January 11, 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.

Notice is hereby given that the State of West Virginia is revising its approved Public Water System Supervision Program. West Virginia has adopted drinking water regulations for the Revised Total Coliform Rule. The U.S. Environmental Protection Agency (EPA) has determined that West Virginia's Revised Total Coliform Rule meets all minimum federal requirements, and that it is no less stringent than the corresponding federal regulation. Therefore, EPA has tentatively decided to approve the State program revisions.

The Licensing Support System Advisory Review Panel was established by the U.S. Nuclear Regulatory Commission (NRC) as a Federal Advisory Committee in 1989. Its purpose was to provide advice on the fundamental issues of design and development of an electronic information management system to be used to store and retrieve documents relating to the licensing of a geologic repository for the disposal of high-level radioactive waste, and on the operation and maintenance of the system. This electronic information management system was known as the Licensing Support System (LSS). In November 1998, the Commission approved amendments to title 10 of the Code of Federal Regulations part 2 that renamed the Licensing Support System Advisory Review Panel as the Licensing Support Network Advisory Review Panel. The Licensing Support Network (LSN) was shut down in 2011 and the document collection was submitted to the Office of the Secretary. The document collection was made publically available in the NRC's ADAMS system in August 2016 and contains over 3.69 million documents associated the proposed high-level waste facility at Yucca Mountain. Membership on the Panel will continue to be drawn from those whose interests that could be affected by the use of the LSN document collection, including the Department of Energy, the NRC, the State of Nevada, the National Congress of American Indians, affected units of local governments in Nevada, the Nevada Nuclear Waste Task Force, and nuclear industry groups. Federal agencies with expertise and experience in electronic information management systems may also participate on the Panel. The NRC has determined that renewal of the charter for the LSNARP until January 5, 2019, is in the public interest in connection with duties imposed on the Commission by law. This action is being taken in accordance with the Federal Advisory Committee Act after consultation with the Committee Management Secretariat, General Services Administration.

This notice is issued in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i). The National Energy Technology Laboratory (NETL) hereby gives notice that the Department of Energy (DOE) intends to grant an exclusive license to practice the invention described and claimed in U.S. Patent Application Number 14/619,501, ``Variable Grid Method for Simultaneously Visualizing Uncertainty and Attribute Trends Associated with Spatial Data'' to VariGrid Explorations, LLC, a small business, having its principal place of business in Missouri City, Texas. The patent application is owned by the United States of America, as represented by DOE. The prospective exclusive license complies with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

In accordance with Section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department in a competition for funding under the FY 2016 Notice of Funding Availability (NOFA) for the Rural Capacity Building for Community Development and Affordable Housing Program. This announcement contains the names and addresses of the award recipients under said NOFA.

The Department of Commerce (the ``Department'') determines that countervailable subsidies are being provided to producers and exporters of certain biaxial integral geogrid products (``geogrids'') from the People's Republic of China (the ``PRC''). The period of investigation is January 1, 2015, through December 31, 2015. For information on the estimated subsidy rates, see the ``Suspension of Liquidation'' section of this notice.

The Law Enforcement Committee of the Mid-Atlantic Fishery Management Council (Council) will hold a meeting.

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 10) of the presiding administrative law judge (``ALJ'') granting a joint motion to terminate the investigation based upon settlement. The investigation is terminated.

The Department of the Navy (DoN), after carefully considering the environmental consequences of the proposed action, announces its decision to implement a project for the conjunctive use of surface water and groundwater within the Lower Santa Margarita River (SMR) Basin. The DoN has selected the preferred alternative as identified in the 2016 Final Environmental Impact Statement (EIS)/Environmental Impact Report (EIR). This alternative consists of construction and operation of new facilities for adaptive management of surface water and groundwater resources that would be achieved through the enhanced diversion of SMR surface waters to groundwater recharge ponds and the active use of groundwater aquifers for water storage. The proposed action would resolve the water rights disputes between the United States (on behalf of the Marine Corps) and Fallbrook Public Utility District (FPUD) and satisfy the United States District Court for the Southern District of California order to find a ``physical solution'' to the ongoing litigation in United States v. Fallbrook Public Utility District, et al. The Proposed Action would also efficiently meet the long-term water demands of Marine Corps Installations (MCI) West-MCB Camp Pendleton and FPUD, reduce FPUD's dependence on imported water, maintain watershed resources, and improve water supply reliability by managing the yield of the Lower SMR Basin. The DoN and Reclamation are the designated co-lead agencies for review of this project under the National Environmental Policy Act (NEPA), and FPUD is the designated lead agency for review of this project under the California Environmental Quality Act (CEQA) in the preparation of the joint EIS/ EIR. This ROD documents why the DoN has chosen to implement the preferred alternative as described in the 2016 Final EIS/EIR. The ROD includes descriptions and discussions of the anticipated environmental impacts of the proposed action as well as all practical means to avoid or minimize environmental impacts from the selected alternative. It also includes descriptions and discussions of all related actions and their anticipated impacts.

The New England Fishery Management Council (Council) is scheduling a public meeting of its Habitat Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

Notice is hereby given that the Department of the Interior, U.S. Fish and Wildlife Service (DOI), together with the State of New York Department of Environmental Conservation (DEC), reached agreement on a proposed settlement with Atlantic Richfield Company regarding natural resource damages arising from environmental contamination at the Sinclair Refinery Superfund Site, located in Allegany County, New York. The settlement will resolve claims under the Comprehensive Environmental Response, Compensation, and Liability Act; the Oil Pollution Act; the Clean Water Act; and applicable State law.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry and FDA staff entitled ``Current Good Manufacturing Practice Requirements for Combination Products.'' The guidance describes and explains the document on current good manufacturing practice (CGMP) requirements for combination products, which published in the Federal Register of January 22, 2013, and includes general considerations for CGMP compliance as well as analysis of hypothetical scenarios.

We, the U.S. Fish and Wildlife Service (Service), announce the availability of our finding of no significant impact (FONSI) and final environmental assessment (Final EA) for the Marianas Trench Marine National Monument (Monument) Northern Islands Submerged Lands (submerged lands) Transfer to the Commonwealth of the Northern Mariana Islands (CNMI). The FONSI documents our decision to implement Alternative 2, as it is described in the Final EA, resulting in the Department of the Interior (DOI) conveying title to certain submerged lands within the Monument from the United States to the CNMI Government through a Patent, under the authority of the Territorial Submerged Lands Act (TSLA), as amended, 48 U.S.C. 1705, et seq. The effective date of the submerged lands transfer was December 21, 2016, the day the Patent was signed by the Governor of the CNMI.