February 16, 2018 – Federal Register Recent Federal Regulation Documents
Results 51 - 95 of 95
Safety Zone; Santa Rosa Sound, Pensacola Beach, FL
The Coast Guard is establishing a temporary safety zone for the navigable waters within a 500 yard radius of the Kokosing Cable Lay Barge on the Santa Rosa Sound, Pensacola Beach, FL. This temporary safety zone is necessary to provide for the safety of life and property on these navigable waters during a power cable laying project taking place on the waterway. Entry into or transiting in this zone is prohibited to all vessels, mariners, and persons unless specifically authorized by the Captain of the Port Sector Mobile (COTP) or a designated representative.
Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits
This final rule amends the Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single- Employer Plans to prescribe interest assumptions under the regulation for valuation dates in March 2018. The interest assumptions are used for paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.
Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Early Alzheimer's Disease: Developing Drugs for Treatment.'' This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer's disease (AD) that occur before the onset of overt dementia. This guidance revises the draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease'' issued February 8, 2013.
Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of X-linked Duchenne muscular dystrophy (DMD) and related dystrophinopathies. This guidance finalizes the draft guidance of the same name issued on June 10, 2015.
Migraine: Developing Drugs for Acute Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Migraine: Developing Drugs for Acute Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of prescription drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of prescription drugs for the acute treatment of migraine. This guidance finalizes the draft guidance of the same name issued October 22, 2014.
Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy From Adults to Pediatric Patients 4 Years of Age and Older; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older.'' The draft guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients. Specifically, it addresses FDA's thinking regarding clinical development programs that can support extrapolation of evidence of effectiveness in treatment of POS in adults to pediatric patients 4 years of age and older.
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of amyotrophic lateral sclerosis (ALS). Specifically, it addresses FDA's current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of ALS. This guidance addresses the clinical development of drugs intended to treat the main neuromuscular aspects of ALS (i.e., muscle weakness and its direct consequences, including shortened survival).
Towing Safety Advisory Committee
The Towing Safety Advisory Committee and its subcommittees will meet in Charleston, South Carolina to review and discuss recommendations from its subcommittees and to receive briefs on items listed in the agenda. All meetings will be open to the public.
Draft List of Critical Minerals
The United States is heavily reliant on imports of certain mineral commodities that are vital to the Nation's security and economic prosperity. This dependency of the United States on foreign sources creates a strategic vulnerability for both its economy and military to adverse foreign government action, natural disaster, and other events that can disrupt supply of these key minerals. Pursuant to Executive Order 13817 issued on December 20, 2017, ``A Federal Strategy To Ensure Secure and Reliable Supplies of Critical Minerals,'' the Secretary of the Interior presents a draft list of 35 mineral commodities deemed critical under the definition provided in the Executive Order. Specifically, an analysis using multiple criteria identified 35 minerals or mineral material groups that are currently considered critical. These include: Aluminum (bauxite), antimony, arsenic, barite, beryllium, bismuth, cesium, chromium, cobalt, fluorspar, gallium, germanium, graphite (natural), hafnium, helium, indium, lithium, magnesium, manganese, niobium, platinum group metals, potash, rare earth elements group, rhenium, rubidium, scandium, strontium, tantalum, tellurium, tin, titanium, tungsten, uranium, vanadium, and zirconium. These commodities merit consideration in furthering the policy of the Federal Government to reduce the Nation's vulnerability for the security and prosperity of the United States. A summary report describing the methodologies and data sources used to develop the draft critical minerals list may be accessed at https:// doi.org/10.3133/ofr20181021. The Department of the Interior (DOI) seeks comments addressing the following topics: The make-up of the draft list and the rationale associated with potential additions or subtractions to the draft list.
Determination of Regulatory Review Period for Purposes of Patent Extension; COTELLIC
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for COTELLIC 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.
Security Zone; Delaware River, Schuylkill River; Philadelphia, PA
The Coast Guard is establishing a permanent security zone within portions of the Delaware River, and Schuylkill River, for the protection of Very Important Persons (VIP) who arrive or depart from Philadelphia International Airport, Philadelphia, PA. This permanent rule will allow for the expedited enforcement of the security zone when short notice is received by the Coast Guard regarding such travel arrangements. The security zone will be enforced only during times of a protected VIP transit to or from the airport and will restrict vessel traffic while the zone is being enforced. Only vessels or people specifically authorized by the Captain of the Port, Delaware Bay, or designated representative, may enter or remain in the regulated area.
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. The proposed information collection was previously published in the Federal Register on Thursday, November 16, 2017, allowing a 60-day comment period. Following publication of the 60-day notice, the Bureau of Justice Statistics received three requests for the survey instrument and one communication containing general comments on the importance of the collection.
Pediatric Medical Device Development; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Pediatric Medical Device Development.'' The purpose of the public meeting is to identify strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of pediatric populations. (The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients, for medical device purposes, as age 21 years or younger at the time of diagnosis or treatment and specifies categories of pediatric subpopulations.) Topics for discussion will include ways to improve research infrastructure and research networks to facilitate the conduct of clinical studies of pediatric devices, extrapolation, use of postmarket registries and data to increase pediatric medical device labeling, assistance to medical device manufacturers in developing devices for pediatric populations, and identifying barriers to pediatric device development and incentives to address such barriers.
Proposal of Special Measure Against ABLV Bank, AS as a Financial Institution of Primary Money Laundering Concern
FinCEN is issuing a notice of proposed rulemaking (NPRM), pursuant to Section 311 of the USA PATRIOT Act, to prohibit the opening or maintaining of a correspondent account in the United States for, or on behalf of, ABLV Bank, AS.
Airworthiness Directives; The Boeing Company Airplanes
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 757 airplanes. This proposed AD was prompted by reports of bolt rotation in the engine drag fitting joint and fasteners heads; an inspection of the fastener holes revealed that cracks were found in the skin on two airplanes. This proposed AD would require repetitive inspections for skin cracking and shim migration at the upper link drag fittings, diagonal brace cracking, and fastener looseness; and applicable on-condition actions. We are proposing this AD to address the unsafe condition on these products.
Proposed Agency Information Collection Activities; Comment Request
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the voluntary Policy Impact Survey (FR 3075 OMB No. 7100- 00362).
Notice of Receipt of Complaint; Solicitation of Comments; Relating to the Public Interest
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Multi-Domain Test and Measurement Instruments, DN 3295; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.
Agency Information Collection Activities: Submission for OMB Review; Comment Request (OMB No. 3064-0177)
The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collection, as required by the Paperwork Reduction Act of 1995. On November 28, 2017, the FDIC requested comment for 60 days on a proposal to renew the information collection described below. One comment was received and was generally supportive of the requirements in the rule but did not address the paperwork burden for this information collection. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.
Availability of the Integrated Risk Information System (IRIS) Assessment Plan for Uranium; correction
The Environmental Protection Agency (EPA) announced a 30-day public comment period in the Federal Register of January 31, 2018, associated with the draft IRIS Assessment Plan for Uranium. The announcement contained an incorrect docket number.
Notice of Public Meeting of the West Virginia 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 meeting of the West Virginia Advisory Committee to the Commission will convene by conference call at 12:00 p.m. (EST) on Friday, March 2, 2018. The purpose of the meeting is to receive status reports from the Planning Workgroup on recommendations for examining the Committee's examination of the collateral consequences of felony convictions in WV and to make decisions, as needed.
Notice of Public Meeting of the Indiana Advisory Committee To Hear Testimony Regarding Voting Rights in Indiana
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 that the Indiana Advisory Committee (Committee) will hold a meeting on Friday, March 2, 2018, from 9:00 a.m.-5:00 p.m. EST. The Committee will hear testimony regarding voting rights in the state.
Approval and Revision of Air Quality Implementation Plans; State of New York; Regional Haze State and Federal Implementation Plans
The Environmental Protection Agency (EPA) is approving a source-specific revision to the New York State Implementation Plan (SIP). The SIP revision establishes Best Available Retrofit Technology (BART) emission limits for sulfur dioxide that are identical to those set by the EPA's Federal Implementation Plan (FIP) for the Roseton Generating Station, Units 1 and 2, which was promulgated in an action taken on August 28, 2012. The EPA finds that the SIP revision fulfills the requirements of the Clean Air Act and the EPA's Regional Haze Rule for Roseton Units 1 and 2. In conjunction with this approval, the EPA is withdrawing the FIP that addresses BART for Roseton Units 1 and 2.
Allocations of Cross-State Air Pollution Rule Allowances From New Unit Set-Asides for 2017 Control Periods
The Environmental Protection Agency (EPA) is providing notice of the availability of data on emission allowance allocations to certain units under the Cross-State Air Pollution Rule (CSAPR) trading programs. EPA has completed calculations for the second round of allocations of allowances from the CSAPR new unit set-asides (NUSAs) for the 2017 control periods to new units and has posted spreadsheets containing the calculations on EPA's website. In addition to the eligible units identified in the previous notice regarding this round of 2017 NUSA allocations, EPA is allocating allowances to two newly affected units in Wisconsin that were not previously identified as eligible to receive such allocations. EPA has also completed calculations for allocations of the remaining 2017 NUSA allowances to existing units and has posted spreadsheets containing those calculations on EPA's website as well.
Arms Sales Notification
The Department of Defense is publishing the unclassified text of an arms sales notification.
Determination That LOTENSIN HCT (Benazepril Hydrochloride; Hydrochlorothiazide) Oral Tablets, 5 Milligrams and 6.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 milligrams (mg) and 6.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for benazepril hydrochloride; hydrochlorothiazide oral tablets, 5 mg and 6.25 mg, if all other legal and regulatory requirements are met.
Defense Advisory Committee on Investigation Prosecution and Defense of Sexual Assault in the Armed Forces; Notice of Federal Advisory Committee Meeting
The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Investigation Prosecution and Defense of Sexual Assault in the Armed Forces will take place. This meeting will be open to the public.
Division of Longshore and Harbor Workers' Compensation Proposed Extension of Existing Collection; Comment Request
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the paperwork Reduction Act of 1995 (PRA95). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs (OWCP) is soliciting comments concerning the proposed collection: Notice of Payment (LS-208). A copy of the proposed information collection request can be obtained by contacting the office listed below in the address section of this Notice.
Lightweight Thermal Paper From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016
On December 1, 2017, the Department of Commerce (Commerce) published in the Federal Register the preliminary results of the 2015- 2016 administrative review (AR) of the antidumping duty (AD) order on lightweight thermal paper (LWTP) from the People's Republic of China (China), covering the period of review (POR) November 1, 2015, through October 31, 2016. We received no comments or requests for a hearing. Therefore, we have made no changes for these final results and continue to find that none of the companies under review established eligibility for a separate rate status and, thus, are part of the China-wide entity.
Hot-Rolled Steel Products From Brazil: Rescission of 2016 Countervailing Duty Administrative Review
The Department of Commerce (Commerce) is rescinding the administrative review of the countervailing duty order on hot-rolled steel products from Brazil for the period of review (POR) January 15, 2016, through December 31, 2016.
Office of the Under Secretary of State for Public Diplomacy and Public Affairs Request for Proposal (RFP) for the Fundraising, Project Management, Design, Construction, Operation, Disassembly and Removal of a USA Pavilion at Expo 2020 Dubai
The Expo Unit within the Office of the Under Secretary of State for Public Diplomacy and Public Affairs of the U.S. Department of State requests proposals from private U.S. individuals, firms, associations, educational institutions, and organizations (for profit and non-profit) for the fundraising, project management, design, construction, operation, and disassembly and removal of a USA Pavilion at Expo 2020 Dubai, in the United Arab Emirates (UAE) (https:// expo2020dubai.ae/). The UAE is a strong U.S. partner, and the largest export market for U.S. goods and services in the Middle East. The six- month long Expo 2020 Dubai from October 2020-April 2021 will be the first Expo (also known as World's Fair) to take place in the Middle East, North Africa, or South Asia and is expected to attract 25 million visitors and coincides with the UAE's 50th founding anniversary. Proposals from non-U.S. citizens or non-U.S. firms or organizations shall be deemed ineligible for consideration.
Record of Decision for the Presidential Aircraft Recapitalization Program at Joint Base Andrews-Naval Air Facility Washington, Maryland Final Environmental Impact Statement
The United States Air Force signed the Record of Decision for the Presidential Aircraft Recapitalization at Joint Base Andrews-Naval Air Facility Washington, Maryland (hereafter referred to as ``the Program'') Final Environmental Impact Statement. The Air Force will construct and operate a two-bay Presidential Aircraft Recapitalization Hangar Complex (hereafter referred to as ``the Hangar Complex'') facility on Joint Base Andrews at a location known as Alternative 4 to house two separately acquired Boeing 747-8 aircraft.
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