October 2017 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 2,664
Appraisal Subcommittee Notice of Meeting
Document Number: 2017-23533
Type: Notice
Date: 2017-10-30
Agency: Federal Financial Institutions Examination Council, Agencies and Commissions
Notice of Public Meeting, BLM Alaska Resource Advisory Council
Document Number: 2017-23532
Type: Notice
Date: 2017-10-30
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Federal Land Policy and Management Act of 1976 as amended and the Federal Advisory Committee Act of 1972, the Bureau of Land Management (BLM) Alaska Resource Advisory Council (RAC) will meet as indicated below.
Motor Vehicle Safety Standards; Electronic Stability Control Systems for Heavy Vehicles
Document Number: 2017-23531
Type: Rule
Date: 2017-10-30
Agency: National Highway Traffic Safety Administration, Department of Transportation
This final rule addresses a petition for reconsideration of the final rule for FMVSS No. 136, Electronic stability control systems for heavy vehicles. The petitioner, Truck and Engine Manufacturers Association (EMA), requested that NHTSA amend the test conditions for the agency's performance test by allowing a larger lane width for long wheelbase truck tractors. After a careful technical review of the petition and the issues raised by the petitioner, the agency has decided to grant the petition because there is sufficient evidence to indicate that a larger lane width is needed for testing of long wheelbase truck tractors.
North Pacific Fishery Management Council; Public Meeting
Document Number: 2017-23530
Type: Notice
Date: 2017-10-30
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The North Pacific Fishery Management Council (Council) Social Science Plan Team will meet telephonically on November 14, 2017.
Notice of OFAC Sanctions Actions
Document Number: 2017-23529
Type: Notice
Date: 2017-10-30
Agency: Department of the Treasury, Office of Foreign Assets Control
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of nine persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
Advisory Committee on Infant Mortality; Notice of Charter Renewal
Document Number: 2017-23528
Type: Notice
Date: 2017-10-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Infant Mortality (ACIM) has been rechartered. The effective date of the renewed ACIM charter is September 30, 2017.
Release of Waybill Data
Document Number: 2017-23527
Type: Notice
Date: 2017-10-30
Agency: Surface Transportation Board, Department of Transportation
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability
Document Number: 2017-23526
Type: Notice
Date: 2017-10-30
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 ``Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.'' This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Previously Approved Collection: Red Ribbon Week Patch
Document Number: 2017-23524
Type: Notice
Date: 2017-10-30
Agency: Department of Justice
The Department of Justice (DOJ), Drug Enforcement Administration, 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.
Cost-of-Living Increase and Other Determinations for 2018
Document Number: 2017-23522
Type: Notice
Date: 2017-10-30
Agency: Social Security Administration, Agencies and Commissions
Under title II of the Social Security Act (Act), there will be a 2.0 percent cost-of-living increase in Social Security benefits effective December 2017. In addition, the national average wage index for 2016 is $48,664.73. The cost-of-living increase and national average wage index affect other program parameters as described below.
Social Security Disability Program Demonstration Project: Promoting Opportunity Demonstration (POD)
Document Number: 2017-23521
Type: Notice
Date: 2017-10-30
Agency: Social Security Administration, Agencies and Commissions
We are announcing a demonstration project for the Social Security disability program under title II of the Social Security Act (Act). Under this project, we will modify program rules applied to beneficiaries who work and receive title II disability benefits. We are required to conduct the Promoting Opportunity Demonstration (POD), in compliance with section 823 of the Bipartisan Budget Act (BBA) of 2015. In this project, we will test simplified work incentives and use a benefit offset based on earnings as an alternative to rules we currently apply to title II disability beneficiaries who work. Under the benefit offset, we will reduce title II disability benefits by $1 for every $2 that a beneficiary earns above a certain threshold. We will select beneficiaries and offer them the opportunity to volunteer for the project. When we make the selection, we will include beneficiaries who receive title II disability benefits only as well as beneficiaries who receive both title II disability benefits and Supplemental Security Income (SSI) based on disability or blindness under title XVI of the Act. We are modifying rules that apply to the title II program and the Ticket to Work program under title XI. We will continue to apply the usual SSI program rules for participants who receive SSI payments in addition to title II disability benefits.
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-23520
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.'' FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made in light of the risk of tissue dissemination and relates to use of these devices in the removal of uterine fibroids.
Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by the Food and Drug Administration; Request for Information
Document Number: 2017-23519
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is requesting information to assist in identifying standard development organizations (SDOs) that meet the requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act), of the 21st Century Cures Act (Cures Act), which was signed into law on December 13, 2016.
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements
Document Number: 2017-23518
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the requirements for electronic submission of postmarketing safety reports for human drug and biological products.
Manufacturers Sharing Patient-Specific Information From Medical Devices With Patients Upon Request; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-23517
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request.'' FDA developed this guidance to clarify our position regarding manufacturers appropriately and responsibly sharing ``patient-specific information''information unique to an individual patient or unique to that patient's treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical devicewith that patient at that patient's request. This guidance provides information and recommendations to industry, health care providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with individual patients when they request it.
Medical Devices; Neurological Devices; Classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System
Document Number: 2017-23516
Type: Rule
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-EEG physiological signal based seizure monitoring system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows
Document Number: 2017-23515
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Survey of Alumni Commissioner's Fellowship Program Fellows.
Victory Media, Inc.; Analysis To Aid Public Comment
Document Number: 2017-23514
Type: Notice
Date: 2017-10-30
Agency: Federal Trade Commission, Agencies and Commissions
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order embodied in the consent agreementthat would settle these allegations.
Medical Devices; Immunology and Microbiology Devices; Classification of the Streptococcus SPP. Nucleic Acid-Based Assay
Document Number: 2017-23513
Type: Rule
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the Streptococcus spp. nucleic acid-based assay into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Streptococcus spp. nucleic acid-based assay's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Marine Mammals; File No. 21431
Document Number: 2017-23512
Type: Notice
Date: 2017-10-30
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that Gregory Bossart, V.M.D., Ph.D., Georgia Aquarium, 225 Baker Street Northwest, Atlanta, GA 30313, has applied in due form for a permit to conduct research on bottlenose dolphins (Tursiops truncatus).
Agency Information Collection Activities; Proposed eCollection; eComments Requested InfraGard Membership Application and Profile
Document Number: 2017-23511
Type: Notice
Date: 2017-10-30
Agency: Department of Justice
Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Training Division's Curriculum Management Section (CMS) 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. This proposed information collection was previously published in the Federal Register, on August 3, 2017 allowing for a 60 day comment period.
Update to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or Manager
Document Number: 2017-23510
Type: Notice
Date: 2017-10-30
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in the Federal Register) may be relied upon as ``of record'' notice that the Corporation has been appointed receiver for purposes of the statement of policy published in the July 2, 1992, issue of the Federal Register (57 FR 29491). For further information concerning the identification of any institutions which have been placed in liquidation, please visit the Corporation Web site at www.fdic.gov/ bank/individual/failed/banklist.html or contact the Manager of Receivership Oversight in the appropriate service center.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-23509
Type: Notice
Date: 2017-10-30
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
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 August 18, 2017, the FDIC requested comment for 60 days on a proposal to renew the information collection described below. No comments were received. 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.
Presidential Declaration Amendment of a Major Disaster for the State of Florida
Document Number: 2017-23508
Type: Notice
Date: 2017-10-30
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for the State of Florida (FEMA4337DR), dated 09/10/ 2017. Incident: Hurricane Irma. Incident Period: 09/04/2017 through 10/18/2017.
Covered Securities Pursuant to Section 18 of the Securities Act of 1933
Document Number: 2017-23507
Type: Rule
Date: 2017-10-30
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission (``SEC'' or ``Commission'') is adopting an amendment to Rule 146 under Section 18 of the Securities Act of 1933, as amended (``Securities Act''), to designate certain securities listed, or authorized for listing, on Investors Exchange LLC (``IEX'' or ``Exchange'') as covered securities for purposes of Section 18(b) of the Securities Act. Covered securities under Section 18(b) of the Securities Act are exempt from state law registration requirements. The Commission also is amending Rule 146 to reflect name changes of certain exchanges referenced in the Rule.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Florida
Document Number: 2017-23506
Type: Notice
Date: 2017-10-30
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4337-DR), dated 09/21/2017. Incident: Hurricane Irma. Incident Period: 09/04/2017 through 10/18/2017.
Submission for OMB Review; Comment Request
Document Number: 2017-23505
Type: Notice
Date: 2017-10-30
Agency: Department of Commerce
Submission for OMB Review; Comment Request
Document Number: 2017-23504
Type: Notice
Date: 2017-10-30
Agency: Department of Commerce
Endangered Species Recovery Permit Applications
Document Number: 2017-23502
Type: Notice
Date: 2017-10-30
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (Act) prohibits activities with endangered and threatened species unless a Federal permit allows such activity. The Act also requires that we invite public comment before issuing recovery permits to conduct certain activities with endangered species.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2017-23501
Type: Notice
Date: 2017-10-30
Agency: Federal Reserve System, Agencies and Commissions
Acceptance Review for De Novo Classification Requests; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-23500
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Acceptance Review for De Novo Classification Requests.'' The purpose of this draft guidance is to explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. This draft guidance discusses De Novo acceptance review policies and procedures, ``Refuse to Accept'' principles, and the elements of the De Novo Acceptance Checklist and the Recommended Content Checklist and is being issued to be responsive to an explicit deliverable identified in the Medical Device User Fee Amendments of 2017 (MDUFA IV). This draft guidance is not final nor is it in effect at this time.
Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments; Reopening of Comment Period
Document Number: 2017-23498
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period provided in the notice entitled ``Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments,'' published in the Federal Register of July 25, 2017 (82 FR 34531). That notice announced the public workshop to be held on October 10, 2017, and requested comments by October 18, 2017. The Agency is taking this action to allow interested parties additional time to submit comments.
Medical Devices; Immunology and Microbiology Devices; Classification of the Newborn Screening Test for Severe Combined Immunodeficiency Disorder
Document Number: 2017-23496
Type: Rule
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the newborn screening test for severe combined immunodeficiency disorder (SCID) into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the newborn screening test for SCID's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Advisory Council to the Internal Revenue Service; Meeting
Document Number: 2017-23495
Type: Notice
Date: 2017-10-30
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Internal Revenue Service Advisory Council (IRSAC) will hold a public meeting on Wednesday, November 15, 2017.
Proposed Information Collection; Comment Request
Document Number: 2017-23494
Type: Notice
Date: 2017-10-30
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Internal Revenue Service, 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 and/ or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice provides guidance relating to the waiver of 2009 required minimum distributions, described in section 401(a)(9) of the Internal Revenue Code (``Code''), from certain plans under the Worker, Retiree, and Employer Recovery Act of 2008 (``WRERA'').
Proposed Collection; Comment Request for Form 1041-N
Document Number: 2017-23493
Type: Notice
Date: 2017-10-30
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Internal Revenue Service, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Form 1041-N, U.S. Income Tax Return for Electing Alaska Native Settlement Trusts.
De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-23492
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``De Novo Classification Process (Evaluation of Automatic Class III Designation).'' The purpose of this document is to provide guidance on the process for the submission and review of a De Novo classification request (hereafter a ``De Novo request'') under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the De Novo classification process. FDA is issuing this guidance to also provide updated recommendations for interactions with FDA related to the De Novo classification process, including what information to submit when seeking a path to market via the De Novo classification process. This guidance replaces ``New Section 513(f)(2)Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff,'' dated February 19, 1998.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Acute Kidney Injury Test System
Document Number: 2017-23491
Type: Rule
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the acute kidney injury test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the acute kidney injury test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss
Document Number: 2017-23490
Type: Rule
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final order entitled ``Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss'' that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.
Medical Devices; Immunology and Microbiology Devices; Classification of the Aquaporin-4 Autoantibody Immunological Test System
Document Number: 2017-23489
Type: Rule
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the Aquaporin-4 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Aquaporin-4 autoantibody immunological test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Petition for Exemption; Summary of Petition Received; Airlines for America
Document Number: 2017-23486
Type: Notice
Date: 2017-10-30
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.