April 2014 – Federal Register Recent Federal Regulation Documents

We are proposing to amend the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. We intend to replace the current label format, which reflects any of four different levels of effectiveness, with a single, uniform label format. We are also proposing to require biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A simpler label format along with publicly available safety and efficacy data will help biologics producers to more clearly communicate product performance to their customers.

This document contains the final revisions to the rules of practice before the Judicial Officer in proceedings under section 5 of the Debt Collection Act. These rules of procedure completely replace and supersede the prior rules.

The Food and Drug Administration (FDA or Agency) is classifying the eyelid weight into class II (special controls). The Agency is exempting the external eyelid weight from premarket notification, but continuing to require premarket notification for implantable eyelid weights in order to provide a reasonable assurance of safety and effectiveness of the device. Both external and implantable eyelid weight devices are subject to special controls. The eyelid weight may be adhered to the outer skin of the upper eyelid (external eyelid weight) or implanted into the upper eyelid (implantable eyelid weight), and is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).

The Coast Guard is establishing a temporary safety zone within the Lake Moolvalya region of the navigable waters of the Colorado River in Parker, Arizona in support of the Blue Water Resort and Casino (BWRC) West Coast Nationals high speed boat race. This safety zone is necessary to provide for the safety of the participants, crew, spectators, participating vessels, and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.

The Environmental Protection Agency (EPA) is promulgating amendments to the New Source Review (NSR) Prevention of Significant Deterioration (PSD) program that amend certain outdated language that limited the EPA's ability to delegate the federal PSD program to interested Indian tribes. This final action provides consistency with the current federal PSD regulatory requirements by allowing the EPA to delegate the PSD program to interested tribes for their attainment areas. The EPA regulations already provide for the administrative delegation of the PSD program to state and local governments for their attainment areas and administrative delegation of the nonattainment NSR program to states, tribes and local governments. This final rule deletes a restriction on tribes' ability to take delegation of the PSD program and includes tribes, along with state and local governments, to make it clear that tribes, as well as states and local governments, may voluntarily request and assume direct delegation of the NSR program in areas that are currently attaining the national ambient air quality standards (NAAQS). This final rule does not create any new requirements.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to remove coverage concerning contracting officer's representative responsibilities that is procedural in nature.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to revise and update transportation-related clauses and their prescriptions to create basic and alternate clauses structured in a manner to facilitate use of automated contract writing systems. The rule also includes the full text of each alternate, rather than only showing the paragraphs that differ from the basic clause.

On July 10, 2013, the U.S. Department of Energy (DOE) issued a notice of proposed rulemaking (NOPR) to amend the test procedures for refrigerators, refrigerator-freezers, and freezers. That proposed rulemaking serves as the basis for this action. This final rule amends the test procedure that will be required for the testing of these products starting on September 15, 2014. The amendments include test procedures for products with multiple compressors and an alternative method for measuring and calculating energy consumption for refrigerator-freezers and refrigerators with freezer compartments. DOE is also amending certain aspects of the test procedure in order to ensure better test accuracy and repeatability. This final rule does not address the proposal's approach regarding the measurement of energy use associated with ice making, nor does it address the proposed treatment of built-in products, as DOE plans to address these topics in a future rule.

Under the Clean Air Act, the Environmental Protection Agency (EPA) is taking final action to disapprove the state implementation plan (SIP) for the Commonwealth of the Northern Mariana Islands (CNMI) with respect to prevention of significant deterioration (PSD), and to incorporate by reference the Federal PSD regulations into the applicable CNMI plan. EPA is also taking final action to grant a petition by CNMI for an exemption of the applicable PSD major source baseline date, and to establish an alternate date, January 13, 1997, as the major source baseline date and trigger date in CNMI. EPA is also making certain corrections to errors that were made in previous rulemakings related to the CNMI SIP. This action establishes the Federal PSD regulations as a basic element of the applicable CNMI plan and, through the exemption, establishes January 13, 1997 as the major source baseline date (and trigger date) under the PSD program in CNMI for sulfur dioxide, PM10 and nitrogen dioxide.

The Federal Deposit Insurance Corporation (``FDIC'') proposes to rescind and remove regulations transferred from the Office of Thrift Savings (``OTS''), and amend its rules of practice and procedure in ways that will ensure that all insured depository institutions, for which the FDIC is the appropriate Federal banking agency (``FBA''), are subject to the same substantive and procedural rules governing administrative hearings.

NMFS reopens commercial penaeid shrimp trawling, i.e., for brown, pink, and white shrimp, in the exclusive economic zone (EEZ) off South Carolina in the South Atlantic. NMFS previously closed commercial penaeid shrimp trawling in the EEZ off South Carolina on February 13, 2014. The reopening is intended to maximize harvest benefits while protecting the penaeid shrimp resource.

With this notice, OSHA is withdrawing the proposed rule that accompanied its direct final rule revising the record requirements contained in the Mechanical Power Presses Standard.

We, the U.S. Fish and Wildlife Service, published a final rule in the Federal Register on March 17, 2014, to amend the refuge-specific regulations for certain refuges that pertain to migratory game bird hunting, upland game hunting, big game hunting, and sport fishing for the 2013-2014 season. Inadvertently, we made two technical errors in our regulatory text for Arapaho National Wildlife Refuge in Colorado. This action makes the necessary corrections to the regulations for that refuge.

This action amends Class E airspace at Paragould, AR. Decommissioning of the Paragould non-directional radio beacon (NDB) at Kirk Field Airport has made reconfiguration necessary for standard instrument approach procedures and for the safety and management of Instrument Flight Rule (IFR) operations at the airport. Geographic coordinates are also updated.

The Environmental Protection Agency (EPA) is finalizing approval of revisions to the El Dorado County Air Quality Management District (EDAQMD) portion of the California State Implementation Plan (SIP). This action was proposed in the Federal Register on October 25, 2013 and concerns negative declarations for volatile organic compound (VOC) source categories for EDAQMD. We are approving these negative declarations under the Clean Air Act (CAA or the Act).

The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the Virginia State Implementation Plan (SIP). The SIP revision consists of a revision to the operating permit for the control of visibility-impairing emissions from GP Big Island, LLC on a shutdown of an individual unit. EPA is approving this revision in accordance with the requirements of the Clean Air Act (CAA).

The Environmental Protection Agency (EPA) is partially approving and partially disapproving revisions to the South Dakota State Implementation Plan (SIP) submitted by the South Dakota Department of Environment and Natural Resources (DENR) to EPA on June 20, 2011. The SIP revisions address the permitting of sources of greenhouse gases (GHGs). Specifically, we are approving revisions to the State's Prevention of Significant Deterioration (PSD) program to incorporate the provisions of the federal PSD and Title V Greenhouse Gas Tailoring Rule (Tailoring Rule). The SIP revisions incorporate by reference the federal Tailoring Rule's emission thresholds for determining which new stationary sources and modifications to existing stationary sources become subject to South Dakota's PSD permitting requirements for their GHG emissions. EPA is finalizing disapproval of a related provision that would rescind the State's Tailoring Rule revision in certain circumstances. EPA will take separate action on an amendment to the chapter Construction Permits for New Sources or Modifications in the June 20, 2011 submittal, regarding permits for minor sources. EPA is finalizing this action under section 110 and part C of the Clean Air Act (the Act or CAA).

The Federal Aviation Administration (FAA) published in the Federal Register of May 3, 2013 a document amending the design requirements in the airworthiness standards for transport category airplanes to minimize the occurrence of design-related flightcrew errors. This document corrects an inadvertent amendment number that appears in the heading of the publication of that final rule.

The Coast Guard is establishing a temporary safety zone on the navigable waters of Colorado River in Lake Havasu, AZ for the Lucas Oil Drag Boats Racing Series from May 2, 2014 through May 4, 2014. The safety zone would be in effect from 7 a.m. to 7 p.m. daily during this timeframe. This temporary safety zone is necessary to provide for the safety of the participants, crew, spectators, participating vessels, and other vessels and users of the waterway. Persons and vessels would be prohibited from entering into, transiting through or anchoring within this safety zone unless authorized by the Captain of the Port or his designated representative.

The Coast Guard proposes to establish a special local regulation pertaining to the Beaufort Water Festival from 11:30 a.m. through 4:30 p.m. on July 19, 2014. This action is necessary to ensure safety of life on navigable waters of the United States during the Beaufort Water Festival Air Show. During the enforcement period, the special local regulation establishes a regulated area which all people and vessels will be prohibited from entering, transiting through, anchoring, or remaining within. Vessels may enter, transit through, anchor in, or remain within the area if authorized by the Captain of the Port Charleston or a designated representative.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Southern Railroad Drawbridge across the Tennessee River, mile 304.4, at Decatur, Alabama. The deviation is necessary to allow the bridge owner time to replace and adjust the down haul operating ropes 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.

The Department of State is correcting the inadvertent omission of regulatory text in a recent final rule.

We propose to adopt a new airworthiness directive (AD) for certain the Boeing Company Model DC-9-10, DC-9-20, DC-9-30, DC-9-40, and DC-9-50 series airplanes. This proposed AD was prompted by an evaluation by the design approval holder (DAH) indicating that the bulkhead dome tees, which connect the bulkhead web to the fuselage, are subject to widespread fatigue damage (WFD). This proposed AD would require repetitive inspections of the improved ventral aft pressure bulkhead tees and replacement if necessary. We are proposing this AD to detect and correct fatigue cracking of the bulkhead dome tees, which could result in reduced structural integrity and rapid decompression of the airplane.