May 2018 – Federal Register Recent Federal Regulation Documents

The Coast Guard proposes to establish a temporary safety zone for certain navigable waters of Cooper River at Patriot's Point in Charleston, SC. This action is necessary to provide for the safety of the general public, spectators, vessels, and the marine environment from potential hazards during a fireworks display. This proposed rulemaking would prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Charleston (COTP) or a designated representative. We invite your comments on this proposed rulemaking.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.'' This guidance provides recommendations to industry for establishing the clinical effectiveness of drugs for the treatment of acne vulgaris (acne). This guidance finalizes the draft guidance for industry entitled ``Acne Vulgaris: Developing Drugs for Treatment,'' issued September 19, 2005.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Bioanalytical Method Validation.'' This final guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.

The Board of Overseers of the Malcolm Baldrige National Quality Award (Board of Overseers) and the Judges Panel of the Malcolm Baldrige National Quality Award (Judges Panel) will meet in open session on Thursday, June 7, 2018, from 8:30 a.m. to 3:00 p.m. Eastern time. The Board of Overseers, appointed by the Secretary of Commerce, reports the results of the Malcolm Baldrige National Quality Award (Award) activities to the Director of the National Institute of Standards and Technology (NIST) each year, along with its recommendations for the improvement of the Award process. The Judges Panel, also appointed by the Secretary of Commerce, ensures the integrity of the Award selection process and recommends Award recipients to the Secretary of Commerce. The purpose of this meeting is to discuss and review information received from the National Institute of Standards and Technology and from the Chair of the Judges Panel. The agenda will include: Baldrige Program News, Alliance for Performance Excellence Update, Baldrige Foundation Update, Report from the Baldrige Judges Panel, Ethics Review, Baldrige Enterprise Planning, Award Process Redesign, Proposal to Expand Award Categories, and New Business/Public Comment.

The National Institute of Standards and Technology (NIST), U.S. Department of Commerce, is contemplating the grant of an exclusive license throughout the world, to NIST's interest in the invention embodied in PCT Application PCT\US18\20679, titled ``Non-resonant Electron Spin Resonant Probe and Associated Hardware'' (NIST Docket 17- 017) to Global Resonance Technologies, LLC. The grant of the license would be for the manufacture and use of a system for determination of radiation dosimetry.

The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, is establishing the Metrology of Additive Construction by Extrusion (MACE) Consortium and invites organizations to participate in this Consortium. The Consortium will study the measurement science needs for the successful adoption of additive manufacturing by the construction industry. Participation in this Consortium is open to all eligible organizations, as described below. Participants will be required to sign a Cooperative Research and Development Agreement (CRADA).

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 60 days of public comment.

The Coast Guard proposes to modify the Marine Air Terminal, LaGuardia Airport Security Zone. The modification of the security zone would expand the existing security zone boundary north along the Rikers Island Bridge to the intersecting point on the southern tip of Rikers Island then east to the western end of LaGuardia Airport. This expanded security zone is necessary to protect the port, waterfront facilities, and waters of the United States from terrorism, sabotage, or other subversive acts and incidents of a similar nature during visits to New York City by various dignitaries. We invite your comments on this proposed rulemaking.

The New England Fishery Management Council (Council, NEFMC) will hold a three-day meeting to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

The Pacific Fishery Management Council's (Pacific Council) Coastal Pelagic Species Advisory Subpanel (CPSAS) and Coastal Pelagic Species Management Team (CPSMT) will hold a meeting via webinar that is open to the public.

The Pacific Fishery Management Council (Pacific Council) and its advisory entities will hold public meetings.

The Coast Guard announces that the U.S. Coast Guard First District Prevention Department has issued a certificate of alternative compliance from the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), for the TUG EXPORTER, Washburn & Doughty Hull 122. We are issuing this notice because its publication is required by statute. Due to the construction and placement of the vessel's side lights, TUG EXPORTER cannot fully comply with the light, shape, or sound signal provisions of the 72 COLREGS without interfering with the vessel's design and construction. This notification of issuance of a certificate of alternative compliance promotes the Coast Guard's marine safety mission.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

On March 1, 2018, the Department of Commerce (Commerce) published the preliminary results of the administrative review of the antidumping duty order on stainless steel bar (SSB) from Brazil. The period of review (POR) is February 1, 2016, through January 31, 2017. For the final results of this review, we continue to find that Villares Metals S.A. (Villares) has not made sales of subject merchandise at less than normal value during the POR.

Matador Power Marketing, Inc. (Matador or Applicant) has applied for authority to transmit electric energy from the United States to Canada pursuant to the Federal Power Act.

The Department of Energy (DOE) has submitted to the Office of Management and Budget (OMB) for clearance, a proposal for collection of information under the provisions of the Paperwork Reduction Act of 1995. The proposed collection, titled the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Commercialization Survey will satisfy the program requirements of the Small Business Act, including requirements established in the SBIR program reauthorization legislation. DOE will collect the survey data via web-enabled software and provide it to the Small Business Administration (SBA) to maintain information about the DOE SBIR/STTR awards issued through the two programs. This data will be provided by DOE based on information collected from SBIR/STTR awardees. This data will be used by DOE, SBA, and Congress to assess the commercial impact of these two programs. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, please advise the DOE Desk Officer at OMB of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at 202-395-1254 or emailed at james.n.tyree@omb.eop.gov.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Monmouth County Highway Bridge (alternatively referred to as the ``Sea Bright Bridge'' or the ``S-32 Bridge'') across the Shrewsbury River, mile 4.0, at Sea Bright, New Jersey. This deviation will test a proposed change to the drawbridge operation schedule to determine whether a permanent change to the schedule is warranted. This deviation will allow the bridge to operate under an alternate schedule that seeks to balance the seasonally high volume of roadway traffic crossing the bridge during peak hours with the existing needs of marine traffic.