December 17, 2012 – Federal Register Recent Federal Regulation Documents

FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 11 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the operation of the Norfolk Southern V2.8 Railroad Bridge across the Elizabeth River (Eastern Branch), mile 2.7, at Norfolk, VA. This deviation is necessary to facilitate replacing bearings on the Norfolk Southern V2.8 Railroad Bridge. This temporary deviation will allow the drawbridge to remain in the closed-to-navigation position on specific dates and times.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces its intent to prepare an Environmental Impact Statement (EIS) for the proposed 2015-2025 Facilities Master Plan for HHS/CDC's Edward R. Roybal Campus located at 1600 Clifton Road NE., in Atlanta, Georgia. This announcement follows the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR Part 1500-1508); and, the Department of Health and Human Services (HHS) General Administration Manual Part 30 Environmental Procedures, dated February 25, 2000.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.'' The purpose of this document is to provide guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). This document defines several types of enrichment strategies, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials.

Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

APHIS is amending the regulations governing the importation of certain animal embryos and animal semen by removing one of the conditions for the importation of swine semen from the APHIS-defined European CSF region, a region of Europe that we recognize as a single low-risk region for classical swine fever. We have determined that the 40-day holding period for swine semen and donor boars after the collection of swine semen is unnecessary. We are also announcing the addition of Estonia, Hungary, Slovakia, and Slovenia to the APHIS- defined European CSF region, the addition of Estonia, Slovakia, and Slovenia to the list of regions APHIS considers free of swine vesicular disease (SVD), and the addition of Slovakia and Slovenia to the list of regions APHIS considers free of foot-and-mouth disease (FMD) and rinderpest. These actions will relieve some restrictions on the importation into the United States of certain animals and animal products from those regions, while continuing to protect against the introduction of CSF, SVD, FMD, and rinderpest into the United States.

The Department of the Treasury, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 706-D, United States Additional Estate Tax Return Under Code Section 2057.

This document contains amendments to temporary regulations relating to guidance regarding deduction and capitalization of expenditures related to tangible property. These amendments change the applicability dates of the temporary regulations to taxable years beginning on or after January 1, 2014, while permitting taxpayers to choose to apply the temporary regulations for taxable years beginning on or after January 1, 2012. The amendments to the temporary regulations will affect all taxpayers that acquire, produce, or improve tangible property.

In accordance with relevant provisions of the Harmonized Tariff Schedule of the United States (HTS), the Office of the United States Trade Representative (USTR) is providing notice of its determination of the trade surplus in certain sugar and syrup goods and sugar-containing products of Chile, Morocco, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Peru, Colombia, and Panama. As described below, the level of a country's trade surplus in these goods relates to the quantity of sugar and syrup goods and sugar-containing products for which the United States grants preferential tariff treatment under (i) the United States-Chile Free Trade Agreement (Chile FTA); (ii) the United States-Morocco Free Trade Agreement (Morocco FTA); (iii) the Dominican Republic-Central America- United States Free Trade Agreement (CAFTA-DR); (iv) the United States- Peru Trade Promotion Agreement (Peru TPA); (v) the United States- Colombia Trade Promotion Agreement (Colombia TPA), and (vi) the United States-Panama Trade Promotion Agreement (Panama TPA).

Under the provisions of the Paperwork Reduction Act, Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning Accident Prevention Plans and Recordkeeping. A notice was published in the Federal Register at 77 FR 56645 on September 13, 2012. No comments were received. Public comments are particularly invited on: Whether this collection of information is necessary; whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

The Commission announces the next meeting date, time, and agenda of the Open Internet Advisory Committee (Committee). The Committee was established to track and evaluate the effects of the Commission's Open Internet rules, and to provide any recommendations it deems appropriate to the Commission regarding policies and practices related to preserving the open Internet. The Committee will observe market developments regarding the freedom and openness of the Internet and will focus in particular on issues addressed in the Commission's Open Internet rules, such as transparency, reasonable network management practices, differences in treatment of fixed and mobile broadband services, specialized services, and technical standards.

The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (``PRA''), 44 U.S.C. 3501 et seq., Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment. The Commission recently adopted a final rule and interim final rule, as required by the Dodd-Frank Wall Street Reform and Consumer Protection Act (``Dodd-Frank Act''), governing commodity options. That rulemaking includes a requirement that counterparties to unreported trade options must file an annual notice with the Commission on new Form TO. This notice solicits comments on the reporting requirement that would be imposed by Form TO.