Arts and Artifacts Indemnity Panel Advisory Committee
Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Federal Council on the Arts and the Humanities will hold a meeting of the Arts and Artifacts Domestic Indemnity Panel.
Medical Device User Fee Rates for Fiscal Year 2017
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2017, which apply from October 1, 2016, through September 30, 2017. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2017, you should not submit a FY 2017 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2017 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``General Wellness: Policy for Low Risk Devices.'' The guidance is intended to provide clarity to industry and FDA staff on Center for Devices and Radiological Health's (CDRH) compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). By clarifying the policy on general wellness products, we hope to improve the predictability, consistency, and transparency on CDRH's regulation of these products. For purposes of the guidance, CDRH defines ``general wellness products'' as products which meet the following factors: They are intended for only general wellness use as defined in the guidance and present a low risk to the safety of users and other persons.
Information Collections Being Submitted for Review and Approval to the Office of Management and Budget
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Petitions for Reconsideration and Clarification of Action in Rulemaking Proceeding
Petitions for Reconsideration and Clarification (Petitions) have been filed in the Commission's rulemaking proceeding by Mary J. Sisak on behalf of Custer Telephone Cooperative, Inc., et al, Michael R. Romano on behalf of NTCA-The Rural Broadband Association, Robert W. Schwartz on behalf of Madison Telephone Company, Derrick B. Owens on behalf of WTA-Advocates For Rural Broadband.
Commission Information Collection Activities (Ferc-539); Comment Request
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collection FERC-539 (Gas Pipeline Certificates: Import & Export Related Applications) to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission previously issued a Notice in the Federal Register (81 FR 21859, 4/13/ 2016) requesting public comments. The Commission received no comments on the FERC-539 and is making this notation in its submittal to OMB.
Proposed Establishment of Class E Airspace; Iron Mountain, MI
This action proposes to amend Class E en route airspace around the Iron Mountain VHF omnidirectional range/distance measuring equipment, Iron Mountain, MI. This action would add additional airspace to facilitate the vectoring of Instrument Flight Rules (IFR) aircraft under control of the Minneapolis Air Route Traffic Control Center (ARTCC) in the Great Lakes area located north and northwest of the Iron Mountain, MI, VHF Omnidirectional Range/Distance Measuring Equipment (VOR/DME) navigation aid. This proposed action would enhance the safety and management of aircraft operations within the National Airspace System (NAS).
Meeting of the Office of Justice Programs' Science Advisory Board
This notice announces a forthcoming meeting of OJP's Science Advisory Board (``the Board''). This meeting is scheduled for September 15-16, 2016. General Function of the Board: The Board is chartered to provide OJP, a component of the Department of Justice, with valuable advice in the areas of science and statistics for the purpose of enhancing the overall impact and performance of its programs and activities in criminal and juvenile justice.
Voluntary Intermodal Sealift Agreement Open Season
The Maritime Administration (MARAD) announces that the open season for Fiscal Year 2017 applications for participation in the Voluntary Intermodal Sealift Agreement (VISA) program will run for 30 days beginning today and ending August 29, 2016. The purpose of this notice is to invite interested, qualified U.S.-flag vessel operators that are not currently enrolled in the VISA program to apply. This is the only planned enrollment period for carriers to join the VISA program and derive benefits for Department of Defense (DOD) peacetime contracts initiated during the period from October 1, 2016, through September 30, 2017. Any U.S.-flag vessel operator organized under the laws of a state of the United States, or the District of Columbia, who is able and willing to commit militarily useful sealift assets and assume the related consequential risks of commercial disruption, may be eligible to participate in the VISA program. The mission of VISA is to provide commercial sealift and intermodal shipping services and systems, including access to vessels, vessel space, intermodal systems and equipment, terminal facilities, and related management services, to the Department of Defense (DOD), as necessary, to meet national defense contingency requirements or national emergencies. Carriers enrolled in the VISA program provide DOD with assured access to such services during contingencies. In return for their VISA commitment, DOD gives VISA participants priority for carriage of peacetime cargos.
Airworthiness Directives; Bombardier, Inc. Airplanes
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), Model CL-600-2D24 (Regional Jet Series 900), and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. This AD was prompted by reports of corrosion found on the slat and flap torque tubes in the slat and flap control system. This AD requires replacement of the slat and flap torque tubes in the slat and flap control system. We are issuing this AD to prevent rupture of a corroded slat or flap torque tube. This condition could result in an inoperative slat or flap system and consequent reduced controllability of the airplane.
Information Collection; Forest Industries and Logging Operations Data Collection Systems
In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the renewal of a currently approved information collection, Forest Industries and Residential Fuelwood and Post Data Collection Systems with a revision adding a Logging Operations Data Collection System.
Airworthiness Directives; The Boeing Company Airplanes
We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 757-200 and -200CB series airplanes. This AD was prompted by an evaluation by the design approval holder (DAH) indicating that the lap splices at stringer S-14R, lower fastener row, are subject to widespread fatigue damage (WFD). This AD requires external dual frequency eddy current (DFEC) or internal high frequency eddy current (HFEC) inspections of the lap splice, inner skin fasteners, at stringer S-14R, station (STA) 440 through STA 540, and corrective action if necessary. We are issuing this AD to detect and correct cracking of the fuselage skin lap splice. Such cracking could result in reduced structural integrity of the airplane.
Special Conditions: ATR Model ATR-42-200/-300/-320/-500 and ATR-72-102/-202/-212/-212A Airplanes; Seats With Non-Traditional, Large, Non-Metallic Panels
These special conditions are issued for ATR Model ATR-42-200/- 300/-320/-500 and ATR-72-102/-202/-212/-212A airplanes. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport- category airplanes. This design feature is seats with non-traditional, large, non-metallic panels. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Embraer S.A. Model EMB-545 and EMB-550 Airplanes; Installation of an Airbag System To Limit the Axial Rotation of the Upper Leg on Single- and Multiple-Place Side-Facing Seats
These special conditions are issued for the Embraer S.A. (Embraer) Model EMB-545 and EMB-550 series airplanes. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport- category airplanes. This feature is an airbag system designed to limit the axial rotation of the upper leg on single-place and multiple-place side-facing seats. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Revised Critical Infrastructure Protection Reliability Standards
The Federal Energy Regulatory Commission (Commission) directs the North American Electric Reliability Corporation to develop a new or modified Reliability Standard that addresses supply chain risk management for industrial control system hardware, software, and computing and networking services associated with bulk electric system operations. The new or modified Reliability Standard is intended to mitigate the risk of a cybersecurity incident affecting the reliable operation of the Bulk- Power System.
Air Plan Approval; Alabama: Volatile Organic Compounds
The Environmental Protection Agency (EPA) is approving a revision to the Alabama State Implementation Plan (SIP) submitted by the Alabama Department of Environmental Management (ADEM) on October 26, 2015. The revision modifies the definition of ``volatile organic compounds'' (VOC). Specifically, the revision adds three compounds to the list of those excluded from the VOC definition on the basis that these compounds make a negligible contribution to tropospheric ozone formation. This action is being taken pursuant to the Clean Air Act (CAA or Act).
Air Plan Approval; Alabama: Volatile Organic Compounds
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Alabama State Implementation Plan submitted by the Alabama Department of Environmental Management on October 26, 2015. The revision modifies the definition of ``volatile organic compounds'' (VOC). Specifically, the revision adds three compounds to the list of those excluded from the VOC definition on the basis that these compounds make a negligible contribution to tropospheric ozone formation. This action is being taken pursuant to the Clean Air Act.
Partial Approval and Partial Disapproval of Implementation Plans; State of Iowa; Infrastructure SIP Requirements for the 2008 Ozone National Ambient Air Quality Standard
The Environmental Protection Agency (EPA) is proposing to partially approve and partially disapprove elements of a State Implementation Plan (SIP) submission from the State of Iowa for the 2008 National Ambient Air Quality Standards (NAAQS) for ozone. Infrastructure SIPs address the applicable requirements of Clean Air Act (CAA) section 110, which requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by the EPA. These SIPs are commonly referred to as ``infrastructure'' SIPs. 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.
Rulemaking Activities Being Discontinued by the NRC
The U.S. Nuclear Regulatory Commission (NRC) is discontinuing eight rulemaking activities. The purpose of this action is to inform members of the public that these rulemaking activities are being discontinued and to provide a brief discussion of the NRC's decision to discontinue them. These rulemaking activities will no longer be reported in the NRC's portion of the Unified Agenda of Regulatory and Deregulatory Actions (the Unified Agenda).
Reauthorization of the United States Grain Standards Act
The Department of Agriculture (USDA) Grain Inspection, Packers and Stockyards Administration (GIPSA) is revising existing regulations and adding new regulations under the United States Grain Standards Act (USGSA), as amended, in order to comply with amendments to the USGSA made by the Agriculture Reauthorizations Act of 2015. Specifically, this rulemaking eliminates mandatory barge weighing, removes the discretion for emergency waivers of inspection and weighing, revises GIPSA's fee structure, revises exceptions to official agency geographic boundaries, extends the length of licenses and designations, and imposes new requirements for delegated States.
Energy Conservation Program for Consumer Products: Final Coverage Determination; Test Procedures for Miscellaneous Refrigeration Products; Correction
On July 18, 2016, the U.S. Department of Energy published a final rule establishing a final coverage determination and test procedures for miscellaneous refrigeration products. This correction addresses technical errors in the preamble and regulatory text. Neither the errors nor the corrections in this document affects the substance of the rulemaking or any of the conclusions reached in support of the final rule.
Updating Weatherization Health and Safety Guidance
The U.S. Department of Energy (DOE) is updating Weatherization Health and Safety Guidance related to the implementation and installation of health and safety measures as part of the DOE Weatherization Assistance Program (WAP). The draft guidance also provides required components for Grantees to include in their Health and Safety (H&S) Plans. This guidance will assist Grantee decision- making during H&S Plan development. This notice also serves to inform the public of the availability of an online tool which provides notification of, and allows individuals to submit comments on, the draft guidance related to the DOE Weatherization Assistance Program. All future draft guidance releases will be made via the online tool. Individuals who wish to receive notification of draft guidance releases may receive that notification via the online tool. For information on the web address of the online tool see the ADDRESSES section of this notice.
Notice of Meeting, Front Range Resource Advisory Council
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Front Range Resource Advisory Council (RAC), will meet as indicated below.
Change of Address for the Food and Drug Administration Center for Food Safety and Applied Nutrition
The Food and Drug Administration (FDA or we) is providing notice that the street address for the Center for Food Safety and Applied Nutrition's (CFSAN's) Harvey W. Wiley Federal Building in College Park, MD has changed. The new street address is 5001 Campus Drive.
Change of Address; Technical Amendment
The Food and Drug Administration (FDA or we) is amending our regulations to reflect a change in the address for the Center for Food Safety and Applied Nutrition (CFSAN). This action is editorial in nature and is intended to improve the accuracy of our regulations.
Federal Property Suitable as Facilities To Assist the Homeless
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Amendments to Designated Areas
ONRR convened two technical conferences on November 20, 2015 to discuss amending the boundaries of four of the designated areas it uses to calculate the index-based major portion prices in its regulations. At the technical conferences, the participants discussed issues regarding the appropriate boundary line between the North Fort Berthold and South Fort Berthold Designated Areas and adding additional counties to one or both of the two designated areas in the Uintah and Ouray Reservation.
Membership in the National Parks Overflights Advisory Group Aviation Rulemaking Committee
The Federal Aviation Administration (FAA) and the National Park Service (NPS) are inviting interested persons to apply to fill one upcoming opening on the National Parks Overflights Advisory Group (NPOAG) Aviation Rulemaking Committee (ARC). The upcoming opening will represent commercial air tour operator interests. The selected member will serve a 3-year term.
Clarification and Update of the Trade Fair Certification Program
The U.S. Department of Commerce (Commerce) is intending to update the Trade Fair Certification Program, which recognizes and endorses U.S. participation in selected, privately organized, foreign trade fairs, in the coming months. Proposed changes will be announced through the Federal Register and comments will be solicited and reviewed before a final rule is issued. This ANPRM solicits feedback on some of the concepts Commerce is considering for the update, and reiterates the requirements, procedures, and application review criteria of the current Trade Fair Certification Program, originally published April 30, 1993. The purpose of this document is to reiterate existing terms in the 1993 document in order to inform the public of proposed guidelines. The concepts being considered for updating the program can be found in the last section of the Supplementary Information section of this document.
Onshore Oil and Gas Operations; Federal and Indian Oil and Gas Leases; Onshore Oil and Gas Order Number 1, Approval of Operations
The Bureau of Land Management (BLM) is proposing to amend its existing Onshore Oil and Gas Order Number 1 (Onshore Order 1) to require the electronic filing (or e-filing) of all Applications for Permit to Drill (APD) and Notices of Staking (NOS). Currently, Onshore Order 1 states that an ``operator must file an APD or any other required documents in the BLM Field Office having jurisdiction over the lands described in the application,'' but allows for e-filing of such documents in the alternative. This proposal would change that structure to make e-filing the required method of submission, subject to limited exceptions. The BLM is making this change to improve the efficiency and transparency of the APD and NOS processes.
National School Lunch Program and School Breakfast Program: Eliminating Applications Through Community Eligibility as Required by the Healthy, Hunger-Free Kids Act of 2010
This final rule establishes requirements for State agencies, local educational agencies, and schools operating the Community Eligibility Provision, a reimbursement option that allows the service of school meals to all children at no-cost in high poverty schools without collecting household applications. By eliminating the household application process and streamlining meal counting and claiming procedures through the Community Eligibility Provision, local educational agencies may substantially reduce administrative burden related to operating the National School Lunch and School Breakfast Programs. This rule codifies many requirements that were implemented through policy guidance following enactment of the Healthy, Hunger-Free Kids Act of 2010, as well as provisions of the proposed rule. These requirements will result in consistent, national implementation of the Community Eligibility Provision.
Administrative Reviews in the School Nutrition Programs
As required by the Healthy, Hunger-Free Kids Act of 2010, this final rule revises the State agency's administrative review process in the National School Lunch Program and School Breakfast Program to establish a unified accountability system designed to ensure that school food authorities offering school meals comply with program requirements. The updated administrative review process includes new procedures, retains key existing requirements from the Coordinated Review Effort and the School Meals Initiative, provides new review flexibilities and efficiencies for State agencies, and simplifies fiscal action procedures. In addition to establishing a unified administrative review process, this rule requires State Agencies public disclosure of a summary of the administrative review results. These changes are expected to strengthen program integrity through a more robust, effective, and transparent process for monitoring school nutrition program operations.
Local School Wellness Policy Implementation Under the Healthy, Hunger-Free Kids Act of 2010
This final rule requires all local educational agencies that participate in the National School Lunch and School Breakfast Programs to meet expanded local school wellness policy requirements consistent with the requirements set forth in section 204 of the Healthy, Hunger- Free Kids Act of 2010. The final rule requires each local educational agency to establish minimum content requirements for the local school wellness policies, ensure stakeholder participation in the development and updates of such policies, and periodically assess and disclose to the public schools' compliance with the local school wellness policies. These regulations are expected to result in local school wellness policies that strengthen the ability of a local educational agency to create a school nutrition environment that promotes students' health, well-being, and ability to learn. In addition, these regulations will increase transparency for the public with regard to school wellness policies and contribute to integrity in the school nutrition program.
National School Lunch Program and School Breakfast Program: Nutrition Standards for All Foods Sold in School as Required by the Healthy, Hunger-Free Kids Act of 2010
This rule adopts as final, with some modifications, the National School Lunch Program and School Breakfast Program regulations set forth in the interim final rule published in the Federal Register on June 28, 2013. The requirements addressed in this rule conform to the provisions in the Healthy, Hunger-Free Kids Act of 2010 regarding nutrition standards for all foods sold in schools, other than food sold under the lunch and breakfast programs. Most provisions of this final rule were implemented on July 1, 2014, a full year subsequent to publication of the interim final rule. This was in compliance with section 208 of the Healthy, Hunger-Free Kids Act of 2010, which required that State and local educational agencies have at least one full school year from the date of publication of the interim final rule to implement the competitive food provisions. Based on comments received on the interim final rule and implementation experience, this final rule makes a few modifications to the nutrition standards for all foods sold in schools implemented on July 1, 2014. In addition, this final rule codifies specific policy guidance issued after publication of the interim rule. Finally, this rule retains the provision related to the standard for total fat as interim and requests further comment on this single standard.
Amendments to the Commission's Rules of Practice
The Securities and Exchange Commission (``Commission'') is adopting amendments to its Rules of Practice. These changes concern, among other things, the timing of hearings in administrative proceedings, depositions, summary disposition, and the contents of an answer.
Hazardous Materials: Oil Spill Response Plans and Information Sharing for High-Hazard Flammable Trains
PHMSA, in consultation with the Federal Railroad Administration, is issuing this NPRM to propose revisions to regulations that would expand the applicability of comprehensive oil spill response plans (OSRPs) based on thresholds of liquid petroleum oil that apply to an entire train consist. Specifically, we are proposing to expand the applicability for comprehensive OSRPs so that any railroad that transports a single train carrying 20 or more loaded tank cars of liquid petroleum oil in a continuous block or a single train carrying 35 or more loaded tank cars of liquid petroleum oil throughout the train consist must also have a current comprehensive written OSRP. We are further proposing to revise the format and clarify the requirements of a comprehensive OSRP (e.g., requiring that covered railroads develop response zones describing resources available to arrive onsite to a worst-case discharge, or the substantial threat of one, which are located within 12 hours of each point along the route used by trains subject to the comprehensive OSRP). We also solicit comment on defining high volume areas and staging resources using alternative response times, including shorter response times for spills that could affect such high volume areas. Further, in accordance with the Fixing America's Surface Transportation Act of 2015, this action proposes to require railroads to share information about high-hazard flammable train operations with state and tribal emergency response commissions to improve community preparedness and seeks comments on these proposals. Lastly, PHMSA is proposing to incorporate by reference an initial boiling point test for flammable liquids from the ASTM D7900 method referenced in the American National Standards Institute/American Petroleum Institute Recommend Practices 3000, ``Classifying and Loading of Crude Oil into Rail Tank Cars,'' First Edition, September 2014 as an acceptable testing alternative to the boiling point tests currently specified in the HMR. PHMSA believes providing this additional boiling test option provides regulatory flexibility and promotes enhanced safety in transport through accurate packing group assignment.