September 15, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is implementing its authority to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by issuing a rule that provides to the owner or consignee notice and an opportunity to appear and introduce testimony to the Agency prior to destruction. This regulation is authorized by amendments made to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Implementation of this authority will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.

The Homeland Security Advisory Council (HSAC) will meet in person on September 29, 2015. Members of the public may participate in person. The meeting will be partially closed to the public.

The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Benzene Waste Operations (40 CFR part 61, subpart FF) (Renewal)'' (EPA ICR No. 1541.11, OMB Control No. 2060-0183), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through September 30, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This document reopens the comment period for the July 16, 2015 proposed rule entitled ``Reform of Requirements for Long-Term Care Facilities''. The comment period for the proposed rule, which ends on September 14, 2015, is reopened for 30 days.

The New England Fishery Management Council (Council, NEFMC) will hold a three-day meeting to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), to approve of and assign OMB numbers to collection of information requests and requirements conducted or sponsored by the Board. Board- approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number.

These special conditions are issued for the Gulfstream Model GVII-G500 airplane. These airplanes have a novel or unusual design feature as compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature includes engine size and the potential torque loads imposed by sudden engine stoppage. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA) (44 U.S.C. Chapter 35), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the Federal Register notifying the public that the agency has made such a submission. This notice also allows an additional 30 days for public comments.

The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, as amended), the Rural Utilities Service, a Rural Development agency of the United States Department of Agriculture invites comments on the following information collections for which the Agency intends to request approval from the Office of Management and Budget (OMB).

The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an amendment to Facility Operating License No. NFP-90, issued to the Tennessee Valley Authority (the licensee), for operation of the Watts Bar Nuclear Plant (WBN), Unit No. 1. The proposed amendment would modify the technical specifications (TSs) to define support systems needed in the first 48 hours after a unit shutdown when steam generators are not available for heat removal. The proposed amendment would also make changes consistent with Technical Specification Task Force (TSTF) Traveler TSTF-273-A, Revision 2, to provide clarifications related to the requirements of the Safety Function Determination Program (SFDP). The proposed license amendment was submitted by letter dated June 17, 2015, and was supplemented by letters dated July 14, August 28, and September 3, 2015. The NRC staff previously made a proposed determination that the amendment involves no significant hazards consideration. By letter dated September 3, 2015, the licensee provided additional information that expanded the scope of the amendment request as originally noticed. The September 3, 2015, supplement proposed new modifications to TS 3.3.2 and TS 3.4.6. This notice supersedes the previous notice in its entirety to update the description of the amendment request and the no significant hazards determination.

Pursuant to Section 189a. (2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued from August 18 to August 31, 2015. The last biweekly notice was published on September 1, 2015.

The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

We, the U.S. Fish and Wildlife Service (Service), propose to list Platanthera integrilabia (white fringeless orchid), a plant species from Alabama, Georgia, Kentucky, Mississippi, South Carolina, and Tennessee, as a threatened species under the Endangered Species Act (Act). If we finalize this rule as proposed, it would extend the Act's protections to this species.

We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 747-400F series airplanes. This proposed AD was prompted by an analysis of the production methods used to increase fatigue resistance of the upper closure fittings at the nose cargo door portal's C-3 frame, which indicated that cracking could start too early to be caught in a timely manner by the inspection or maintenance program. This proposed AD would require inspections of the upper closure fitting and connected strap and doubler at the nose cargo door portal for cracking, and related investigative and corrective actions if necessary. We are proposing this AD to detect and correct such cracking, which could result in sudden decompression and loss of the airplane's structural integrity.

We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the New England cottontail (Sylvilagus transitionalis) as an endangered or threatened species and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). After review of the best available scientific and commercial information, we find that listing the New England cottontail is not warranted at this time. However, we ask the public to submit to us any new information that becomes available concerning the threats to the New England cottontail or its habitat at any time.

We are adopting a new airworthiness directive (AD) for certain CFM International S.A. (CFM) CFM56-7B and CFM56-3 turbofan engines. This AD was prompted by a report of an uncommanded in-flight shutdown (IFSD) on a CFM CFM56-7B engine following rupture of the 73-tooth gearshaft located in the engine accessory gearbox (AGB). This AD requires AGB/transfer gearbox (TGB) magnetic chip detector (MCD) inspection of the affected gearshafts until removal. We are issuing this AD to prevent failure of certain engine AGB gearshafts, which could lead to failure of one or more engines, loss of thrust control, and damage to the airplane.

The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the State Implementation Plan (SIP) submitted by the State of Nebraska in a letter dated March 30, 2015. This SIP revision provides Nebraska's state-determined allowance allocations for existing electric generating units (EGUs) in the State for the 2016 control periods and replaces the allowance allocations for the 2016 control periods established by EPA under the Cross-State Air Pollution Rule (CSAPR). The CSAPR addresses the ``good neighbor'' provision of the Clean Air Act (CAA or Act) that requires states to reduce the transport of pollution that significantly affects downwind air quality. In this final action EPA is approving Nebraska's SIP revision, incorporating the state-determined allocations for the 2016 control periods into the SIP, and amending the regulatory text of the CSAPR Federal Implementation Plan (FIP) to reflect this approval and inclusion of the state-determined allocations. EPA is taking direct final action to approve Nebraska's SIP revision because it meets the requirements of the CAA and the CSAPR requirements to replace EPA's allowance allocations for the 2016 control periods. This action is being taken pursuant to the CAA and its implementing regulations. EPA's allocations of CSAPR trading program allowances for Nebraska for control periods in 2017 and beyond remain in place until the State submits and EPA approves state-determined allocations for those control periods through another SIP. The CSAPR FIPs for Nebraska remain in place until such time as the State decides to replace the FIPs with a SIP revision.

The Environmental Protection Agency (EPA) is taking final action to partially approve and disapprove elements of a State Implementation Plan (SIP) submission from the State of Nebraska addressing the applicable requirements of Clean Air Act (CAA) section 110 for the 2008 National Ambient Air Quality Standards (NAAQS) for Ozone (O3), which requires that each state adopt and submit a SIP to support implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by EPA. These SIPs are commonly referred to as ``infrastructure'' SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.