October 30, 2018 – Federal Register Recent Federal Regulation Documents

The Federal Mine Safety and Health Act of 1977 and the Code of Federal Regulations govern the application, processing, and disposition of petitions for modification. This Federal Register notice notifies the public that MSHA has investigated and issued a final decision on certain mine operator petitions to modify a safety standard.

This notice is to advise interested persons that on Tuesday, November 13, 2018, OSHA will conduct a public meeting to discuss proposals in preparation for the 36th session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS) to be held December 5 through December 7, 2018, in Geneva, Switzerland. OSHA, along with the U.S. Interagency Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Coordinating Group, plans to consider the comments and information gathered at this public meeting when developing the U.S. Government positions for the UNSCEGHS meeting. OSHA also will give an update on the Regulatory Cooperation Council (RCC). Also on Tuesday, November 13, 2018, the Department of Transportation (DOT), Pipeline and Hazardous Materials Safety Administration (PHMSA) will conduct a public meeting (See Docket No. PHMSA-2018-0024 Notice No. 2018-11) to discuss proposals in preparation for the 54th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCE TDG) to be held November 26 through December 4, 2018, in Geneva, Switzerland. During this meeting, PHMSA is also requesting comments relative to potential new work items that may be considered for inclusion in its international agenda. PHMSA will also provide an update on recent actions to enhance transparency and stakeholder interaction through improvements to the international standards portion of its website.

The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to receive suggestions and comments from interested parties (including academic institutions, regulated industry, and patient groups) on the Agency's publication of the surrogate endpoint table (SE table). FDA has developed a web page, available at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ DevelopmentResources/ucm613636.htm that displays the SE table, describes the purpose of the table, and provides additional background information. Comments received on the SE table will help FDA determine its utility and may assist FDA in developing future iterations of the SE table and identifying best methods for conveying information about SEs on the FDA's website.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0088, Voyage Planning for Tank Barge Transits in the Northeast United States. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry.'' This guidance is intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma products in the United States. The draft guidance document provides considerations for the successful development and licensing of dried plasma products and for the approval of devices used to manufacture dried plasma. The guidance includes recommendations on optimal sources of input plasma; manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions.

The Food and Drug Administration (FDA or we) invites data and other information on the prevalence and severity of sesame allergies in the United States and the prevalence of sesame-containing foods sold in the United States that are not required to disclose sesame as an ingredient. We are taking this action to inform possible regulatory action on sesame to protect and promote the public health.

The Environmental Protection Agency (EPA) is granting final authorization to the hazardous waste program revisions submitted by North Dakota on September 20, 2016 and March 24, 2017. The EPA published a proposed rule on June 5, 2018, and provided for public comment. The comment period ended on July 5, 2018. No comments were received for this rulemaking. No further opportunity for comment will be provided. This final rule also codifies and incorporates by reference the authorized provisions of the North Dakota regulations in the Code of Federal Regulations.

The Environmental Protection Agency (EPA or the ``Agency'') has reviewed changes to the North Dakota Air Pollution Control Rules. Concluding review of those changes, the EPA is proposing interim approval of revisions to the North Dakota operating permit program for stationary sources subject to title V of the Clean Air Act (CAA or the ``Act'') and recodification of the title V program under a new title of the North Dakota Administrative Code (NDAC). This document also proposes approval of North Dakota's revision and recodification of the State's programs for implementing and enforcing delegated requirements under certain sections of the Act, and consequentially the means for the Agency's proposed approval of a revised delegation arrangement between the EPA and the State of North Dakota for transfer of authority to regulate sources under those sections. Upon final approval of this rulemaking action North Dakota will receive delegation of authority to implement and enforce CAA section 111 New Source Performance Standards (NSPS) and section 112 National Emission Standards for Hazardous Air Pollutants (NESHAP), including Maximum Achievable Control Technology (MACT) requirements within the state, excluding Indian country, exactly as the requirements were promulgated by EPA (i.e., ``straight delegation''). Straight delegation of sections 111 and 112 authorities does not include those authorities reserved by the EPA Administrator or otherwise reserved by the EPA, nor the authority to implement and enforce regulations not incorporated unchanged into state code, and does not include those regulations unincorporated by North Dakota and omitted from the State's request for delegation. Upon finalization of this rulemaking, North Dakota will also continue to be eligible for future automatic delegation of incorporated, unchanged federal requirements, without need for request of Agency approval on a case-by- case basis. The proposed action effects the transfer of title V program administration and delegated authority to implement and enforce sections 111 and 112 requirements from the North Dakota Department of Health (NDDH) to the newly created North Dakota Department of Environmental Quality (NDDEQ or the ``Department''). The EPA is taking these actions pursuant to sections 501-506, 111 and 112 of the Act.

The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption for prior NRC approval of any departure from Tier 2* information or any departure from Tier 2 information that involves a change to or departure from Tier 2* information, provided that specified criteria are not met, and is issuing License Amendment Nos. 142 and 141 to Combined Licenses (COLs) NPF-91 and NPF-92, respectively. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, and the City of Dalton, Georgia (collectively SNC); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia. The granting of the exemption allows the imposition of License Condition 2.D.13 asked for in the amendment request. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.

The invention listed below is jointly owned by an agency of the U.S. Government with Pontificia Universidad Catolica de Chile and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Department of Defense is publishing the unclassified text of an arms sales notification.

The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

Notice is hereby given that a public meeting will be held for the purpose of providing information and receiving comments on the preliminary recommendation by the State of Connecticut that portions of the Lower Connecticut River and Eastern Long Island Sound be proposed to NOAA for designation as a National Estuarine Research Reserve. The public meeting will be held at 6 p.m. on November 13, 2018 in the Academic Building Auditorium at the University of Connecticut's Avery Point campus, located at 1084 Shennecossett Rd, Groton, CT 06340. The state agencies holding the meeting: The Connecticut Department of Energy and Environmental Protection's Coastal Management Program; the University of Connecticut; and Connecticut Sea Grant. NOAA's Office for Coastal Management will assist with the meeting. The proposed research reserve site is comprised of the following state-owned properties: Lord Cove Wildlife Management Area; Great Island Wildlife Management Area; Bluff Point State Park and Coastal Reserve and Natural Area Preserve; Haley Farm State Park; and the public trust portions of waterbodies defined by: (a) Long Island Sound ranging approximately west to east from the mouth of the Connecticut River to Mason's Island and north to south waterward of the mean high water shoreline to just shy of the Connecticut state boundary in Long Island Sound; (b) the area waterward of the mean high shoreline of the lower Thames River from approximately the Gold Star Bridge south to the area described in (a); (c) the area waterward of the mean high shoreline of the lower Connecticut River from approximately Lord Cove south to the area described in (a). The views of interested persons and organizations regarding the proposed site recommendation are solicited. This information may be expressed orally and in written statements. A presentation about the proposed site and the National Estuarine Research Reserve System will be provided. Written comments may be also be sent to: Kevin O'Brien, Connecticut Department of Energy and Environmental ProtectionLand & Water Resources Division, 79 Elm Street, Hartford, CT 06106-5127 or to: kevin.obrien@ct.gov. All written comments must be received no later than seven calendar days following the public meeting. All comments received will be considered by the State in formally nominating a site to NOAA. The research reserve system is a federal and state partnership program administered by the federal government, specifically the National Oceanic and Atmospheric Administration (NOAA). The research reserve system currently has 29 sites and protects more than 1.3 million acres of estuarine and Great Lakes habitat for long-term research, monitoring, education, and stewardship. Established by the Coastal Zone Management Act of 1972, each reserve is managed by a lead state agency or university, with input from local partners. NOAA provides partial funding and national programmatic guidance. This particular site selection effort is a culmination of several years of local, grassroots-support for a research reserve site in Connecticut. The preliminary site recommendation follows a comprehensive evaluation process that sought the views of the public, affected landowners, and other interested parties. State and local agency representatives, as well as estuarine experts, served as committee members and evaluated site proposals. The committee is recommending the Lower Connecticut River and Eastern Long Island Sound as the preferred site for the state to nominate to NOAA.

The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collections described below (3064-0121 and 3064-0135). On August 20, 2018, the FDIC requested comment for 60 days on a proposal to renew the information collections described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these information collections, and again invites comment on these renewals.

Under the Paperwork Reduction Act of 1995 (PRA), this notice announces that FRA is forwarding the Information Collection Requests (ICRs) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICRs describe the information collections and their expected burden. On August 1, 2018, FRA published a notice providing a 60-day period for public comment on the ICRs.

This action changes the effective date of a final rule published in the Federal Register on September 7, 2018, amending VHF Omnidirectional Range (VOR) Federal airways V-72 and V-429 in the vicinity of Mattoon and Charleston, IL. The FAA is delaying the effective date to coincide with the expected completion and flight check of enroute and terminal procedures associated with the planned decommissioning of the Mattoon, IL, VOR.