2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry'' dated December 2014. The draft guidance document provides sponsors, clinicians, and other establishments that manufacture and use adipose tissue, with recommendations for complying with the regulatory framework for HCT/Ps. For purposes of applying the HCT/P regulatory framework, FDA considers connective tissue, including adipose tissue, to be a structural tissue. This draft guidance is not final nor is it in effect at this time.

We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-300, 747-400, 747-400D, and 747SR series airplanes. This AD was prompted by a report of a cracked reveal made from a casting found within a group of airplanes that should have machined reveals made only from 6061 aluminum. This AD requires an inspection to determine the material of the number 3 main entry door (MED) corner reveal, repetitive inspections of certain reveals for cracking, and corrective action if necessary. This AD also requires repetitive inspections for cracking of 6061 machined aluminum one-piece corner reveals, and replacement with 6061 machined aluminum two-piece corner reveals if necessary, which terminates certain repetitive inspections. We are issuing this AD to detect and correct fatigue cracking of the lower forward corner reveal of the number 3 MEDs, which could lead to the door escape slide departing the airplane when the door is opened and the slide is deployed, and consequent injuries to passengers and crew using the door escape slide during an emergency evacuation.

This rule maintains the rail equipment accident/incident monetary reporting threshold at $10,500 for railroad accidents/ incidents involving property damage that occur during calendar year (CY) 2015 that FRA's accident/incident reporting regulations require to be reported to the agency. FRA is maintaining the reporting threshold at the CY 2014 level because, in part, wage data for the second-quarter of 2014, (the data used to calculate the threshold) was abnormally high due to retroactive payment of wage increases resulting from labor contract agreements affecting several railroads. FRA believes that the data does not accurately reflect the changes in labor costs for the second-quarter of 2014 and leads to an overinflated threshold calculation for CY 2015. In addition, FRA is maintaining the monetary threshold for CY 2015 at the CY 2014 level while it reexamines the method for calculating the monetary threshold it last updated in 2005.

The Coast Guard proposes to amend its safety zones regulations for Annual Events in the Captain of the Port Lake Michigan zone. This proposed amendment updates 18 permanent safety zones, adds 5 new permanent safety zones, and reformats the coordinates for safety zones. These amendments and additions are necessary to protect spectators, participants, and vessels from the hazards associated with annual maritime events, including fireworks displays, boat races, and air shows, and improves the precision and compatibility of safety zone coordinates.

We are adopting a new airworthiness directive (AD) for Alpha Aviation Concept Limited Model R2160 airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as paint adherence defects inside the engine air intake box and cohesion defects inside the laminated ducting from the filter to the air intake box. We are issuing this AD to require actions to address the unsafe condition on these products.

The OCC, Board, FDIC, Commission, FHFA, and HUD (the agencies) are adopting a joint final rule (the rule, or the final rule) to implement the credit risk retention requirements of section 15G of the Securities Exchange Act of 1934, as added by section 941 of the Dodd- Frank Wall Street Reform and Consumer Protection Act (the Act or Dodd- Frank Act). Section 15G generally requires the securitizer of asset- backed securities to retain not less than 5 percent of the credit risk of the assets collateralizing the asset-backed securities. Section 15G includes a variety of exemptions from these requirements, including an exemption for asset-backed securities that are collateralized exclusively by residential mortgages that qualify as ``qualified residential mortgages,'' as such term is defined by the agencies by rule.

EPA is revising the regulations that pertain to the labeling of pesticide products and devices that are intended solely for export. Pesticide products and devices intended solely for export will be able to meet the Agency's export labeling requirements by attaching a label to the immediate product container or by providing collateral labeling that is either attached to the immediate product being exported or that accompanies the shipping container of the product being exported at all times when it is shipped or held for shipment in the United States. Collateral labeling will ensure the availability of the required labeling information, while allowing pesticide products and devices that are intended solely for export to be labeled for use in, and consistent with the applicable requirements of the importing country.

The Federal Deposit Insurance Corporation (``FDIC'') is adopting a final rule to rescind and remove regulations entitled ``Loans in Areas Having Flood Hazards'' and to amend regulations entitled ``Loans in Areas Having Flood Hazards.'' The final rule will integrate the flood insurance regulations for State nonmember banks and State savings associations in accordance with the requirements of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the ``Dodd- Frank Act''). The integration of the regulations was originally proposed as part of an interagency joint notice of proposed rulemaking issued in October 2013 pursuant to the Biggert-Waters Flood Insurance Reform Act of 2012 (the BW Act). The FDIC has decided to integrate the flood insurance regulations by means of an individual final rule.

We announce our intention to establish a negotiated rulemaking committee to prepare proposed regulations governing the William D. Ford Federal Direct Loan (Federal Direct Loan) Program authorized under title IV of the Higher Education Act of 1965, as amended (HEA). The committee will include representatives of organizations or groups with interests that are significantly affected by the topics proposed for negotiations. We request nominations for individual negotiators who represent key stakeholder constituencies for the issues to be negotiated to serve on the committee, and we set a schedule for committee meetings.

This document contains corrections to DFARS final rule 2015- D001, Elimination of Quarterly Reporting of Actual Performance Outside the United States, which was published Thursday, December 11, 2014 (79 FR 73499). The rule that is the subject of this correction eliminates the requirement for quarterly reporting of actual contract performance outside the United States contained at DFARS clause 252.225-7006.

On December 12, 2014, pursuant to authority delegated to the Director, Office of Energy Policy and Innovation, a data request was issued to each ISO and RTO regarding the effect on the reliable and efficient operations of natural gas-fired generators of the current 9 a.m. CCT start to the Gas Day. The requests seek data from the ISOs/ RTOs with respect to derates by natural gas generators during the morning ramp period.

The Deputy Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule three synthetic cannabinoids into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. The substances are: N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H- indazole-3-carboxamide (common name: AB-CHMINACA), N-(1-amino-3-methyl- 1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (common name: AB- PINACA) and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- yl)methanone (common name: THJ-2201). This action is based on a finding by the Deputy Administrator that the placement of these synthetic cannabinoids into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I substances under the CSA on the manufacture, distribution, possession, importation, exportation, research, and conduct of instructional activities of these synthetic cannabinoids.

In this document, the Commission proposes to amend its rules governing broadcast licensee-conducted contests (the ``Contest Rule'') in a manner that reflects how consumers access information in the 21st Century. This document proposes to amend the Contest Rule by, among other things, allowing licensees to comply with their obligation to disclose material contest terms either through broadcast announcements or by making such terms available in writing on a publicly accessible Internet Web site. In addition, the Commission proposes to adopt rules that would define the disclosure obligation in cases where a station chooses to meet that obligation through an Internet Web site.

This proposed rule would update the Tribal Transportation Program regulations (formerly the Indian Reservation Roads Program) to comply with the current surface transportation authorization, Moving Ahead for Progress in the 21st Century, as extended, reflect changes in the delivery options for the program that have occurred since the regulation was published in 2004, remove certain sections that were provided for informational purposes only, and make technical corrections.

The Energy Policy and Conservation Act of 1975 (EPCA), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including residential dishwashers. EPCA also requires the U.S. Department of Energy (DOE) to determine whether amended standards would be technologically feasible and economically justified, and would save a significant amount of energy. In this notice, DOE proposes amended energy conservation standards for residential dishwashers. The notice also announces a public meeting to receive comment on these proposed standards and associated analyses and results.

This joint interim final rule implements for all Federal award-making agencies the final guidance Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) published by the Office of Management and Budget (OMB) on December 26, 2013. This rule is necessary in order to incorporate into regulation and thus bring into effect the Uniform Guidance as required by OMB. Implementation of this guidance will reduce administrative burden and risk of waste, fraud, and abuse for the approximately $600 billion per year awarded in Federal financial assistance. The result will be more Federal dollars reprogrammed to support the mission, new entities able to compete and win awards, and ultimately a stronger framework to provide key services to American citizens and support the basic research that underpins the United States economy.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Jackson Street Drawbridge across the Red River, mile 88.6, at Alexandria, Louisiana. The deviation is necessary to allow the bridge owner to install four new pinion gears that are essential to the continued safe operation of the drawbridge. This deviation allows the bridge to remain in the closed-to-navigation position and not open to vessel traffic.

This document contains final rules that would amend the regulations of the Susquehanna River Basin Commission (Commission) to clarify the water uses involved in hydrocarbon development that are subject to the consumptive use regulations, as implemented by the Approval by Rule (ABR) program.

The Commission announces its disposition of a Petition for Rulemaking (``Petition'') filed on August 28, 2014, by National Convention PBC. The Petition asks the Commission to amend 11 CFR 100.4 to revise the definition of ``federal office'' to include delegates to a constitutional convention. The Commission has decided not to initiate a rulemaking at this time. The Petition and other documents relating to this matter are available on the Commission's Web site, https:// www.fec.gov/fosers/, and in the Commission's Public Records Office.

The Wireless Telecommunications Bureau extends the deadline for filing comments and reply comments on its Competitive Bidding Notice of Proposed Rulemaking (Competitive Bidding NPRM), which sought comment on the revision of certain part 1 competitive bidding rules and provided notice of the Commission's intention to resolve longstanding petitions for reconsideration.

The Environmental Protection Agency (EPA) is taking direct final action to approve a submission by the State of Indiana as a revision to the Indiana State Implementation Plan (SIP). The submitted regulations revise Indiana's ambient air quality standards for ozone and particulate matter (PM) to be consistent with EPA's 2008 ozone and 2012 fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS). EPA is therefore approving this SIP submission, in accordance with the requirements of the Clean Air Act (CAA).

NMFS issues a final rule under authority of the Magnuson- Stevens Fishery Conservation and Management Act (MSA) to implement Amendment 18 to the Pacific Coast Salmon Fishery Management Plan for Commercial and Recreational Salmon Fisheries off the Coasts of Washington, Oregon, and California (FMP). Amendment 18 revises the description and identification of essential fish habitat (EFH) for Pacific salmon managed under the FMP, designates habitat areas of particular concern (HAPCs), updates information on fishing activities, and updates the list of non-fishing related activities that may adversely affect EFH and potential conservation and enhancement measures to minimize those effects. NMFS approved Amendment 18 on September 12, 2014.

The FAA proposes to amend certain airworthiness regulations for transport category airplanes regarding lightning protection of fuel tanks and systems. This action would establish design requirements for both normal conditions and possible failures of fuel tank structure and systems that could lead to fuel tank explosions, add new maintenance requirements related to lightning protection features, and impose specific requirements for airworthiness limitations in the instructions for continued airworthiness. We would create performance-based standards for prevention of catastrophic fuel vapor ignition caused by lightning by regulating the risk due to both ignition sources and fuel tank flammability. This change would allow designers to take advantage of flammability reduction technologies whose effectiveness was not foreseen when earlier revisions to these rules were written. This change would also relieve some of the administrative burdens created by the current regulations. These proposed amendments are based on recommendations from the Large Airplane Fuel System Lightning Protection Aviation Rulemaking Committee (Lightning ARC).

The Board of Governors of the Federal Reserve System (Board) is inviting public comment on a framework to establish risk-based capital surcharges for the largest, most interconnected U.S.-based bank holding companies pursuant to section 165 of the Dodd-Frank Wall Street Reform and Consumer Protection Act. The proposal is based upon the international standard adopted by the Basel Committee on Banking Supervision, modified to reflect systemic risk concerns specific to the funding structures of large U.S. bank holding companies. The proposed framework would require a U.S. top-tier bank holding company with $50 billion or more in total consolidated assets to calculate a measure of its systemic importance and would identify a subset of those companies as global systemically important bank holding companies based on that measure. A global systemically important bank holding company would be subject to a risk-based capital surcharge that would increase its capital conservation buffer under the Board's regulatory capital rule. The proposed framework would be phased in beginning on January 1, 2016 through year-end 2018, becoming fully effective on January 1, 2019. The proposal would also revise the terminology used to identify the firms subject to the enhanced supplementary leverage ratio standards to ensure consistency of the scopes of application of both rulemakings.

The Office of the Comptroller of the Currency (OCC), the Board of Governors of the Federal Reserve System (Board), and the Federal Deposit Insurance Corporation (FDIC) (collectively, the agencies) are seeking comment on an NPR that would clarify, correct, and update aspects of the agencies' regulatory capital rule applicable to banking organizations that are subject to the advanced approaches risk-based capital rule (advanced approaches banking organizations). The proposed revisions are largely driven by observations made by the agencies during the parallel-run review process of advanced approaches banking organizations. They are also intended to enhance consistency of the U.S. regulations with international standards for use of the advanced approaches rule.