March 15, 2019 – Federal Register Recent Federal Regulation Documents

The Office of Surface Mining Reclamation and Enforcement (OSMRE) announces its decision to adopt the U.S. Forest Service (USFS) Supplemental Final Environmental Impact Statement (SFEIS) for Federal Coal Lease Modifications COC-1362 and COC-67232 (including on-lease exploration plan) at the West Elk Mine located in Gunnison County, CO. In accordance with Section 102 of the National Environmental Policy Act of 1969 (``NEPA''), the Council on Environmental Quality's (``CEQ'') regulations implementing NEPA, and other applicable authorities, OSMRE has conducted an independent review and evaluation of the USFS's SFEIS for Federal Coal Lease Modifications COC-1362 and COC-67232 (including on-lease exploration plan) at the West Elk Mine dated August 2017. As a cooperating agency with responsibility for the Federal Lands Program and the preparation of mining plan decision documents for review by the Assistant Secretary for Land and Minerals Management (ASLM), OSMRE provided subject matter expertise to the USFS during the environmental review process. Based on its independent review and evaluation, OSMRE has determined the SFEIS, including all supporting documentation, as incorporated by reference, adequately assesses and discloses the environmental impacts for the mining plan modification, and that adoption of the 2017 SFEIS by OSMRE is authorized under 40 CFR 1506.3, Adoption. Accordingly, OSMRE adopts the 2017 SFEIS, and takes full responsibility for the scope and content that addresses the proposed mining plan modification at West Elk Mine. Documents are available on OSMRE's website: https://www.wrcc.osmre.gov/ westElkMine.shtm.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding value engineering requirements.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; the accuracy of the 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 the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use through May 31, 2019. DoD proposes that OMB extend its approval for use for three additional years beyond the current expiration date.

The U.S. Nuclear Regulatory Commission (NRC) has issued an amendment to Facility Operating License No. NPF-86, issued to NextEra Energy Seabrook, LLC, for operation of the Seabrook Station, Unit No. 1. The amendment revised the Facility Operating License and Updated Final Safety Analysis Report to adopt a methodology for the analysis of seismic Category I structures with concrete affected by alkali-silica reaction.

The U.S. Department of Commerce Trade Finance Advisory Council (TFAC or the Council) will hold a meeting on Wednesday, March 27, 2019, at the U.S. Department of Commerce, in Washington, DC. The meeting is open to the public with registration instructions provided below.

In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service (Service), are proposing to renew an information collection.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public, limited only by the space available. The meeting room accommodates up to 80 people. Public participants should pre-register for the meeting as described below. Members of the public that wish to attend this meeting in person should pre-register by submitting the following information by email, facsimile, or phone (see Contact Person for More Information) no later than 12:00 noon (EDT) on Thursday, April 18, 2019:

HHS gives notice of a decision to designate a class of employees from the Y-12 Plant in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). This meeting is open to the public, limited only by the space available. The meeting room will accommodate up to 60 people. The public is also welcome to listen to the meeting by telephone, limited only by the number of ports available (100). Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is Monday, April 15, 2019. Persons who desire to make an oral statement, may request it at the time of the public comment period on April 16, 2019 at 3:20 p.m. EDT.

NMFS is prohibiting directed fishing for Pacific cod by vessels using jig gear in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2019 Pacific cod total allowable catch apportioned to vessels using jig gear in the Western Regulatory Area of the GOA.

NMFS has received a request from the U.S. Navy (Navy) for authorization to take marine mammals incidental to training and testing activities conducted in the Mariana Islands Training and Testing (MITT) Study Area for a period of seven years, from August, 2020 through August, 2027. Pursuant to regulations implementing the Marine Mammal Protection Act (MMPA), NMFS is announcing receipt of the Navy's request for the development and implementation of regulations governing the incidental taking of marine mammals. NMFS invites the public to provide information, suggestions, and comments on the Navy's application and request.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.'' This guidance outlines nonclinical studies recommended for the development of pharmaceuticals used to treat patients with severely debilitating or life-threatening hematologic disorders (SDLTHDs) and addresses comments received to the docket. This guidance is intended to streamline the development of pharmaceuticals used to treat patients with SDLTHDs, other than cancer, while protecting patients' safety and avoiding unnecessary use of animals, in accordance with the 3R (reduce, refine, replace) principles. This guidance applies to pharmaceuticals used both to treat the active disease and to prevent the recurrence of a life-threatening or debilitating event.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``A Risk- Based Approach to Monitoring of Clinical Investigations: Questions and Answers.'' The draft guidance provides information to sponsors on risk- based approaches to monitoring of investigational studies of human drug and biological products, medical devices, and combinations thereof. This guidance expands on the guidance for industry entitled ``Oversight of Clinical InvestigationsA Risk-Based Approach to Monitoring'' (August 2013) (the RBM Guidance) by providing additional guidance to facilitate sponsors' implementation of risk-based monitoring.

The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.

In a decision served on March 11, 2019, the Board proposed to adopt 1.005 (0.5% per year) as the measure of average (geometric mean) change in railroad productivity for the 2013-2017 (five-year) period. This represents an increase of 0.9% from the average for the 2012-2016 period. The Board's March 11, 2019 decision in this proceeding stated that comments may be filed addressing any perceived data and computational errors in the Board's calculation. The decision also stated that unless a further order is issued postponing the effective date, this decision is effective on March 29, 2019.

The U.S. Copyright Office is announcing the release of a public draft of an update to its administrative manual, the Compendium of U.S. Copyright Office Practices, Third Edition. The update has been released in draft form to give the public an opportunity to review and provide comments on the revisions.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Oil and Natural Gas Production and Natural Gas Transmission and Distribution (EPA ICR Number 2437.04, OMB Control Number 2060-0673), 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 May 30, 2018 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 National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of 10 draft skin notation profile documents now available for public comment entitled: