May 1, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 27, 2014 (79 FR 17156). The document announced an opportunity to request a hearing on the Agency's proposal to withdraw approval of abbreviated new drug applications (ANDAs) from multiple sponsors. The document incorrectly stated that the approval of ANDAs 40825, 40822, and 40824, held by Ranbaxy Laboratories Inc. and Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540, and ANDA 40182, held by Pharmaceutical Associates, Inc., 201 Delaware St., Greenville, SC 29605, had not been voluntarily withdrawn. FDA confirms that the approval of ANDAs 40825, 40824, 40822, and 40182 has been voluntarily withdrawn.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Providing Information about Pediatric Uses of Medical Devices.'' FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Coast Guard proposes to amend its safety zones regulations for annually reoccurring firework displays and marine events within the Captain of the Port Zone Buffalo. The safety zones that would be amended or established by this proposed rulemaking are necessary to protect the surrounding public, spectators, participants, and vessels from the hazards associated with fireworks displays, hydroplane boat races, and other events of a similar nature posing a potential hazard to the safety of life and property on the navigable waters. This proposed rule is intended to restrict vessels from designated areas on navigable waterways during these events.

This proposed rule would delete a provision in the Department of the Interior's land-into-trust regulations that excludes from the scope of the regulations, with one exception, land acquisitions in trust in the State of Alaska.

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 a notice of proposed rulemaking (proposed rule) that would revise the definition of eligible guarantee as incorporated into the agencies' advanced approaches risk-based capital rule, adopted in the agencies' July 2013 regulatory capital rule (2013 capital rule). The agencies inadvertently limited the recognition of guarantees of wholesale exposures under the advanced approaches risk-based capital rule as incorporated into subpart E of the 2013 capital rule (advanced approaches). To address this matter, the proposed rule would remove the requirement that an eligible guarantee be made by an eligible guarantor for purposes of calculating the risk-weighted assets of an exposure (other than a securitization exposure) under the advanced approaches. The proposed change to the definition of eligible guarantee would apply to all banks, savings associations, bank holding companies, and savings and loan holding companies that are subject to the advanced approaches.

We are adopting a new airworthiness directive (AD) for certain M7 Aerospace LLC Models SA26-T, SA26-AT, SA226-AT, SA226-T, SA226-T(B), SA226-TC, SA227-AC (C-26A), SA227-AT, SA227-TT, SA227-BC (C-26A), SA227-CC, and SA227-DC (C-26B) airplanes. This AD was prompted by reports of jamming of the aileron control cable chain in the pilot and copilot control columns due to inadequate lubrication and maintenance of the chain. This AD requires repetitively replacing and lubricating the aileron chain, sprocket, and bearings in the control columns. We are issuing this AD to correct the unsafe condition on these products.

We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 777F series airplanes. This AD was prompted by a report of a fire that originated near the first officer's seat and caused extensive damage to the flight deck. This AD requires replacing the low-pressure oxygen hoses with non-conductive low-pressure oxygen hoses in the stowage box and supernumerary ceiling area. We are issuing this AD to prevent electrical current from passing through an internal, anti-collapse spring of the low-pressure oxygen hose, which can cause the low-pressure oxygen hose to melt or burn and lead to an oxygen-fed fire near the flight deck.

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 issuing a notice of proposed rulemaking (proposed rule) that would revise the denominator of the supplementary leverage ratio (total leverage exposure) that the agencies adopted in July 2013 as part of comprehensive revisions to the agencies' regulatory capital rules (2013 revised capital rule). Specifically, the proposed rule would revise the treatment of on- and off-balance sheet exposures for purposes of determining total leverage exposure, and more closely align the agencies' rules on the calculation of total leverage exposure with international leverage ratio standards. The proposed rule would incorporate in total leverage exposure the effective notional principal amount of credit derivatives and other similar instruments through which a banking organization provides credit protection (sold credit protection), modify the calculation of total leverage exposure for derivatives and repo-style transactions, and revise the credit conversion factors (CCFs) applied to certain off- balance sheet exposures. The proposed rule also would make changes to the methodology for calculating the supplementary leverage ratio and to the public disclosure requirements for the supplementary leverage ratio. The proposed rule would apply to all banks, savings associations, bank holding companies, and savings and loan holding companies (banking organizations) that are subject to the agencies' advanced approaches risk-based capital rules (advanced approaches banking organizations), as defined in the 2013 revised capital rule, including advanced approaches banking organizations that are subject to the enhanced supplementary leverage ratio standards that the agencies have adopted in final form and published elsewhere in today's Federal Register (the eSLR standards). Consistent with the 2013 revised capital rule, advanced approaches banking organizations will be required to disclose their supplementary leverage ratios beginning January 1, 2015, and will be required to comply with a minimum supplementary leverage ratio capital requirement of 3 percent and, as applicable, the eSLR standards beginning January 1, 2018. The agencies are seeking comment on all aspects of the proposed rule.

This document amends the Commission rules governing the operation of unlicensed National Information Infrastructure (U-NII) devices in the 5 GHz band to make broadband technologies more widely available for consumers and businesses by increasing power and permitting outdoor use in the U-NII-1 band and by adding 25 megahertz to the U-NII-3 band; it also takes steps to reduce the potential for harmful interference to incumbent operations. The proceeding satisfies the requirements of the Spectrum Act, by which Congress required that the Commission begin a proceeding regarding U-NII devices in the 5 GHz band within a year if it determined, after consultation with NTIA, that incumbents will be protected and their missions will not be compromised.

We are superseding Airworthiness Directive (AD) 2000-11-06 for certain The Boeing Company Model 767 airplanes. AD 2000-11-06 required repetitive inspections to detect discrepancies of the wiring and surrounding Teflon sleeves of the fuel tank boost pumps and override/ jettison pumps; replacement of the sleeves with new sleeves, for certain airplanes; and repair or replacement of the wiring and sleeves with new parts, as necessary. This new AD requires reducing the initial compliance time and repetitive inspection interval in AD 2000-11-06; mandates a terminating action for the repetitive inspections to eliminate wire damage; removes certain airplanes from the applicability; and requires revising the maintenance program to incorporate changes to the airworthiness limitations section. This AD was prompted by fleet information indicating that the repetitive inspection interval in AD 2000-11-06 is too long, because excessive chafing of the sleeving continues to occur much earlier than expected between scheduled inspections. We are issuing this AD to detect and correct chafing of the fuel pump wire insulation and consequent exposure of the electrical conductor, which could result in electrical arcing between the wires and conduit and consequent fire or explosion of the fuel tank.