January 2013 – Federal Register Recent Federal Regulation Documents

This notice is to advise interested parties of cost-sharing rate change for the Pharmacy Benefits Program.

The Food and Drug Administration (FDA) is announcing a public conference entitled ``Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What Should We Do About It?'' This conference will be cosponsored with the Critical Path Institute (C-Path) and the Pharmaceutical Research and Manufacturers of America. Its purpose is to discuss, debate, and build consensus among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling.'' This guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence variants, could affect a drug's pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety. The guidance provides recommendations on when and how genomic principles should be considered and applied in early-phase clinical studies to address questions arising during drug development and regulatory review.

The Coast Guard is extending the temporary safety zone established on the waters of the Atlantic Intracoastal Waterway at Oak Island, North Carolina. The safety zone is necessary to provide for the safety of mariners on navigable waters during maintenance on the NC 133 Fixed Bridge crossing the Atlantic Intracoastal Waterway, mile 311.8, at Oak Island, North Carolina. The safety zone extension will temporarily restrict vessel movement within the designated area starting on February 14, 2013 through June 15, 2013.

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.

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.

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).

This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/fema/csb.shtm.

Over the past three years, PHMSA has made a number of amendments to pipeline data regulations and reporting forms for gas, hazardous liquids, and liquefied natural gas (LNG) operators. Most recently, on December 5, 2012, the Office of Management and Budget approved revisions to the gas transmission and gathering annual report. Based on the significant changes to the gas transmission and gathering annual report, PHMSA is extending the filing deadline for calendar year 2012 data from March 15, 2013, to June 15, 2013. In addition, certain operators with Operator Identification Numbers (OPID) established prior to January 1, 2011, are required to validate their OPID data before June 30, 2012. PHMSA has determined that a number of operators have not completed their OPID data validations. Therefore, PHMSA is using this notice to remind operators to validate their OPID data. PHMSA has also noticed that annual reports submitted by gas transmission and LNG operators contain data that conflicts with other required reports submitted to PHMSA. Operators should review their annual report data to ensure it is accurate and submit supplemental reports to correct errors.

The Office of Competition and Economic Analysis (``OCEA'') of the International Trade Administration, Department of Commerce, has received an application to amend an Export Trade Certificate of Review (``Certificate''). This notice summarizes the proposed amendment and requests comments relevant to whether the amended Certificate should be issued.

Seven Technical Advisory Committees (TACs) advise the Department of Commerce on the technical parameters for export controls applicable to dual-use commodities and technology and on the administration of those controls. The TACs are composed of representatives from industry representatives, academic leaders and U.S. Government representing diverse points of view on the concerns of the exporting community. Industry representatives are selected from firms producing a broad range of goods, technologies, and software presently controlled for national security, non-proliferation, foreign policy, and short supply reasons or that are proposed for such controls, balanced to the extent possible among large and small firms. TAC members are appointed by the Secretary of Commerce and serve terms of not more than four consecutive years. The membership reflects the Department's commitment to attaining balance and diversity. TAC members must obtain secret-level clearances prior to appointment. These clearances are necessary so that members may be permitted access to the classified information needed to formulate recommendations to the Department of Commerce. Each TAC meets approximately four times per year. Members of the Committees will not be compensated for their services. The seven TACs are responsible for advising the Department of Commerce on the technical parameters for export controls and the administration of those controls within the following areas: Information Systems TAC: Control List Categories 3 (electronics), 4 (computers), and 5 (telecommunications and information security); Materials TAC: Control List Category 1 (materials, chemicals, microorganisms, and toxins); Materials Processing Equipment TAC: Control List Category 2 (materials processing); Regulations and Procedures TAC: The Export Administration Regulations (EAR) and Procedures for implementing the EAR; Sensors and Instrumentation TAC: Control List Category 6 (sensors and lasers); Transportation and Related Equipment TAC: Control List Categories 7 (navigation and avionics), 8 (marine), and 9 (propulsion systems, space vehicles, and related equipment) and the Emerging Technology and Research Advisory Committee: (1) The identification of emerging technologies and research and development activities that may be of interest from a dual-use perspective; (2) the prioritization of new and existing controls to determine which are of greatest consequence to national security; (3) the potential impact of dual-use export control requirements on research activities; and (4) the threat to national security posed by the unauthorized exports of technologies. To respond to this recruitment notice, please send a copy of your resume to Ms. Yvette Springer at Yvette.Springer@bis.doc.gov. Deadline: This Notice of Recruitment will be open for one year from its date of publication in the Federal Register.

In this document, the Wireline Competition Bureau releases for discussion a number of virtual workshop topics related to the development and adoption of the forward-looking cost model for Connect America Phase II.

In accordance with Section 122(i)(1) of the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended (CERCLA), 42 U.S.C. 9622(i) and Section 7003(d) of the Resource Conservation and Recovery Act, as amended (RCRA), 42 U.S.C. 6973, notice is hereby given of a proposed administrative settlement with 47 de minimis settling parties for recovery of response costs concerning the Operating Industries, Inc. Superfund Site in Monterey Park, California. The settlement is entered into pursuant to Section 122(g) of CERCLA, 42 U.S.C. 9622(g) and it requires the settling parties to pay $1,624,928 to the United States Environmental Protection Agency (Agency). The settlement includes a covenant not to sue the settling parties pursuant to Sections 106 or 107(a) of CERCLA, 42 U.S.C. 9606 or 9607(a), and Section 7003(d) of RCRA, 42 U.S.C. 6973. For thirty (30) days following the date of publication of this Notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at 75 Hawthorne Street, San Francisco, CA 94105.

Section 1525 of the Moving Ahead for Progress in the 21st Century Act (MAP-21) requires the Secretary of Transportation to modify FHWA regulations to ensure that States shall have the autonomy to determine culvert and storm sewer material types to be included in the construction of a project on a Federal-aid highway. This final rule is intended to implement this legislative requirement.

The Department of Justice (the Department) proposes three amendments to part 25 of title 28 of the Code of Federal Regulations. These proposed changes are intended to promote public safety, to enhance the efficiency of the National Instant Criminal Background Check System (NICS) operations, and to resolve difficulties created by unforeseen processing conflicts within the system. The proposed amendments are for the following purposes: to add tribal criminal justice agencies to those entities authorized to receive information in connection with the issuance of a firearm-related permit or license; to authorize access for criminal justice agencies to the FBI-maintained NICS Index to permit background checks for the purpose of disposing of firearms in the possession of those agencies; and to permit NICS to retain in a separate database its Audit Log records relating to denied transactions beyond 10 years, rather than transferring them to a Federal Records Center for storage.

Pursuant to the Order of the Binational Panel dated December 18, 2012, the panel review was completed on January 18, 2013.

We are adopting a new airworthiness directive (AD) for CFM International, S.A. CFM56-3, CFM56-3B, and CFM56-3C turbofan engines. This AD requires removal from service of certain high-pressure turbine (HPT) disks manufactured by Global Material Solutions of Pratt & Whitney, at reduced maximum life limits. This AD was prompted by a report of a forging process error during manufacture of these HPT disks. We are issuing this AD to prevent uncontained release of multiple turbine blades, damage to the engine, and damage to the airplane.