.C. 3501, et seq.). Rights.

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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations 61307

Executive Order 12988 (Civil Justice ■ 2. Amend § 625.4 by revising 2008, 2010, 2011, 2012, 2014, and 2015
Reform) paragraphs (a), (b), and (d), and adding Interim Revisions (incorporated by
This action meets applicable paragraph (e) to read as follows: reference; see § 625.4(d)).
standards in sections 3(a) and 3(b)(2) of (5) AASHTO/AWS D1.5M/D1.5: 2010
§ 625.4 Standards, policies, and standard Bridge Welding Code, 6th Edition,
Executive Order 12988, Civil Justice specifications.
Reform, to minimize litigation, AASHTO, 2011, with 2011 and 2012
* * * * * Interim Revisions (incorporated by
eliminate ambiguity, and reduce (a) Roadway and appurtenances. (1) A
burden. reference; see § 625.4(d)).
Policy on Geometric Design of (6) D1.4/D1.4M: 2011Structural
Executive Order 13045 (Protection of Highways and Streets, AASHTO, 2011 Welding Code-Reinforcing Steel,
Children) (incorporated by reference; see American Welding Society, 2011
§ 625.4(d)). (incorporated by reference; see
The FHWA analyzed this action (2) A Policy on Design Standards
under Executive Order 13045, § 625.4(d)).
Interstate System, AASHTO, January (7) Standard Specifications for
Protection of Children from 2005 (incorporated by reference; see
Environmental Health Risks and Safety Structural Supports for Highway Signs,
§ 625.4(d)). Luminaires and Traffic Signals, 6th
Risks, and certifies that this proposed (3) The geometric design standards for
action would not cause an Edition, AASHTO, 2013 (incorporated
resurfacing, restoration, and by reference; see § 625.4(d)).
environmental risk to health or safety rehabilitation (RRR) projects on NHS
that may disproportionately affect (8) Navigational Clearances for
highways other than freeways shall be Bridges, refer to 23 CFR part 650,
children. the procedures and the design or design subpart H.
Executive Order 12898 (Environmental criteria established for individual
projects, groups of projects, or all non- * * * * *
Justice)
freeway RRR projects in a State, and as (d) Documents incorporated by
The Executive Order 12898 requires approved by the FHWA. The other reference. The Director of the Federal
that each Federal agency make geometric design standards in this Register approves the incorporation by
achieving environmental justice part of section do not apply to RRR projects on reference of the documents listed in this
its mission by identifying and NHS highways other than freeways, section in accordance with 5 U.S.C.
addressing, as appropriate, except as adopted on an individual 552(a) and 1 CFR part 51. The
disproportionately high and adverse State basis. The RRR design standards documents listed in this paragraph are
human health or environmental effects shall reflect the consideration of the incorporated by reference and available
of its programs, policies, and activities traffic, safety, economic, physical, for inspection at the U.S. Department of
on minorities and low-income community, and environmental needs of Transportation’s National
populations. The FHWA determined the projects. Transportation Library at 1200 New
that this rule does not raise any (4) Location and Hydraulic Design of Jersey Avenue SE., Washington, DC
environmental justice issues. Encroachments on Flood Plains, refer to 20590; (800) 853–1351. The documents
Regulation Identifier Number 23 CFR part 650, subpart A. also are available for inspection at the
(5) Procedures for Abatement of National Archives and Records
A regulation identifier number (RIN) Administration (NARA). For
Highway Traffic Noise and Construction
is assigned to each regulatory action information on the availability of this
Noise, refer to 23 CFR part 772.
listed in the Unified Agenda of Federal (6) Accommodation of Utilities, refer material at NARA, call 202–741–6030,
Regulations. The Regulatory Information to 23 CFR part 645, subpart B. or go to: http://www.archives.gov/
Service Center publishes the Unified (7) Pavement Design, refer to 23 CFR federal_register/code_of_federal_
Agenda in April and October of each part 626. regulations/ibr_locations.html. Copies
year. The RIN number contained in the (b) Bridges and structures. (1) For of these documents may be obtained
heading of this document can be used existing bridges originally designed to from the following organizations:
to cross-reference this action with the any edition of the AASHTO Standard (1) American Association of State
Unified Agenda. Specifications for Highway Bridges, Highway and Transportation Officials
List of Subjects in 23 CFR Part 625 modifications may be designed to the (AASHTO), Suite 249, 444 North
Standard Specifications for Highway Capitol Street NW., Washington, DC
Design standards, Grant programs- 20001; www.transportation.org; or (202)
Bridges, 17th Edition, AASHTO, 2002
transportation, Highways and roads, 624–5800.
(incorporated by reference; see
Incorporation by reference. (i) A Policy on Geometric Design of
§ 625.4(d)), or to the standards and
Issued on: October 6, 2015. specifications that are listed in Highways and Streets, 6th Edition,
Gregory G. Nadeau, § 625.4(b). 2011.
Administrator, Federal Highway (2) AASHTO LRFD Bridge (ii) A Policy on Design Standards
Administration. Construction Specifications, 3rd Interstate System, January 2005.
In consideration of the foregoing, the Edition, AASHTO, 2010, with 2010, (iii) Standard Specifications for
FHWA amends 23 CFR part 625 as 2011, 2012, and 2014 Interim Revisions Highway Bridges, 17th Edition, 2002
follows: (incorporated by reference; see (iv) AASHTO LRFD Bridge
§ 625.4(d)). Construction Specifications, 3rd
asabaliauskas on DSK5VPTVN1PROD with RULES

PART 625—DESIGN STANDARDS FOR (3) AASHTO LRFD Bridge Design Edition, 2010; with:
HIGHWAYS Specifications, 7th Edition, AASHTO, (A) Interim Revisions, 2010,
2014, with 2015 Interim Revisions (B) Interim Revisions, 2011,
■ 1. The authority citation for part 625 (incorporated by reference; see (C) Interim Revisions, 2012, and
continues to read as follows: § 625.4(d)). (D) Interim Revisions, 2014.
Authority: 23 U.S.C. 109, 215, and 402; (4) AASHTO LRFD Movable Highway (v) AASHTO LRFD Bridge Design
Sec. 1073 of Pub. L. 102–240, 105 Stat. 1914, Bridge Design Specifications, 2nd Specifications, 7th Edition, 2014, with:
2012; 49 CFR 1.48(b) and (n). Edition, AASHTO, 2007, including (A) 2015 Interim Revisions.

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61308 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations

(B) [Reserved]. in the Federal Register. The to nonperiodic payments that are
(vi) AASHTO LRFD Movable amendments to the temporary significant.
Highway Bridge Design Specifications, regulations provide guidance to
2nd Edition, 2007, with: taxpayers who are parties making and List of Subjects in 26 CFR Part 1
(A) Interim Revisions, 2008, receiving nonperiodic payments under Income taxes, Reporting and
(B) Interim Revisions, 2010, notional principal contracts. recordkeeping requirements.
(C) Interim Revisions, 2011, DATES: Effective Date: These
(D) Interim Revisions, 2012, amendments are effective on October Amendments to the Regulations
(E) Interim Revisions, 2014, and 13, 2015.
(F) Interim Revisions, 2015 Accordingly, 26 CFR part 1 is
Applicability Date: For the date of corrected by making the following
(vii) AASHTO/AWS D1.5M/D1.5:
applicability, see § 1.446–3T(j)(2), as correcting amendments:
2010 Bridge Welding Code, 6th Edition,
corrected.
2010, with:
(A) Interim Revisions, 2011, and PART 1—INCOME TAXES
FOR FURTHER INFORMATION CONTACT:
(B) Interim Revisions, 2012 Alexa Dubert at (202) 317–6945 (not a
(viii) Standard Specifications for toll-free number). ■ Paragraph 1. The authority citation
Structural Supports for Highway Signs, for part 1 continues to read in part as
SUPPLEMENTARY INFORMATION: follows:
Luminaires and Traffic Signals, 6th
Edition, AASHTO 2013. Background Authority: 26 U.S.C. 7805 * * *
(2) American Welding Society (AWS), The temporary regulations that are the
8869 NW 36 Street, #130 Miami, FL ■ Par. 2. Section 1.446–3T is amended
subject of these amendments are under
33166–6672; www.aws.org; or (800) by revising paragraph (j)(2) to read as
section 446(b) of the Internal Revenue
443–9353 or (305) 443–9353. follows:
Code (Code). The temporary regulations
(i) D1.4/D1.4M: 2011 Structural (TD 9719) were published in the § 1.446–3T Notional principal contracts
Welding Code—Reinforcing Steel, 2011. Federal Register on Friday, May 8, 2015 (temporary).
(ii) [Reserved]. (80 FR 26437).
(e) The FHWA supports using, as * * * * *
design resources to achieve context Need for Amendments (j) * * *
sensitive designs, guides that national Section 1.446–3T(g)(4)(i) of the (2) Application of § 1.446–3T(g)(4).
organizations develop from peer- temporary regulations provides that, Paragraph (g)(4)(i) of this section and
reviewed research, or equivalent guides subject to certain exceptions set forth in paragraph (g)(6) Example 2 of this
that are developed in cooperation with § 1.446–3T(g)(4)(ii), a notional principal section apply to notional principal
State or local officials, when such contract with one or more nonperiodic contracts entered into on or after the
guides are not in conflict with Federal payments is treated as two separate later of January 1, 2017, or 180 days
laws and regulations. transactions consisting of an on-market, after the date of publication of the
[FR Doc. 2015–25931 Filed 10–9–15; 8:45 am] level payment swap and one or more Treasury decision adopting these rules
BILLING CODE 4910–22–P loans (the embedded loan rule). Section as final regulations in the Federal
1.446–3T(g)(4)(i) eliminated the Register. Paragraph (g)(4)(ii) of this
exception to the embedded loan rule for section applies to notional principal
DEPARTMENT OF THE TREASURY non-significant, nonperiodic payments contracts entered into on or after May 8,
set forth in the final regulations (TD 2015. However, before the later of
Internal Revenue Service 8491) published in the Federal Register January 1, 2017, or 180 days after the
on October 14, 1993 (58 FR 53125) (the date of publication of the Treasury
26 CFR Part 1 1993 Regulations). See § 1.446–3. decision adopting paragraph (g)(4)(i) of
[TD 9719] Section 1.446–3T(g)(4)(i) applies to this section as final regulations in the
notional principal contracts entered into Federal Register, taxpayers may rely on
RIN 1545–BM62 on or after November 4, 2015. After the provision in § 1.446–3(g)(4), as
publication of the temporary contained in 26 CFR part 1, revised
Notional Principal Contracts; Swaps April 1, 2015, which (except for
regulations, the Treasury Department
With Nonperiodic Payments purposes of section 956) limits the
and the IRS received comments
AGENCY: Internal Revenue Service (IRS), requesting the delay of the applicability application of the embedded loan rule
Treasury. date of the embedded loan rule set forth to nonperiodic payments that are
ACTION: Temporary regulations; in the temporary regulations. In significant, even if the requirements for
correcting amendments. response to those comments, this the exceptions in paragraph (g)(4)(ii) of
document amends the applicability date this section are not met. Taxpayers may
SUMMARY: This document contains to make § 1.446–3T(g)(4)(i) and § 1.446– apply paragraph (g)(4)(i) of this section,
amendments to temporary regulations 3T(g)(6) Example 2 apply to notional paragraph (g)(4)(ii) of this section, or
relating to guidance for the treatment of principal contracts entered into on or both to notional principal contracts
nonperiodic payments made or received after the later of January 1, 2017, or 180 entered into before the dates set forth in
pursuant to certain notional principal days after the date of publication of the this paragraph (j)(2).
asabaliauskas on DSK5VPTVN1PROD with RULES

contracts. These amendments change Treasury decision adopting these rules * * * * *


the applicability date of the embedded as final regulations in the Federal
loan rule for the treatment of Register. Prior to the date of Martin Franks,
nonperiodic payments from November applicability of § 1.446–3T(g)(4)(i), as Branch Chief, Publications & Regulations
4, 2015, to the later of January 1, 2017, corrected, taxpayers may continue to Branch, Legal Processing Division, Associate
or six months after the date of apply the 1993 Regulations that (except Chief Counsel (Procedure & Administration).
publication of the Treasury decision for purposes of section 956) limit the [FR Doc. 2015–25921 Filed 10–9–15; 8:45 am]
adopting these rules as final regulations application of the embedded loan rule BILLING CODE 4830–01–P

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