Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory 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. FDA is establishing a docket for public comment on this document.
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' This draft guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain intended changes in policies and procedures surrounding its application.
Ford Motor Company, Receipt of Petition for Inconsequentiality and Decision Denying Request for Deferral of Determination
On July 10, 2017, Takata Corporation (``Takata'') filed a defect information report (``DIR'') in which it determined that a safety-related defect exists in certain phase-stabilized ammonium nitrate (``PSAN'') driver-side airbag inflators that it manufactured with a calcium sulfate desiccant, including inflators that it supplied to Ford Motor Company (``Ford''), Mazda North American Operations (``Mazda''), and Nissan North America Inc. (``Nissan'') for use in certain vehicles. Ford has petitioned the Agency for a decision that, because analysis of inflators installed in certain Ford vehicles does not demonstrate propellant-tablet density degradation or increased inflation pressure, and because there are design differences between the inflators installed in Ford vehicles and an inflator variant installed in Nissan vehicles, the equipment defect determined to exist by Takata is inconsequential as it relates to motor vehicle safety in the Ford vehicles affected by Takata's DIR. Ford requests relief from its notification and remedy obligations under the National Traffic and Motor Vehicle Safety Act of 1966 and its applicable regulations, and further requests that the Agency allow Ford until March 31, 2018 to complete certain analysis and testing before the Agency decides on the petition.
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, November 20 at 10:00 a.m. (EST). The purpose of the meeting is to discuss what more needs to be done to complete the record of the briefing meeting conducted in Wilmington on November 1, 2017, titled, Implicit Bias and Policing in Communities of Color in Delaware. The Committee will also discuss tasks needed to prepare the report of its review to the Commission.
National Park System Advisory Board; Request for Nominations
The National Park Service (NPS), U.S. Department of the Interior (Department), is seeking nominations for individuals to be considered for appointment to the National Park System Advisory Board (Board). The Board advises the Secretary of the Interior (Secretary) and the Director of the National Park Service (Director) on matters relating to the National Park Service (NPS), the National Park System, and programs administered by the NPS. The Board is a discretionary committee established by authority of the Secretary under 54 U.S.C. 100906 and regulated by the Federal Advisory Committee Act (FACA).
Parts and Accessories Necessary for Safe Operation; Exemption Renewal for Ford Motor Company
FMCSA announces its decision to renew for a period of 5 years Ford Motor Company's (Ford) current exemption allowing motor carriers to operate Ford's Transit-based commercial motor vehicles (CMV) that do not meet the exhaust system location requirements in the Federal Motor Carrier Safety Regulations (FMCSR). The FMCSRs require (1) the exhaust system of a bus powered by a gasoline engine to discharge to the atmosphere at or within 6 inches forward of the rearmost part of the bus and (2) the exhaust system of every truck and truck tractor to discharge to the atmosphere at a location to the rear of the cab or, if the exhaust projects above the cab, at a location near the rear of the cab. Although the Ford Transit does not meet these requirements, it has undergone performance-based testing that demonstrates that the exhaust system achieves a level of safety equivalent to, or greater than, the level of safety that would be obtained by complying with the regulation. Ford performed carbon monoxide (CO) concentration tests, which used CO monitors at various locations within the vehicle to measure the concentration of CO ingress into the occupant compartment (from the vehicles' own powertrain and exhaust system), under various driving conditions including idle and top speed. The tests showed that the resulting CO concentration is below every threshold used by Federal Agencies. The Agency has concluded that granting this exemption renewal will maintain a level of safety equivalent to, or greater than, the level of safety provided by the rule restricting the location of exhaust systems on CMVs to ensure that exhaust fumes will not affect the driver's alertness or health or the health of passengers.
Certain Wireless Audio Systems and Components Thereof; Commission Determination Not To Review an Initial Determination Granting Complainant's Motion for Leave To Amend the Complaint
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 9) of the presiding administrative law judge (``ALJ''), granting complainant's motion for leave to amend the complaint in the above-captioned investigation
Agency Information Collection Activities; Proposed eCollection eComments Requested; Application and Permit for Temporary Importation of Firearms and Ammunition by Nonimmigrant Aliens-ATF F 6NIA (5330.3D)
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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. The proposed information collection was previously published in the Federal Register, on September 11, 2017, allowing for a 60-day comment period.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Report of Multiple Sale or Other Disposition of Certain Rifles-ATF Form 3310.12
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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. The proposed information collection was previously published in the Federal Register, on September 12, 2017, allowing for a 60-day comment period. This Information Collection is being revised due to a reduction in the number of respondents, responses, and burden hours respectively.
Safety Zone; Annual Fireworks Display on the Ohio River, Monongahela River, Allegheny River, Pittsburgh, PA
The Coast Guard will enforce the subject safety zone for the annual fireworks display that takes place every November on the Ohio River, Monongahela River and Allegheny River extending the entire width of the rivers. The zone is needed to protect vessels transiting the area and event spectators from the hazards associated with the fireworks display. During the enforcement period, entry into, transiting, or anchoring in the safety zone is prohibited to all vessels not registered with the sponsor as participants or official patrol vessels, unless specifically authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative.
Agency Information Collection Activities: Proposed eCollection eComments Requested; Reinstatement, With Change, of a Previously Approved Collection: 2018 Census of State and Local Law Enforcement Agencies (CSLLEA)
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, 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; Pipelines and Pipeline Rights-of-Way
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Safety and Environmental Enforcement (BSEE) are proposing to renew an information collection with revisions.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Operations in the Outer Continental Shelf for Minerals Other Than Oil, Gas, and Sulphur
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Safety and Environmental Enforcement (BSEE) are proposing to renew an information collection with revisions.
Special Conditions: General Electric Company, GE9X Engine Models; Endurance Test Special Conditions
These special conditions are issued for the General Electric Company turbofan engine models GE9X-105B1A, -105B1A1, -105B1A2, - 105B1A3, -102B1A, -102B1A1, -102B1A2, -102B1A3, and -93B1A. In these special conditions, the engine models will be referred to as ``GE9X.'' The engines will have novel or unusual design features associated with the engine design. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. 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.
Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.
Mepergan Fortis Capsules; Final Decision on Proposal To Refuse Approval of Supplemental New Drug Application; Availability of Final Decision
The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), to refuse approval of the supplemental new drug application (sNDA) for Mepergan Fortis Capsules (MFC) (meperidine HCl, promethazine HCl), is the final decision of the Commissioner by operation of law. In the Initial Decision, the ALJ found that MFC had not been shown to be supported by substantial evidence consisting of adequate and well- controlled studies to be effective for sedation and analgesia in patients with concurrent moderate pain and apprehension, such as postoperative and post-trauma patients with those symptoms; that the drug did not satisfy the combination drug policy; and that it is a ``new drug.'' The sNDA applicant filed exceptions to the ALJ's Initial Decision. FDA recently requested that the current owner of the sNDA application affirm its desire to pursue the appeal of the ALJ's Initial Decision; however, the applicant did not affirm its desire to pursue the appeal within the specified timeframe. Accordingly, FDA now deems those exceptions as withdrawn. Consequently, the proceeding is in the same procedural position as if no exceptions to the ALJ's Initial Decision had been filed; therefore, the ALJ's Initial Decision has become the final decision of the Commissioner by operation of law.
Safety Zone; Atlantic Ocean, Rehoboth Beach, DE
On November 9, 2017, the Coast Guard published a rule establishing temporary safety zones in the Atlantic Ocean, off the coast of Rehoboth Beach, DE and in Breakwater Harbor near Cape Henlopen. The rule was made enforceable from November 6, 2017, through February 28, 2018. However, in regulatory text the February date was mistakenly given as February 28, 2017. This document corrects that error.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Strengthening United States Response to Resistant Gonorrhea (SURRG).'' The goal of the study is to strengthen the U.S response to resistant gonorrhea by enhancing state and local public health surveillance and program infrastructure, build capacity to support rapid detection and public health response to antibiotic-resistant gonorrhea, and advance the understanding of epidemiological factors contributing to antibiotic- resistant gonorrhea.
Offer Caps in Markets Operated by Regional Transmission Organizations and Independent System Operators
The Federal Energy Regulatory Commission is granting in part and denying in part requests for rehearing and clarification of its determinations in Order No. 831, which amended its regulations to address incremental energy offer caps in markets operated by regional transmission organizations and independent system operators.
Commission Information Collection Activities (FERC-725HH); Comment Request; Revision and Extension
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on revisions to the information collection, FERC-725HH (RF Reliability Standards) which will be submitted to the Office of Management and Budget (OMB) for review of the information collection requirements.
Submission of Data by State Educational Agencies; Submission Dates for State Revenue and Expenditure Reports for Fiscal Year 2017, Revisions to Those Reports, and Revisions to Prior Fiscal Year Reports
The Secretary announces dates for State educational agencies (SEAs) to submit expenditure and revenue data and average daily attendance statistics on ED Form 2447 (the National Public Education Financial Survey (NPEFS)) for fiscal year (FY) 2017, revisions to those reports, and revisions to reports for previous fiscal years. The Secretary sets these dates to ensure that data are available to serve as the basis for timely distribution of Federal funds. The U.S. Census Bureau is the data collection agent for this request of the Department of Education's National Center for Education Statistics (NCES). The data will be published by NCES and will be used by the Secretary in the calculation of allocations for FY 2019 appropriated funds.
Submission for OMB Review; 30-Day Comment Request; NCI Cancer Genetics Services Directory Web-Based Application and Update Mailer (National Cancer Institute)
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.
Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Bats BZX Exchange, Inc.; Bats EDGA Exchange, Inc.; Bats EDGX Exchange, Inc.; BOX Options Exchange LLC; C2 Options Exchange, Incorporated; Chicago Board Options Exchange, Incorporated; Chicago Stock Exchange, Inc.; Financial Industry Regulatory Authority, Inc.; Investors Exchange LLC; Miami International Securities Exchange, LLC; MIAX PEARL LLC; Nasdaq BX, Inc.; Nasdaq GEMX, LLC; Nasdaq ISE, LLC; Nasdaq MRX, LLC; Nasdaq PHLX LLC; The Nasdaq Stock Market LLC; New York Stock Exchange LLC; NYSE Arca, Inc. and NYSE MKT LLC; Notice of Designation of Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Changes To Establish Fees for Industry Members To Fund the Consolidated Audit Trail
Submission for OMB Review; 30-Day Comment Request; Generic Clearance To Support the Safe To Sleep® Campaign (Eunice Kennedy Shriver National Institute of Child Health and Human Development); Correction
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on November 9, 2017. That Notice inadvertently contained an error in the Supplementary Information section.
Prospective Grant of Exclusive Patent Commercialization License: Direct Reading Detection Kits for Surface Contamination by Antineoplastic Drugs
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to Becton, Dickinson and Company, located in Franklin Lakes, New Jersey, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.