September 6, 2018 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 117
Surgeon General's Call to Action: “Community Health and Prosperity”
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on an upcoming Surgeon General's document/ Call to Action with a working title ``Community Health and Prosperity''. CDC is the lead agency to support the Office of the Surgeon General to publish a Call to Action that will be science-informed and actionable, outlining a conceptual framework with case examples and available evidence on the business case for investing in community health. The goal of the Call to Action is to: Clearly demonstrate that investments in community health have the potential to improve the health and prosperity of communities and issue a call to action to the private sector and local policy makers for investment in communities, unilaterally or as part of multi-sector or other consortium, to improve community health.
Citizens Coinage Advisory Committee Public Meeting
The United States Mint announces the Citizens Coinage Advisory Committee (CCAC) public meeting scheduled for September 27, 2018. Date: September 27, 2018. Time: 10:00 a.m. to 3:30 p.m. Location: Second Floor Conference Room, United States Mint, 801 9th Street NW, Washington, DC 20220. Subject: Review and discussion of candidate designs for the 2020 America the Beautiful Quarter honoring Weir Farm National Historic Site; candidate designs for the 2019 American Liberty High Relief 24k Gold Coin and Silver Medal; and candidate designs for the 2018 American Innovation $1 Coin. Interested members of the public may either attend the meeting in person or dial in to listen to the meeting at (866) 564-9287/Access Code: 62956028. Interested persons should call the CCAC HOTLINE at (202) 354-7502 for the latest update on meeting time and room location. Any member of the public interested in submitting matters for the CCAC's consideration is invited to submit them by email to info@ccac.gov. The CCAC advises the Secretary of the Treasury on any theme or design proposals relating to circulating coinage, bullion coinage, Congressional Gold Medals, and national and other medals; advises the Secretary of the Treasury with regard to the events, persons, or places to be commemorated by the issuance of commemorative coins in each of the five calendar years succeeding the year in which a commemorative coin designation is made; and makes recommendations with respect to the mintage level for any commemorative coin recommended. Members of the public interested in attending the meeting in person will be admitted into the meeting room on a first-come, first-serve basis as space is limited. Conference Room A&B can accommodate up to 50 members of the public at any one time. In addition, all persons entering a United States Mint facility must adhere to building security protocol. This means they must consent to the search of their persons and objects in their possession while on government grounds and when they enter and leave the facility, and are prohibited from bringing into the facility weapons of any type, illegal drugs, drug paraphernalia, or contraband. The United States Mint Police Officer conducting the screening will evaluate whether an item may enter into or exit from a facility based upon Federal law, Treasury policy, United States Mint Policy, and local operating procedure; and all prohibited and unauthorized items will be subject to confiscation and disposal.
International Wildlife Conservation Council; Public Meeting
In accordance with the Federal Advisory Committee Act, the U.S. Fish and Wildlife Service announces a public meeting of the International Wildlife Conservation Council, which provides advice and recommendations to the Secretary of the Interior regarding the benefits that result from U.S. citizens traveling to foreign nations to engage in hunting.
Hazardous Materials: Notice of Applications for Special Permits
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.
Hazardous Materials: Notice of Applications for Special Permits
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the ``Nature of Application'' portion of the table below as follows: 1 Motor vehicle, 2Rail freight, 3Cargo vessel, 4Cargo aircraft only, 5Passenger-carrying aircraft.
Hazardous Materials: Notice of Applications for Special Permits
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the ``Nature of Application'' portion of the table below as follows: 1Motor vehicle, 2Rail freight, 3Cargo vessel, 4Cargo aircraft only, 5Passenger-carrying aircraft.
Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Pacific Coast Groundfish Fishery; Applications for Exempted Fishing Permits (EFP)
NMFS announces the receipt of three exempted fishing permit (EFP) applications. NMFS has made a preliminary determination that these EFP applications warrant further consideration. The applications, submitted by the San Francisco Community Fishing Association, Scott Cook, and Real Good Fish, request exemptions from prohibitions to fish for rockfish species in the non-trawl Rockfish Conservation Areas during the 2019-2020 fishing years. All three applicants request to test hook-and-line gear that selectively harvests underutilized, midwater rockfish species while avoiding bottom-dwelling, overfished rockfish species. NMFS requests public comment on these applications.
Senior Executive Service Performance Review Boards Membership
DOT published the names of the persons selected to serve on Departmental PRBs as required.
Draft Guidances Relating to the Development of Human Gene Therapy Products; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notices of availability for six draft guidance documents relating to the development of human gene therapy products that appeared in the Federal Register of July 12, 2018. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments and any new information.
Announcement of Intent To Establish the 2020 Dietary Guidelines Advisory Committee and Solicitation of Nominations for Membership
The Departments of Agriculture and Health and Human Services announce the intent to establish a Dietary Guidelines Advisory Committee and invite nominations for the Committee.
Wild Horse and Burro Advisory Board Meeting
In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Wild Horse and Burro Advisory Board (Advisory Board) will meet as indicated below.
Prohibition of Target Shooting on Public Lands in the Eastern Lake Mountains, Utah County, Utah
The Bureau of Land Management (BLM) Utah State Director hereby establishes an interim final supplementary rule (rule) prohibiting target shooting within a 2,004-acre area on BLM-administered public lands in the Eastern Lake Mountains area of the Salt Lake Field Office, Eastern Lake Mountains, Utah County, Utah. The rule is necessary to implement and enforce this long-term prohibition to provide for public safety and historic properties (specifically Native American petroglyphs), as authorized in the Decision Record for the Eastern Lake Mountains Target Shooting Resource Management Plan Amendment (RMPA). The rule does not restrict other public activities in or access to or through the Lake Mountains, including legal hunting.
Competitive Coal Lease Sale, North Dakota
Notice is hereby given that coal resources in lands in Oliver County, North Dakota, will be offered for competitive lease by sealed bid in accordance with the provisions of the Mineral Leasing Act of 1920, as amended.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Capacity Building Assistance Program: Assessment and Quality Control. The purpose of this information collection is to assess how well the capacity building assistance (CBA) program meets the needs of health care staff from organizations funded directly or indirectly by the CDC, involved in HIV prevention service delivery. The program will assess customer satisfaction with CBA services and changes in capacity, knowledge, skills, and self-efficacy as a result of CBA service delivery.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Prenatal Assessment of Environmental Risk (PAER)''. This web-based data collection will provide information on behavioral risks for environmental exposures for patients seeking preconception and prenatal care, and for their reproductive health care clinicians (RHCCs).
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/ or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Assessment of Outcomes Associated with the Preventive Health and Health Services Block Grant''. This assessment will assess select cross-cutting outputs and outcomes of the Preventive Health and Health Services Block Grant and demonstrates the utility of the grant on a national level.
Alaska; Hunting and Trapping in National Preserves-Extension of Public Comment Period
The National Park Service is extending the public comment period for the proposed rule to amend its regulations for sport hunting and trapping in National Preserves in Alaska. Extending the comment period will allow more time for the public to review the proposal and submit comments.
Air Plan Approval; Vermont; Infrastructure State Implementation Plan Requirements for the 2012 PM2.5
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of Vermont that addresses the infrastructure SIP requirements of the Clean Air Act (CAA or Act)including the interstate transport provisionsfor the 2012 fine particle (PM2.5) National Ambient Air Quality Standards (NAAQS). The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA. EPA is taking this action under the Clean Air Act.
Whistleblower Protection; Public Meeting
The Occupational Safety and Health Administration (OSHA) is announcing a public meeting to solicit comments and suggestions from stakeholders in the financial industry, including employers, employees, and representatives of employers and employees, on issues facing the agency in its administration of the whistleblower protection provisions of the Consumer Financial Protection Act of 2010, Section 1057 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, and the Sarbanes-Oxley Act.
The Cadmium in General Industry Standard; 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 Cadmium in General Industry Standard.
Environmental Management Site-Specific Advisory Board, Northern New Mexico
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.
Environmental Management Site-Specific Advisory Board, Savannah River Site
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.
Environmental Management Site-Specific Advisory Board, Nevada
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.
Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Unmanned Aerial Vehicles and Components Thereof, DN 3335; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.
Large Diameter Welded Pipe From Canada, China, Greece, India, Korea, and Turkey; Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty Investigations
The Commission hereby gives notice of the scheduling of the final phase of antidumping and countervailing duty investigation Nos. 701-TA-593-596 and 731-TA-1401-1406 (Final) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of large diameter welded pipe (LDWP) from Canada, China, Greece, India, Korea, and Turkey, provided under subheadings 7305.11.1030, 7305.11.1060, 7305.11.5000, 7305.12.1030, 7305.12.1060, 7305.12.5000, 7305.19.1030, 7305.19.1060, 7305.19.5000, 7305.31.4000, 7305.31. 6010, 7305.31.6090, 7305.39.1000, and 7305.39.5000 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce (``Commerce'') to be subsidized and/or sold at less-than-fair-value.
U.S. SME Exports: Trade-Related Barriers Affecting Exports of U.S. Small- and Medium-Sized Enterprises to the United Kingdom; Institution of Investigation and Scheduling of Hearing
Following receipt of a request from the U.S. Trade Representative (USTR) on August 3, 2018, under section 332(g) of the Tariff Act of 1930, the U.S. International Trade Commission has instituted investigation No. 332-569, U.S. SME Exports: Trade-Related Barriers Affecting Exports of U.S. Small and Medium-Sized Enterprises to the United Kingdom, for the purpose of providing a report that catalogs trade-related barriers that small and medium-sized enterprises (SMEs) perceive as disproportionately affecting U.S. SMEs exporting to the United Kingdom (UK), compared to larger U.S. exporters to the UK.
Product Change-Priority Mail Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance
The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.
Hours of Service of Drivers: American Concrete Pavement Association, Inc.; Application for Exemption
FMCSA announces that it has received an application from the American Concrete Pavement Association, Inc. (ACPA) requesting exemptions from two requirements of the hours-of-service (HOS) regulations for drivers of certain commercial motor vehicles (CMVs) operated by ACPA members: The 30-minute rest break provision; and the requirement that short-haul drivers utilizing the record of duty status (RODS) exception return to their work-reporting location within 12 hours of coming on duty. The first exemption would enable drivers engaged in the transportation of ready-mixed concrete in vehicles, other than those outfitted with rotating mixer drums, and related materials and equipment to use 30 minutes or more of on-duty ``waiting time'' to satisfy the requirement for the 30-minute rest break, provided they do not perform any other work during the break. The second exemption would allow these drivers to use the short-haul exception but return to their work-reporting location within 14 hours instead of the usual 12 hours. FMCSA requests public comment on ACPA's application for exemptions.
Hours of Service
The FMCSA announces that it will hold a public listening session concerning potential changes to its hours-of-service (HOS) rules for truck drivers. On August 23, 2018, FMCSA published an Advance Notice of Proposed Rulemaking (ANPRM) seeking public comment on four specific aspects of the HOS rules for which the Agency is considering changes: The short-haul HOS limit; the HOS exception for adverse driving conditions; the 30-minute rest break provision; and the split- sleeper berth rule to allow drivers to split their required time in the sleeper berth. In addition, the Agency requested public comment on petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.org (TruckerNation). The Agency encourages vendors of electronic logging devices (ELDs) to participate to address potential implementation issues should changes to the HOS rules be made. The listening session will be held at the U.S. Department of Transportation in Washington, DC. The listening session will be webcast for the benefit of those not able to attend in person. The listening session will allow interested persons to present comments, views, and relevant research on topics mentioned above. All comments will be transcribed and placed in the rulemaking docket for the FMCSA's consideration.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Application for Community Disaster Loan (CDL) Program
The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.'' This guidance document describes FDA's current approach to considering uncertainty in making benefit-risk determinations to support certain FDA premarket decisions for medical devicespremarket approval applications (PMAs), De Novo requests, and humanitarian device exemption (HDE) applications. This guidance document elaborates on the consideration of uncertainty as part of our overarching approach to a benefit-risk based framework that is intended to assure greater predictability, consistency, and efficiency through the application of least burdensome principles. This draft guidance also provides examples of how the principles for considering uncertainty could be applied in the context of clinical evidence and circumstances where greater uncertainty could be appropriate in premarket decisions, balanced by postmarket controlsPMAs for Breakthrough Devices and PMAs for devices for small patient populations. This draft guidance is not final nor is it in effect at this time.
Allergic Rhinitis: Developing Drug Products for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Allergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued on February 16, 2016.
Nonallergic Rhinitis: Developing Drug Products for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonallergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this guidance is to assist applicants of new drug applications and biologics license applications in developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults. This guidance incorporates the comments received and finalizes the draft guidance of the same name issued on February 16, 2016.
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