November 10, 2014 – Federal Register Recent Federal Regulation Documents

This notice amends the notice of a major disaster declaration for the State of California (FEMA-4193-DR), dated September 11, 2014, and related determinations.

We are advising the public that the Animal and Plant Health Inspection Service has received a petition from the J.R. Simplot Company seeking a determination of nonregulated status for Innate\TM\ Potato designated as Russet Burbank event W8, which has been genetically engineered for late blight resistance, low acrylamide potential, reduced black spot bruising, and lowered reducing sugars. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the J.R. Simplot Company petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that the Animal and Plant Health Inspection Service may determine should be considered in our evaluation of the petition.

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 the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

The Susquehanna River Basin Commission will hold its regular business meeting on December 5, 2014, in Annapolis, Maryland. Details concerning the matters to be addressed at the business meeting are contained in the Supplementary Information section of this notice.

This notice contains a summary of a petition seeking relief from specified requirements of Title 14, Code of Federal Regulations (14 CFR). The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

The Federal Aviation Administration (FAA) is correcting a final rule published in the Federal Register on August 12, 2014, (79 FR 46974). In that rule, the FAA removed a word to address what the agency perceived to be a previous oversight. After publication, and based on information in a petition for rulemaking, the FAA realized that the word should remain. Since the final rule's changes do not become effective until November 10, 2014, this correction will ensure that the word remains in the regulation.

The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act at Title 45 Part 670 of the Code of Federal Regulations. This is the required notice of permit applications received.

We are adopting as a final rule, with changes, an interim rule that amended the brucellosis regulations to, among other things, reduce the amount of testing required to maintain Class Free status for States that have been Class Free for 5 or more years and have no Brucella abortus in wildlife. This document amends the interim rule to change the age at which cattle and domestic bison are included in herd blood tests from 6 months to 18 months of age for all sexually intact cattle and domestic bison, except when conducting herd blood tests as part of affected herd investigations or other epidemiological investigations. In addition, the rule allows certain States the option of either conducting brucellosis ring tests and participating in the slaughter surveillance program or developing an alternative surveillance plan that would have to meet or exceed the level of disease detection provided by combined brucellosis ring testing and slaughter surveillance testing. The rule also makes several minor changes in order to clarify the regulations. These changes are necessary to create flexibility in the brucellosis program, to refocus resources to control and prevent the spread of brucellosis, and to protect and maintain the economic viability of the domestic livestock industry.

This is a notice of an Administrative declaration of a disaster for the Commonwealth of Kentucky dated 10/30/2014. Incident: Severe Storms, Flooding, Landslides, and Mudslides. Incident Period: 08/18/2014 through 08/23/2014.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Armando Santos from providing services in any capacity to a person that has an approved or pending drug product application for a period of 12 years. FDA bases this order on a finding that Mr. Santos was convicted of seven felony counts under Federal law for conduct involving health care fraud, conspiracy to commit health care fraud, and false statements related to health care matters and that this pattern of conduct is sufficient to find that there is reason to believe he may violate requirements under the FD&C Act relating to drug products. Mr. Santos was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Santos failed to respond. Mr. Santos's failure to respond constitutes a waiver of his right to a hearing concerning this action.

The Agricultural Marketing Service (AMS) of the Department of Agriculture (USDA) requests public comments to inform its development of a beef promotion, research, and information order under the Commodity Promotion, Research, and Consumer Information Act of 1996 (1996 Act). This request for comments offers the opportunity for interested individuals and organizations to provide views concerning provisions that would be included in an industry-funded promotion, research, and information program for beef and beef products. The proposed order would be in addition to the existing beef promotion and research program established under the Beef Promotion and Research Act of 1985 (1985 Act). A referendum on an order established under the 1996 Act would be conducted 3 years after assessments begin to determine whether beef producers favor the program and if it should continue. A second referendum would be held within 7 years of the start of the program.

This document contains final regulations under section 312 of the Internal Revenue Code (Code) that clarify the regulations under section 312 regarding the allocation of earnings and profits in tax- free transfers from one corporation to another. These regulations affect corporations involved in these transfers and their shareholders. This document also contains final regulations under section 381 of the Code that modify the definition of an acquiring corporation for purposes of section 381 with regard to certain acquisitions of assets. These regulations affect corporations that acquire the assets of other corporations in corporate reorganizations.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Louisiana State Route 23 (SR 23) vertical lift span bridge, also known as the Judge Perez Bridge, across the Gulf Intracoastal Waterway (Algiers Alternate Route), mile 3.8, at Belle Chasse, Plaquemines Parish, Louisiana. This deviation is necessary to provide for the safe movement of vehicular traffic during major plant reconstruction on one side of the waterway and the resulting change in work schedule and increase in workforce transiting the bridge. This deviation allows the bridge to remain temporarily closed to navigation for an additional one hour in the evening during weekdays for two months.

The EPA is approving the Alaska State Implementation Plan (SIP) as meeting specific infrastructure requirements of the Clean Air Act (CAA) for the National Ambient Air Quality Standards (NAAQS) promulgated for fine particulate matter (PM2.5) on July 18, 1997 and October 17, 2006, and for ozone on March 12, 2008. Whenever a new or revised NAAQS is promulgated, the CAA requires states to submit a plan for the implementation, maintenance and enforcement of such NAAQS. The plan is required to address basic program elements, including but not limited to regulatory structure, monitoring, modeling, legal authority, and adequate resources necessary to implement, maintain, and enforce the standards. These elements are referred to as infrastructure requirements.

On October 30, 2002, the Environmental Protection Agency (EPA) published a direct final rule in the Federal Register approving North Carolina State Implementation Plan (SIP) revisions, submitted through the North Carolina Department of Environment and Natural Resources (NC DENR), Division of Air Quality (DAQ), regarding the State's enhanced inspection and maintenance (I/M) program. This correcting amendment corrects inadvertent errors for two rule titles in the regulatory text of EPA's October 30, 2002, direct final rule.

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 Form 5500 information collection to reflect the hour burden required to implement annual reporting changes for multiple employer plans required by the Cooperative and Small Employer Charity Pension Flexibility Act. A copy of the information collection request (ICR) may be obtained by contacting the office listed in the ADDRESSES section of this notice.

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

The Environmental Protection Agency (EPA) is approving portions of two revisions to the Texas State Implementation Plan (SIP) submitted by the Texas Commission on Environmental Quality (TCEQ) to the EPA on October 5, 2010, and April 16, 2014. Together, these two SIP submittals revise the Texas Prevention of Significant Deterioration (PSD) Program to provide for the regulation of greenhouse gas (GHG) emissions and clarify the applicability of Best Available Control Technology (BACT) for all PSD permit applications. The EPA is approving portions of the October 5, 2010, and April 16, 2014, SIP revisions to the Texas SIP and New Source Review (NSR) permitting program as consistent with federal requirements for PSD permitting of GHG emissions. The EPA is taking no action on the portion of the October 5, 2010, SIP revision which pertains to the Texas Minor NSR program for Qualified Facilities and portions of the April 16, 2014, submittal that appear no longer appropriate for inclusion in the Texas SIP after the recent United States Supreme Court decision discussing greenhouse gas emissions. The EPA is approving this action under Section 110 and Part C of the Clean Air Act (CAA). In a separate but simultaneous action published elsewhere in this issue of the Federal Register, the EPA is also rescinding the GHG PSD Federal Implementation Plan (FIP) for Texas, with three limited circumstances for retained authority.