October 25, 2017 – Federal Register Recent Federal Regulation Documents

Harley-Davidson Motor Company, Inc. (Harley-Davidson), has determined that certain model year (MY) 2016-2017 Harley-Davidson XL 1200CX Roadster motorcycles do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 120, Tire selection and rims and motor home/recreation vehicle trailer load carrying capacity information for motor vehicles with a GVWR of more than 4,536 kilograms (10,000 pounds). Harley-Davidson filed a noncompliance information report dated November 4, 2016. Harley-Davidson also petitioned NHTSA on November 28, 2016, for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety.

Veteran's Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice.

In accordance with the Privacy Act of 1974, the Department of Homeland Security is giving notice that it proposes to rescind the Department of Homeland Security/Federal Emergency Management Agency's Privacy Act system of records notice, ``Letter of Map Amendment System (LOMA), DHS/FEMA/NFIP/LOMA-1'', 71 FR 7990 (Feb. 15, 2006), which covered applicants who were seeking a Letter of Map Amendment as part of FEMA's National Flood Insurance Program (NFIP) Letter of Map Amendment (LOMA) system.

The FHWA, on behalf of ODOT, is issuing this notice to announce actions taken by ODOT that are final. The actions relate to the proposed modification of the existing interchange at Interstate Route 71 (I-71), United States Route 36 (US-36), and State Route 37 (SR-37) in the County of Delaware, State of Ohio. Those actions grant licenses, permits, and approvals for the project.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Deciding When to Submit a 510(k) for a Change to an Existing Device.'' FDA is issuing this final guidance document to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. This guidance document supersedes ``Deciding When to Submit a 510(k) for a Change to an Existing Device,'' issued January 10, 1997. FDA is correcting an error in the docket number assigned to the ``Deciding When to Submit a 510(k) for a Change to an Existing Device'' notice of availability when it published in the Federal Register (81 FR 52443, August 8, 2016). The docket number currently is FDA-2016-D-2021. FDA is changing the docket number to FDA-2011-D-0453. This action is administrative in nature and is being taken to avoid any potential confusion in the docket.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff.'' This guidance document describes policies that FDA intends to use to implement the new Breakthrough Devices Program, established by the 21st Century Cures Act (Cures Act). The Breakthrough Devices Program supersedes and combines elements from FDA's Expedited Access Pathway (EAP), which was intended to facilitate the development and expedite review of breakthrough technologies, as well as the Priority Review Program, which implemented statutory criteria for granting priority review to premarket approval applications (PMAs) and applied those criteria to other types of premarket submissions for medical devices. This draft guidance clarifies certain principles and features of the new program, the designation criteria for Breakthrough Devices, the designation request review process, the process for withdrawing from the program, as well as the recommended information device manufacturers should provide in their designation request for entrance into the program. This draft guidance is not final nor is it in effect at this time.

The purpose of this notice is to request public nominations on the North Slope Science Initiative (NSSI) 15-member Science Technical Advisory Panel (Panel). The Panel advises the NSSI Oversight Group on technical issues such as identifying and prioritizing inventory, monitoring, and research needs across the North Slope of Alaska and the adjacent marine environment.

The North Pacific Fishery Management Council (Council) Groundfish Plan Team will meet November 13 through November 17, 2017.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 30 days of public comment.

HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for 30 days of public comment.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 30 days of public comment.

This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

The U.S. Nuclear Regulatory Commission (NRC) is correcting a notice that was published in the Federal Register (FR) on October 13, 2017 regarding submission of the renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, ``Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste and Reactor-Related Greater than Class C Waste.'' This action is necessary to correct the burden hours.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of the Animal Drug User Fee Act (ADUFA) reauthorization draft recommendations and extending the comment period to allow interested persons 30 days to submit comments on these draft recommendations.

The Office of Fossil Energy (FE) of the Department of Energy gives notice that during July 2017, it issued orders under section 3 of the Natural Gas Act, 15 U.S.C. 717b, as summarized in the attached appendix. These orders may be found on the FE Web site at https:// energy.gov/fe/listing-doefe-authorizationsorders-issued-2017. They are also available for inspection and copying in the U.S. Department of Energy (FE-34), Division of Natural Gas Regulation, Office of Regulation and International Engagement, Office of Fossil Energy, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

This is a notice of the Presidential declaration of an emergency for the State of Florida (FEMA-3395-EM), dated October 8, 2017, and related determinations.

This notice provides the Performance Review Board Standing Register for the Department of Energy. This listing supersedes all previously published lists of PRB members.

Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.

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