2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TRULANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

This document corrects the preamble in the DATES section to a final rule published in the Federal Register on November 19, 2018. The Environmental Protection Agency (EPA) published a final rule approving Connecticut's State Implementation Plan (SIP) revision that amended requirements for controlling volatile organic compound (VOC) emissions from consumer products and architectural and industrial maintenance (AIM) coatings by revising Regulations of Connecticut State Agencies (RCSA) sections 22a-174-40, 22a-174-41, and adding section 22a-174-41a.

The Environmental Protection Agency (EPA) is approving two State Implementation Plan (SIP) submissions from New Hampshire that address the infrastructure SIP requirements, including the interstate transport requirements, of the Clean Air Act (CAA or Act) for the 2012 fine particle (PM2.5) National Ambient Air Quality Standards (NAAQS). The approval does not address CAA section 110(a)(2)(K) (regarding air quality modeling and data), which EPA will address in a later rulemaking. The infrastructure SIP requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities with respect to this NAAQS under the CAA, including the obligations related to transport. The EPA is taking this action under the Clean Air Act.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEM (EXABLATE) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0001, Report of Marine Casualty and Chemical Testing of Commercial Vessel Personnel; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

The Pension Benefit Guaranty Corporation (PBGC) intends to request that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act, a collection of information necessary for PBGC to determine whether a plan is covered under title IV of the Employee Retirement Security Income Act of 1974. This notice informs the public of PBGC's intent and solicits public comment on the collection of information.

Notice is hereby given that the presiding administrative law judge has issued a final initial determination on a section 337 violation and a recommended determination on remedy, the public interest, and bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief, should the Commission find a violation. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to Commission rules.

The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on a revised information collection request (ICR), Health Benefits Election, SF 2809.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the disclosure of returns and return information to a designee of a taxpayer.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the disclosure of reportable transactions.

The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to take this opportunity to comment on a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and respondents are not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning the renewal of its information collection titled, ``Leasing.''

In May 2003 and April 2005, FMCSA published interim final rules (IFR) regarding the limitations on the issuance of commercial driver's licenses with a hazardous materials endorsement. The comment period for the May 2003 IFR closed on July 7, 2003; there was no comment period for the April 2005 IFR. The Agency received over 50 comments on the 2003 IFR. FMCSA now plans to adopt the provisions of the IFRs that have not previously been made final. To ensure that interested parties have an opportunity to provide comments, the Agency has re-opened the comment period for 15 days.

The purpose of this notice is to inform the public and interested State and local government officials of the filing of Plats of Survey in Nevada.

The Environmental Protection Agency (EPA) is approving two state implementation plan (SIP) revisions submitted by the State of West Virginia. The revisions pertain to a West Virginia regulation that established the nitrogen oxides (NOX) ozone season trading program under the Clean Air Interstate Rule (CAIR), which implemented requirements for NOX reductions necessary to reduce interstate transport of pollution. The EPA-administered trading programs under CAIR were discontinued upon the implementation of the Cross-State Air Pollution Rule (CSAPR), which was promulgated by EPA to replace CAIR. CSAPR established Federal implementation plans (FIPs) for 28 states, including West Virginia, and applied to electric generating units (EGUs). The SIP submittals are comprised of revisions to the West Virginia regulation that implemented the CAIR ozone season NOX trading program that had previously been included in the West Virginia SIP. The revised West Virginia regulation removed the CAIR ozone season NOX trading program provisions, which also addressed certain large non-electric generating units (non-EGUs), established new requirements for these large non-EGUs, included a state-wide NOX emissions cap, and recodified certain other provisions that address the NOX emission reductions required for cement kilns and internal combustion engines. EPA is approving these SIP revisions to West Virginia's ozone season NOX regulation in accordance with the requirements of the Clean Air Act (CAA).

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.