August 20, 2018 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 101
Neurological Devices Panel Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA or Agency) announces a forthcoming public Advisory Committee meeting of the Neurological Devices Panel (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.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Previously Approved Collection; COPS Extension Request Form
The Department of Justice (DOJ), Community Oriented Policing Services (COPS) Office, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Previously Approved Collection; COPS Extension Request Form
The Department of Justice (DOJ), Community Oriented Policing Services (COPS) Office, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
New Postal Products
The Commission is noticing a recent Postal Service filing 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that cannot be resolved at the division level.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Food and Drug Administration's Evaluation of Approaches To Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the request for comments that appeared in the Federal Register of May 24, 2018. In the request for comments, FDA requested comments on the design of studies intended to generate data to support substantial evidence of effectiveness for investigational new animal drugs intended for the prevention of heartworm disease in dogs. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. FDA is establishing a docket for public comments on this document.
Special Local Regulation; Wheeling Vintage Regatta, Wheeling, WV
The Coast Guard will enforce a special local regulation for certain navigable waters of the Ohio River during the Wheeling Vintage Regatta on September 1, 2018 and September 2, 2018, to provide for the safety of persons, vessels, and the marine environment on the navigable waterways during this event. Our special local regulations for annual marine events in the Eighth Coast Guard District identify the regulated area for this event in Wheeling, WV. During the enforcement period, entry into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.
Safety Zone; Allegheny River Miles 0.7 to 1.0, Pittsburgh, PA
The Coast Guard is establishing a temporary safety zone for all navigable waters of the Allegheny River, extending the entire width of the river, from mile marker (MM) 0.7 to MM 1.0. This safety zone is necessary to protect persons, vessels, and the marine environment from potential hazards associated with a fireworks display. Entry of persons or vessels into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.
Safety Zone; Ohio River Miles 0.0 to 0.5, Pittsburgh, PA
The Coast Guard is establishing a temporary safety zone for all navigable waters of the Ohio River, extending the entire width of the river, from mile marker (MM) 0.0 to MM 0.5. This safety zone is necessary to protect persons, vessels, and the marine environment from potential hazards associated with a fireworks display. Entry of persons or vessels into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.
Questions and Answers Regarding Food Facility Registration (Seventh Edition); Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition).'' The guidance provides updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Supplemental Questions and Answers Regarding Food Facility Registration; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Supplemental Questions and Answers Regarding Food Facility Registration.'' This draft guidance is intended to supplement the guidance document entitled ``Questions and Answers Regarding Food Facility Registration.''
Recurring Safety Zone; Wheeling Annual Dragon Boat Race, Wheeling, WV
The Coast Guard will enforce the safety zone for the Wheeling Annual Dragon Boat Race to provide for the safety of persons, vessels, and the marine environment on the navigable waters of the Ohio River during this event. Our regulation for marine events within the Eighth Coast Guard District identifies the regulated area for this event in Wheeling, WV. During the enforcement periods, entry into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.
Proposed Submission of Information Collection for OMB Review; Comment Request; Annual Reporting (Form 5500 Series)
The Pension Benefit Guaranty Corporation (PBGC) intends to request that the Office of Management and Budget (OMB) extend approval (with modifications), under the Paperwork Reduction Act of 1995, of its collection of information for Annual Reporting under OMB control number 1212-0057, which expires on March 31, 2021. This notice informs the public of PBGC's intent and solicits public comment on the collection of information.
Summary of Commission Practice Relating to Administrative Protective Orders
Since February 1991, the U.S. International Trade Commission (``Commission'') has published in the Federal Register reports on the status of its practice with respect to violations of its administrative protective orders (``APOs'') under title VII of the Tariff Act of 1930, in response to a direction contained in the Conference Report to the Customs and Trade Act of 1990. Over time, the Commission has added to its report discussions of APO breaches in Commission proceedings other than under title VII and violations of the Commission's rules including the rule on bracketing business proprietary information (``BPI'') (the ``24-hour rule''). This notice provides a summary of breach investigations (APOB investigations) completed during calendar year 2017. This summary addresses an APOB investigation related to a proceeding under title VII of the Tariff Act of 1930. The Commission intends that this report inform representatives of parties to Commission proceedings as to some specific types of APO breaches encountered by the Commission and the corresponding types of actions the Commission has taken.
Modernized Drawback; Correction
This document corrects a proposed regulation in a notice of proposed rulemaking published in the Federal Register of August 2, 2018, regarding Modernized Drawback. Specifically, CBP inadvertently proposed in 19 CFR 190.32(d)(2) an exemption for drawback claims for wine which included an imprecise reference to the entirety of paragraph (b). The reference should have been only to paragraphs (b)(1) and (b)(2), the specific paragraphs regarding the ``lesser of'' rule. As is evident from the entirety of the proposed rule, paragraph (b)(3), which implements the statutory prohibition on double drawback, applies to all drawback claims for wine. This technical correction remedies a clerical error that occurred when the language of paragraph (b)(3) was moved from a different part of the proposed regulations.
Security From a Wireless Spectrum Perspective: Technology Innovation and Policy Research Needs
This workshop will focus on the R&D challenges of securing the wireless spectrum access medium to assure spectrum availability, reliability and performance over wireless links. Representatives from Federal agencies, academia and the private sector will discuss the current technologies, tools and practices that are effective, and identify the gaps and issues that will require additional research.
Nationwide Number Portability; Numbering Policies for Modern Communications
In this document, the Federal Communications Commission (Commission) adopts final rules based on public comments to promote nationwide number portability. These rules eliminate unnecessary toll interexchange dialing parity requirements and database query requirements that may result in obstacles and inefficiencies in an eventual nationwide number portability regime.
Agency Information Collection Activities: Proposed Collection; Comment Request-Special Milk Program for Children
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this information collection. This collection is a revision of a currently approved collection which FNS employs to determine public participation in Special Milk Program for Children.
Agency Information Collection Activities: Proposed Collection; Comment Request-Study of School Food Authority (SFA) Procurement Practices
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a new information collection for the Study of School Food Authority (SFA) Procurement Practices. This study is intended to describe and assess the practices of SFAs related to procuring goods and services for school meal programs (e.g., National School Lunch Program [NSLP], and the School Breakfast Program [SBP]), and to better understand how SFAs make decisions that lead to these procurement practices. The SFA Procurement Practices study will go beyond previous studies that concentrated on single food service or Child Nutrition programs (e.g., NSLP, SBP, or the Summer Food Service Program [SFSP]) or studies that focused on single procurement practices (e.g., use of Food Service Management Companies [FSMCs]) at the SFA level. This collection includes a mixed-methods approach of qualitative and quantitative information utilizing a structured web-based survey, as well as in-depth interviews (IDIs) to be conducted by telephone. Data will be collected from a subsample of the SFA population participating in the second year of the Child Nutrition Program Operations Study-II (CN-OPS II) (OMB Number 0584-0607).
Comprehensive River Management Plan for Black Butte Wild and Scenic River, Including Portions of Cold Creek, Mendocino National Forest, Mendocino County, California
In accordance with Section 3(d)(1) of the Wild and Scenic Rivers Act, the USDA Forest Service announces the completion and availability of the comprehensive river management plan for Black Butte Wild and Scenic River, including portions of Cold Creek. On May 11, 2018, Acting Mendocino Forest Supervisor, Gar Abbas signed a decision notice to adopt a comprehensive river management plan (``CRMP'') for Black Butte Wild and Scenic River (including Cold Creek). The Black Butte Wild and Scenic River CRMP (including Cold Creek) addresses resource protection, development of lands and facilities, user capacities, and other management practices necessary or desirable to achieve the purposes of the Wild and Scenic Rivers Act. This CRMP was prepared after consultation with State and local governments and the interested public. An environmental assessment (EA) was prepared as part of the CRMP development. This EA has been prepared in compliance with the National Environmental Policy Act and other relevant federal laws and regulations. The EA discloses the direct, indirect, and cumulative environmental effects that would result from adopting the CRMP. The Black Butte Wild and Scenic River CRMP (including Cold Creek) and the EA are available for review at https://www.fs.usda.gov/project/ ?project=50351 and the following offices: Upper Lake Ranger District, 10025 Elk Mountain Road, Upper Lake, CA 95484. Mendocino National Forest Supervisor's Office, 825 N Humboldt Ave., Willows, CA 95988.
Willamette National Forest, McKenzie River Ranger District; Oregon; Flat Country Project
The Flat Country Project is located on the western slope of the Cascades, extending from Scott Mountain to the upper reach of the McKenzie River, eight miles east of McKenzie Bridge, Oregon. The project area is approximately 74,063 acres. There is a high amount of mid-seral stands, moving the seral distribution away from historic levels and limiting stand structure and species diversity across the landscape. This project proposes to thin, reduce the number of trees, and increase the size and structure of the remaining forest over time. Activities proposed include forest management treatments across approximately 5,001 acres, including forest thinning (including riparian reserve thinning) and regenerating harvests. Additional proposed activities would include road work (including maintenance, reconstruction, temporary road construction, and decommissioning), and meadow enhancements.
Revisions to California State Implementation Plan; South Coast Air Quality Management District, San Joaquin Valley Air Pollution Control District and Yolo-Solano Air Quality Management; Nonattainment New Source Review Requirements for the 2008 8-Hour Ozone Standard
The Environmental Protection Agency (EPA) is proposing to approve three state implementation plan (SIP) revisions submitted by the State of California addressing the nonattainment new source review (NNSR) requirements for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS). These SIP revisions address the South Coast Air Quality Management District (SCAQMD or District), San Joaquin Valley Air Pollution Control District (SJVAPCD or District) and Yolo- Solano Air Quality Management District (YSAQMD or District) portions of the California SIP. This action is being taken pursuant to the Clean Air Act (CAA or ``Act'') and its implementing regulations.
Air Plan Approval; ID, Incorporations by Reference Updates and Rule Revisions
EPA is taking final action to approve revisions to Idaho's State Implementation Plan (SIP) submitted by the Idaho Department of Environmental Quality (IDEQ) on March 20, 2018 and April 12, 2018. The submitted revisions update incorporation by reference of Federal regulations in the Idaho's rules. The revisions also remove an interim regulation that expired in 2003.
Air Plan Approval; Washington; Interstate Transport Requirements for the 2012 PM2.5
The Clean Air Act requires each State Implementation Plan (SIP) to contain adequate provisions prohibiting emissions that will have certain adverse air quality effects in other states. On February 7, 2018, the State of Washington made a submission to the Environmental Protection Agency (EPA) to address these requirements. The EPA is approving the submission as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will contribute significantly to nonattainment or interfere with maintenance of the 2012 annual fine particulate matter (PM2.5) national ambient air quality standard (NAAQS) in any other state.
Establishment of Class E Airspace, Creswell, OR
This action establishes Class E airspace extending upward from 700 feet above the surface at Hobby Field, Creswell, OR, to accommodate new area navigation (RNAV) procedures at this airport, for the safety and management of instrument flight rules (IFR) operations.
Use of Spectrum Bands Above 24 GHz for Mobile Radio Services
In this document, a Fourth Notice of Proposed Rulemaking (4th FNPRM) invites members of the public to comment on how best to transition existing spectrum holdings in the 39 GHz band to the new flexible-use band plan, and on using an incentive auction mechanism. The Federal Communications Commission (Commission or FCC) proposes to modify the 39 GHz, Upper 37 GHz, and 47 GHz band plans from 200 megahertz to 100 megahertz channels to facilitate the auctioning of all three bands at the same time. The Commission also proposes an incentive auction to reduce encumbrances and create contiguous blocks of spectrum through the 39 GHz and Upper 37 GHz bands. These proposals will promote the efficient use of this spectrum by incumbents and new licensees.
Amendment of Class E Airspace; New Castle, IN
This action modifies Class E airspace extending upward from 700 feet above the surface at New Castle-Henry County Municipal Airport, New Castle, IN. This action is the result of an airspace review due to the decommissioning of the Richmond VHF omnidirectional range (VOR) navigation aid as part of the VOR Minimum Operational Network (MON) Program. The geographic coordinates of the airport are also updated to coincide with the FAA's aeronautical database.
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.
Agency Information Collection Request; 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Inbound Parcel Post (at UPU Rates)
The Commission is acknowledging a recent filing by the Postal Service of its intention to change prices not of general applicability to be effective January 1, 2019. This document informs the public of the filing, invites public comment, and takes other administrative steps.
Inbound EMS 2
The Commission is acknowledging a recent Postal Service filing of its intention to change prices not of general applicability to be effective January 1, 2019. This document informs the public of the filing, invites public comment, and takes other administrative steps.
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of Revisions to the Provider Enrollment Moratoria Access Waiver Demonstration for Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Moratoria-Designated Geographic Locations
This document announces revisions to the Provider Enrollment Moratoria Access Waiver Demonstration (PEWD) for Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies. The demonstration was implemented in accordance with section 402(a)(1)(J) of the Social Security Amendments of 1967 and, as revised, gives CMS the authority to grant waivers to the statewide enrollment moratoria on a case-by-case basis in response to access to care issues and previously denied enrollment applications because of statewide moratoria implementation, and to subject providers and suppliers enrolling via such waivers to heightened screening, oversight, and investigations.
Airworthiness Directives; Airbus SAS Airplanes
We are superseding Airworthiness Directive (AD) 2017-15-17, which applied to certain Airbus Model A300 B4-600R series airplanes, Model A300 C4-605R Variant F airplanes, and Model A300 F4-600R series airplanes. AD 2017-15-17 required an inspection of the lower area of a certain frame (FR) radius for cracking, and corrective action if necessary. This AD requires new repetitive inspections of the forward fitting lower radius of a certain frame for cracking, and corrective actions if necessary. This AD was prompted by a determination that repetitive inspections and applicable corrective actions are necessary. We are issuing this AD to address the unsafe condition on these products.
Connect America Fund
In this document, the Wireline Competition Bureau (WCB), the Wireless Telecommunications Bureau (WTB) (jointly referred to herein as the Bureaus), and the Office of Engineering and Technology (OET) adopt requirements promoting greater accountability for certain recipients of Connect America Fund (CAF) high-cost universal service support, including price cap carriers, rate-of-return carriers, rural broadband experiment (RBE) support recipients, Alaska Plan carriers, and CAF Phase II auction winners. Specifically, the Bureaus and OET establish a uniform framework for measuring the speed and latency performance for recipients of high-cost universal service support to serve fixed locations.
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