2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the drug products have been withdrawn or removed from the market after the drug products or components of such drug products were found to be unsafe or not effective. Specifically, the proposed rule would add 25 drug products to this list of drug products and modify the description of one drug product on this list to add an exception. These revisions are necessary because new information has come to the Agency's attention since March 8, 1999, when FDA published the original list as a final rule. FDA is also withdrawing the previous proposed rule regarding additions to this list (see the Federal Register of January 4, 2000).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April and May 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to remove an obsolete entry for a drug for which approval was withdrawn in 1996.

The Food and Drug Administration (FDA) is withdrawing approval of those parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for growth promotion indications in swine. This action is being taken at the sponsor's request because the three-way Type A medicated article is no longer manufactured.

We propose to supersede Airworthiness Directive (AD) 2013-24- 13, which applies to certain The Boeing Company Model 737-100, -200, - 200C, -300, -400, -500, -600, -700, -700C, -800, and -900 series airplanes. AD 2013-24-13 currently requires replacing the pivot link assembly for certain airplanes, replacing the seat track link assemblies or modifying the existing seat track link assembly for certain airplanes, or modifying the existing seat track link assembly fastener for certain airplanes. AD 2013-24-13 also requires inspecting, changing, or repairing the seat track link assembly for certain other airplanes. Since we issued AD 2013-24-13, a paragraph reference was found to be mis-identified. This proposed AD would correct this paragraph reference. We are proposing this AD to prevent seat detachment in an emergency landing, which could cause injury to occupants of the passenger compartment and affect emergency egress.

The Environmental Protection Agency (EPA) is proposing amendments to the national emission standards for hazardous air pollutants (NESHAP) for off-site waste and recovery operations (OSWRO) to address the results of the residual risk and technology review (RTR) conducted under the Clean Air Act (CAA). In light of our residual risk and technology review, we are proposing to amend the requirements for leak detection and repair and the requirements for certain tanks. In addition, the EPA is proposing amendments to revise regulatory provisions pertaining to emissions during periods of startup, shutdown and malfunction; add requirements for electronic reporting of performance test results; revise the routine maintenance provisions; clarify provisions pertaining to open-ended valves and lines; add monitoring requirements for pressure relief devices; clarify provisions for some performance test methods and procedures; and make several minor clarifications and corrections.

The Environmental Protection Agency (EPA) is issuing this Notice of Data Availability (NODA) in support of the proposed rule titled, ``Standards of Performance for New Residential Wood Heaters, New Residential Hydronic Heaters and Forced-Air Furnaces, and New Residential Masonry Heaters'' that was published on February 3, 2014. Through this NODA, the EPA is making available to the public, and soliciting comment on, the specific additional information on residential wood heater testing and certification that has been added to the docket for the proposed rule. This comment period is limited to comments on the specific data added and issues that relate to this data; it is not an additional period to comment on other aspects of this proposed rule.

This document contains corrections to final and temporary regulations (TD 9657), which were published in the Federal Register on Thursday, March 6, 2014 (79 FR 12812). The regulations relate to information reporting by foreign financial institutions (FFIs) with respect to U.S. accounts and withholding on certain payments to FFIs and other foreign entities.

The Coast Guard is establishing a safety zone on the Atlantic Ocean near Ocean City, NJ, from 9:10 p.m. to 10:20 p.m. on July 16, 2014 with a rain date scheduled for July 17, 2014. The safety zone will restrict vessel traffic in the North Atlantic Ocean within a 500 yard radius of a fireworks barge located at position 39-16.22 N, 074-33.54 W. This safety zone is necessary to protect the surrounding public and vessels from the hazards associated with a fireworks display. This regulation is necessary to provide for the safety of life on the navigable waters of the North Atlantic Ocean. This safety zone is intended to restrict vessel traffic movement to ensure the safety of the surrounding public and vessels.

The Coast Guard is establishing a safety zone on the Delaware River in Philadelphia, PA, from 8:30 p.m. to 9:30 p.m. on July 1, 2014. The safety zone will restrict vessel traffic on the Delaware River while a fireworks event is taking place, inside a boundary described as spanning from the Pennsylvania shore to the New Jersey shore and is bounded in the south by a line from position 39[deg]56'18'' N, longitude 075[deg]08'30'' W; thence to latitude 39[deg]56'17'' N, longitude 075[deg]07'56'' W, and bounded on the north by the Benjamin Franklin Bridge. This safety zone is necessary to protect the public and vessels in the surrounding area from the hazards associated with a fireworks display.

We are revising an earlier proposed airworthiness directive (AD) for certain The Boeing Company Model 757-200, -200PF, -200CB, and -300 series airplanes. The NPRM proposed to require, for certain airplanes, installing new relays adjacent to two of the spoiler control modules. For certain other airplanes, the NPRM proposed to require torquing the bracket assembly installation nuts and ground stud nuts, and doing bond resistance tests between the bracket assemblies and the terminal lugs on the ground studs. The NPRM was prompted by numerous reports of unintended lateral oscillations during final approach, just before landing. This action revises the NPRM by adding actions that are necessary to address the identified unsafe condition. We are proposing this supplemental NPRM (SNPRM) to reduce the chance of unintended lateral oscillations near touchdown, which could result in loss of lateral control of the airplane, and consequent airplane damage or injury to flight crew and passengers. Since these actions impose an additional burden over that proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these proposed changes.

NMFS published a proposed rule on June 3, 2014, to, in part, implement provisions that would expand portions of the northern and western boundaries of the Oculina Bank habitat area of particular concern (HAPC) (Oculina Bank HAPC). The proposed rule stated ``the proposed rule would increase the size of the Oculina Bank HAPC by 405.42 square miles (1,050 square km), for a total area of 694.42 square miles (1,798.5 square km)''. However, this is incorrect. The proposed rule would actually increase the size of the Oculina Bank HAPC by 343.42 square miles (889.5 square km), for a total area of 632.42 square miles (1,638 square km). This notification corrects these two values published in the proposed rule.

In this document, the Federal Housing Finance Agency (FHFA) provides notice that it issued an Order to supplement its Orders dated November 26, 2013 and December 13, 2013, with respect to the reporting of each Federal Home Loan Banks' results under section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act).

We propose to supersede Airworthiness Directive (AD) 2011-09- 04, which applies to all Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 382, 382B, 382E, 382F, and 382G airplanes. AD 2011-09-04 currently requires repetitive inspections for any damage of the lower surface of the center wing box, and corrective actions if necessary. Since we issued AD 2011-09-04, an evaluation by the design approval holder (DAH) indicated that the center wing box is subject to widespread fatigue damage (WFD). This proposed AD would also require replacement of the center wing box, which would terminate the repetitive inspections. This proposed AD would also add a concurrent related investigative action. We are proposing this AD to detect and correct fatigue cracking of the lower surface of the center wing box, which could result in structural failure of the wings.

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 777-200, 777-200LR, 777-300ER, and 777F series airplanes. This proposed AD was prompted by a report indicating that sealant may not have been applied in production to the wing skin panel gaps above certain underwing fittings. This proposed AD would require an inspection for missing sealant, and applicable other specified, related investigative, and corrective actions. We are proposing this AD to detect and correct missing sealant from the wing skin panel gaps above the underwing fittings, which could result in corrosion and fatigue cracking in the wing skin panel, and consequent loss of limit load capability of the wing skin and potential subsequent structural failure of the wings.

The Bureau of Indian Affairs (BIA) is extending the comment period on the proposed rule for land acquisitions in Alaska, which was published in the Federal Register on May 1, 2014. The original comment period would end June 30, 2014; however, the BIA has received several requests for extension. BIA has reviewed these requests and determined that a 30-day extension is appropriate.

The Coast Guard is establishing temporary safety zones in the navigable waters of the San Francisco Bay near Aquatic Park in support of San Francisco Independence Day Fireworks Display on July 4, 2014. These safety zones are established to ensure the safety of participants and spectators from the dangers associated with pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zones without permission of the Captain of the Port or their designated representative.

The Coast Guard will enforce the safety zones for annual firework displays in the Captain of the Port, Puget Sound Zone during the dates and times noted in this document. This action is necessary to prevent injury and to protect life and property of the maritime public from the hazards associated with the firework displays. During the enforcement periods, entry into, transit through, mooring, or anchoring within these safety zones is prohibited unless authorized by the Captain of the Port, Puget Sound or their Designated Representative.

The Coast Guard will enforce the safety zone for the San Francisco Giants Fireworks display in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).

The Solid Waste Disposal Act, as amended, commonly referred to as the Resource Conservation and Recovery Act (RCRA), allows the Environmental Protection Agency (EPA) to authorize States to operate their hazardous waste management programs in lieu of the Federal program. The EPA uses the regulations entitled ``Approved State Hazardous Waste Management Programs'' to provide notice of the authorization status of State programs and to incorporate by reference those provisions of the State statutes and regulations that will be subject to the EPA's inspection and enforcement. The rule codifies in the regulations the prior approval of Oklahoma's hazardous waste management program and incorporates by reference authorized provisions of the State's statutes and regulations.

The Environmental Protection Agency (EPA) is proposing to approve revisions to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD) portion of the California State Implementation Plan (SIP). These revisions concern basic enforcement authorities under the Clean Air Act (CAA or the Act).

The Food and Drug Administration (FDA) is confirming the effective date of July 30, 2014, for the final rule that appeared in the Federal Register of March 17, 2014. The direct final rule amends the regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information will be disclosed by the Agency. This change ensures that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It also permits more timely public disclosure of approval-related information, increasing the transparency of FDA decisionmaking in the approval of new animal drugs. This document confirms the effective date of the direct final rule.

This action establishes Class E airspace at Memphis, MO. Controlled airspace is necessary to accommodate new Area Navigation (RNAV) Standard Instrument Approach Procedures at Memphis Memorial Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport.

OSHA is correcting typographical errors in its Vehicle-mounted elevating and rotating work platforms and Logging operations standards.

We are superseding Airworthiness Directive (AD) 2007-10-16 for all British Aerospace Regional Aircraft Jetstream Model 3201 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 the need to incorporate revisions to the Airworthiness Limitations section of the Instructions for Continued Airworthiness. We are issuing this AD to require actions to address the unsafe condition on these products.

NMFS proposes to implement Steller sea lion protection measures to insure that groundfish fisheries in the Bering Sea and Aleutian Islands Management Area (BSAI) off Alaska are not likely to jeopardize the continued existence of the western distinct population segment (WDPS) of Steller sea lions or destroy or adversely modify its designated critical habitat. These management measures would disperse fishing effort temporally and spatially to provide protection from potential competition for important Steller sea lion prey species in the BSAI. The intent of this proposed action is to protect the endangered WDPS of Steller sea lions, as required by the Endangered Species Act, and to minimize, to the extent practicable, the economic impact of fishery management measures, as required by the Magnuson- Stevens Fishery Conservation and Management Act.