July 20, 2015 – Federal Register Recent Federal Regulation Documents

The Secretary is publishing the following list of correspondence from the U.S. Department of Education (Department) to individuals during the second and third quarters of 2014. The correspondence describes the Department's interpretations of the Individuals with Disabilities Education Act (IDEA) or the regulations that implement the IDEA. This list and the letters or other documents described in this list, with personally identifiable information redacted, as appropriate, can be found at: www2.ed.gov/policy/speced/ guid/idea/.

The U.S. Nuclear Regulatory Commission (NRC) is considering a request from GE Hitachi Nuclear Energy to approve the release from their NRC power reactor licenses of a portion of their Vallecitos Nuclear Center property for unrestricted use. The NRC will approve or deny the request based on its review of the request and the result of an NRC confirmatory survey of the property proposed for release. Approval of the request would allow GE to sell the released portion of the property to a non-GE controlled entity. The NRC is requesting public comment on the contemplated action and invites stakeholders and interested persons to participate. The NRC plans to hold a public meeting to promote full understanding of the contemplated action and facilitate public comment.

The EPA is taking a direct final action to approve revisions to the Texas State Implementation Plan (SIP) related to Low Reid Vapor Pressure (RVP) Fuel Regulations that were submitted by the State of Texas on January 5, 2015. The EPA evaluated the SIP submittal from Texas and determined these revisions are consistent with the requirements of the Clean Air Act (Act or CAA). The EPA is approving this action under the federal CAA.

The Environmental Protection Agency (EPA) is proposing to approve portions of the May 14, 2012, State Implementation Plan (SIP) submission, provided by the Georgia Department of Natural Resources, Environmental Protection Division (hereafter referred to as GA EPD) for inclusion into the Georgia SIP. This proposal pertains to the Clean Air Act (CAA or the Act) infrastructure requirements for the 2008 8-hour ozone national ambient air quality standards (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an ``infrastructure'' SIP. GA EPD certified that the Georgia SIP contains provisions that ensure the 2008 8-hour ozone NAAQS is implemented, enforced, and maintained in Georgia. With the exception of provisions pertaining to prevention of significant deterioration (PSD) permitting and interstate transport requirements, EPA is proposing to approve Georgia's infrastructure SIP submission provided to EPA on May 14, 2012, as satisfying the required infrastructure elements for the 2008 8-hour ozone NAAQS.

EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.

The Environmental Protection Agency (EPA) is proposing to approve a revision to the State Implementation Plan (SIP) submitted by the State of Florida through the Department of Environmental Protection (DEP) on July 31, 2009. The revision grants a variance to the Combs Oil Company, located in Naples, Florida. This source specific revision relieves the Combs Oil Company of the requirement to comply with the Florida rule governing installation and operation of vapor collection and control systems on loading racks at bulk gasoline plants. EPA is proposing approval of Florida's July 31, 2009, SIP revision.

The HHS Centers for Disease Control and Prevention's Division of Select Agents and Toxins (DSAT) and the USDA Animal and Plant Health Inspection Service (APHIS), Agriculture Select Agent Services (AgSAS) are jointly charged with the oversight of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. The purpose of the webcast is to provide guidance related to the Federal Select Agent Program for interested individuals.

The Department of Commerce (the Department) preliminarily determines that TPBI Public Company Limited (TPBI) is the successor-in- interest to Thai Plastic Bags Industries Company Limited (Thai Plastic Bags) for purposes of the antidumping duty order on polyethylene retail carrier bags (PRCBs) from Thailand and, as such, will be entitled to Thai Plastic Bags's exclusion from the antidumping duty order. We invite interested parties to comment on these preliminary results.

The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

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 ``New Objectivity: Modern German Art in the Weimar Republic 1919-1933,'' 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 Los Angeles County Museum of Art, Los Angeles, California, from on or about October 4, 2015, until on or about January 18, 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 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.