July 19, 2018 – Federal Register Recent Federal Regulation Documents

The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans that are final. The actions relate to a proposed highway project, the State Route 1 (SR 1) Lagunitas Creek Bridge Project from post miles 28.4 to 28.6 on SR 1 in the County of Marin, State of California. Those actions grant licenses, permits, and approvals for the project.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, OGE seeks comment on the development of a Generic Information Collection Request for the collection of qualitative feedback on agency service delivery for approval under the Paperwork Reduction Act. This notice announces OGE's intent to submit this collection to the Office of Management and Budget for approval and allows for an additional 30 days of public comment.

The Department of Commerce is currently seeking applications from travel and tourism leaders from specific industries for membership on the Board of Directors (Board) of the Corporation for Travel Promotion (doing business as Brand USA). The purpose of the Board is to guide the Corporation for Travel Promotion on matters relating to the promotion of the United States as a travel destination and communication of travel facilitation issues, among other tasks.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Nevada Advisory Committee (Committee) to the Commission will be held at 1:00 p.m. (Pacific Time) Thursday, July 26, 2018, the purpose of the meeting is for the Committee to continue planning for August 9, 2018 briefing on policing practices in Nevada.

FinCEN invites comment on the renewal of information collections in existing regulations requiring insurance companies and non-bank residential mortgage lenders and originators to develop and implement written anti-money laundering programs reasonably designed to prevent those financial institutions from being used to facilitate money laundering and the financing of terrorist activities. This request for comments is being made pursuant to the Paperwork Reduction Act (``PRA'') of 1995.

As part of its continuing effort to reduce paperwork and respondent burden, FinCEN invites comment on a renewal without change to a currently approved information collection contained in 31 CFR 1022.380 and the Registration of Money Services Business report, FinCEN Form 107. The form will be used by currency dealers or exchangers; check cashers; issuers of traveler's checks, money orders or prepaid access; sellers of traveler's checks, money orders or prepaid access; redeemers of traveler's checks, money orders or prepaid access; and money transmitters to register with the Department of the Treasury as required by statute. This request for comments is being made pursuant to the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. 3506(c)(2)(A).

This is a notice of the Presidential declaration of a major disaster for the State of Maryland (FEMA-4374-DR), dated June 25, 2018, and related determinations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``E17 General Principles for Planning and Design of Multiregional Clinical Trials.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance describes general principles for planning and designing multiregional clinical trials (MRCTs). The guidance is intended to increase the acceptability of data from MRCTs as the primary source of evidence supporting marketing approval in global regulatory submissions and thereby facilitate more efficient drug development and earlier access to medicines.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that EPIDIOLEX (cannabidiol oral solution) manufactured by GW Research Ltd., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Labeling for Biosimilar Products.'' This guidance is intended to help applicants develop draft labeling for proposed biosimilar products. The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for certain recommendations pertaining to FDA- approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). This guidance provides an overview of FDA's recommendations for labeling for biosimilar products. This guidance finalizes the draft guidance issued on April 4, 2016.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Field Alert Report Submission: Questions and Answers.'' This draft guidance, when finalized, will provide the Agency's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and will outline FDA's recommendations for FAR submissions to help increase their consistency and relevancy. The draft guidance also addresses certain frequently asked questions about FARs.

Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.

New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.

Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Federal Council on the Arts and the Humanities will hold a meeting of the Arts and Artifacts Domestic Indemnity Panel.

This is a notice of the Presidential declaration of a major disaster for the State of Oklahoma (FEMA-4373-DR), dated June 25, 2018, and related determinations.