Results 201 - 250 of 417,965
Proposed Information Collection; Comment Request; Renewal Without Change of Bank Secrecy Act Regulations Requiring Money Services Businesses To Report Suspicious Activity
Document Number: 2018-15400
Type: Notice
Date: 2018-07-19
Agency: Department of the Treasury, Financial Crimes Enforcement Network
FinCEN, a bureau of the U.S. Department of the Treasury (``Treasury''), invites all interested parties to comment on its proposed renewal without change of the Bank Secrecy Act (``BSA'') Suspicious Activity Reporting requirements for money services businesses (``MSBs''). FinCEN intends to submit this requirement for approval by the Office of Management and Budget (``OMB'') of a three- year renewal of Control Number 1506-0015. This request for comments is made pursuant to the Paperwork Reduction Act (``PRA'') of 1995, Public Law 104-13, 44 U.S.C. 3506(c)(2)(A).
Proposed Collection; Comment Request; Renewal Without Change of the Registration of Money Services Business, Regulation and FinCEN Form 107
Document Number: 2018-15399
Type: Notice
Date: 2018-07-19
Agency: Department of the Treasury, Financial Crimes Enforcement Network
As part of its continuing effort to reduce paperwork and respondent burden, FinCEN invites comment on a renewal without change to a currently approved information collection contained in 31 CFR 1022.380 and the Registration of Money Services Business report, FinCEN Form 107. The form will be used by currency dealers or exchangers; check cashers; issuers of traveler's checks, money orders or prepaid access; sellers of traveler's checks, money orders or prepaid access; redeemers of traveler's checks, money orders or prepaid access; and money transmitters to register with the Department of the Treasury as required by statute. This request for comments is being made pursuant to the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. 3506(c)(2)(A).
Federal Travel Regulation (FTR); Relocation Allowances-Waiver of Certain Provisions of the FTR Chapter 302 for Official Relocation Travel to Locations in the U.S. Virgin Islands and Commonwealth of Puerto Rico Impacted by Hurricanes Irma and Maria
Document Number: 2018-15398
Type: Notice
Date: 2018-07-19
Agency: General Services Administration, Agencies and Commissions
The purpose of this notice is to inform Federal agencies that certain provisions of the FTR governing official relocation travel expenses are temporarily waived for United States (U.S.) Virgin Islands and Commonwealth of Puerto Rico locations impacted by Hurricanes Irma and Maria. As a result of the storm damage caused by Hurricanes Irma and Maria, agencies should consider delaying all non-essential relocations to the affected areas given the statutory 120-day maximum for Temporary Quarters Subsistence Expenses (TQSE). Due to the lasting effects of the storm damage to these affected areas, finding lodging facilities and/or adequate meals may be difficult, and distances involved may be great, resulting in increased costs for relocation per diem expenses. FTR Bulletin 18-07 and all other FTR Bulletins can be found at www.gsa.gov/ftrbulletin.
Maryland; Major Disaster and Related Determinations
Document Number: 2018-15397
Type: Notice
Date: 2018-07-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the State of Maryland (FEMA-4374-DR), dated June 25, 2018, and related determinations.
Hawaii; Amendment No. 1 to Notice of a Major Disaster Declaration
Document Number: 2018-15396
Type: Notice
Date: 2018-07-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the State of Hawaii (FEMA-4365-DR), dated May 8, 2018, and related determinations.
E17 General Principles for Planning and Design of Multiregional Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2018-15395
Type: Notice
Date: 2018-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``E17 General Principles for Planning and Design of Multiregional Clinical Trials.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance describes general principles for planning and designing multiregional clinical trials (MRCTs). The guidance is intended to increase the acceptability of data from MRCTs as the primary source of evidence supporting marketing approval in global regulatory submissions and thereby facilitate more efficient drug development and earlier access to medicines.
Humic Product Trade Association; Withdrawal of Food Additive Petition (Animal Use)
Document Number: 2018-15394
Type: Proposed Rule
Date: 2018-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2290) proposing that the food additive regulations be amended to provide for the safe use of humate, fluvic acid, and humic substances as a source of iron in animal feed.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2018-15393
Type: Notice
Date: 2018-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that EPIDIOLEX (cannabidiol oral solution) manufactured by GW Research Ltd., meets the criteria for a priority review voucher.
Privacy Act of 1974; System of Records
Document Number: 2018-15392
Type: Notice
Date: 2018-07-19
Agency: Commodity Futures Trading Commission, Agencies and Commissions
In accordance with the requirements of the Privacy Act of 1974, as amended, the Commodity Futures Trading Commission (CFTC or Commission) is republishing two existing System of Record Notices (SORNs): CFTC-39, Freedom of Information Act Requests and CFTC-40, Privacy Act Requests. The modification will add three routine uses, clarify existing routine uses, and bring the SORNs in compliance with the Office of Management and Budget (OMB) Circular A-108 SORN template. Two of the new routine uses pertain to sharing information to mitigate a breach and are required by OMB Memorandum 17-12. The third new routine use is requested by the Office of Government Information Services (OGIS) to allow disclosure of personally identifiable information to OGIS for Freedom of Information Act (FOIA) dispute resolution and compliance review purposes. Other updates include identifying the specific routine uses applicable to each of the systems of records rather than relying on CFTC's previously published blanket routine uses, and administrative updates to comply with the OMB Circular A-108 SORN template format.
Labeling for Biosimilar Products; Guidance for Industry; Availability
Document Number: 2018-15391
Type: Notice
Date: 2018-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Labeling for Biosimilar Products.'' This guidance is intended to help applicants develop draft labeling for proposed biosimilar products. The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for certain recommendations pertaining to FDA- approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). This guidance provides an overview of FDA's recommendations for labeling for biosimilar products. This guidance finalizes the draft guidance issued on April 4, 2016.
Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry; Availability
Document Number: 2018-15390
Type: Notice
Date: 2018-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Use of Electronic Health Record Data in Clinical Investigations.'' The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. The guidance finalizes the draft guidance issued in May 2016.
Field Alert Report Submission: Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2018-15389
Type: Notice
Date: 2018-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Field Alert Report Submission: Questions and Answers.'' This draft guidance, when finalized, will provide the Agency's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and will outline FDA's recommendations for FAR submissions to help increase their consistency and relevancy. The draft guidance also addresses certain frequently asked questions about FARs.
Hawaii; Amendment No. 1 to Notice of a Major Disaster Declaration
Document Number: 2018-15388
Type: Notice
Date: 2018-07-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the State of Hawaii (FEMA-4366-DR), dated May 11, 2018, and related determinations.
Proposed Flood Hazard Determinations
Document Number: 2018-15387
Type: Notice
Date: 2018-07-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Changes in Flood Hazard Determinations
Document Number: 2018-15386
Type: Notice
Date: 2018-07-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.
Changes in Flood Hazard Determinations
Document Number: 2018-15385
Type: Notice
Date: 2018-07-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.
Proposed Flood Hazard Determinations
Document Number: 2018-15384
Type: Notice
Date: 2018-07-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Arts and Artifacts Indemnity Panel Advisory Committee
Document Number: 2018-15383
Type: Notice
Date: 2018-07-19
Agency: National Foundation on the Arts and the Humanities, Agencies and Commissions
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.
Submission for OMB Review; Comment Request
Document Number: 2018-15382
Type: Notice
Date: 2018-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Proposed Collection; Comment Request
Document Number: 2018-15381
Type: Notice
Date: 2018-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2018-15380
Type: Notice
Date: 2018-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Proposed Collection; Comment Request
Document Number: 2018-15379
Type: Notice
Date: 2018-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2018-15378
Type: Notice
Date: 2018-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2018-15377
Type: Notice
Date: 2018-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2018-15376
Type: Notice
Date: 2018-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2018-15375
Type: Notice
Date: 2018-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2018-15374
Type: Notice
Date: 2018-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2018-15373
Type: Notice
Date: 2018-07-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Suspension of Community Eligibility
Document Number: 2018-15372
Type: Rule
Date: 2018-07-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-flood-insurance-program-community-statu s-book.
Oklahoma; Major Disaster and Related Determinations
Document Number: 2018-15371
Type: Notice
Date: 2018-07-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the State of Oklahoma (FEMA-4373-DR), dated June 25, 2018, and related determinations.
Endangered and Threatened Wildlife and Plants; Draft Recovery Plan for the Southern California Distinct Population Segment of the Mountain Yellow-legged Frog (Rana muscosa)
Document Number: 2018-15362
Type: Notice
Date: 2018-07-19
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, announce the availability of the Draft Recovery Plan for the Southern California Distinct Population Segment of the Mountain Yellow-legged Frog (Rana muscosa) for public review and comment. The draft recovery plan includes objective, measurable criteria, and site-specific management actions as may be necessary to reclassify the species from endangered to threatened and also for removal from the Federal List of Endangered and Threatened Wildlife.
Atlantic and Western Railway, Limited Partnership-Acquisition and Operation Exemption-CSX Transportation, Inc.
Document Number: 2018-15361
Type: Notice
Date: 2018-07-19
Agency: Surface Transportation Board, Department of Transportation
Meeting of the Judicial Conference Advisory Committee on Rules of Criminal Procedure
Document Number: 2018-15360
Type: Notice
Date: 2018-07-19
Agency: Judicial Conference of the United States, Agencies and Commissions
The Advisory Committee on Rules of Criminal Procedure will hold a meeting on October 10, 2018. The meeting will be open to public observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at: http:// www.uscourts.gov/rules-policies/records-and-archives-rules-co mmittees/ agenda-books.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-15359
Type: Notice
Date: 2018-07-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2018-15358
Type: Notice
Date: 2018-07-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2018-15357
Type: Notice
Date: 2018-07-19
Agency: Department of Health and Human Services, National Institutes of Health
Fine Denier Polyester Staple Fiber From China, India, Korea, and Taiwan; Determinations
Document Number: 2018-15356
Type: Notice
Date: 2018-07-19
Agency: International Trade Commission, Agencies and Commissions
Special Conditions: Cranfield Aerospace Limited, Textron Aviation Inc. Model 525-Series Airplanes; Tamarack Load Alleviation System and Cranfield Winglets-Interaction of Systems and Structures
Document Number: 2018-15354
Type: Rule
Date: 2018-07-19
Agency: Federal Aviation Administration, Department of Transportation
These amended special conditions are issued for the Textron Aviation Inc. Model 525-series airplanes. These airplanesas modified by Cranfield Aerospace Limitedwill have a novel or unusual design feature associated with the installation of a Tamarack Active Technology Load Alleviation System and Cranfield Winglets. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These amended special conditions contain the additional safety standards the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards, change the Type Certificate holder, and remove the special flight permit requirement.
Air Plan Approval; Oregon; Interstate Transport Requirements for the 2012 PM2.5
Document Number: 2018-15353
Type: Proposed Rule
Date: 2018-07-19
Agency: Environmental Protection Agency
The Clean Air Act (CAA) requires each State Implementation Plan (SIP) to contain adequate provisions prohibiting emissions that will have certain adverse air quality effects in other states. On October 20, 2015, the State of Oregon made a submission to the Environmental Protection Agency (EPA) to address these requirements. The EPA is proposing to approve the submission as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will contribute significantly to nonattainment or interfere with maintenance of the 2012 annual fine particulate matter (PM2.5) national ambient air quality standard (NAAQS) in any other state.
Settlement Policy for Commercial Pilots in Drug and Alcohol Testing Cases
Document Number: 2018-15352
Type: Rule
Date: 2018-07-19
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a procedure for prompt settlement agreements between the FAA and commercial pilots who have: Received a verified positive result for a Department of Transportation (DOT)- required drug test; received a DOT-required alcohol test result of .04 or above alcohol concentration; refused to submit to a DOT-required drug or alcohol test in violation of FAA regulations; or acted or attempted to act as a crewmember of an aircraft in commercial operations in violation of specified FAA regulations under this policy that proscribe the use, being under the influence or affects, or while have proscribed levels of alcohol or drugs. The settlement agreement procedures in this notification are generally available to pilots who, but for the disqualifying DOT drug or alcohol test result, refusal to submit to a DOT test, or violation of the specified alcohol- and drug- related FAA regulations prohibiting acting or attempting to act as a crewmember, would be qualified for a pilot certificate and who are first-time violators of these drug or alcohol provisions.
Solicitation of Nomination for Appointment to the Advisory Committee on Women Veterans
Document Number: 2018-15350
Type: Notice
Date: 2018-07-19
Agency: Department of Veterans Affairs
The Department of Veterans Affairs (VA) is seeking nominations of qualified candidates to be considered for membership on the Advisory Committee on Women Veterans (``the Committee'') for the 2018 membership cycle.
Notice of Funds Availability (NOFA) for the Conservation Reserve Program (CRP) Forest Inventory Analysis Pilot
Document Number: 2018-15349
Type: Notice
Date: 2018-07-19
Agency: Department of Agriculture, Commodity Credit Corporation
The Farm Service Agency (FSA), on behalf of Commodity Credit Corporation (CCC), is announcing the availability of competitive grants to conduct a forest inventory analysis, forest management, and economic outcomes modelling, for certain currently enrolled Conservation Reserve Program (CRP) land. The analysis is focused on lands enrolled in CRP for at least 8 years and located in areas with a substantial concentration of acres enrolled under the following conservation practices devoted to multiple bottomland hardwood tree species: General tree planting, hardwood tree planting, vegetative cover on previously established tree stands, riparian buffers, bottomland timber establishments, and farmable and aquaculture wetlands. Qualified applicants must be non-profit organizations dedicated to conservation, forestry, and wildlife habitats that have experience in conducting accurate forest inventory analysis through the use of advanced, cost- effective technology, as determined by FSA.