December 11, 2014 – Federal Register Recent Federal Regulation Documents

FMCSA announces its decision to grant requests from 5 individuals for exemptions from the regulatory requirement that interstate commercial motor vehicle (CMV) drivers have ``no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.'' The regulation and the associated advisory criteria published in the Code of Federal Regulations as the ``Instructions for Performing and Recording Physical Examinations'' have resulted in numerous drivers being prohibited from operating CMVs in interstate commerce based on the fact that they have had one or more seizures and are taking anti-seizure medication, rather than an individual analysis of their circumstances by a qualified medical examiner. The Agency concluded that granting exemptions for these CMV drivers will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions. FMCSA grants exemptions that will allow these 5 individuals to operate CMVs in interstate commerce for a 2-year period. The exemptions preempt State laws and regulations and may be renewed.

FMCSA announces its decision to grant requests from 9 individuals for exemptions from the regulatory requirement that interstate commercial motor vehicle (CMV) drivers have ``no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.'' The regulation and the associated advisory criteria published in the Code of Federal Regulations as the ``Instructions for Performing and Recording Physical Examinations'' have resulted in numerous drivers being prohibited from operating CMVs in interstate commerce based on the fact that they have had one or more seizures and are taking anti-seizure medication, rather than an individual analysis of their circumstances by a qualified medical examiner. The Agency concluded that granting exemptions for these CMV drivers will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions. FMCSA grants exemptions that will allow these 9 individuals to operate CMVs in interstate commerce for a 2-year period. The exemptions preempt State laws and regulations and may be renewed.

FMCSA announces its decision to renew the exemptions from the Epilepsy and Seizure Disorders requirement in the Federal Motor Carrier Safety Regulations for 9 individuals. FMCSA has statutory authority to exempt individuals from the Epilepsy and Seizure Disorders 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 Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey entitled, ``Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types (2013-2022).''

On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), pursuant to 5 CFR 1320.16, to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board under conditions set forth in 5 CFR part 1320 Appendix A.1. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Department of Labor (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the reporting burden on the public and helps the public understand the Department's information collection requirements and provide the requested data in the desired format. Currently, the Employee Benefits Security Administration is soliciting comments on the revision of the Coverage of Certain Preventive Services Under the Affordable Care Act information collection to reflect the new option of notifying the Department of Health and Human Services of the respondents' objections to providing coverage in response to the Supreme Court of the United States' interim order in connection with an application for an injunction in the pending case of Wheaton College v. Burwell. A copy of the information collection request (ICR) may be obtained by contacting the office listed in the ADDRESSES section of this notice.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment. This notice solicits comments on the information collection provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to make technical corrections, including adding three inadvertently omitted addenda to Section XI, ``Rules for Inservice Inspection of Nuclear Reactor Coolant Systems,'' of the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel (B&PV) Code to the list of documents approved for incorporation by reference; and correcting a footnote number. This final rule is necessary to inform the public of these non-substantive changes to the NRC's regulations.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Budesonide Extended-Release Tablets.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for budesonide extended-release tablets.

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 Environmental Protection Agency (EPA), Region 5 is issuing a Notice of Intent to Delete the Belvidere Municipal Landfill Superfund Site (Site) located in Belvidere, Illinois from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is found at Appendix B of 40 CFR part 300 which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Illinois, through the Illinois Environmental Protection Agency (IEPA), have determined that all appropriate response actions under CERCLA, other than operation, maintenance, and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.

The Commission is noticing a recent Postal Service filing concerning an additional Foreign Postal Operators 1 negotiated service agreement with Royal PostNL BV. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-4023, ``Aquatic Environmental Studies for Nuclear Power Stations.'' This DG provides technical guidance for aquatic environmental studies and analyses supporting decisions related to nuclear power stations by NRC regarding major Federal actions and compliance with the National Environmental Policy Act of 1969.

On January 30, 2014, FEMA published in the Federal Register a proposed flood hazard determination notice at 79 FR 4950 that contained a table which included a Web page address through which the Preliminary Flood Insurance Rate Map (FIRM), and where applicable, the Flood Insurance Study (FIS) report for the communities listed in the table could be accessed. The information available through the Web page address has subsequently been updated. The table provided here represents the proposed flood hazard determinations and communities affected for King and Queen County, Virginia, and Incorporated Areas.

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.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public webinar ``Reverse Toxicokinetics: Using In Vitro Data to Estimate Exposures that Could Be Associated with Adverse Effects In Vivo.'' The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation Alternative Toxicological Methods (NICEATM) and hosted by the Environmental Protection Agency's National Center for Computational Toxicology (NCCT). Interested persons may participate via Adobe[supreg] ConnectTM. Time is allotted for questions from participants.

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.