February 11, 2019 – Federal Register Recent Federal Regulation Documents

The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of amendments to licenses held by Tennessee Valley Authority (TVA, the licensee) for the operation of Watts Bar Nuclear Power Plant (WBN), Units 1 and 2. The proposed amendments would revise the WBN, Unit 2 Technical Specification (TS) 4.2.1, Fuel Assemblies, to add a limit on the number of tritium producing burnable absorber rods (TPBARs) that can be irradiated. This license amendment request also provides proposed changes to the WBN, Units 1 and 2 TSs related to the new criticality analyses performed for the spent fuel storage racks. The NRC is issuing an environmental assessment (EA) and finding of no significant impact (FONSI) associated with the proposed license amendments.

In accordance with the Paperwork Reduction Act of 1995, PHMSA invites comments on certain information collections that are due to expire in 2019. PHMSA will request an extension with no change for the information collections identified by the Office of Management and Budget (OMB) control numbers 2137-0610, 2137-0624, and 2137-0625, which are due to expire on April 30, 2019. PHMSA will also request an extension with no change for the information collection identified by OMB Control number 2137-0589, which is due to expire on 7/31/2019.

On January 19, 2017, the U.S. Department of Energy (DOE) published two final rules adopting revised definitions of general service lamp (GSL), general service incandescent lamp (GSIL) and other supplemental definitions, effective January 1, 2020. DOE has since determined that the legal basis underlying those revisions misconstrued existing law. As a result, DOE is issuing this notice of proposed rulemaking (NOPR) proposing to withdraw the definitions established in the January 19, 2017, final rules. DOE proposes to maintain the existing regulatory definitions of GSL and GSIL, which are the same as the statutory definitions of those terms.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXONDYS 51 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Nonmetallic Mineral Processing (EPA ICR No. 1084.14, OMB Control No. 2060-0050), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through March 31, 2019. Public comments were previously requested, via the Federal Register, on June 29, 2017 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 neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Beverage Can Surface Coating (EPA ICR No. 0663.13, OMB Control No. 2060-0001), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through March 31, 2019. Public comments were previously requested, via the Federal Register, on June 29, 2017 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 neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The Department of the Army intends to prepare an Environmental Impact Statement (EIS) to analyze potential environmental and socioeconomic impacts, and identify related mitigation measures, associated with the Army's proposal to develop, operate, and maintain a Heavy Off Road Mounted Maneuver Training Area (HOMMTA) of at least 2,400 contiguous acres at Fort Benning, Georgia to support off-road armor vehicle movement and maneuver.

The Department of Commerce (Commerce) is rescinding the administrative review of the antidumping duty order on certain oil country tubular goods from Turkey for the period September 1, 2017, through August 31, 2018.

In accordance with the Federal Advisory Committee Act, the Bureau of Indian Education (BIE) Standards, Assessments, and Accountability System Negotiated Rulemaking Committee (Committee), will hold a public meeting to continue the work to advise the Secretary of the Interior (Secretary) through the BIE on a proposed rule to revise the Adequate Yearly Progress regulation. This notice announces the date and location of a fourth in-person Committee meeting.

This notice informs the public that the Assistant Secretary Indian Affairs proclaimed approximately 19.96 acres, more or less, an addition to the reservation of the Shakopee Mdewakanton Sioux Community of Minnesota on December 21, 2018.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Development's intention to request an extension for a currently approved information collection in support of the program, Environmental Policies and Procedures.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Enhancing the Incorporation of Patient Perspectives on Clinical Trials'' and an opportunity for public comment. The workshop will be convened by the Clinical Trials Transformation Initiative (CTTI). The topic to be discussed is stakeholders' (including patients, caregivers, industry, academic researchers, and expert practitioners) perspectives on challenges and barriers to patients participating in clinical trials and best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, and post-trial followup. The workshop will result in a publicly available report from CTTI on proceedings and recommendations from discussions at the workshop. This workshop is intended to meet an FDA commitment included in the sixth authorization of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI).

We, the U.S. Fish and Wildlife Service, invite the public to comment on applications to conduct certain activities with foreign species that are listed as endangered under the Endangered Species Act (ESA). With some exceptions, the ESA prohibits activities with listed species unless Federal authorization is issued that allows such activities. The ESA also requires that we invite public comment before issuing permits for any activity otherwise prohibited by the ESA with respect to any endangered species.

The plats of survey of lands described in this notice are scheduled to be officially filed in the Bureau of Land Management (BLM), California State Office, Sacramento, California 30 calendar days from the date of this publication. The surveys, which were executed at the request of U.S. Forest Service, U.S. Fish and Wildlife Service, General Services Administration, Bureau of Indian Affairs, National Park Service and Bureau of Land Management, are necessary for the management of these lands.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The FHWA and the State of California acting by and through its Department of Transportation (Caltrans), propose renew the MOU authorizing the State's participation in the Categorical Exclusion Assignment Program. This program allows FHWA to assign to States its authority and responsibility for determining whether certain designated activities within the geographic boundaries of the State are categorically excluded from preparation of an Environmental Assessment or an Environmental Impact Statement under the National Environmental Policy Act.

This notice announces that FHWA has received and reviewed an application from the Arizona Department of Transportation (ADOT) requesting participation in the Surface Transportation Project Delivery Program (Program). This Program allows for FHWA to assign, and States to assume, responsibilities under the National Environmental Policy Act of 1969 (NEPA), and all or part of FHWA's responsibilities for environmental review, consultation, or other actions required under any Federal environmental law with respect to one or more Federal highway projects within the State. The FHWA has determined the application to be complete and developed a draft MOU with ADOT outlining how the State would implement the program with FHWA oversight. The FHWA invites the public to comment on ADOT's request, including its application and the proposed MOU, which includes the proposed assignments and assumptions of environmental review, consultation, and other activities.

The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

In compliance with the Paperwork Reduction Act of 1995, the Defense Logistics Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.