Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG-New Drug Application 206545
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZYDELIG based on new drug application (NDA) 206545 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 24 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Projects Rescinded for Consumptive Uses of Water
This notice lists the approved by rule projects rescinded by the Susquehanna River Basin Commission during the period set forth in DATES.
Projects Approved for Consumptive Uses of Water
This notice lists the projects approved by rule by the Susquehanna River Basin Commission during the period set forth in DATES.
Atlantic Highly Migratory Species; Proposed Rule To Revise Atlantic Shark Fishery Closure Regulations
NMFS is proposing to revise the current closure regulations for commercial shark fisheries. These changes would affect commercial shark fisheries in the Atlantic Ocean including the Gulf of Mexico and Caribbean. Proposed revisions include changes to the landings threshold that prompts a closure and the minimum time between filing of the closure with the Federal Register and the closure becoming effective. This action is necessary to allow more flexibility when closing shark fisheries and to facilitate the use of available quota while still preventing overharvests.
Annual Stress Test-Technical and Conforming Changes
On October 27, 2017, the Office of the Comptroller of the Currency (OCC) published a proposed rule that would have made several revisions to its stress testing regulation. The OCC is now adopting the proposed rule as final. The final rule changes the range of possible ``as-of'' dates used in the global market shock component to conform to changes already made by the Board of Governors of the Federal Reserve System (Board) to its stress testing regulations. The final rule also changes the transition process for covered institutions with $50 billion or more in assets. Under the final rule, a covered institution that becomes an over $50 billion covered institution, as that term is defined in the OCC stress testing regulation, before September 30 will become subject to the requirements applicable to an over $50 billion covered institution beginning on January 1 of the second calendar year after the covered institution becomes an over $50 billion covered institution, and a covered institution that becomes an over $50 billion covered institution after September 30 will become subject to the requirements applicable to an over $50 billion covered institution beginning on January 1 of the third calendar year after the covered institution becomes an over $50 billion covered institution. The final rule also makes certain technical changes to clarify the requirements of the OCC's stress testing regulation.
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.
Manufacturing Extension Partnership Advisory Board
The National Institute of Standards and Technology (NIST) announces that the Manufacturing Extension Partnership (MEP) Advisory Board will hold an open meeting on March 7, 2018.
Notice and Request for Comments
The U.S. Department of Transportation (DOT) invites public comment about our intention to request the Office of Management and Budget (OMB) approval to reinstate an information collection. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections.
Notice and Request for Comments
The DOT invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. Before a Federal agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections.
Certain UV Curable Coatings for Optical Fibers, Coated Optical Fibers, and Products Containing Same; Notice of Request for Statements on the Public Interest
Notice is hereby given that the presiding administrative law judge (``ALJ'') has issued a recommended determination on remedy and bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief. The ALJ recommended that a limited exclusion order issue against certain UV curable coatings for optical fibers imported by respondent Momentive UV Coatings (Shanghai) Co., Ltd. of Shanghai, China (``MUV''). The ALJ found no violation of section 337 by respondent OFS Fitel, LLC of Norcross, Georgia (``OFS''). However, should the Commission find a violation of section 337 by OFS, the ALJ recommends that the Commission issue a limited exclusion order against certain coated optical fibers imported by OFS, and that a cease and desist order issue to OFS. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to the Commission's Rules.
Air Plan Approval; OR: Infrastructure Requirements for the 2010 Nitrogen Dioxide, 2010 Sulfur Dioxide, and 2012 Fine Particulate Matter Standards
Whenever a new or revised National Ambient Air Quality Standard (NAAQS) is promulgated, the Clean Air Act (CAA) requires states to submit a plan for the implementation, maintenance, and enforcement of the standard, commonly referred to as infrastructure requirements. The Environmental Protection Agency (EPA) is proposing to approve the Oregon State Implementation Plan (SIP) as meeting infrastructure requirements for the 2010 nitrogen dioxide (NO2), 2010 sulfur dioxide (SO2), and 2012 fine particulate matter (PM2.5) NAAQS. The EPA is also proposing to approve, and incorporate by reference, rule changes made by the state to implement the PM2.5 NAAQS, relevant to this infrastructure action, and also the ozone NAAQS, which is unrelated to this action, but included for efficiency.
Indaziflam; Pesticide Tolerances for Emergency Exemptions
This regulation establishes time-limited tolerances for residues of indaziflam in or on rangeland, pastures, and areas subject to the Conservation Reserve Program (CRP). This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide in or on grass, forage, fodder, and hay, group 17, forage and grass, forage, fodder, and hay, group 17, hay, grown in rangeland, pastures, and areas subject to the CRP. This regulation establishes a maximum permissible level for residues of indaziflam in or on these commodities. The time-limited tolerances expire on December 31, 2020.
Withdrawal of Pleadings
The Commission proposes to adopt a more accurate title of Withdrawal of pleadings (Rule 216), for Rule 216 of the Commission's Rules of Practice and Procedure. The Commission also proposes to clarify the text of the Rule.
Requirements for Insurance; National Credit Union Share Insurance Fund Equity Distributions
The NCUA Board (Board) is adopting amendments to its share insurance requirements rule to provide stakeholders with greater transparency regarding the calculation of each eligible financial institution's pro rata share of a declared equity distribution from the National Credit Union Share Insurance Fund (NCUSIF). The Board is also adopting a temporary provision to govern all NCUSIF equity distributions related to the Corporate System Resolution Program (CSRP), a special purpose program established by the Board to stabilize the corporate credit union system following the 2007-2009 financial crisis. Furthermore, the Board is making technical and conforming amendments to other aspects of the share insurance requirements rule to account for these changes.
Airworthiness Directives; The Boeing Company Airplanes
We propose to adopt a new airworthiness directive (AD) for The Boeing Company Model 787 series airplanes powered by Rolls Royce Trent 1000 engines. This proposed AD was prompted by a report of failures of the inner fixed structure (IFS) forward upper fire seal and damage to thermal insulation blankets in the forward upper area of the thrust reverser (TR). This proposed AD would require an inspection to determine the part number of the IFS forward upper fire seal, and applicable on-condition actions. We are proposing this AD to address the unsafe condition on these products.
The Commodity Futures Trading Commission (the ``Commission'') is amending its primary definitions regulation to make it more user- friendly both to industry and the public. Specifically, the Commission is amending the primary definitions regulation to replace the complex and confusing lettering system with a simple alphabetical list; and replacing all existing cross references to any definition within the primary definitions regulation with a general reference to the revised alphabetical list, rather than to a specific lettered paragraph.
Agency Information Collection Activity: Application for Service-Disabled Veterans Insurance
On February 1, 2018, the Department of Veterans Affairs (VA) erroneously published a consecutive 60-day Federal Register Notice (Application for Service-Disabled Veterans Insurance) Document Number: 2018-01945; OMB control number: 2900-0068.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Halibut and Sablefish Individual Fishing Quota Program; Community Development Quota Program; Modifications to Recordkeeping and Reporting Requirements
NMFS issues a proposed rule that would modify regulations governing the Halibut and Sablefish Individual Fishing Quota (IFQ) Program. This proposed rule includes three actions. The first action would allow Western Alaska Community Development Quota (CDQ) groups to lease (to receive by transfer) halibut individual fishing quota (IFQ) in IFQ regulatory areas 4B, 4C, and 4D in years of extremely low halibut commercial catch limits. This proposed action is necessary to provide additional harvest opportunities to CDQ groups and community residents, and provide IFQ holders with the opportunity to receive value for their IFQ when the halibut commercial catch limits may not be large enough to provide for an economically viable fishery for IFQ holders. The second action would remove an obsolete reference in the IFQ Program regulations. The third action would clarify IFQ vessel use cap regulations. This proposed rule is intended to promote the goals and objectives of the Northern Pacific Halibut Act of 1982, the Magnuson-Stevens Fishery Conservation and Management Act, the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area, and other applicable laws.
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), CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. This AD was prompted by several incidents of electrical shorting and sparks caused by de-icing fluid leaks between flight deck windshields and side windows. This AD requires water spray tests and general visual inspections for water in the flight deck compartment, and water removal and sealant application if necessary. 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 0100 airplanes. This AD was prompted by a report that a jammed control cable prevented the full extension of the nose landing gear (LG). This AD requires a general visual inspection of the LG handle teleflex cable conduit connector for the presence of a grease nipple, a maintenance records check of affected airplanes, a detailed inspection for corrosion and damage of the LG handle teleflex cable, and corrective actions if necessary. This AD also requires revising the maintenance or inspection program, as applicable. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
We are superseding Airworthiness Directive (AD) 2012-12-05, which applied to all The Boeing Company Model 737-100, -200, -200C, - 300, -400, and -500 series airplanes. AD 2012-12-05 required repetitive inspections for cracking under the stop fittings and intercostal flanges and for cracking of the intercostal web, attachment clips, stringer splice channels, frame, reinforcement angle, shear web, frame outer chord and inner chord; a one-time inspection to detect missing fasteners; repetitive inspections of the cargo barrier net fitting for cracking; repetitive inspections for cracking of the stringer S-15L aft intercostal; and repair or corrective action if necessary. For certain airplanes, this AD adds new repetitive inspections of certain areas of the frame inner chord, and applicable on-condition actions. This AD was prompted by reports of additional cracking in locations not covered by the inspections in AD 2012-12-05. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747- 200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, 747SR, and 747SP series airplanes. This AD was prompted by a report of incidents involving fatigue cracking in transport category airplanes that are approaching or have exceeded their design service objective and a structural reevaluation by the manufacturer that identified additional structural elements that qualify as structural significant items (SSIs). This AD requires revising the maintenance or inspection program, as applicable, to include inspections that will give no less than the required damage tolerance rating (DTR) for certain SSI, performing repetitive inspections to detect cracks of all SSIs, and repairing cracked structures if necessary. Additionally, this AD requires all cracks involving an SSI or related structure in close vicinity to the SSI to be reported to Boeing. We are issuing this AD to address the unsafe condition on these products.
Initiation of Antidumping and Countervailing Duty Administrative Reviews
The Department of Commerce (Commerce) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with December anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.
Office of Postsecondary Education; Solicitation of Third-Party Comments Concerning the Performance of Accrediting Agencies
On January 24, 2018, we published in the Federal Register a notice of a call for written third-party comments. That notice provided information to members of the public on submitting written comments with respect to accrediting agencies currently undergoing review for purposes of recognition by the Secretary of Education. That notice established a comment period beginning on January 24, 2018, and closing on February 16, 2018. Pursuant to a recent court order, we are extending the public comment period until March 1, 2018, for the submission of comments on the application of the Accrediting Council for Independent Colleges and Schools (ACICS) for initial recognition and the compliance report submitted by the American Bar Association (ABA).
Response to June 1, 2016 Clean Air Act Section 126(b) Petition From Connecticut
The Environmental Protection Agency (EPA) is proposing to deny a section 126(b) petition submitted by the state of Connecticut pursuant to the Clean Air Act (CAA or Act) on June 1, 2016. The petition requested that EPA make a finding that emissions from Brunner Island Steam Electric Station (Brunner Island), located in York County, Pennsylvania, are significantly contributing to nonattainment and interfering with maintenance of the 2008 ozone national ambient air quality standards (NAAQS) in Connecticut in violation of the good neighbor provision under the CAA. The EPA proposes to deny the petition because Connecticut has not met its burden to demonstrate that the source emits or would emit in violation of the good neighbor provision such that it will significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in Connecticut. The EPA is further proposing to deny the petition based on the conclusion that the Brunner Island facility does not currently emit nor is it expected to emit pollution in violation of the good neighbor provision for the 2008 ozone NAAQS.
Hino Motors, Ltd., Receipt of Petition for Decision of Inconsequential Noncompliance
Hino Motors Sales USA, Inc., a wholly owned subsidiary of Hino Motors, Ltd. (collectively referred to as ``Hino''), has determined that certain model year (MY) 2014-2018 Hino heavy duty trucks do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 101, Controls and Displays. Hino filed a noncompliance report dated December 11, 2017, and subsequently petitioned NHTSA on December 21, 2017, for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety.
General Motors, LLC, Grant of Petition for Decision of Inconsequential Noncompliance
General Motors, LLC, (GM) has determined that certain model year (MY) 2015 GMC multipurpose passenger vehicles (MPV) do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps, Reflective Devices, and Associated Equipment. GM has filed a noncompliance report dated November 5, 2014. GM also petitioned NHTSA on November 26, 2014, for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety.
Proposed Information Collection Request; Comment Request; National Fish Program (Formerly Referred to as the National Listing of Fish Advisories) (Renewal)
The Environmental Protection Agency is planning to submit an information collection request (ICR), National Fish Program (formerly referred to as the National Listing of Fish Advisories), (EPA ICR Number 1959.06, OMB Control Number 2040-0226) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through July 31, 2018. 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.
Request for Public Comment on Proposed Revision of NIJ Standard 0101.06, Ballistic Resistance of Body Armor
The National Institute of Justice (NIJ) seeks feedback from the public on a proposed revision of NIJ Standard 0101.06, Ballistic Resistance of Body Armor, that specifies minimum performance requirements and test methods for the ballistic resistance of body armor used by U.S. law enforcement that is intended to protect the torso against handgun and rifle ammunition.
Request for Public Comment on Proposed Specification Threat Levels and Associated Ammunition To Test Equipment Intended To Protect U.S. Law Enforcement Against Handguns and Rifles
The National Institute of Justice (NIJ) seeks feedback from the public on a proposed specification of the threat levels and associated ammunition intended for use with voluntary NIJ Standards that specify a minimum performance requirement for U.S. law enforcement equipment intended to protect against handgun and rifle ammunition. This document defines ballistic threats identified by U.S. law enforcement as representative of prevalent threats in the United States.
Methyl-alpha-D-mannopyranoside (Alpha Methyl Mannoside); Exemption From the Requirement of a Tolerance
This regulation establishes an exemption from the requirement of a tolerance for residues of the biochemical methyl-alpha-D- mannopyranoside (alpha methyl mannoside) in or on all raw agricultural commodities when applied/used as a plant growth regulator. BRANDT iHammer submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of alpha methyl mannoside.