April 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of February 6, 2015. In the proposed rule, FDA requested comments on its proposal to implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). FDA also requested comment on its proposal to amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) has determined the regulatory review period for FLUBLOK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Department of the Army announces the availability of the Final Programmatic Environmental Impact Statement (FPEIS) for Activities and Operations at Yuma Proving Ground (YPG). This document analyzes and evaluates potential environmental impacts associated with short-term and long-term proposed construction projects and proposed changes to YPG's testing and training mission. The potential for environmental impacts is greatest for the following resource areas: Soils, air quality, solid and hazardous materials/waste, vegetation, and wildlife. Best management practices and other mitigation measures were identified in the FPEIS.

The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese (40 CFR part 63, subpart XXX)(Renewal)'' (EPA ICR No. 1831.06, OMB Control No. 2060-0391) 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 April, 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.

On March 26, 2015, the National Marine Fisheries Service (NMFS) announced the availability for public review of a proposed evaluation of three Hatchery and Genetic Management Plans (HGMPs) submitted by the Washington Department of Fish and Wildlife (WDFW), with the Jamestown S'Klallam Tribe, the Lummi Nation, the Nooksack Tribe, the Stillaguamish Tribes, and the Tulalip Tribes pursuant to the protective regulations promulgated for Pacific salmon and steelhead under the Endangered Species Act (ESA). The HGMPs specify the propagation of early-returning (``early'') winter steelhead in the Dungeness, Nooksack, and Stillaguamish River watersheds of Washington State. The availability of a draft environmental assessment (EA), evaluating the anticipated effects of NMFS' proposed determination on those HGMPs pursuant to the National Environmental Policy Act (NEPA), was included in the announcement. The announcement opened a 30-day public comment period. Due to an issue with one of the email addresses provided for receipt of comments, comments submitted to EWSteelheadHatcheries.wcr@noaa.gov prior to April 14, 2015, may not have been received. Therefore, NMFS requests that any such comments be re-submitted. NMFS is extending the comment period to May 4, 2015, to facilitate this re-submittal.

A Petition for Reconsideration (Petition) has been filed in the Commission's Rulemaking proceeding by Warren Havens, on behalf of Telesaurus Holdings GB LLC., and Skybridge Spectrum Foundation.

In accordance with the National Environmental Policy Act of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) has prepared Draft Resource Management Plan (RMP) Revisions and a Draft Environmental Impact Statement (EIS) for Western Oregon and, by this notice, is announcing the opening of the comment period.

This notice announces actions taken by the FHWA and other Federal Agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to the Wisconsin (WIS) 164 reconditioning project from County Trunk Highway (CTH) Q to CTH E in Washington County, Wisconsin. Those actions grant approvals for the project.

This action proposes to amend Class E Airspace at Campbellsville, KY as the Taylor County NDB has been decommissioned, requiring airspace redesign at Taylor County Airport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport.

This action establishes Class E Airspace at Key Largo, FL, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving Ocean Reef Club Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport.

This action proposes to establish Class E Airspace at Headland, AL, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving Headland Municipal Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport.

This action establishes Class E airspace at Edgeley, ND. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAPs) at Edgeley Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.

This action amends Class E Airspace at Manchester, NH, as a new approach procedure has been developed, requiring airspace redesign at Manchester Airport. This enhances the safety and management of instrument flight rules (IFR) operations at the airport. This action also updates the geographic coordinates of the airport.

This action establishes Class E airspace at Sonora, TX. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAP) at JL Bar Ranch Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.

This action proposes to establish Class E airspace at Highmore, SD. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAPs) at Highmore Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.

The Environmental Protection Agency (EPA) is proposing to conditionally approve the New Hampshire November 15, 2012 State Implementation Plan (SIP) revisions that are intended to ensure that the State's Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NNSR) programs are consistent with the federal PSD and NNSR program requirements. In a letter dated March 20, 2015, the New Hampshire Department of Environmental Services (NH DES) committed to revising its regulations no later than one year from the date when EPA publishes a notice of final conditional approval, and to submitting the revised regulations to EPA for approval into the SIP. EPA is also proposing to fully approve a July 1, 2003 SIP revision that clarifies two definitions related to New Hampshire's permitting programs. These actions are being taken in accordance with the Clean Air Act (CAA).

We propose to adopt a new airworthiness directive (AD) for all Airbus Model A318, A319, A320, and A321 series airplanes. This proposed AD was prompted by a report of a rupture of a main landing gear (MLG) sliding tube axle. This proposed AD would require an inspection to identify the part number and serial number of the MLG sliding tubes installed on the airplane; and an inspection of the axle on certain MLG sliding tubes for burned areas, and replacement of the sliding tube if necessary. We are proposing this AD to detect and correct cracks in the axle and (partial) detachment of the axle and wheel from the sliding tube, which could result in failure of an MLG.

This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.