2017 – Federal Register Recent Federal Regulation Documents
Results 1,151 - 1,200 of 27,453
The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``The Least Burdensome Provisions: Concept and Principles'' FDA utilizes a least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. This document describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time.
Agenda and Notice of Public Meeting of the Delaware Advisory Committee
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Delaware State Advisory Committee to the Commission will convene by conference call, on Monday, January 22, 2018 at 10:00 a.m. (EST). The purpose of the meeting is to review/discuss the panel summaries that were prepared by several Committee members. This review will help the Committee focus on next steps, as it moves toward drafting the Committee report.
Agenda and Notice of Public Meeting of the District of Columbia Advisory Committee
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the District of Columbia Advisory Committee to the Commission will convene at 11:30 a.m. (EST) Tuesday, January 9, 2018 at the offices of the U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue NW, Suite 1150, Washington, DC 20425. The purpose of the meeting is to discuss and vote on the project proposal on the mental health court in DC that will be submitted to the staff director for approval.
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew a generic information collection. As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, FAA has an approved Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery''.
Notice of Availability for the Gulf of Mexico Outer Continental Shelf Lease Sale Final Supplemental Environmental Impact Statement 2018; MMAA10400
The Bureau of Ocean Energy Management (BOEM) is announcing the availability of the Gulf of Mexico Outer Continental Shelf Lease Sale: Final Supplemental Environmental Impact Statement 2018 (2018 GOM Final Supplemental EIS). The 2018 GOM Final Supplemental EIS provides an analysis of the potential significant impacts of a proposed action (a regionwide lease sale), provides an analysis of reasonable alternatives to the proposed action, and identifies BOEM's preferred alternative. This Supplemental EIS is expected to be used to inform decisions on each of the two lease sales scheduled in 2018 (i.e., proposed Lease Sales 250 and 251) and to be supplemented as necessary for future Gulf of Mexico regionwide lease sales.
Approval of Arizona Air Plan Revision; San Manuel, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plan
The Environmental Protection Agency (EPA) is taking final rulemaking action to approve, as part of the State Implementation Plan (SIP) for the State of Arizona, the second 10-year maintenance plan for the San Manuel area for the 1971 National Ambient Air Quality Standards (``standards'') for sulfur dioxide (SO2).
Airworthiness Directives; Rolls-Royce plc Turbojet Engines
We propose to supersede airworthiness directive (AD) 2016-03- 03 that applies to all Rolls-Royce plc (RR) Viper Mk. 521, Viper Mk. 522, and Viper Mk. 601-22 turbojet engines. AD 2016-03-03 requires reducing the life of certain critical parts. Since we issued AD 2016- 03-03, RR determined that additional parts for these RR Viper engine models are affected. This proposed AD would add additional engine parts to the applicability. We are proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Pratt & Whitney Division Turbofan Engines
We propose to supersede Airworthiness Directive (AD) 2017-12- 03, which applies to certain Pratt & Whitney Division (PW) PW2037, PW2037M, and PW2040 turbofan engines. AD 2017-12-03 requires installing a software standard eligible for installation and precludes the use of electronic engine control (EEC) software standards earlier than SCN 5B/ I. Since we issued AD 2017-12-03, software became available for additional PW engines models. This proposed AD would require installing a software standard eligible for installation and preclude the use of EEC software standards earlier than SCN 5B/I or SCN 27A. We are proposing this AD to address the unsafe condition on these products.
Procurement Through Commercial e-Commerce Portals
The General Services Administration (GSA) and the Office of Management and Budget (OMB) are interested in conducting an ongoing dialogue with industry about Section 846 of the National Defense Authorization Act (NDAA) for Fiscal Year 2018, Procurement through Commercial e-Commerce Portals. The dialogue begins with this public notice and request for comment. GSA is providing external stakeholders the opportunity to offer input on the first implementation phase outlined in Section 846, an implementation plan due to Congress within 90 days of enactment. GSA and OMB are hosting a modified town-hall style public meeting to help inform the Phase I submittal.
Allocation of Assets in Single-Employer Plans; Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits
This final rule amends the Pension Benefit Guaranty Corporation's regulations on Benefits Payable in Terminated Single- Employer Plans and Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the benefit payments regulation for valuation dates in January 2018 and interest assumptions under the asset allocation regulation for valuation dates in the first quarter of 2018. The interest assumptions are used for valuing and paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.
Findings of Research Misconduct
Findings of research misconduct have been made on the part of Matthew Endo, former graduate student, Department of Chemistry, University of Illinois at Urbana-Champaign. The questioned research was supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM080436. The administrative actions, including three (3) years of supervision, which are implemented beginning on November 16, 2017, are detailed below.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, with revision, the mandatory Capital Assessments and Stress Testing information collection applicable to bank holding companies (BHCs) with total consolidated assets of $50 billion or more and U.S. intermediate holding companies (U.S. IHCs) established by foreign banking organizations under FR Y- 14A/Q/M; OMB No. 7100-0341.
Revision of the Land Management Plan for the Flathead National Forest and Amending the Land Management Plans of the Helena-Lewis and Clark, Kootenai, and Lolo National Forests
The Forest Service is revising the Flathead National Forest's Land and Resource Management Plan (forest plan). The Forest Service is concurrently amending the forest plans of the Helena-Lewis and Clark, Kootenai, and Lolo National Forests to incorporate habitat management direction for the Northern Continental Divide Ecosystem (NCDE) grizzly bear population. The Flathead National Forest is proposing to incorporate the NCDE grizzly bear habitat management direction as part of its plan revision process. The Forest Service has prepared a single Final Environmental Impact Statement (FEIS) for its revised forest plan and the forest plan amendments, a draft Record of Decision (ROD) for the revised forest plan, and a draft ROD for the forest plan amendments. This notice is to inform the public that a 60-day period is being initiated where individuals or entities with specific concerns on the Flathead National Forest's Revised Land Management Plan and the Northern Continental Divide Ecosystem Grizzly Bear Conservation Strategy forest plan amendments for the Helena-Lewis and Clark, Kootenai, and Lolo National Forests and its associated FEIS may file objections for Forest Service review prior to the approval of the Revised Land Management Plan and forest plan amendments. This is also an opportunity to object to the Regional Forester's list of species of conservation concern for the Flathead National Forest.
Notice of Final Federal Agency Actions on Proposed Highway in Idaho
This notice announces actions taken by the FHWA. The actions relate to a proposed highway project, US 20/26 Corridor Study, Junction I-84 to Eagle Road in Ada and Canyon Counties in the State of Idaho, FHWA Project Number STP-3230(106), Idaho Transportation Department (ITD) Key Number 07826.
Crow Butte Resources, Inc.; Marsland Expansion Area
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft environmental assessment (EA) and draft finding of no significant impact (FONSI) for a proposed amendment of NRC source materials license SUA-1534 that would authorize Crow Butte Resources, Inc., to construct and operate an in situ uranium recovery (ISR) expansion area at the Marsland Expansion Area (MEA) site in Dawes County, Nebraska. The draft EA, ``Environmental Assessment for the Marsland Expansion Area License Amendment Application,'' documents the NRC staff's environmental review of the license amendment application.
Air Plan Approval; CT; Decommissioning of Stage II Vapor Recovery Systems
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the Connecticut Department of Energy and Environmental Protection (CT DEEP). This revision includes regulatory amendments that require gasoline dispensing facilities (GDFs) to decommission their Stage II vapor recovery systems on or before July 1, 2015, and a demonstration that such removal is consistent with the Clean Air Act and EPA guidance. This revision also includes regulatory amendments that strengthen Connecticut's requirements for Stage I vapor recovery systems at GDFs. The intended effect of this action is to approve Connecticut's revised vapor recovery regulations. This action is being taken under the Clean Air Act.
Policy Statement on the Scenario Design Framework for Stress Testing
The Board is requesting public comment on amendments to its policy statement on the scenario design framework for stress testing. The proposed amendments to the policy statement would clarify when the Board may adopt a change in the unemployment rate in the severely adverse scenario of less than 4 percentage points; institute a counter- cyclical guide for the change in the house price index in the severely adverse scenario; and provide notice that the Board plans to incorporate wholesale funding costs for banking organizations in the scenarios. The Board would continue to use the policy statement to develop the macroeconomic scenarios and additional scenario components that are used in the supervisory and company-run stress tests conducted under the Board's stress test rules and the Board's capital plan rule.
Stress Testing Policy Statement
The Board is inviting comment on a proposed policy statement on the approach to supervisory stress testing conducted under the Board's Regulation YY pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) and the Board's capital plan rule.
Enhanced Disclosure of the Models Used in the Federal Reserve's Supervisory Stress Test
The Board is inviting comment on an enhanced disclosure of the models used in the Federal Reserve's supervisory stress test conducted under the Board's Regulation YY pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) and the Board's capital plan rule.
Financial Assistance: Wildlife Restoration, Sport Fish Restoration, Hunter Education and Safety
We, the U.S. Fish and Wildlife Service (Service), are proposing to update regulations for the Pittman-Robertson Wildlife Restoration and the Dingell-Johnson Sport Fish Restoration programs and subprograms, based on comments we received during the last rulemaking that were never resolved, existing guidance that we intend to move to regulation, and updates requested by States to improve the processes under license certification. We believe these changes will clarify and simplify the regulations and help ensure consistency in administering the programs across the Nation.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.
Compliance Date for Form 10-D Hyperlink Requirements
The Securities and Exchange Commission (``Commission'') is publishing this document to inform the public that it has set a compliance date for its previously-adopted exhibit hyperlinking requirements for Form 10-Ds that require hyperlinks to any exhibits filed with Form ABS-EE. The Commission on March 1, 2017 required registrants that file registration statements and reports subject to the exhibit requirements under Item 601 of Regulation S-K, or that file Forms F-10 or 20-F, to include a hyperlink to each exhibit listed in the exhibit index of these filings, but deferred setting a compliance date with respect to any Form 10-D that will require hyperlinks to any exhibits filed with Form ABS-EE until the Commission announced that technical programming changes to allow issuers to include Form 10-D and Form ABS-EE in a single submission had been completed, and published a notification of the compliance date for Form 10-D in the Federal Register.
Agency Information Collection Activities: Proposed Collection; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
The U.S. Small Business Administration (SBA) is submitting a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to the Office of Management and Budget (OMB) for approval under the Paperwork Reduction Act (PRA). This information collection is part of a Federal Government-wide effort to streamline the process to seek feedback from the public on the agency's service delivery. SBA previously published a 60-day notice soliciting public comment on the proposed information collection. This 30-day notice, as required by the PRA, provides an additional opportunity for public comment on the Generic ICR.
Food Crediting in Child Nutrition Programs: Request for Information
The National School Lunch Program, School Breakfast Program, Child and Adult Care Food Program, and Summer Food Service Program (Child Nutrition Programs), which are administered by the United States Department of Agriculture (USDA), Food and Nutrition Service (FNS), play a critical role in ensuring that America's children have access to the nutritious food they need to learn and succeed in the classroom, afterschool, and during the summer. It is FNS' responsibility to establish and support the meal patterns and nutrition standards (collectively referred to as meal patterns) in the Child Nutrition Programs that advance the goals of providing nutritious and satisfying meals to a broad population of children. At the same time, FNS works to simplify the menu planning process for Program operators to promote the efficient use of Program funds and provide a wide variety of food choices to menu planners and children. In order to claim Federal reimbursement, Child Nutrition Program operators must serve meals and snacks that meet the minimum meal pattern requirements of the respective Program. Crediting is the process designed by FNS to specify how individual food items contribute to the Child Nutrition Programs' meal patterns. Several factors impact how food products can credit toward reimbursable meals, such as volume, weight, and overall nutrient profile. The purpose of this Request for Information is to help FNS gather feedback from a wide variety of stakeholders on how FNS' crediting system can best address today's evolving food and nutrition environment, as well as to offer first-rate customer service to those operating and benefitting from the Child Nutrition Programs. FNS welcomes comments from all interested stakeholders. While FNS is interested in your general comments about the crediting process, FNS also invites comments on the crediting of several specific food products. FNS is especially interested in understanding both the possible benefits and any negative impacts associated with potential changes to how certain foods may or may not credit.
Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.'' The purpose of the public workshop is to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act). FDA plans to publish a background document approximately 2 weeks before the workshop date.
Pacific Fishery Management Council; Public Meeting (Webinar)
The Pacific Fishery Management Council's (Pacific Council) will host the Area 2A Pacific Halibut Managers Coordination Meeting via webinar. The meeting is open to the public.
Military Lending Act Limitations on Terms of Consumer Credit Extended to Service Members and Dependents
The Department of Defense (Department) is amending its interpretive rule for the Military Lending Act (the MLA). The MLA, as implemented by the Department, limits the military annual percentage rate (MAPR) that a creditor may charge to a maximum of 36 percent, requires certain disclosures, and provides other substantive consumer protections on ``consumer credit'' extended to Service members and their families. On July 22, 2015, the Department amended its regulation primarily for the purpose of extending the protections of the MLA to a broader range of closed-end and open-end credit products (the July 2015 Final Rule). On August 26, 2016, the Department issued the first set of interpretations of that regulation in the form of questions and answers; the present interpretive rule amends and adds to those questions and answers to provide guidance on certain questions the Department has received regarding compliance with the July 2015 Final Rule.
New Postal Product
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submission for OMB Review; 30-Day Comment Request; Special Volunteer and Guest Researcher Assignment (Office of Intramural Research, Office of the Director)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Meetings of Humanities Panel
The National Endowment for the Humanities will hold three meetings of the Humanities Panel, a federal advisory committee, during January, 2018. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Reporting Requirements Associated with Regulation XX Concentration Limit (FR XX) and Financial Company (as defined) Report of Consolidated Liabilities (FR XX-1) (OMB No. 7100-0363).
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