July 11, 2014 – Federal Register Recent Federal Regulation Documents

Pursuant to the Federal Advisory Committee Act, notice is hereby given of cancellation of the meeting of the Advisory Committee on Voluntary Foreign Aid (ACVFA) on Wednesday, July 9, 2014 in the Horizon Room of the Ronald Reagan Building at 1300 Pennsylvania Ave. NW., Washington, DC, which was published in the Federal Register on June 25, 2014, 79 FR 35995.

We are superseding emergency airworthiness directive (AD) 2014-12-52 for all Honeywell International Inc. TFE731-4, -4R, -5AR, - 5BR, -5R, -20R, -20AR, -20BR, -40, -40AR, -40R, -40BR, -50R, and -60 turbofan engines. Emergency AD 2014-12-52 was sent previously to all known U.S. owners and operators of these engines. AD 2014-12-52 required, before further flight, a review of the engine logbook maintenance records to determine if any affected engines are installed. AD 2014-12-52 also prohibited operation of an airplane with two or more affected engines that have 2nd stage low-pressure turbine (LPT2) blades with less than 250 operating hours since new. This AD retains the requirements of AD 2014-12-52 and clarifies the intent of the mandatory requirements. This AD was prompted by reports of LPT2 blade separations. We are issuing this AD to prevent LPT2 blade failure, multiple engine in-flight shutdowns, and damage to the airplane.

The Defense Intelligence Agency is deleting a system of records notice from its existing inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. The system notice is entitled ``LDIA 0014, Employee Grievance Files''.

The Department of the Navy hereby gives notice of its intent to grant to Xtreme Alternative Defense Systems Ltd. a revocable, nonassignable, partially exclusive license to practice in the United States in the fields of Counter Piracy Application for Commercial Shipping and Counter UAV Systems, the Government-owned invention described below: Patent 8,367,991 (Navy Case 99,995, issued February 5, 2013, entitled ``Modulation Device For A Mobile Tracking Device.''

The Food and Drug Administration (FDA) has determined the regulatory review period for HORIZANT 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 drug product.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA SubmissionsAmendments and Easily Correctable Deficiencies Under GDUFA.'' The guidance document is intended to assist applicants in preparing to submit to FDA amendments to abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by explaining how the Generic Drug User Fee Amendments of 2012 (GDUFA) performance metric goals apply to these submissions. When finalized, this guidance will replace the December 2001 guidance for industry entitled ``Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications'' in consideration of the new amendment review tier system and performance goals under GDUFA.

The Committee is proposing to add a service to the Procurement List that will be provided by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products previously furnished by such agencies.

This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (``Ex-Im Bank''), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this Transaction.

Pursuant to the Mineral Leasing Act of 1920, as amended by the Federal Coal Leasing Amendments Act of 1976, and to Bureau of Land Management (BLM) regulations, members of the public are invited to participate with BNI Coal Ltd. on a pro rata cost sharing basis in a program for the exploration of coal deposits owned by the United States of America in lands located in Oliver County, North Dakota.

Pursuant to the Mineral Leasing Act of 1920, as amended by the Federal Coal Leasing Amendments Act of 1976, and to Bureau of Land Management (BLM) regulations, all interested parties are hereby invited to participate with Bridger Coal Company on a pro rata cost-sharing basis, in its program for the exploration of coal deposits owned by the United States of America in Sweetwater County, Wyoming.

Pursuant to Mineral Leasing Act of 1920, as amended by the Federal Coal Leasing Amendments Act of 1976 and Bureau of Land Management (BLM) regulations, members of the public are invited to participate with Canyon Fuel Company, LLC, on a pro rata cost sharing basis in a program for the exploration of coal deposits owned by the United States of America in Sevier County, Utah.

The Commission is noticing a recent Postal Service filing concerning an addition of Priority Mail Contract 83 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

This Special Fraud Alert addresses compensation paid by laboratories to referring physicians and physician group practices (collectively, physicians) for blood specimen collection, processing, and packaging, and for submitting patient data to a registry or database. OIG has issued a number of guidance documents and advisory opinions addressing the general subject of remuneration offered and paid by laboratories to referring physicians, including the 1994 Special Fraud Alert on Arrangements for the Provision of Clinical Laboratory Services, the OIG Compliance Program Guidance for Clinical Laboratories, and Advisory Opinion 05-08. In these and other documents, we have repeatedly emphasized that providing free or below-market goods or services to a physician who is a source of referrals, or paying such a physician more than fair market value for his or her services, could constitute illegal remuneration under the anti-kickback statute. This Special Fraud Alert supplements these prior guidance documents and advisory opinions and describes two specific trends OIG has identified involving transfers of value from laboratories to physicians that we believe present a substantial risk of fraud and abuse under the anti- kickback statute.

The Gulf of Mexico Fishery Management Council (Council) will hold a meeting of the Reef Fish Advisory Panel.

The New England Fishery Management Council's (Council) Risk Policy Working Group will meet to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

Notice regarding the removal of Compliant Product Lists (CPL) of ballistic resistant body armor models that met superseded versions of the National Institute of Justice (NIJ) Body Armor Standard.

The Defense Health Agency is proposing to establish a new system of records, EDHA 25 DoD, entitled ``Enterprise Blood Management System (EBMS)'' in its inventory of record systems subject to the Privacy Act of 1974, as amended. This system will be used to obtain information from individuals donating blood in order to identify and verify donor demographics; determine donor suitability; associate donors to blood collections for testing; and create records necessary to identify and notify recipients of potential or known infectious blood units. Information collected is also used to determine the suitability of voluntary blood donations, record time of blood donation, and blood type; administer the Armed Services Blood Program (ASBP); and in some instances, recommend medical treatment for prospective blood donors.

To raise awareness of the dangers of carbon monoxide in the home, the Consumer Product Safety Commission (CPSC) announces a poster contest for children in grades six, seven, and eight under section 105 of the America COMPETES Reauthorization Act of 2011, 15 U.S.C. 3719 (America COMPETES Act).

NMFS announces that persons who bring a U.S. purse seine or longline vessel into the fisheries in the western and central Pacific Ocean (WCPO) after July 11, 2014 (``control date''), or who, after the control date, expand the carrying capacity or well volume of a purse seine vessel already in the fishery, are not guaranteed the future participation of that vessel in the fishery if NMFS decides to limit the number of fishing vessels in the fishery or, with respect to purse seine vessels, the fishing capacity of the fleet or of vessels in the fleet in terms of carrying capacity or well volume. Furthermore, with respect to purse seine vessels, even if the future participation of such a vessel is allowed, the vessel's future allowable level of fishing effort and/or catch might be limited if NMFS decides to limit vessels' individual or collective allowable levels of fishing effort or catch. NMFS is considering the need to undertake such actions to implement provisions of a conservation and management measure adopted by the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (WCPFC or Commission).