April 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 43 approved new animal drug applications (NADAs) and 3 approved abbreviated new animal drug applications (ANADAs) from Boehringer Ingelheim Vetmedica, Inc. to Strategic Veterinary Pharmaceuticals, Inc.

EPA is issuing a supplement to its proposed approval of the State of Indiana's request to redesignate the Indianapolis area to attainment for the 1997 annual National Ambient Air Quality Standards (NAAQS or standard) for fine particulate matter (PM2.5). This supplemental proposal revises and expands the basis for proposing approval of the state's request, in light of developments since EPA issued its initial proposal on September 27, 2011. This supplemental proposal addresses four issues, including the effects of two decisions of the United States Court of Appeals for the District of Columbia (D.C. Circuit or Court): the Court's August 21, 2012 decision to vacate and remand to EPA the Cross- State Air Pollution Control Rule (CSAPR) and the Court's January 4, 2013 decision to remand to EPA two final rules implementing the 1997 PM2.5 standard. In this supplemental proposal, EPA is also proposing to approve a supplement to the emission inventories previously submitted by the state. EPA is proposing that the inventories for ammonia and Volatile Organic Compounds (VOC), in conjunction with the inventories for nitrogen oxides (NOX), direct PM2.5, and sulfur dioxide (SO2) that EPA previously proposed to approve, meet the comprehensive emissions inventory requirement of the Clean Air Act (CAA). Finally, this supplemental proposal solicits comment on the state's January 17, 2013 submission of Motor Vehicle Emissions Budgets (MVEBs) developed using EPA's Motor Vehicle Emissions Simulator (MOVES) 2010a emissions model to replace the MOBILE6.2 based MVEBs previously submitted as part of the PM2.5 maintenance plan for the Indianapolis area. EPA is seeking comment only on the issues raised in its supplemental proposal, and is not re-opening for comment other issues raised in its prior proposal.

The EPA is announcing an extension of the public comment period for its proposal titled, ``State Implementation Plans: Response to Petition for Rulemaking; Findings of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown, and Malfunction.'' The EPA has received numerous requests for extension of the comment period beyond the current deadline of April 11, 2013, and one request that it not extend the comment period by an additional 60 to 90 days, and in response to those requests the EPA is extending the comment period by an additional 30 days.

This action proposes to establish Class E surface airspace at Leesburg, VA, to aid Potomac TRACON in the safe and orderly flow of air traffic at Leesburg Executive Airport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport.

This proposed rule would correct the energy conservation standards for room air conditioners. In the direct final rule establishing amended energy conservation standards for residential clothes dryers and room air conditioners, published in the Federal Register on April 21, 2011, and the subsequent notices of effective date and compliance dates for the direct final rule and amendment of compliance dates, published on August 24, 2011, the Department of Energy (DOE) erroneously specified the maximum cooling capacity for product class 5a for room air conditioners without reverse cycle and with louvered sides as 24,999 British thermal units per hour (Btu/h), and the minimum cooling capacity for product class 5b for room air conditioners without reverse cycle and with louvered sides as 25,000 Btu/h, rather than 27,999 Btu/h and 28,000 Btu/h, respectively.

We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This proposed AD was prompted by a determination that certain flap actuators require restoration by installing a redesigned flap actuator inboard pinion seal. This proposed AD would require revising the maintenance program by incorporating new airworthiness limitation tasks. We are proposing this AD to prevent flap system failure, and consequent reduced landing performance of the airplane.

The U.S. Coast Guard proposes to establish safety zones around vessels and persons involved in the Marine Week Seattle Special Marine Air Ground Task Force Demonstration on Lake Washington, Seattle, WA. This event will occur from August 9, 2013, until August 11, 2013. A safety zone is necessary to ensure the safety of the maritime public during this event, which involves demonstrations of low flying aircraft, amphibious vehicles, swimmers, combat equipment, and other elements that could create safety concerns for waterway users. This safety zone would ensure the safety of the maritime public by prohibiting any person or vessel from entering or remaining in the safety zone unless authorized by the Captain of the Port (COTP) or a Designated Representative.

In this document, the Wireline Competition Bureau adopts modifications to the data specifications for collecting study area boundaries for purposes of implementing various reforms. The original specifications were adopted in the Commission's Connect America Fund; High-Cost Universal Service Support, Report and Order, (Study Area Boundary Order), released on November 6, 2012.

The United States Office of Personnel Management (OPM) is issuing a proposed rule to amend the Combined Federal Campaign (CFC) regulations in order to strengthen the integrity, streamline the operations and increase the effectiveness of the program to ensure its continued growth and success.

The Commodity Futures Trading Commission (Commission or CFTC) is adopting regulations to make clear that each swap dealer (SD), major swap participant (MSP), and other Commission registrant with whom an associated person (AP) is associated is required to supervise the AP and is jointly and severally responsible for the activities of the AP with respect to customers common to it and any other SD, MSP or other Commission registrant.

NARA proposes to amend its regulations on the public use of NARA facilities in the Washington, DC area. The regulations are being revised to clarify instances where fees may be charged for services related to building use. It also updates contact information for requesting use of NARA public areas in the Washington, DC National Archives Building and the National Archives at College Park.

NMFS proposes to revise regulations under the Dolphin Protection Consumer Information Act (DPCIA) to enhance the requirements for documentation to support labels on tuna products that represent the product as dolphin-safe. This proposed rule would modify the requirements for the certifications that must accompany the Fisheries Certificate of Origin (FCO); change storage requirements related to dolphin-safe and non-dolphin-safe tuna on board fishing vessels; create new requirements for processors, other than tuna canners, of tuna product labeled dolphin-safe; and modify the reporting requirements associated with tracking domestic tuna canning and processing operations. This proposed rule is intended to better ensure dolphin-safe labels comply with the requirements of the DPCIA and to ensure that the United States satisfies its obligations as a member of the World Trade Organization (WTO).

On February 28, 2013, the U.S. Department of Energy (DOE) published a notice of public meeting and availability of the preliminary analysis on general service fluorescent lamps (GSFLs) and incandescent reflector lamps (IRLs) energy conservation standards in the Federal Register. This notice announces an extension of the public comment period for submitting comments on the preliminary analysis or any other aspect of the rulemaking for GSFLs and IRLs. The comment period is extended to May 13, 2013.

This direct final rule makes nonsubstantive changes to correct and remove citations referenced in NASA's Contract Adjustment Board rule. The revision to this rule is part of NASA's retrospective plan under Executive Order (EO) 13563 completed in August 2011. NASA's full plan and updates can be accessed on the Agency's open Government Web site at https://www.nasa.gov/open/.

This document contains proposed regulations that provide guidance to charitable hospital organizations on the community health needs assessment (CHNA) requirements, and related excise tax and reporting obligations, enacted as part of the Patient Protection and Affordable Care Act of 2010. These proposed regulations also clarify the consequences for failing to meet these and other requirements for charitable hospital organizations. These regulations will affect charitable hospital organizations.

This proposed rule would revise the survey, certification, and enforcement procedures related to CMS oversight of national accreditation organizations (AOs). These revisions would implement certain provisions under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The proposed revisions would also clarify and strengthen our oversight of AOs that apply for, and are granted, recognition and approval of an accreditation program in accordance with the Social Security Act.

We propose to adopt a new airworthiness directive (AD) for certain Pratt & Whitney Canada Corp. (P&WC) PW118A, PW118B, PW119B, PW119C, PW123, PW123B, PW123C, PW123D, PW123E, PW123AF, PW124B, PW125B, PW126A, PW127, PW127E, PW127F, PW127G, and PW127M turboprop engines. This proposed AD was prompted by reports of fractures of the 1st stage power turbine (PT) blade. This proposed AD would require inspection of the 1st stage PT blades and the removal from service of those blades that fail the inspection or their replacement with blades eligible for installation. We are proposing this AD to prevent fracture of the 1st stage PT blade, possible engine fire, and damage to the airplane.

We propose to adopt a new airworthiness directive (AD) for certain Rolls-Royce plc (RR) RB211-524B-02; -524B2-19; -524B3-02; - 524B4-02; -524C2-19; -524D4-19; -524D4-B-19; -524D4-39; -535C-37; - 535E4-37; -535E4-B-37, and -535E4-B-75 turbofan engines, and all RB211- 524G2-19; -524G3-19; -524H2-19; and -524H-36 turbofan engines. This proposed AD was prompted by the discovery of a cracked and distorted front combustion liner (FCL) metering panel, which was made from the wrong material. This proposed AD would require a one-time inspection of the FCL metering panel to determine if it was made from N75 material and replacing it with one made from C263 material if it was made from N75 material. We are proposing this AD to prevent hot gas burning through the engine casing, which could result in an under-cowl fire and damage to the airplane.

The Coast Guard announces a public meeting to take place on May 2, 2013, in Seattle, Washington to receive comments on a notice of proposed rulemaking published in the Federal Register on March 22, 2013, under the title ``Transportation Worker Identification Credential (TWIC)Reader Requirements.'' The Coast Guard encourages members of the public to attend this meeting and provide oral comments on the notice of proposed rulemaking on TWIC reader requirements.

The Coast Guard is temporarily changing the operating schedule that governs the Pelican Island Causeway bridge across Galveston Channel mile 4.5 (GIWW mile 356.1), at Galveston, Texas. The temporary change to the regulations will allow the bridge to remain closed to navigation while major repairs are conducted to the mechanical portions of the bascule span. Failure to complete the repairs in a timely manner may render the bridge completely inoperable for the passage of vessel traffic.

The Office of Personnel Management (OPM) proposes to amend its regulations by granting Federal employees residing in the District of Columbia a partial exemption from the political activity restrictions and adding the District of Columbia to its regulatory list of designated localities. The proposed amendment reflects OPM's determination that the District of Columbia meets the criteria for a partial exemption to issue.

In response to a petition submitted by WildEarth Guardians and Friends of Animals to list the species as threatened or endangered, we, NMFS, have completed a comprehensive status review under the Endangered Species Act (ESA) for the scalloped hammerhead shark (Sphyrna lewini). Based on the best scientific and commercial information available, including the status review report (Miller et al., 2013), and other information available since completion of the status review report, we have determined that the species is comprised of six distinct population segments (DPSs) that qualify as species under the ESA: Northwest Atlantic and Gulf of Mexico (NW Atlantic & GOM DPS); Central and Southwest Atlantic (Central & SW Atlantic DPS); Eastern Atlantic DPS; Indo-West Pacific DPS; Central Pacific DPS; and Eastern Pacific DPS. After reviewing the best available scientific and commercial information on the DPSs, we have determined that two DPSs warrant listing as endangered, the Eastern Atlantic and Eastern Pacific DPSs; two DPSs warrant listing as threatened, the Central & SW Atlantic and Indo-West Pacific DPSs; and two DPSs do not warrant listing at this time, the NW Atlantic & GOM DPS and the Central Pacific DPS. Any protective regulations determined to be necessary and advisable for the conservation of the threatened DPSs under ESA section 4(d) would be proposed in a subsequent Federal Register announcement. Should the proposed listings be finalized, we would also designate critical habitat for the species, to the maximum extent prudent and determinable. We solicit information to assist these listing determinations, the development of proposed protective regulations, and designation of critical habitat in the event these proposed DPSs are finally listed.

This final rule will revise and add several new requirements to regulations for Safety and Environmental Management Systems (SEMS). These requirements pertain to developing and implementing stop work authority (SWA) and ultimate work authority (UWA), requiring an employee participation plan (EPP), and establishing guidelines for reporting unsafe working conditions. The rule establishes additional requirements for conducting job safety analyses (JSA) for activities identified in an operator's SEMS program. In addition, this final rule requires that SEMS programs be audited by an accredited audit service provider (ASP). This rulemaking will further support BSEE's efforts to reduce the occurrence of accidents, injuries, and spills during oil and gas activities on the Outer Continental Shelf (OCS).

The Board is adopting this final rule to establish, for purposes of Title I of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the ``Dodd-Frank Act'' or ``Act''), the requirements for determining if a company is ``predominantly engaged in financial activities''; and definitions of the terms ``significant nonbank financial company'' and ``significant bank holding company.'' These terms are relevant to various provisions of Title I of the Dodd-Frank Act, including section 113, which authorizes the Financial Stability Oversight Council (``Council'') to designate a nonbank financial company for supervision by the Board if the Council determines that the nonbank financial company could pose a threat to the financial stability of the United States.

This rule amends Supplemental Nutrition Assistance Program (SNAP) regulations to implement Section 28 of the Food and Nutrition Act (``FNA'' or the ``Act'') of 2008, as added by Section 241 of the Healthy, Hunger-Free Kids (HHFK) Act of 2010, to award grants to States for provision of nutrition education and obesity prevention programs. These programs will provide services for eligible individuals that promote healthy food choices consistent with the current Dietary Guidelines for Americans (DGAs). This rule provides State agencies with requirements for implementing Section 28 including the grant award process and describes the process for allocating the 100 percent Federal grant funding authorized under the Act to carry out nutrition education and obesity prevention services each fiscal year.