July 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lubiprostone capsules entitled ``Bioequivalence Recommendations for Lubiprostone.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E. O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Ancient Egypt Transformed: The Middle Kingdom,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Metropolitan Museum of Art, New York, New York, from on or about October 12, 2015, until on or about January 24, 2016, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.

The SEDAR 41 assessments of the South Atlantic stocks of red snapper (Lutjanus campechanus) and gray triggerfish (Balistes capriscus) will consist of: Data Workshops; an Assessment Workshop; and a Review Workshop. See SUPPLEMENTARY INFORMATION.

The Department of Defense is publishing this notice to announce the following Federal Advisory Committee meeting of the Judicial Proceedings since Fiscal Year 2012 Amendments Panel (``the Judicial Proceedings Panel'' or ``the Panel''). The meeting is open to the public.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on June 17, 2015, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Reynolds Presto Products Inc. of Appleton, Wisconsin. A supplement to the complaint was filed on July 8, 2015. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain resealable packages with slider devices by reason of infringement of certain claims of U.S. Patent Reexamination Certificate No. 6,427,421 C1 (``the '421 patent''); U.S. Patent No. 6,524,002 (``the '002 patent''); and U.S. Patent No. 7,311,443 (``the '443 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue a general exclusion order, or in the alternative, a limited exclusion order, and cease and desist orders.

The Food and Drug Administration (FDA) is updating an authority citation for the Code of Federal Regulations. This action is technical in nature and is intended to provide accuracy of the Agency's regulations.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) granting special termination of the debarment of David J. Brancato. FDA bases this order on a finding that Dr. Brancato provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction, and that special termination of Dr. Brancato's debarment serves the interest of justice and does not threaten the integrity of the drug approval process.

This action amends Class B airspace at the Louis Armstrong New Orleans International Airport, New Orleans, LA, by removing reference to the Instrument Landing System (ILS) Runway 10 Outer Compass Locator (LOM) from the text header information and surface area (Area A) description and replacing it in the Area A description with the geographic latitude/longitude coordinates of the LOM. This change is necessary due to the planned decommissioning of the LOM navigation aid. The Louis Armstrong New Orleans International Airport and New Orleans Naval Air Station Joint Reserve Base (Alvin Callender Field) airport names and airport reference point (ARP) geographic coordinates are also updated. The St. Charles and Lakefront airports, used in the Class B description, are added in the legal description text header information, as well as, the Harvey VHF Omnidirectional Range/Tactical Air Navigation (VORTAC) navigation aid. Lastly, general editing of the legal description is accomplished to improve clarity. These changes are editorial only to match existing FAA aeronautical database information and do not alter the current charted boundaries or altitudes or the ATC procedures for the New Orleans Class B airspace area.

The Federal Emergency Management Agency (FEMA) Technical Mapping Advisory Council (TMAC) will meet in person on August 4-5, 2015, in Reston, VA. The meeting will be open to the public.

This action proposes to establish restricted area R-2507W, Chocolate Mountains, CA, to support training activities that involve the use of advanced weapons systems. Proposed R-2507W is needed by the United States Marine Corps (USMC) to enhance training and safety requirements in order to maintain, train, and equip combat-ready military forces.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Paul Coverdell National Acute Stroke Program (PCNASP) reporting system, which was established to improve quality of care for acute stroke patients from onset of signs and symptoms through hospital care and rehabilitation and recovery.

The Department of Justice (DOJ), Executive Office for Immigration Review, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the Federal Register at 80 FR 29340, on May 21, 2015, allowing for a 60 day comment period.

FRA hereby gives notice that it is submitting the following Information Collection request (ICR) to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995. FRA requests that OMB authorize the collection of information identified by July 24, 2015, for a period of 180 days.

The Commission is updating the product lists. This action reflects a publication policy adopted by Commission order. The referenced policy assumes periodic updates. The updates are identified in the body of this document. The product lists, which is re-published in its entirety, includes these updates.

The Environmental Protection Agency (EPA) is taking direct final action to approve the State Implementation Plan (SIP) revision submitted by the State of North Carolina, through the North Carolina Department of Environment and Natural Resources on August 13, 2012, pertaining to definition changes for the Nitrogen Dioxide (NO2) and Sulfur Dioxide (SO2) National Ambient Air Quality Standards (NAAQS). EPA is approving this SIP revision because the State has demonstrated that it is consistent with the Clean Air Act (CAA or Act).

Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that three meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference.

The U.S. Nuclear Regulatory Commission (NRC) is correcting a notice that was published in the Federal Register on July 9, 2015, that gave notice to the public that it is considering issuance of an amendment to Combined Licenses (NPF-93 and NPF-94), issued to South Carolina Electric and Gas (SCE&G) and South Carolina Public Service Authority, for construction and operation of the Virgil C. Summer Nuclear Station, Units 2 and 3 located in Fairfield County, South Carolina. This action is being taken to correct the date by which a request for a hearing or a petition for leave to intervene must be filed.

The Environmental Protection Agency (EPA) is amending the exclusion for International Business Machines Corporation (IBM) in Essex Junction, Vermont to reflect changes in ownership and name.

This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4223-DR), dated May 29, 2015, and related determinations.

Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.