October 3, 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access.'' The purpose of the public workshop is to provide an overview of current regulatory science initiatives related to generic topical dermatological drug products, solicit public input on scientific barriers that may limit patient access to such drug products, and discuss approaches to overcome/ address any such barriers. FDA is seeking public input from a variety of stakeholders, including industry, academia, patient advocates, and professional associations.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a briefing meeting of the Delaware Advisory Committee to the Commission will convene at 9:00 a.m. (EDT) on Wednesday, November 1, 2017 at Widener University Delaware Law School, 4601 Concord Pike, Wilmington DE 19803-0406. The purpose of the briefing is to hear from government officials, advocates, and others on Policing in Communities of Color and Implicit Bias in Delaware.

The Coast Guard is establishing a temporary safety zone for certain waters of the Patapsco River, Northwest Harbor and Inner Harbor. This action is necessary to provide for the safety of life on the navigable waters at Baltimore, MD, during the movement of the historic sloop-of-war USS CONSTELLATION on October 26, 2017. If necessary, due to inclement weather, the event will be rescheduled for October 27, 2017. This action will prohibit persons and vessels from entering the safety zone unless authorized by the Captain of the Port MarylandNational Capital Region.

The Pacific Fishery Management Council's (Pacific Council) Salmon Technical Team (STT) and Science and Statistical salmon subcommittee (SSC-Salmon) will hold a joint one-day methodology review meeting via webinar, which is open to the public.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) has determined that SPECTAZOLE (econazole nitrate) topical cream, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Coast Guard is establishing a special local regulation for all navigable waters of the Cumberland River from mile marker (MM) 190.0 to MM 195.0. This action is necessary to provide for the safety of life on these navigable waters near Nashville, TN during the Music City Head Race. Entry into, transiting through, or anchoring within this regulated area is prohibited unless authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 29, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Sharp Corporation of Japan and Sharp Electronics Corporation of Montvale, New Jersey. Supplements to the complaint were filed on August 30, 2017 and September 21, 2017. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain Wi-Fi enabled electronic devices and components thereof by reason of infringement of certain claims of U.S. Patent No. 8,325,838 (``the '838 patent'') and U.S. Patent No. 8,279,809 (``the '809 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

This notice announces the public meeting via conference call of the Saint Lawrence Seaway Development Corporation Advisory Board.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.

The Environmental Protection Agency (EPA) proposes to approve, as a state implementation plan (SIP) revision, the 2011 base year inventory for the Baltimore, Maryland moderate nonattainment area for the 2008 8-hour ozone national ambient air quality standard (NAAQS) submitted by the State of Maryland through the Maryland Department of the Environment (MDE). In the Final Rules section of this issue of the Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A more detailed description of the state submittal and EPA's evaluation is included in a technical support document (TSD) prepared in support of this rulemaking action. A copy of the TSD is available, upon request, from the EPA Regional Office listed in the ADDRESSES section of this document or is also available electronically within the Docket for this rulemaking action. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

The Coast Guard is establishing a temporary safety zone for one mile of navigable waters of the Roanoke River in Plymouth, North Carolina. This temporary safety zone is intended to restrict vessel traffic from a portion of the Roanoke River during the Virginia Outlaw Drag Boat Association End of the Year Showdown high speed boat race. This action is intended to restrict vessel traffic movement in the regulated area to protect participants, spectators, and property from the hazards posed by high speed boat races. Entry of vessels or persons into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP), North Carolina or a designated representative.

The following public hearing on proposed amendments to the Federal Rules of Criminal Procedure has been canceled: Criminal Rules Hearing on October 24, 2017, in Chicago, Illinois.