2017 – Federal Register Recent Federal Regulation Documents
Results 1,901 - 1,950 of 27,453
Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry.'' The guidance document provides recommendations to blood collection establishments regarding the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and blood components. The recommendations apply to the collection of blood and blood components, except Source Plasma, for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device. The guidance announced in this notice supersedes the guidance entitled ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance) and finalizes the draft guidance entitled ``Amendment to `Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'; Draft Guidance for Industry'' dated November 2016 (2016 Draft Chagas Guidance). The guidance incorporates recommendations for blood donor testing, deferral, and donor reentry from the 2016 Draft Chagas Guidance.
Technical Advisory Committee; Request for Nominations
The BLS is soliciting new members for the Technical Advisory Committee (TAC). Five current membership terms expire on April 19, 2018. The TAC provides advice to the Bureau of Labor Statistics on technical aspects of data collection and the formulation of economic measures and makes recommendations on areas of research. On some technical issues there are differing views, and receiving feedback at public meetings provides BLS with the opportunity to consider all viewpoints. The Committee will consist of 16 members and will be chosen from a cross-section of economists, statisticians, and behavioral scientists who represent a balance of expertise. The economists will have research experience with technical issues related to BLS data and will be familiar with employment and unemployment statistics, price index numbers, compensation measures, productivity measures, occupational and health statistics, or other topics relevant to BLS data series. The statisticians will be familiar with sample design, data analysis, computationally intensive statistical methods, non- sampling errors, or other areas which are relevant to BLS work. The behavioral scientists will be familiar with questionnaire design, usability, or other areas of survey development. BLS invites persons interested in serving on the TAC to submit their names for consideration for committee membership.
Advisory Committee on Earthquake Hazards Reduction Meeting
The Advisory Committee on Earthquake Hazards Reduction (ACEHR or Committee), will meet on Monday, March 12, 2018 from 8:30 a.m. to 5:00 p.m. Eastern Time and Tuesday, March 13, 2018, from 8:30 a.m. to 2:30 p.m. Eastern Time. The primary purpose of this meeting is to review the National Earthquake Hazards Reduction Program (NEHRP) agency updates on their latest activities and receive the NEHRP agency responses to the Committee's 2017 Report on the Effectiveness of the NEHRP. The agenda may change to accommodate Committee business. The final agenda and any meeting materials will be posted on the NEHRP Web site at https://nehrp.gov/.
Presidential Declaration of a Major Disaster for Public Assistance Only for the State of CALIFORNIA
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of CALIFORNIA (FEMA- 4344-DR), dated 11/28/2017. Incident: Wildfires. Incident Period: 10/08/2017 through 10/31/2017.
Product Change-Priority Mail Express, Priority Mail, & First-Class Package Service 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 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.
Meeting of the Interagency Task Force on Veterans Small Business Development
The U.S. Small Business Administration (SBA) is issuing this notice to announce the location, date, time and agenda for the next meeting of the Interagency Task Force on Veterans Small Business Development. The meeting is open to the public.
Certain Small Diameter Seamless Carbon and Alloy Standard, Line and Pressure Pipe From Germany: Final Results of the Expedited Fourth Sunset Review of the Antidumping Duty Order
As a result of this sunset review, the Department of Commerce (the Department) finds that revocation of the antidumping duty order on certain small diameter seamless carbon and alloy standard, line and pressure pipe (seamless pipe) from Germany would be likely to lead to continuation or recurrence of dumping at the levels indicated in the ``Final Results of Sunset Review'' section of this notice.
Proposed Amendment of Class D and Class E Airspace; Lewiston, ID
This action proposes to amend controlled airspace at Lewiston- Nez Perce County Airport, Lewiston, ID, by enlarging Class D airspace, and Class E surface airspace, and reducing Class E airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface. Also, this action would remove the part-time Notice to Airmen (NOTAM) status from Class E airspace designated as an extension. Additionally, an editorial change would be made to the legal descriptions replacing ``Airport/Facility Directory'' with the term ``Chart Supplement''. This action would enhance safety and management of instrument flight rules (IFR) operations at the airport.
Proposed Amendment of Class D and Class E Airspace; Twin Falls, ID
This action proposes to modify Class E airspace designated as an extension, and modify Class E airspace extending upward from 700 feet above the surface at Joslin Field-Magic Valley Regional Airport, Twin Falls, ID. Also, the part-time Notice to Airmen (NOTAM) status would be removed from Class E airspace designated as an extension. Additionally, an editorial change would be made to the Class D airspace, Class E surface airspace, and Class E extension airspace legal descriptions replacing ``Airport/Facility Directory'' with the term ``Chart Supplement.'' Also, this proposal would remove the words ``Twin Falls'' from the airport name in the airspace designations for Class D and E airspace noted in this proposal. A biennial review found these changes are necessary to accommodate airspace redesign for the safety and management of instrument flight rules (IFR) operations within the National Airspace System.
Proposed Establishment of Class E Airspace; Rangely, CO
This action proposes to establish Class E airspace extending upward from 700 feet above the surface, at Rangely Airport, Rangely, CO, to accommodate new area navigation (RNAV) procedures at the airport. This action would ensure the safety and management of instrument flight rules (IFR) operations within the National Airspace System.
Establishment of Class E Airspace; Kaunakakai, HI
This action corrects a final rule published in the Federal Register of October 11, 2017, that establishes Class E airspace and amends Class D and E airspace at Molokai Airport, Kaunakakai, HI. The airspace description for the airport in Class E airspace extending upward from 700 feet above the surface contained the following wording in error: ``That airspace extending upward from the surface . . .'' It is removed and replaced by ``That airspace extending upward from 700 feet above the surface . . . .''
Establishment of Class E Airspace, Twin Bridges, MT
This action establishes Class E airspace extending upward from 700 and 1,200 feet above the surface at Twin Bridges Airport, Twin Bridges, MT, to accommodate the development of instrument flight rules (IFR) operations under standard instrument approach and departure procedures at the airport, for the safety and management of aircraft within the National Airspace System. This action also makes a minor correction to one geographic coordinate of the airport reference point.
Notice of Availability of the Federal Aviation Administration's Record of Decision for the Establishment and Modification of Oregon Military Training Special Use Airspace Identified as Warning Area 570, Eel Military Operation Area Complex, Redhawk Military Operation Area Complex, and Juniper/Hart Military Operation Area Complex and the Federal Aviation Administration's Adoption of the Final Environmental Impact Statement (EIS) Prepared by the Oregon Air National Guard/National Guard Bureau for the Proposed Establishment and Modification of Oregon Military Training Airspace (EIS No. 20170197)
On September 29, 2017, the FAA signed its Adoption/Record of Decision (ROD) for its aeronautical actionthe modification and establishment of Military Operation Areas (MOAs), Air Traffic Controlled Assigned Airspace (AATCAs) and Warning Areas for the Oregon Military Training Airspace. The Adoption/ROD identifies the aeronautical action and states the FAA decision to modify existing airspace and establish new airspace to support the Oregon Air National Guard's F-15 training operations. In accordance with FAA Order 1050.1F, paragraphs 9-2, Adoption of Other Agencies' National Environmental Policy Act Documents, and 7400.2L, paragraph 32-2-3, the FAA has conducted an independent review and evaluation of the Air National Guard, National Guard Bureau and U.S. Air Force's Final Environmental Impact Statement (FEIS) for the proposed Establishment and Modification of Military Operation Areas (MOAs) and Warning Area. Based on its independent review, the FAA has determined that the EIS and its supporting documentation, as incorporated by reference, adequately assess and disclose the environmental impacts of the FAA's proposed aeronautical action and that the adoption of the FEIS by the FAA is authorized. Accordingly, the FAA adopts the FEIS, Appendices and all information identified therein, incorporated by reference and made publicly available. Further, the FAA's September 29, 2017 Adoption/ Record of Decision (ROD) is based on its adoption of the FEIS and the FEIS' identification, analysis and conclusions regarding resources, and environmental effects of the ANG/NGB's Proposed Action.
U.S. Endangered Species; Receipt of Recovery Permit Applications
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications for permits to conduct activities intended to enhance the propagation or survival of endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits certain activities that constitute take of listed species unless a Federal permit is issued that allows such activity. The ESA also requires that we invite public comment before issuing these permits.
Review of Existing Regulatory and Information Collection Requirements; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the Requests for Comments and Information that appeared in the Federal Register of September 8, 2017. In the Requests for Comments and Information, FDA requested comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Airworthiness Directives; The Boeing Company Airplanes
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 767-200 and -300 series airplanes. This proposed AD was prompted by a report of two cracks at a certain frame inner chord. This proposed AD would require a detailed inspection for any material review board (MRB) filler installed in the area from the frame web to the stub-beam fitting at certain stations to determine if the filler extends above the frame-to-stub-beam joint, and applicable on-condition actions. We are proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Fokker Services B.V. Airplanes
We are adopting a new airworthiness directive (AD) for all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition on these products, and doing the actions specified in those instructions. This AD was prompted by a report of sparks and an electrical smell on the flight deck of a Model F28 Mark 0070 airplane. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Fokker Services B.V. Airplanes
We are adopting a new airworthiness directive (AD) for certain Fokker Services B.V. Model F28 Mark 1000, 2000, 3000, and 4000 airplanes. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition on these products, and doing the actions specified in those instructions. This AD was prompted by reports indicating that certain exit signs have a hydrogen isotope that decays over time, causing the signs to lose their brightness. We are issuing this AD to address the unsafe condition on these products.
Implementation of Statutory Amendments Requiring the Modification of the Definition of Hard Cider; Delayed Compliance Date for the Hard Cider Tax Class Labeling Statement Requirement; Reopening of Comment Period
On January 23, 2017, the Alcohol and Tobacco Tax and Trade Bureau (TTB) published a temporary rule, T.D. TTB-147, Implementation of Statutory Amendments Requiring the Modification of the Definition of Hard Cider, that amended its regulations to implement changes made to the definition of ``hard cider'' in the Internal Revenue Code of 1986 by the Protecting Americans from Tax Hikes Act (PATH Act) of 2015. The amended regulations included a requirement that the statement ``Tax class 5041(b)(6)'' appear on the container of any wine for which the hard cider tax rate is claimed if the wine is removed from wine premises or customs custody on or after January 1, 2018. Concurrent with the temporary rule, TTB published Notice of Proposed Rulemaking No. 168 requesting comments on the regulatory amendments made by T.D. TTB-147. In response to a comment received from a cider industry trade association, TTB, in a temporary rule published elsewhere in this issue of the Federal Register, is now delaying the compliance date for the hard cider tax class labeling requirement by one year, until January 1, 2019. In this document, TTB is requesting comments on that delayed compliance date, and we are also re-opening the comment period for Notice No. 168 for an additional 60 days to request comments on the regulatory amendments described in T.D. TTB-147.
Implementation of Statutory Amendments Requiring the Modification of the Definition of Hard Cider; Delayed Compliance Date of the Hard Cider Tax Class Labeling Statement Requirement
This temporary rule delays the compliance date of a wine labeling requirement that was established by T.D. TTB-147, a temporary rule published on January 23, 2017. In that rule, TTB required the statement ``Tax class 5041(b)(6)'' to appear on the container of any wine for which the hard cider tax rate is claimed if it is removed from wine premises or customs custody on or after January 1, 2018. This temporary rule delays the compliance date for that requirement by one year. Specifically, the tax class statement ``Tax Class 5041(b)(6)'' will not be required to appear on containers of wine that are taxed at the hard cider tax rate until January 1, 2019. Through a notice of proposed rulemaking published elsewhere in this issue of the Federal Register, TTB is soliciting comments from all interested parties on this delay of the compliance date for the wine labeling requirement, and, also in that document, TTB is reopening for 60 days the comment period for Notice No 168, the notice of proposed rulemaking that published concurrently with T.D. TTB-147 on January 23, 2017.
Emergency Import Restrictions Imposed on Archaeological and Ethnological Materials From Libya
This document amends the U.S. Customs and Border Protection (CBP) regulations to reflect the imposition of emergency import restrictions on certain archaeological and ethnological materials from Libya. The Acting Under Secretary for Public Diplomacy and Public Affairs, United States Department of State, has determined that conditions warrant the imposition of emergency import restrictions on categories of archaeological and ethnological materials from Libya, which represent the cultural heritage of Libya. This document contains the Designated List of Archaeological and Ethnological Material of Libya that describes the types of objects or categories of archaeological or ethnological material to which the import restrictions apply. The emergency import restrictions imposed on certain archaeological and ethnological materials from Libya will be in effect for a five-year period. These restrictions are being imposed pursuant to determinations of the United States Department of State made under the terms of the Convention on Cultural Property Implementation Act, which implements the 1970 United Nations Educational, Scientific and Cultural Organization (UNESCO) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property.
New Postal Products
The Commission is noticing recent Postal Service filings for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Requirements of the Vessel Monitoring System Type-Approval
All owners of vessels participating in a NOAA Vessel Monitoring System (VMS) program are required to acquire a NMFS-approved Enhanced Mobile Transmitting Unit (EMTU) or Mobile Transmitting Unit (MTU) to comply with the Vessel Monitoring System requirements. This proposed action would amend the existing VMS Type-Approval regulations by removing the requirement for VMS vendors to periodically renew their EMTU/MTU type-approvals. This renewal process has proved to be unnecessary, has cost fishermen and approved VMS vendors additional time and expense, and has imposed unnecessary costs on the government. Removing the type-approval renewal requirement will spare fishermen, VMS vendors and the government the time and expense associated with the renewal process.
Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.'' FDA has developed this leapfrog guidance to provide FDA's initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. This guidance outlines technical considerations associated with additive manufacturing processes as well as testing and characterization for final finished devices fabricated using additive manufacturing.
Food and Drug Administration Categorization of Investigational Device Exemption Devices To Assist the Centers for Medicare and Medicaid Services With Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff.'' This guidance modifies the FDA's current policy on categorization of investigational device exemption (IDE) devices, which assists the CMS in determining whether or not an IDE device should be covered (reimbursed) by CMS. On December 2, 2015, FDA's Center for Devices and Radiological Health (CDRH) and CMS's Coverage and Analysis Group (CAG) executed a Memorandum of Understanding (MOU) to streamline and facilitate the efficient categorization of investigational medical devices in order to support CMS's ability to make Medicare coverage (reimbursement) determinations for those devices. This guidance document further explains the framework that FDA intends to follow for such categorization decisions.
Inflation Catch-Up Adjustment of Civil Monetary Penalty Amounts
This final rule amends USDA's civil monetary penalty regulations by making inflation adjustments as mandated by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. USDA also removes one obsolete civil monetary penalty (CMP) regulation previously authorized under a statute that is no longer current law.
Incidental Take Permit Applications Received To Participate in the American Burying-Beetle Amended Oil and Gas Industry Conservation Plan in Oklahoma
Under the Endangered Species Act (ESA), as amended, we, the U.S. Fish and Wildlife Service, invite the public to comment on federally listed American burying-beetle incidental take permit (ITP) applications. The applicants anticipate American burying-beetle take as a result of impacts to habitat the species uses for breeding, feeding, and sheltering in Oklahoma. The take would be incidental to the applicants' activities associated with oil and gas well field and pipeline infrastructure (gathering, transmission, and distribution), including geophysical exploration (seismic), construction, maintenance, operation, repair, decommissioning, and reclamation. If approved, the permits would be issued under the approved American Burying Beetle Amended Oil and Gas Industry Conservation Plan (ICP) Endangered Species Act Section 10(a)(1)(B) Permit Issuance in Oklahoma.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Disaster Response Cooperative Agreements
The Corporation for National and Community Service (CNCS) has submitted a public information collection request (ICR) entitled Disaster Response Cooperative Agreements for review and approval in accordance with the Paperwork Reduction Act of 1995.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Continuous Release Reporting Requirements; Reporting Air Releases of Hazardous Substances From Animal Wastes at Farms Under CERCLA Section 103
The Environmental Protection Agency has submitted an information collection request (ICR), ``Continuous Release Reporting Requirements; Reporting Air Releases of Hazardous Substances From Animal Wastes at Farms Under CERCLA Section 103'' (EPA ICR No. 1445.13, OMB Control No. 2050-0086) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a request for approval of a collection for a sector (farms) that were not included in the ICR currently approved by OMB (Control No. 2050-0086) (EPA ICR No. 1445.12). A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Removal of Source-Specific Requirements for Permanently Shutdown Facilities
The Environmental Protection Agency (EPA) is proposing to approve a state implementation plan (SIP) revision submitted by the State of West Virginia. This revision pertains to the removal of source-specific SIP requirements for the following five facilities in West Virginia that have permanently shutdown: Mountaineer Carbon Company; Standard Lafarge; Follansbee Steel Corporation; International Mill Service, Inc.; and Columbian Chemicals Company. These sources have permanently ceased operation; therefore, SIP requirements for these sources are obsolete and no longer necessary for attaining and maintaining the national ambient air quality standards (NAAQS). This action is being taken under the Clean Air Act (CAA).
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