83 FR 54876 - Design Standards for Highways
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration Federal Register Volume 83, Issue 212 (November 1, 2018)
Federal Highway Administration
Federal Register Volume 83, Issue 212 (November 1, 2018)
| Page Range | 54876-54881 | |
| FR Document | 2018-23821 |
[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)] [Rules and Regulations] [Pages 54876-54881] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23821] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Highway Administration 23 CFR Part 625 [Docket No. FHWA-2017-0001] RIN 2125-AF72 Design Standards for Highways AGENCY: Federal Highway Administration (FHWA), U.S. Department of Transportation (DOT). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This final rule updates the regulations governing design standards [[Page 54877]] and standard specifications that apply to new construction, reconstruction, resurfacing (except for maintenance resurfacing), restoration, and rehabilitation projects on the National Highway System (NHS). In issuing this final rule, FHWA incorporates by reference the latest versions of design standards and standard specifications previously adopted and incorporated by reference, and removes the corresponding outdated or superseded versions of these standards and specifications. Use of the updated standards is required for all NHS projects authorized to proceed with design activities on or after the effective date of the final rule. DATES: This final rule is effective December 3, 2018. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of December 3, 2018. The incorporation by reference of certain other publications listed in the rule was approved by the Director of the Federal Register as of November 12, 2015. FOR FURTHER INFORMATION CONTACT: Elizabeth Hilton, Office of Program Administration (HIPA-20), (512) 536-5970, or via email at Elizabeth.Hilton@dot.gov, or Jomar Maldonado, Office of the Chief Counsel (HCC-30), (202) 366-1373, or via email at Jomar.Maldonado@dot.gov. Office hours are from 8:00 a.m. to 4:30 p.m., e.t., Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: Electronic Access and Filing This document, the notice of proposed rulemaking (NPRM), and all comments received may be viewed online under the docket number noted above through the Federal eRulemaking portal at: http://www.regulations.gov. Electronic submission and retrieval help and guidelines are available on the website. Please follow the online instructions. An electronic copy of this document may also be downloaded from the Office of the Federal Register's website at: http://www.archives.gov/federal-register and the Government Publishing Office's website at: http://www.thefederalregister.org/fdsys. Background This rulemaking updates existing regulations governing new construction, reconstruction, resurfacing (except for maintenance resurfacing), restoration, and rehabilitation projects on the NHS (including the Interstate System), by incorporating by reference the current versions of design standards and standard specifications previously adopted and incorporated by reference under 23 CFR 625.4, and removing the outdated or superseded versions of these standards and specifications. Several of these design standards and standard specifications were established by the American Association of State Highway and Transportation Officials (AASHTO) and the American Welding Society (AWS) and were previously adopted by FHWA through rulemaking. The new standards or specifications replace previous versions of these documents and represent the most recent refinements that professional organizations have formally accepted. The FHWA formally adopts them for NHS projects. The revisions include referencing the 2016 edition of the AASHTO A Policy on Design Standards--Interstate System; the 2017 edition of Transportation Materials, parts 1-3; the 2017 edition of the AASHTO Load and Resistance Factor Design (LRFD) Bridge Construction Specifications; the 2015 edition of the AASHTO/AWS D1.5M/D1.5:2015 Bridge Welding Code (as reprinted in 2016), with 2018 Interim Revisions; and the 2017 edition of the AASHTO LRFD Bridge Design Specifications. The revisions will also adopt two alternative specifications: the 2013 edition of AASHTO's Standard Specifications for Structural Supports of Highway Signs, Luminaires, and Traffic Signals (including Errata September 2013), with 2015 Interim Revisions, as well as the 2015 edition of AASHTO's LRFD Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, with 2017 and 2018 Interim Revisions. The AASHTO is an organization that represents 52 State highway and transportation agencies (including the District of Columbia and Puerto Rico). Its members consist of the duly constituted heads and other chief officials of those agencies. The Secretary of Transportation is an ex-officio member, and DOT staff participates in various AASHTO activities as nonvoting representatives. Among other functions, AASHTO develops and issues standards, specifications, policies, guides, and related materials for use by the States for highway projects. Many of the standards, policies, and standard specifications that were approved by FHWA and incorporated into 23 CFR part 625 were developed and issued by AASHTO. While these adopted standards and specifications apply to all projects on the NHS (including the Interstate System), FHWA encourages the use of flexibility and a context-sensitive approach to consider a full range of project and user needs and the impacts to the community and natural and human environment. The FHWA also encourages State departments of transportation (State DOT) and local agencies to consider using design exceptions to achieve a design that balances project and user needs, performance, cost, environmental implications, and community values. These adopted design standards provide a range of acceptable values for highway features, and this flexibility should allow for a design that best suits the desires of the community while satisfying the purpose for the project and needs of its users. At a minimum, State DOTs and local agencies should select design values based on an evaluation of the context of the facility, needs of all the various project users, safety, mobility (i.e., traffic performance), human and natural environmental impacts, and project costs. For most situations, there is sufficient flexibility within the range of acceptable values to achieve a balanced design. However, when this is not possible, a design exception may be appropriate. State and local agencies may consider designs that deviate from the design standards when warranted based on the conditions, context, and consequences of the proposed projects. Additional information on FHWA's adopted design standards and design exceptions is available at: http://www.fhwa.dot.gov/design/standards and in FHWA's publication titled Mitigation Strategies for Design Exceptions, available at: http://safety.fhwa.dot.gov/geometric/pubs/mitigationstrategies/fhwa_sa_07011.pdf. Discussion Under 1 CFR Part 51 The documents that FHWA is incorporating by reference are reasonably available to interested parties, primarily State DOTs and local agencies carrying out Federal-aid highway projects. These documents represent the most recent refinements that professional organizations have formally accepted and are currently in use by the transportation industry. The documents are also available for review at DOT's National Transportation Library or may be obtained from AASHTO or AWS. The specific standards are discussed in greater detail elsewhere in this preamble. Section-by-Section Discussion of Changes to 23 CFR Part 625 The FHWA is removing the introductory text of Sec. 625.4. It is duplicative of information contained in paragraph (d) and does not meet Office of the Federal Register formatting [[Page 54878]] requirements for incorporation by reference. The FHWA is revising Sec. 625.4(a)(2) to replace the reference to the January 2005 edition of A Policy on Design Standards--Interstate System with the May 2016 edition. This Policy is a comprehensive manual to assist State DOTs and local agencies in administrative, planning, and educational efforts pertaining to design formulation for projects on the Dwight D. Eisenhower National System of Interstate and Defense Highways (Interstate). The AASHTO May 2016 edition incorporates the latest research and current industry practices, and is applicable to new construction and reconstruction projects on the Interstate except in Alaska and Puerto Rico (23 U.S.C. 103(c)(1)(B)(ii)). Resurfacing, restoration, and rehabilitation projects must meet the Interstate standards that were in place at the time of original construction or inclusion into the Interstate System. The updated guide clarifies ambiguities in the prior edition and provides additional flexibility regarding the design traffic volumes to be accommodated. It increases the median width in rural areas to reduce cross-median crashes and adds recommendations about extended access control and multimodal considerations at interchanges. Basic criteria for other geometric design standards remain essentially the same. The Agency considers the changes made in the 2016 version minor in nature. With respect to the design standards and standards specifications for bridges and structures under Sec. 625.4(b), FHWA is adopting the current versions of the standards and specifications it has previously adopted from AASHTO and AWS. The updated documents contain changes that represent discoveries or improvements in the state-of-the-knowledge and practices of State DOTs and local agencies that have occurred since the previous standards and specifications were incorporated by reference into 23 CFR part 625. The FHWA is revising Sec. 625.4(b)(2) to incorporate by reference the current version of the revised AASHTO bridge construction specifications entitled LRFD Bridge Construction Specifications, 4th Edition. These specifications, which are intended for use in the construction of bridges, employ the LRFD methodology and are designed to be used in conjunction with the below referenced AASHTO LRFD Bridge Design Specifications. Changes in the 4th Edition reflect the latest research and developments, and specifications promulgated by AASHTO. The FHWA is revising Sec. 625.4(b)(3) to incorporate by reference the current version of the revised AASHTO bridge design specifications entitled AASHTO LRFD Bridge Design Specifications, 8th Edition. The AASHTO LRFD Bridge Design Specifications are intended for use in the design, evaluation, and rehabilitation of bridges, and are mandated by the FHWA for use on all bridges using Federal funding. These Specifications employ the LRFD methodology using factors developing from current statistical knowledge of loads and structural performance. Changes in the 8th Edition reflect the latest research, developments, and specifications promulgated by AASHTO. The FHWA is making a minor editorial correction to the reference to the LRFD Movable Highway Bridge Design Specifications referenced in paragraph Sec. 625.4(b)(4) to change ``including'' to ``with'' when citing the Interim Revisions, but is not changing the material that is already incorporated. The FHWA is revising Sec. 625.4(b)(5) to incorporate by reference the current version of the revised AASHTO bridge welding code entitled AASHTO/AWS D1.5M/D1.5:2015-AMD1 Bridge Welding Code; AASHTO, as corrected and reprinted in 2016, and including 2018 Interim Revisions (The 2015 publication was the 7th edition). This document covers AASHTO welding requirements for welded highway bridges made from carbon and low-alloy construction steels. Chapters cover design of welded connections, workmanship, technique, procedure and performance qualification, inspection, and stud welding. Changes in the 7th Edition, including the 2018 Interim Revisions, reflect the latest research, developments, and specifications promulgated by AASHTO and AWS. The FHWA is revising Sec. 625.4(b)(7) to incorporate by reference two alternative Specifications applicable to the structural design of supports for highway signs, luminaires, and traffic signals. State DOTs must choose one of these alternative Specifications to guide the design, fabrication, and erection of these types of supports. The first alternative is the most current version of the revised AASHTO structural support specification entitled Standard Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, 6th Edition, AASHTO, 2013, with 2015 Interim Revisions. Changes in the 2015 Interim Revisions reflect more recent research, developments, and specifications promulgated by AASHTO than the prior adopted version. The second alternative Specification is AASHTO's LRFD Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, 1st Edition, AASHTO, 2015, with 2017 and 2018 Interim Revisions. While the LRFD specification is a more comprehensive, improved specification that reflects the latest research and knowledge, the agency has determined that design pursuant to either Specification provides for safe and reliable structural supports for highways signs, luminaires, and traffic signals. The FHWA is revising Sec. 625.4(c)(2) to incorporate by reference the current version of the revised AASHTO sampling and testing specification entitled 2017 Edition of Transportation Materials AASHTO, 2017. It contains specifications, test methods, and provisional standards commonly used in the construction of highway facilities. This edition of the standard specifications will replace those adopted by AASHTO in 1995. Changes in the 2016 standard specifications reflect current materials and testing technologies and practices. The FHWA is revising Sec. 625.4(c)(3) to update the title and cross-reference of the referenced regulation to ``Quality Assurance Procedures for Construction.'' Use of the updated standards will be required for all NHS projects authorized to proceed with design activities on or after the effective date of the final rule, subject to the exceptions in 23 CFR 625.3(f). Summary Discussion of Comments Received in Response to the NPRM On May 11, 2018, FHWA published an NPRM in the Federal Register at 83 FR 21972 soliciting public comments on its proposal to update the existing regulations. The following presents an overview of the comments received to the NPRM. The docket contained 4 total comments. The FHWA appreciates the feedback the commenters provided, carefully reviewed and analyzed all the comments that were submitted, and made revisions to the NPRM to incorporate suggestions where necessary. An individual commented that the Standard Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, 6th Edition, AASHTO, 2013 with 2015 Interim Revisions had been superseded by the LRFD Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, 1st Edition, AASHTO, 2015, with 2017 and 2018 Interim Revisions. [[Page 54879]] The LRFD Specification does not supersede the Standard Specification. At this time, many State DOTs are using the Standard Specification and are not ready to fully implement the LRFD Specification. Because the LRFD specification is a more comprehensive, improved specification that reflects the latest research and knowledge, FHWA plans to work with AASHTO to develop a timeline to phase out use of the Standard Specification in the future. However, the agency has determined that design pursuant to either Specification provides for safe and reliable structural supports for highways signs, luminaires, and traffic signals.\1\ Therefore, in the interim, FHWA is adopting the updated Standard Specification and the LRFD Specification as alternative Specifications applicable to the structural design of supports for highway signs, luminaires, and traffic signals. States DOTs must choose one of these alternative Specifications to guide the design, fabrication, and erection of these types of supports. Accordingly, FHWA has revised Sec. 625.4(b)(7) to accommodate State DOTs that are ready to begin transitioning to the LRFD Specification. --------------------------------------------------------------------------- \1\ This determination is supported by National Cooperative Highway Research Program Report 796: Development and Calibration of AASHTO LRFD Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, which found that ``[t]he [LRFD Specifications] were calibrated using the AASHTO [Standard Specifications] allowable stress design method as a baseline,'' which means that both the Standard Specifications and the LRFD Specifications ensure a consistent level of safety. --------------------------------------------------------------------------- That individual also commented that 2018 Interim Revisions had been released for the 2015 Bridge Welding Code, 7th Edition. These Interim Revisions were not available when the NPRM was developed, however, FHWA has decided to incorporate the 2018 Interim Revisions by reference in this final rule because they reflect the latest research, developments, and specifications promulgated by AASHTO and AWS. An individual commenter suggested that rather than adopt specific editions of standards, FHWA should adopt ``the most current version at the time of contract advertisement,'' to eliminate the need to continuously revise 23 CFR part 625. Procedures and requirements for incorporation by reference are covered in 1 CFR part 51, which requires that the language incorporating a publication by reference be precise and complete and must clearly state the title, date, edition, author, publisher and identification number of the publication. Therefore, no change was made to the final rule. An individual commented that the updated standards would not allow certain products and therefore provided for a lower margin of safety. The final rule adopts current versions of industry publications and does not pertain to specific merchandise or products. Use of these current publications will improve safety because the newer versions incorporate updated research within each specific area of concern. Therefore, no change was made to the final rule. An individual commented that existing practice of allowing for design exceptions undermined existing regulations. Design exceptions, which have been allowed by the regulations for decades, are essential to developing projects that are congruent with the natural surroundings, community context, and the purpose and need of the project. Therefore, no change was made to the final rule. Rulemaking Analyses and Notices Executive Order 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs), and USDOT Regulatory Policies and Procedures The FHWA has determined that this action does not constitute a significant regulatory action within the meaning of Executive Order (E.O.) 12866 or within the meaning of DOT regulatory policies and procedures. The amendments update several industry design standards and standard specifications adopted and incorporated by reference under 23 CFR part 625 and removes the corresponding outdated or superseded versions of these standards and specifications. In addition, this action complies with the principles of E.O. 13563. After evaluating the costs and benefits of these amendments, FHWA anticipates that the economic impact of this rulemaking is minimal. These incremental changes are not anticipated to adversely affect, in any material way, any sector of the economy. In addition, these changes will not create a serious inconsistency with any other agency's action or materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs. These updated standards and specifications represent the most recent refinements that professional organizations have formally accepted. The FHWA anticipates that the economic impact of this rulemaking will be minimal; therefore, a full regulatory evaluation is not necessary. Finally, this rule is not an E.O. 13771 regulatory action because it is not significant under E.O. 12866. Regulatory Flexibility Act In compliance with the Regulatory Flexibility Act (Pub. L. 96-354; 5 U.S.C. 60l-612), FHWA has evaluated the effects of this final rule on small entities, such as local governments and businesses. Based on the evaluation, FHWA anticipates that this action does not have a significant economic impact on a substantial number of small entities. The amendments update several industry design standards and standard specifications adopted and incorporated by reference under 23 CFR part 625. The FHWA believes the projected impact upon small entities that utilize Federal-aid highway program funding for the development of highway improvement projects on the NHS is negligible. Therefore, I certify that the action will not have a significant economic impact on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 The FHWA has determined that this rule does not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995, 109 Stat. 48). The actions in this final rule will not result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $155 million or more in any 1 year (when adjusted for inflation) in 2014 dollars for either State, local, and Tribal governments in the aggregate, or by the private sector. In addition, the definition of ``Federal Mandate'' in the Unfunded Mandates Reform Act excludes financial assistance of the type in which State, local, or Tribal governments have authority to adjust their participation in the program in accordance with changes made in the program by the Federal Government. The Federal-aid highway program permits this type of flexibility. Executive Order 13132 (Federalism Assessment) The FHWA has analyzed this final rule in accordance with the principles and criteria contained in E.O. 13132. The FHWA has determined that this action does not have sufficient federalism implications to warrant the preparation of a federalism assessment. The FHWA has also determined that this action does not preempt any State law or State regulation or affect the [[Page 54880]] States' ability to discharge traditional State governmental functions. Executive Order 12372 (Intergovernmental Review) The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program. This E.O. applies because State and local governments are directly affected by this regulation, which is a condition on Federal highway funding. Local entities should refer to the Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction, for further information. Paperwork Reduction Act Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et seq.), Federal agencies must obtain approval from the Office of Management and Budget for each collection of information they conduct, sponsor, or require through regulations. The FHWA has determined that this final rule does not contain collection of information requirements for the purposes of the PRA. National Environmental Policy Act The FHWA has analyzed this final rule for the purposes of the National Environmental Policy Act (NEPA) (42 U.S.C. 4321, et seq.) and has determined that this action does not have any effect on the quality of the human and natural environment because it only makes technical changes and incorporate by reference the latest versions of design standards and standard specifications previously adopted and incorporated by reference under 23 CFR part 625 and removes the corresponding outdated or superseded versions of these standards and specifications. The final rule qualifies as a categorical exclusion to NEPA under 23 CFR 771.117(c)(20). Executive Order 13175 (Tribal Consultation) The FHWA has analyzed this final rule under EO13175, and believes that it will not have substantial direct effects on one or more Indian Tribes, does not impose substantial direct compliance costs on Indian Tribal governments, and does not preempt Tribal law. This rule does not impose any direct compliance requirements on Indian Tribal governments nor does it have any economic or other impacts on the viability of Indian Tribes. Therefore, a Tribal summary impact statement is not required. Executive Order 13211 (Energy Effects) The FHWA has analyzed this final rule under E.O. 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use. The FHWA has determined that this action is not a significant energy action under the E.O. and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required. Executive Order 12630 (Taking of Private Property) The FHWA has analyzed this rule under E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. The FHWA does not anticipate that this action will effect a taking of private property or otherwise have taking implications under E.O. 12630. Executive Order 12988 (Civil Justice Reform) This action meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Executive Order 13045 (Protection of Children) The FHWA has analyzed this action under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. The FHWA certifies that this action will not cause an environmental risk to health or safety that may disproportionately affect children. Regulation Identifier Number A Regulation Identifier Number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda. List of Subjects in 23 CFR Part 625 Design standards, Grant programs--transportation, Highways and roads, Incorporation by reference. Issued on: October 24, 2018. Brandye L. Hendrickson, Deputy Administrator, Federal Highway Administration. In consideration of the foregoing, FHWA amends 23 CFR part 625 as follows: PART 625--DESIGN STANDARDS FOR HIGHWAYS 0 1. The authority citation for part 625 continues to read as follows: Authority: 23 U.S.C. 109, 315, and 402; Sec. 1073 of Pub. L. 102-240, 105 Stat. 1914, 2012; 49 CFR 1.48(b) and (n). 0 2. Amend Sec. 625.4 by: 0 a. Removing the introductory text; 0 b. Revising paragraphs (a)(2), (b)(2) through (5), (7), (c)(2) and (3), the introductory text of paragraph (d), and paragraphs (d)(1)(ii), (iv), (v), (vii), and (viii); 0 c. Adding paragraphs (d)(1)(ix) and (x); and 0 d. Revising the introductory text of paragraph (d)(2). The revisions and additions read as follows: Sec. 625.4 Standards, policies, and standard specifications. (a) * * * (2) A Policy on Design Standards--Interstate System, AASHTO (paragraph (d) of this section). * * * * * (b) * * * (2) AASHTO LRFD Bridge Construction Specifications (paragraph (d) of this section). (3) AASHTO LRFD Bridge Design Specifications (paragraph (d) of this section). (4) AASHTO LRFD Movable Highway Bridge Design Specifications (paragraph (d) of this section). (5) AASHTO/AWS D1.5M/D1.5 Bridge Welding Code (paragraph (d) of this section). * * * * * (7) Standard Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, (paragraph (d) of this section); or LRFD Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals (paragraph (d) of this section). * * * * * (c) * * * (2) Transportation Materials, AASHTO (paragraph (d) of this section). (3) Quality Assurance Procedures for Construction, refer to 23 CFR part 637, subpart B. (d) Documents incorporated by reference. The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at U.S. Department of Transportation's National Transportation Library at 1200 New [[Page 54881]] Jersey Avenue SE, Washington, DC 20590; (800) 853-1351 and is available from the sources indicated below. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741- 6030 or go to www.archives.gov/federal-register/cfr/ibr-locations.html. (1) * * * (ii) A Policy on Design Standards--Interstate System, May 2016. * * * * * (iv) AASHTO-LRFD Bridge Construction Specifications, 4th Edition, copyright 2017. (v) AASHTO LRFD-8, LRFD Bridge Design Specifications, 8th Edition, 2017. * * * * * (vii) AASHTO/AWS D1.5M/D1.5: 2015-AMD1, Bridge Welding Code, Amendment: Second Printing December 12, 2016; with (A) AASHTO BWC-7-I1-OL, 2018 Interim Revisions to AASHTO/AWS D1.5M/ D1.5: 2015 Bridge Welding Code, 7th Edition, copyright 2017. (B) [Reserved] (viii) AASHTO LTS-6, Standard Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, 6th Edition, copyright 2013, with: (A) AASHTO LTS-6-I1, 2015 Interim Revisions to Standard Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, copyright 2014. (B) [Reserved] (ix) AASHTO LRFDLTS-1, LRFD Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, 1st Edition, copyright 2015, with: (A) AASHTO LRFDLTS-1-I1-OL, 2017 Interim Revisions to LRFD Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, copyright 2016, and (B) AASHTO LRFDLTS-1-I2-OL, 2018 Interim Revisions to LRFD Specifications for Structural Supports for Highway Signs, Luminaires, and Traffic Signals, copyright 2017. (x) 2017 Edition of Transportation Materials, Parts 1-3, copyright 2017. (2) American Welding Society (AWS), 8669 NW 36 Street, #130 Miami, FL 33166-6672; www.aws.org; or (800) 443-9353 or (305) 443-9353. * * * * * [FR Doc. 2018-23821 Filed 10-31-18; 8:45 am] BILLING CODE 4910-22-P
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required to mitigate these risks in Table
1.
TABLE 1—MEPROBAMATE TEST SYSTEM RISKS AND MITIGATION MEASURES
Identified risks Mitigation measures
Clinical action based on incorrect test results (false positive results, Special controls (1) (21 CFR 862.3590(b)(1)), (2) (21 CFR
false negative results) may lead to inappropriate clinical decision 862.3590(b)(2)), and (3) (21 CFR 862.3590(b)(3)).
making.
Incorrect understanding of the device and test system and results may Special controls (2) (21 CFR 862.3590(b)(2)) and (3) (21 CFR
lead to inappropriate clinical decision making. 862.3590(b)(3)).
FDA has determined that special regulations, have been approved under but not limited to, specificity, cross-
controls, in combination with the OMB control number 0910–0073; and reactivity to relevant endogenous and
general controls, address these risks to the collections of information in 21 CFR exogenous substances, and the
health and provide reasonable assurance parts 801 and 809, regarding labeling, reproducibility of analyte detection
of safety and effectiveness. For a device have been approved under OMB control around the cutoff(s).
to fall within this classification, and number 0910–0485. (2) The intended use of the device
thus avoid automatic classification in must not include an indication for use
List of Subjects in 21 CFR Part 862 in monitoring therapeutic drug
class III, it would have to comply with
the special controls named in this final Medical devices. concentrations or informing dosing
order. The necessary special controls Therefore, under the Federal Food, adjustment decisions.
appear in the regulation codified by this Drug, and Cosmetic Act and under (3) Your 21 CFR 809.10 labeling must
order. This device is subject to authority delegated to the Commissioner include the following:
premarket notification requirements of Food and Drugs, 21 CFR part 862 is (i) If indicated for use as a screening
under section 510(k) of the FD&C Act. amended as follows: test to identify preliminary results for
At the time of classification, further confirmation, the intended use
meprobamate test systems are for PART 862—CLINICAL CHEMISTRY must state ‘‘This assay provides only a
prescription use only. AND CLINICAL TOXICOLOGY preliminary analytical result. A more
DEVICES specific alternative chemical
III. Analysis of Environmental Impact confirmatory method (e.g., gas or liquid
We have determined under 21 CFR ■ 1. The authority citation for part 862 chromatography and mass spectrometry)
25.34(b) that this action is of a type that continues to read as follows: must be used to obtain a confirmed
does not individually or cumulatively Authority: 21 U.S.C. 351, 360, 360c, 360e, analytical result. Clinical consideration
have a significant effect on the human 360j, 360l, 371. and professional judgment must be
environment. Therefore, neither an exercised with any drug of abuse test,
■ 2. Add § 862.3590 to subpart D to read particularly when the preliminary test
environmental assessment nor an as follows:
environmental impact statement is result is positive.’’
(ii) A limiting statement that reads as
required. § 862.3590 Meprobamate test system.
follows: ‘‘This test should not be used
IV. Paperwork Reduction Act of 1995 (a) Identification. A meprobamate test to monitor therapeutic drug
system is a device intended to measure concentrations or to inform dosing
This final order establishes special meprobamate in human specimens.
controls that refer to previously adjustment decisions.’’
Measurements obtained by this device
approved collections of information are used to detect the presence of Dated: October 29, 2018.
found in other FDA regulations and meprobamate to diagnose the use or Leslie Kux,
guidance. These collections of overdose of meprobamate or Associate Commissioner for Policy.
information are subject to review by the structurally-related drug compounds [FR Doc. 2018–23911 Filed 10–31–18; 8:45 am]
Office of Management and Budget (e.g., prodrugs). BILLING CODE 4164–01–P
(OMB) under the Paperwork Reduction (b) Classification. Class II (special
Act of 1995 (44 U.S.C. 3501–3520). The controls). The special controls for this
collections of information in the device are: DEPARTMENT OF TRANSPORTATION
guidance document ‘‘De Novo (1) Design verification and validation
Classification Process (Evaluation of must include: Federal Highway Administration
Automatic Class III Designation)’’ have (i) Robust data demonstrating the
been approved under OMB control accuracy of the device when used in the 23 CFR Part 625
number 0910–0844; the collections of intended specimen matrix. The
[Docket No. FHWA–2017–0001]
information in 21 CFR part 814, accuracy data must include a
subparts A through E, regarding comparison between the meprobamate RIN 2125–AF72
premarket approval, have been test system results and meprobamate
approved under OMB control number results that are measured on an FDA- Design Standards for Highways
0910–0231; the collections of accepted measurement method that is
amozie on DSK3GDR082PROD with RULES
AGENCY: Federal Highway
information in part 807, subpart E, specific and accurate (e.g., gas or liquid Administration (FHWA), U.S.
regarding premarket notification chromatography combined with tandem Department of Transportation (DOT).
submissions, have been approved under mass spectrometry). ACTION: Final rule.
OMB control number 0910–0120; the (ii) Robust analytical data
collections of information in 21 CFR demonstrating the performance SUMMARY: This final rule updates the
part 820, regarding quality system characteristics of the device, including, regulations governing design standards
VerDate Sep<11>2014 20:21 Oct 31, 2018 Jkt 247001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\01NOR1.SGM 01NOR1](https://thefederalregister.org/doc/83_FR_55088/page/1.svg)
![Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Rules and Regulations 54879
The LRFD Specification does not publication. Therefore, no change was will be minimal; therefore, a full
supersede the Standard Specification. made to the final rule. regulatory evaluation is not necessary.
At this time, many State DOTs are using An individual commented that the Finally, this rule is not an E.O. 13771
the Standard Specification and are not updated standards would not allow regulatory action because it is not
ready to fully implement the LRFD certain products and therefore provided significant under E.O. 12866.
Specification. Because the LRFD for a lower margin of safety.
specification is a more comprehensive, The final rule adopts current versions Regulatory Flexibility Act
improved specification that reflects the of industry publications and does not In compliance with the Regulatory
latest research and knowledge, FHWA pertain to specific merchandise or Flexibility Act (Pub. L. 96–354; 5 U.S.C.
plans to work with AASHTO to develop products. Use of these current 60l–612), FHWA has evaluated the
a timeline to phase out use of the publications will improve safety effects of this final rule on small
Standard Specification in the future. because the newer versions incorporate entities, such as local governments and
However, the agency has determined updated research within each specific businesses. Based on the evaluation,
that design pursuant to either area of concern. Therefore, no change FHWA anticipates that this action does
Specification provides for safe and was made to the final rule. not have a significant economic impact
reliable structural supports for highways An individual commented that on a substantial number of small
signs, luminaires, and traffic signals.1 existing practice of allowing for design entities. The amendments update
Therefore, in the interim, FHWA is exceptions undermined existing several industry design standards and
adopting the updated Standard regulations. standard specifications adopted and
Specification and the LRFD Design exceptions, which have been incorporated by reference under 23 CFR
Specification as alternative allowed by the regulations for decades, part 625. The FHWA believes the
Specifications applicable to the are essential to developing projects that projected impact upon small entities
structural design of supports for are congruent with the natural that utilize Federal-aid highway
highway signs, luminaires, and traffic surroundings, community context, and program funding for the development of
signals. States DOTs must choose one of the purpose and need of the project. highway improvement projects on the
these alternative Specifications to guide Therefore, no change was made to the NHS is negligible. Therefore, I certify
the design, fabrication, and erection of final rule. that the action will not have a
these types of supports. Accordingly, significant economic impact on a
FHWA has revised § 625.4(b)(7) to Rulemaking Analyses and Notices
substantial number of small entities.
accommodate State DOTs that are ready Executive Order 12866 (Regulatory
to begin transitioning to the LRFD Planning and Review), Executive Order Unfunded Mandates Reform Act of 1995
Specification. 13563 (Improving Regulation and The FHWA has determined that this
That individual also commented that Regulatory Review), Executive Order rule does not impose unfunded
2018 Interim Revisions had been 13771 (Reducing Regulation and mandates as defined by the Unfunded
released for the 2015 Bridge Welding Controlling Regulatory Costs), and
Code, 7th Edition. Mandates Reform Act of 1995 (Pub. L.
USDOT Regulatory Policies and 104–4, March 22, 1995, 109 Stat. 48).
These Interim Revisions were not Procedures
available when the NPRM was The actions in this final rule will not
developed, however, FHWA has The FHWA has determined that this result in the expenditure by State, local,
decided to incorporate the 2018 Interim action does not constitute a significant and Tribal governments, in the
Revisions by reference in this final rule regulatory action within the meaning of aggregate, or by the private sector, of
because they reflect the latest research, Executive Order (E.O.) 12866 or within $155 million or more in any 1 year
developments, and specifications the meaning of DOT regulatory policies (when adjusted for inflation) in 2014
promulgated by AASHTO and AWS. and procedures. The amendments dollars for either State, local, and Tribal
An individual commenter suggested update several industry design governments in the aggregate, or by the
that rather than adopt specific editions standards and standard specifications private sector. In addition, the
of standards, FHWA should adopt ‘‘the adopted and incorporated by reference definition of ‘‘Federal Mandate’’ in the
most current version at the time of under 23 CFR part 625 and removes the Unfunded Mandates Reform Act
contract advertisement,’’ to eliminate corresponding outdated or superseded excludes financial assistance of the type
the need to continuously revise 23 CFR versions of these standards and in which State, local, or Tribal
part 625. specifications. In addition, this action governments have authority to adjust
Procedures and requirements for complies with the principles of E.O. their participation in the program in
incorporation by reference are covered 13563. After evaluating the costs and accordance with changes made in the
in 1 CFR part 51, which requires that benefits of these amendments, FHWA program by the Federal Government.
the language incorporating a publication anticipates that the economic impact of The Federal-aid highway program
by reference be precise and complete this rulemaking is minimal. These permits this type of flexibility.
and must clearly state the title, date, incremental changes are not anticipated Executive Order 13132 (Federalism
edition, author, publisher and to adversely affect, in any material way, Assessment)
identification number of the any sector of the economy. In addition,
these changes will not create a serious The FHWA has analyzed this final
1 This determination is supported by National inconsistency with any other agency’s rule in accordance with the principles
Cooperative Highway Research Program Report 796: action or materially alter the budgetary and criteria contained in E.O. 13132.
Development and Calibration of AASHTO LRFD
impact of any entitlements, grants, user The FHWA has determined that this
amozie on DSK3GDR082PROD with RULES
Specifications for Structural Supports for Highway
Signs, Luminaires, and Traffic Signals, which found fees, or loan programs. These updated action does not have sufficient
that ‘‘[t]he [LRFD Specifications] were calibrated standards and specifications represent federalism implications to warrant the
using the AASHTO [Standard Specifications] the most recent refinements that preparation of a federalism assessment.
allowable stress design method as a baseline,’’
which means that both the Standard Specifications
professional organizations have formally The FHWA has also determined that
and the LRFD Specifications ensure a consistent accepted. The FHWA anticipates that this action does not preempt any State
level of safety. the economic impact of this rulemaking law or State regulation or affect the
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![Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Rules and Regulations 54881
Jersey Avenue SE, Washington, DC (B) [Reserved] (2) American Welding Society (AWS),
20590; (800) 853–1351 and is available (viii) AASHTO LTS–6, Standard 8669 NW 36 Street, #130 Miami, FL
from the sources indicated below. It is Specifications for Structural Supports 33166–6672; www.aws.org; or (800)
also available for inspection at the for Highway Signs, Luminaires, and 443–9353 or (305) 443–9353.
National Archives and Records Traffic Signals, 6th Edition, copyright * * * * *
Administration (NARA). For 2013, with: [FR Doc. 2018–23821 Filed 10–31–18; 8:45 am]
information on the availability of this (A) AASHTO LTS–6–I1, 2015 Interim BILLING CODE 4910–22–P
material at NARA, call 202–741–6030 or Revisions to Standard Specifications for
go to www.archives.gov/federal-register/ Structural Supports for Highway Signs,
cfr/ibr-locations.html. Luminaires, and Traffic Signals,
(1) * * * copyright 2014. DEPARTMENT OF VETERANS
(ii) A Policy on Design Standards— (B) [Reserved] AFFAIRS
Interstate System, May 2016. (ix) AASHTO LRFDLTS–1, LRFD
Specifications for Structural Supports 38 CFR Part 4
* * * * * for Highway Signs, Luminaires, and
(iv) AASHTO–LRFD Bridge
Traffic Signals, 1st Edition, copyright
Construction Specifications, 4th 2015, with: RIN 2900–AO19
Edition, copyright 2017. (A) AASHTO LRFDLTS–1–I1–OL,
(v) AASHTO LRFD–8, LRFD Bridge Schedule for Rating Disabilities: The
2017 Interim Revisions to LRFD
Design Specifications, 8th Edition, 2017. Hematologic and Lymphatic Systems
Specifications for Structural Supports
* * * * * for Highway Signs, Luminaires, and Correction
(vii) AASHTO/AWS D1.5M/D1.5: Traffic Signals, copyright 2016, and
2015–AMD1, Bridge Welding Code, (B) AASHTO LRFDLTS–1–I2–OL, In rule 2018–23517 beginning on page
Amendment: Second Printing December 2018 Interim Revisions to LRFD 54250 in the issue of Monday, October
12, 2016; with Specifications for Structural Supports 29, 2018, make the following correction:
(A) AASHTO BWC–7–I1–OL, 2018 for Highway Signs, Luminaires, and § 4.117 [Corrected]
Interim Revisions to AASHTO/AWS Traffic Signals, copyright 2017.
D1.5M/D1.5: 2015 Bridge Welding Code, (x) 2017 Edition of Transportation ■ In § 4.117, On page 54255, in the
7th Edition, copyright 2017. Materials, Parts 1–3, copyright 2017. table, entry 7703 should read as follows:
7703 Leukemia (except for chronic myelogenous leukemia):
When there is active disease or during a treatment phase ......................................................................................................... 100
Otherwise rate residuals under the appropriate diagnostic code(s).
Chronic lymphocytic leukemia or monoclonal B-cell lymphocytosis (MBL), asymptomatic, Rai Stage 0 ................................... 0
Note (1): A 100 percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic
chemotherapy, or other therapeutic procedures. Six months after discontinuance of such treatment, the appropriate disability
rating shall be determined by mandatory VA examination. Any change in evaluation based upon that or any subsequent ex-
amination shall be subject to the provisions of § 3.105(e) of this chapter. If there has been no recurrence, rate on residuals.
Note (2): Evaluate symptomatic chronic lymphocytic leukemia that is at Rai Stage I, II, III, or IV the same as any other leu-
kemia evaluated under this diagnostic code.
Note (3): Evaluate residuals of leukemia or leukemia therapy under the appropriate diagnostic code(s). Myeloproliferative Dis-
orders: (Diagnostic Codes 7704, 7718, 7719).
[FR Doc. C1–2018–23517 Filed 10–31–18; 8:45 am] SUMMARY: NMFS is prohibiting directed authority of the Magnuson-Stevens
BILLING CODE 1301–00–D fishing for Pacific cod by catcher vessels Fishery Conservation and Management
greater than or equal to 60 feet (18.3 Act. Regulations governing fishing by
meters (m)) length overall (LOA) using U.S. vessels in accordance with the FMP
DEPARTMENT OF COMMERCE pot gear in the Bering Sea and Aleutian appear at subpart H of 50 CFR part 600
Islands management area (BSAI). This and 50 CFR part 679.
National Oceanic and Atmospheric action is necessary to prevent exceeding The 2018 Pacific cod total allowable
Administration the 2018 Pacific cod total allowable catch (TAC) allocated to catcher vessels
catch allocated to catcher vessels greater greater than or equal to 60 feet (18.3m)
50 CFR Part 679 than or equal to 60 feet (18.3m) LOA LOA using pot gear in the BSAI is
[Docket No. 170817779–8161–02] using pot gear in the BSAI. 15,235 metric tons (mt) as established
DATES: Effective 1200 hours, Alaska by the final 2018 and 2019 harvest
RIN 0648–XG477
local time (A.l.t.), October 30, 2018, specifications for groundfish in the
Fisheries of the Exclusive Economic through 1200 hours, A.l.t., December 31, BSAI (89 FR 8365, February 27, 2018).
Zone Off Alaska; Pacific Cod by 2018.
In accordance with § 679.20(d)(1)(iii),
Catcher Vessels Greater Than or Equal FOR FURTHER INFORMATION CONTACT: Josh the Administrator, Alaska Region,
to 60 Feet Length Overall Using Pot Keaton, 907–586–7228. NMFS (Regional Administrator), has
Gear in the Bering Sea and Aleutian SUPPLEMENTARY INFORMATION: NMFS determined that the 2018 Pacific cod
Islands Management Area manages the groundfish fishery in the TAC allocated as a directed fishing
amozie on DSK3GDR082PROD with RULES
AGENCY: National Marine Fisheries BSAI exclusive economic zone allowance to catcher vessels greater than
Service (NMFS), National Oceanic and according to the Fishery Management or equal to 60 feet (18.3m) LOA using
Atmospheric Administration (NOAA), Plan for Groundfish of the Bering Sea pot gear in the BSAI will soon be
Commerce. and Aleutian Islands Management Area reached. Consequently, NMFS is
(FMP) prepared by the North Pacific prohibiting directed fishing for Pacific
ACTION: Temporary rule; closure.
Fishery Management Council under cod by catcher vessels greater than or
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Document Created: 2018-11-01 01:05:09
Document Modified: 2018-11-01 01:05:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This final rule is effective December 3, 2018. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of December 3, 2018. The incorporation by reference of certain other publications listed in the rule was approved by the Director of the Federal Register as of November 12, 2015. | |
| Contact | Elizabeth Hilton, Office of Program Administration (HIPA-20), (512) 536-5970, or via email at [email protected], or Jomar Maldonado, Office of the Chief Counsel (HCC-30), (202) 366-1373, or via email at [email protected] Office hours are from 8:00 a.m. to 4:30 p.m., e.t., Monday through Friday, except Federal holidays. | |
| FR Citation | 83 FR 54876 | |
| RIN Number | 2125-AF72 | |
| CFR Associated | Design Standards; Grant Programs-Transportation; Highways and Roads and Incorporation by Reference |
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