2016 – Federal Register Recent Federal Regulation Documents

The U.S. Nuclear Regulatory Commission (NRC) has issued combined license numbers NPF-99 and NPF-100 to Duke Energy Florida, LLC (DEF) for Levy Nuclear Plant Units 1 and 2 (LNP Units 1 and 2). In addition, the NRC has prepared a Summary Record of Decision (ROD) that supports the NRC's decision to issue combined license numbers NPF-99 and NPF-100.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a reinstatement of a previously approved information collection.

The Bureau of Land Management (BLM) has examined and found suitable for classification for lease to the Maricopa County Parks and Recreation Department (MCPRD) under the provisions of the Recreation and Public Purposes (R&PP) Act, as amended (43 U.S.C. 869 et seq.), approximately 1,046.24 acres of public land in Maricopa County, Arizona. The MCPRD proposes to use the land for recreation purposes. Related improvements include picnic and camping facilities, restrooms, trailheads, developed day use facilities, and parking.

This notice announces the members of the Senior Executive Service Performance Review Board (PRB) for the Gulf Coast Ecosystem Restoration Council as required by 5 U.S.C. 4314(c)(4). The PRB is comprised of a Chairperson and a mix of career Federal senior executives and State members from the Council. The PRB meets annually to review and evaluate performance appraisal documents and provides a written recommendation to the Secretary for final approval of each executive's performance rating, performance-based pay adjustment, and performance award.

This notice announces the members of the Senior Executive Service and Senior Level and Scientific or Professional Performance Review Boards (PRB), as required by 5 U.S.C. 4314(c)(4). Agriculture has six PRBs: the Office of the Secretary; Departmental Management and Staff Offices; Marketing and Regulatory Programs and Food Safety; Farm and Foreign Agricultural Services; Food, Nutrition and Consumer Services; and Rural Development; Natural Resources and Environment; and Research, Education and Economics. Each PRB is comprised of a Chairperson and a mix of career and noncareer senior executives that meet annually to review and evaluate performance appraisal documents and provide a written recommendation to the Secretary for final approval of each executive's performance rating, performance-based pay adjustment, and performance award.

In a final rule published in the Federal Register on August 30, 2016, and effective on October 31, 2016, we amended the Virus- Serum-Toxin Act regulations to make veterinary biologics labeling requirements more consistent with current science and veterinary practice. However, we inadvertently removed a requirement for an indications statement that should appear on final container labels, carton labels, and enclosures. This document corrects that error.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Ninth Annual Sentinel Initiative Public Workshop.'' Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this 1- day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of FDA's Sentinel Initiative, including an overview of the current state of Sentinel System safety surveillance activities, and uses of the Sentinel System accomplished in 2016. In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel Initiative projects.

The Food and Drug Administration (FDA or Agency) has determined that CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for verapamil hydrochloride extended-release oral tablet, 180 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.'' This draft guidance contains 15 sections of a multisection guidance intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. Sec. 552b, as amended), and 41 CFR Sec. 102- 3.150, the Department of Defense announces that the following Federal advisory committee meeting will take place.

As required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-21 (PRA), the Surface Transportation Board (STB or Board) gives notice of its intent to seek approval from the Office of Management and Budget (OMB) for an extension of the collection of Class I Railroad Annual Reports, described below. The Board previously published a notice about this collection in the Federal Register. 81 FR 47486 (July 21, 2016). That notice allowed for a 60-day public review and comment period. No comments were received.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that Novus International, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of poly (2- vinylpyridine-co-styrene) as a nutrient protectant for methionine hydroxy analog in animal food for beef cattle, dairy cattle, and replacement dairy heifers. Additionally, the petition proposes that the food additive regulations be amended to provide for the safe use of ethyl cellulose as a binder for methionine hydroxy analog to be incorporated into animal food.

We, the U.S. Fish and Wildlife Service (Service), have received an application from Kamehameha Schools (KS), a private charitable education trust, for an enhancement of survival permit (permit) under the Endangered Species Act of 1973, as amended (ESA). The permit application includes a draft Safe Harbor Agreement (SHA) between KS, the Service, and the Hawaii Department of Land and Natural Resources (DLNR). Kamehameha Schools is proposing to conduct proactive conservation activities to promote the survival and recovery of 32 federally endangered species and one species currently proposed for listing (``covered species'') across the Keauhou and Kilauea Forest Lands, which comprise 32,280 acres on the southeastern slope of Mauna Loa, Hawaii Island. We invite comments from all interested parties on the permit application, including the draft SHA and a draft environmental action statement (EAS) prepared pursuant to the requirements of the National Environmental Policy Act (NEPA).

Public notice is hereby given that the National Park Service proposes to award a sole-source concession contract for the conduct of certain visitor services within Lake Mead National Recreation Area (Lake Mead NRA) for a term not to exceed five (5) years. The visitor services include the provision of wireless Internet access within remote but developed areas of Lake Mead NRA.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non- profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SDSP template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDSP template for regulatory submissions.

The U.S. Nuclear Regulatory Commission (NRC) is withdrawing Regulatory Guide (RG) 5.3, ``Statistical Terminology and Notation for Special Nuclear Materials Control and Accountability,'' that was issued in 1973. This document is being withdrawn in part because regulatory guidance is not needed for common statistical terminology and notation information that is commonly used in the field of statistics. Further, RG 5.3 provided guidance on the term ``limits of error'' as defined in the NRC's regulations. This term is no longer a defined regulatory term and is no longer used by the NRC except in certain transaction reports. Also, RG 5.3 endorsed a 1972 American National Standards Institute (ANSI) standard that was later withdrawn. Therefore, the NRC finds that RG 5.3 is obsolete.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

PHMSA is seeking nominations for individuals to serve as members for three-year terms on the Voluntary Information-Sharing System (VIS) Working Group. This is a newly created working group established in accordance with section 10 of the Protecting our Infrastructure of Pipelines and Enhancing Safety (PIPES) Act of 2016 (Pub. L. 114-183), the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., App. 2, as amended), and 41 CFR 102-3.50(a). The Secretary of Transportation (Secretary) must convene a working group by December 19, 2016 to consider the development of a voluntary information-sharing system to encourage collaborative efforts to improve inspection information feedback and information sharing with the purpose of improving gas transmission and hazardous liquid pipeline facility integrity risk analysis. PHMSA intends to comply with section 10 of the PIPES Act of 2016 by convening a working group by December 19, 2016.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501- 3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

This document proposes revisions to Wireless Emergency Alert (WEA) rules to improve WEA, leveraging advancements in technology to improve WEA's multimedia, multilingual and geo-targeting capabilities, as well as lessons learned from alert originators' experience since WEA was initially deployed. This document also proposes steps to improve the availability of information about WEA, both to empower consumers to make informed choices about the emergency information that they will receive, as well as to promote transparency for emergency management agencies and other WEA stakeholders. By this action, the Commission affords interested parties an opportunity to participate more fully in WEA, and to enhance the utility of WEA as an alerting tool.

The Commission hereby gives notice of the scheduling of full reviews pursuant to the Tariff Act of 1930 (``the Act'') to determine whether revocation of the antidumping duty orders on frozen warmwater shrimp from Brazil, China, India, Thailand, and Vietnam would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. The Commission has determined to exercise its authority to extend the review period by up to 90 days.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.