May 22, 2018 – Federal Register Recent Federal Regulation Documents
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Notice of Availability of Categorical Exclusion and Record of Decision for the Proposed West Flow Area Navigation Standard Instrument Departure Procedures at Phoenix Sky Harbor International
The FAA, Western Service Area is issuing this notice to advise the public of the availability of the Categorical Exclusion/Record of Decision (CATEX/ROD) for the Proposed West Flow Area Navigation (RNAV) Standard Instrument Departure (SID) Procedures at Phoenix Sky Harbor International Airport in Phoenix, AZ. The FAA reviewed the action and determined it to be categorically excluded from further environmental documentation.
Information Collection Being Submitted for Review and Approval to the Office of Management and Budget
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Information Collection Being Reviewed by the Federal Communications Commission
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Proposed Information Collection; Comment Request; Direct Investment Surveys: BE-15, Annual Survey of Foreign Direct Investment in the United States
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Proposed Information Collection; Comment Request; Direct Investment Surveys: BE-11, Annual Survey of U.S. Direct Investment Abroad
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Drawbridge Operation Regulation; Long Creek & Sloop Channel, Hempstead, NY
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Loop Parkway Bridge across Long Creek, mile 0.7, and Meadowbrook State Parkway Bridge across Sloop Channel, mile 12.8, both at Hempstead, New York. This deviation is necessary in order to facilitate a motorcycle ride event and allows both bridges to remain in the closed position for two hours.
Safety Zone; Marshwalk Group Independence Day Fireworks, Murrells Inlet, SC
The Coast Guard proposes to establish a temporary safety zone for certain waters of Murrells Inlet, 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.
Safety Zone; Fourth of July Fireworks Patriots Point, Charleston, SC
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.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Application Package for AmeriCorps Enrollment and Exit Forms
In accordance with the Paperwork Reduction Act of 1995, CNCS is proposing to revise an information collection.
Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment; Guidance for Industry; Availability
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.
Framework for Assessing pH-Dependent Drug-Drug Interactions; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket to assist with the development of a policy or guidance document on the assessment of pH-dependent drug-drug interactions (DDIs). In October 2017, FDA published two draft guidance documents on DDIs entitled ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies'' (In Vitro Studies Draft Guidance) and ``Clinical Drug Interaction StudiesStudy Design, Data Analysis, and Clinical Implications'' (Clinical Drug Interaction Studies Draft Guidance). These two draft guidances focus on enzyme- and transporter-based DDIs and do not include a framework to assess pH-dependent DDIs. FDA is seeking public input on best practices in the planning and evaluation of pH-dependent DDIs.
Bioanalytical Method Validation; Guidance for Industry; Availability
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.
Metro Two-Way, LLC; Notice of Hearing
This document commences a hearing to determine whether Metro Two-Way, LLC (Metro) is qualified to be and to remain a Federal Communications Commission (Commission) licensee, and as a consequence thereof, whether any or all of its licenses should be revoked, and whether its pending application should be denied. As discussed more fully below, based on the totality of the evidence, there are substantial and material questions of fact as to whether Metro repeatedly made misrepresentations to and lacked candor with the Commission in its submission of several applications in connection with various Wireless Radio Service authorizations.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
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.
Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year; Corrections
This document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 16, 2017 entitled ``Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year'' (hereinafter referred to as the ``CY 2018 Quality Payment Program final rule'').
Board of Overseers of the Malcolm Baldrige National Quality Award and Judges Panel of the Malcolm Baldrige National Quality Award
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.
Termination of a Selected National Voluntary Laboratory Accreditation Program (NVLAP) Service
The Chief of the National Institute of Standards and Technology's (NIST) National Voluntary Laboratory Accreditation Program (NVLAP) announces the termination of the Chemical Calibration: Certifiers of Spectrophotometric NIST Traceable Reference Materials (NTRMs) Program offered by NVLAP. The Chemical Calibration: Certifiers of Spectrophotometric NTRMs Program comprised laboratories that designed, prepared, characterized, certified and distributed NTRM filter reference materials.
Prospective Grant of Exclusive Patent License
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.
Judges Panel of the Malcolm Baldrige National Quality Award
The Judges Panel of the Malcolm Baldrige National Quality Award (Judges Panel) will meet on Wednesday, June 6, 2018, from 9:00 a.m. to 3:30 p.m. Eastern time. The purpose of this meeting is to discuss and review the role and responsibilities of the Judges Panel and information received from the National Institute of Standards and Technology (NIST) in order to ensure the integrity of the Malcolm Baldrige National Quality Award (Award) selection process. The agenda will include: Judges Panel roles and processes; Baldrige Program updates; new business/public comment; lessons learned from the 2017 judging process; and the 2018 Award process. A portion of this meeting is closed to the public in order to protect the proprietary data to be examined and discussed.
NIST Consortium for Metrology of Additive Construction by Extrusion (MACE)
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).
Proposed Agency Information Collection Activities; Comment Request
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the Recordkeeping Requirements Associated with Changes in Foreign Investments (Made Pursuant to Regulation K) (FR 2064; OMB No. 7100-0109).
Implementation of the Tribal HUD-VA Supportive Housing Program
On October 21, 2015, HUD published in the Federal Register a Notice that established the policies and procedures for the administration of a supportive housing and rental demonstration called ``Implementation of the Tribal HUD-VA Supportive Housing Program'' (Tribal HUD-VASH). The program provides rental assistance and supportive services to Native American veterans who are Homeless or At Risk of Homelessness living on or near a reservation or other Indian areas. HUD also issued technical corrections in the Federal Register on December 6, 2016 to clarify the program's intent and address various issues that arose during the implementation of the program. Today's Federal Register Notice consolidates all Tribal HUD-VASH program requirements in one Notice and supersedes the prior Notices. This Notice also establishes HUD's procedures for issuing renewal funding, subject to the availability of future appropriations.
60-Day Notice of Proposed Information Collection: Survey to Assess Operational and Capacity Status of Housing Counseling Agencies after a Disaster
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.
Foreign Futures and Options Transactions
The Commodity Futures Trading Commission (Commission or CFTC) is granting an exemption to certain member firms designated by the National Stock Exchange of India Ltd. (NSE) from the application of certain of the Commission's foreign futures and option regulations based upon substituted compliance with certain comparable regulatory and self-regulatory requirements of a foreign regulatory authority consistent with conditions specified by the Commission, as set forth herein. This Order is issued pursuant to Commission Regulation 30.10, which permit persons to file a petition with the Commission for exemption from the application of certain of the Regulations set forth in part 30 and authorizes the Commission to grant such an exemption if such action would not be otherwise contrary to the public interest or to the purposes of the provision from which exemption is sought. The Commission notes that this Order does not pertain to any transaction in swaps, as defined in Section 1a(47) of the Commodity Exchange Act (Act).
Security Zones; Dignitary Arrival/Departure and United Nations Meetings, New York, NY
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.
Notice of Public Meeting in Preparation for the Sixty-Eighth Session of the IMO's Technical Cooperation Committee Meeting and the One Hundred Twentieth Session of the IMO Council
The United States Coast Guard will conduct an open meeting in Washington, DC in preparation for the upcoming sixty-eighth session of the International Maritime Organization's (IMO) Technical Cooperation Committee Meeting and the one hundred twentieth session of the IMO Council to be held at the IMO Headquarters, London, United Kingdom, on June 18-20, 2018 and July 2-6, 2018, respectively.
New England Fishery Management Council; Public Meetings
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).
Western Pacific Fishery Management Council; Public Meetings
The Western Pacific Fishery Management Council (Council) will hold its 129th Scientific and Statistical Committee (SSC) meeting and, 173rd Council and associated meetings to take actions on fishery management issues in the Western Pacific Region.
Pacific Fishery Management Council; Public Meeting
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.
Mid-Atlantic Fishery Management Council (MAFMC); Public Meetings
The Mid-Atlantic Fishery Management Council (Council) will hold public meetings of the Council and its Committees.
Pacific Fishery Management Council; Public Meetings
The Pacific Fishery Management Council (Pacific Council) and its advisory entities will hold public meetings.
Safety Zones; Annual Events Requiring Safety Zones in the Captain of the Port Lake Michigan Zone-Michigan City Summerfest Fireworks, Lake Michigan
The Coast Guard will enforce the safety zone in 33 CFR 165.929 for the Michigan City Summerfest Fireworks on a portion of Lake Michigan on July 4, 2018. This action is necessary and intended to ensure safety of life and property on navigable waters prior to, during, and immediately after the fireworks display. During the enforcement period listed below, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated representative.
Certificate of Alternative Compliance for the TUG EXPORTER, Washburn & Doughty Hull 122
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.
Permit-Required Confined Spaces; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements
OSHA solicits public comments concerning the proposal to extend OMB approval of the information collection requirements contained in the Standard on Permit-Required Confined Spaces.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MAYFLOWER; Invitation for Public Comments
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.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MAGELLAN; Invitation for Public Comments
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.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel CATHERINE; Invitation for Public Comments
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.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel CATATONIC; Invitation for Public Comments
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.
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