2018 – Federal Register Recent Federal Regulation Documents
Results 7,201 - 7,250 of 27,748
Notice of Orders Issued Under Section 3 of the Natural Gas Act During August 2018
The Office of Fossil Energy (FE) of the Department of Energy gives notice that during August 2018, it issued orders granting authority to import and export natural gas, to import and export liquefied natural gas (LNG), to Amend Long-Term-Multi-Contract Authorization to Export LNG, and to Allow Electronic Service in Proceeding. These orders are summarized in the attached appendix and may be found on the FE website at https://www.energy.gov/fe/listing- doefe-authorizationsorders-issued-2018-0. They are also available for inspection and copying in the U.S. Department of Energy (FE-34), Division of Natural Gas Regulation, Office of Regulation, Analysis, and Engagement, Office of Fossil Energy, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.
Request for Information on Update to the 2016 National Artificial Intelligence Research and Development Strategic Plan
On behalf of the National Science and Technology Council's (NSTC) Select Committee on Artificial Intelligence (Select Committee), NITRD NCO requests input from all interested parties on the National Artificial Intelligence Research and Development Strategic Plan. Through this Request for Information (RFI), NITRD NCO seeks input from the public, including those directly performing Artificial Intelligence (AI) research and development (R&D) and directly affected by such R&D, on whether the strategic plan should be revised and, if so, the ways in which it may be improved. This includes suggestions as to the addition, removal, or modification of strategic aims, comments as to existing strategic aims as well as their past or future implementation by the Federal government. The public input provided in response to this RFI will inform NITRD NCO and the Select Committee in updating the National Artificial Intelligence Research and Development Strategic Plan.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Cigarette Warnings
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 an experimental study of cigarette warnings that is being conducted in support of the graphic label statement provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2019
The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2019 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2019.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2019
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2019 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2018 (ADUFA IV), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2019.
Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2019
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the applicants of material threat MCM applications that meet all of the requirements of this program upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA to review of a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2019 and outlines the payment procedures for such fees.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management 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 Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Allergenic Products Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee (APAC). 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.
Tobacco Product Application Review; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Tobacco Product Application Review.'' This meeting is intended to improve public understanding and provide FDA feedback on the policies and processes for submitting and reviewing tobacco product marketing applications, including the general scientific principles relevant to various application pathways, to assist those considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Insanitary Conditions at Compounding Facilities; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled, ``Insanitary Conditions at Compounding Facilities.'' Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients. FDA is issuing this revised draft guidance to help compounding facilities identify insanitary conditions so that they can implement appropriate corrective actions. This revised draft guidance is also intended to help state regulatory agencies understand some examples of what FDA considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious to health. This guidance revises the draft guidance entitled ``Insanitary Conditions at Compounding Facilities'' that was published on August 4, 2016.
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities; Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities.'' This guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies, Federal facilities, and other entities that hold a radioactive materials (RAM) license for medical use issued by the Nuclear Regulatory Commission (NRC) or by an Agreement State. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it generally does not intend to take action for violations of certain provisions of the FD&C Act when these entities compound or repackage radiopharmaceuticals.
Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.'' Specifically, this guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by entities that are registered with FDA as outsourcing facilities. This guidance describes how FDA generally intends to apply section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions under which FDA generally does not intend to take action for violations of certain provisions of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals.
Xanthan Gum From China; Scheduling of an Expedited Five-Year Review
The Commission hereby gives notice of the scheduling of an expedited review pursuant to the Tariff Act of 1930 (``the Act'') to determine whether revocation of the antidumping duty order on xanthan gum from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
Proposed Information Collection Request; Comment Request; National Emission Standards for Hazardous Air Pollutants for Asbestos (40 CFR Part 61, Subpart M) (Renewal)
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ``National Emission Standard for Hazardous Air Pollutants (NESHAP) for Asbestos (40 CFR part 61, subpart M) (Renewal)'' (EPA ICR No. 0111.15, OMB Control No. 2060-0101) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a second notice requesting comment on the proposed extension of the ICR, which is currently approved through March 31, 2019. The burden in this notice includes changes in reporting and recordkeeping resulting from a recent action on an alternative work practice and a planned change to allow electronic reporting for notifications. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Privacy Act of 1974; System of Records
In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to modify a current DHS system of records titled, ``DHS/All-016 Correspondence Records System of Records.'' This system of records allows the Department to collect and maintain correspondence records. The Department is updating this system of records to reflect changes to the categories of individuals, categories of records, and routine uses. Specifically, these changes include expanding the categories of individuals to include third party subjects of correspondence who may not be the sender or recipient. The Department is also expanding the categories of records to permit the collection of an individual's phone number, call and customer service center records, receipt number, case numbers relevant to the correspondence, and account IDs associated with correspondence between the Department and the responding party. DHS is updating routine use (E) and adding routine use (F) to comply with new policies pertaining to data breach procedures. The Department is making non-substantive edits to the routine uses to align with previously published Department systems of records notices (SORNs). Lastly, this notice includes non- substantive changes to simplify the formatting and text of the previously published notice. This modified system will be included in the DHS inventory of record systems.
Notice of Intent of Waiver With Respect to Land
The FAA is considering a proposal to change 55.4 acres of airport land from aeronautical use to non-aeronautical use and to authorize the sale of airport property Rantoul National Aviation Center-Frank Elliott Field, Rantoul, Illinois. The aforementioned land is not needed for aeronautical use. The parcels are located east of Pacesetter Drive and Galaxy Drive on Rantoul National Aviation Center- Frank Elliott Field. The Village of Rantoul has determined that the parcels are no longer needed for the direct operations of the airport.
Proposed Primary Category Design Standards; Vertical Aviation Technologies (VAT) Model S-52L Rotorcraft
This notice announces the existence of and requests comments on the proposed airworthiness design standards for acceptance of the Vertical Aviation Technologies (VAT) Model S-52L rotorcraft under the regulations for primary category aircraft.
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Disclosure of Seat Dimensions To Facilitate the Use of Child Safety Seats on Airplanes During Passenger-Carrying Operations
In accordance with the Paperwork Reduction Act of 1995, the Federal Aviation Administration (FAA) invites public comments about our intention to request Office of Management and Budget (OMB) approval to renew an information collection. The collection involves each passenger carrying air carrier operating under part 121 of title 14, Code of Federal Regulations, to post on the internet website of the air carrier the maximum dimensions of a child safety seat that can be used on those aircraft. The information to be collected will be used to facilitate the use of child restraint systems onboard airplanes and is required by section 412 of the FAA Modernization and Reform Act of 2012. The Federal Register Notice with a 60-Day comment period soliciting comments on the renewal of this previously approved information collection was published on July 25, 2018. No comments were received.
Agency Information Collection Activities: Requests for Comments; Clearance of Revised Approval of Information Collection Certification Procedures for Products and Parts
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew a previously approved information collection. Applicable federal regulations prescribe certification standards for aircraft, aircraft engines, propellers appliances and parts. The information collected is used to determine compliance and applicant eligibility. The respondents are aircraft parts designers, manufacturers, and aircraft owners.
Establishment of Class E Airspace; Glen Ullin, ND
This action establishes Class E airspace extending upward from 700 feet above the surface at Glen Ullin Regional Airport, Glen Ullin, ND. Controlled airspace is necessary to accommodate new standard instrument approach procedures developed at Glen Ullin Regional Airport, for the safety and management of instrument flight rules (IFR) operations at this airport.
Agency Information Collection Activities: Proposed Collection; 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Endangered and Threatened Species; Take of Abalone
Notice is hereby given that NMFS has received a permit application request for one new enhancement permit. The proposed work is intended to increase knowledge of species listed under the Endangered Species Act (ESA) and to help guide management, conservation, and recovery efforts. The application may be viewed online at: https://apps.nmfs.noaa.gov/preview/ preview_open_for_comment.cfm.
Administrative Declaration of a Disaster for the State of Kansas
This is a notice of an Administrative declaration of a disaster for the State of Kansas dated 09/14/2018. Incident: Flash Flooding, Flooding and Severe Storms. Incident Period: 09/01/2018 through 09/03/2018.
Delegations of Authority: Delegation of Authority No. 12-G (Revision 1), Amendment 1
This document provides the public notice of an amendment to Delegation of Authority No. 12-G (Revision 1) (79 FR 56842, September 23, 2014) (the ``Delegation''), which delegated authority for lender oversight and enforcement activities by the Administrator of the Small Business Administration (``SBA'') to the Director, Office of Credit Risk Management (``D/OCRM''), the Lender Oversight Committee (``LOC''), and the Associate Administrator for Capital Access (``AA/CA''). By this amendment (this ``Amendment''), the Administrator is delegating additional lender oversight authority to the D/OCRM and revising the membership of the LOC consistent with new requirements in The Small Business 7(a) Lending Oversight Reform Act of 2018 (June 21, 2018). This Amendment to the Delegation includes the authority of the D/OCRM to participate in the review and approval of initial applications by 7(a) Lenders and Certified Development Companies (``CDCs'') for delegated lending authorities. This Amendment also provides that the D/ OCRM consult with the Director, Office of Financial Assistance (``D/ FA'') on Community Advantage Pilot Program (``Community Advantage'') authority. Finally, this Amendment implements the new statutory provisions revising LOC membership and voting authority.
Monitoring the Effectiveness of Maintenance at Nuclear Power Plants
The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 4 to Regulatory Guide (RG) 1.160, ``Monitoring the Effectiveness of Maintenance at Nuclear Power Plants.'' Regulatory Guide 1.160, Revision 4, has been revised to address new issues identified since Revision 3 of RG 1.160 was issued. This RG endorses, with clarifications, NUMARC 93-01, ``Industry Guidelines for Monitoring the Effectiveness of Maintenance at Nuclear Power Plants,'' Revision 4F. The proposed revision describes methods that are acceptable to the NRC staff for compliance with the requirements for monitoring the effectiveness of maintenance at nuclear power plants.
National Vaccine Injury Compensation Program: List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Notice of Request for Extension and Revision of a Currently Approved Information Collection: Advisory Committee and Research and Promotion Background Information
This notice announces the U.S. Department of Agriculture's (USDA) intention to request an extension and a revision to the currently approved Advisory Committee and Research and Promotion Background Information AD-755 Supplemental ListAgricultural Marketing Service Commodity Specific Questionnaire. The revised form will now require applicants to indicate their U.S. citizenship status. The primary objective is to determine the qualifications, suitability, and availability of a candidate to serve on advisory committees and/or research and promotion boards.
Air Plan Approval; Tennessee: Volatile Organic Compounds
The Environmental Protection Agency (EPA) is taking final action to approve a portion of a revision to the Chattanooga-Hamilton County portion of the Tennessee State Implementation Plan (SIP) submitted by the State of Tennessee through the Tennessee Department of Environment and Conservation (TDEC) on behalf of the Chattanooga- Hamilton County Air Pollution Control Bureau (Chattanooga-Hamilton County) on June 25, 2008. The revision amends the definition of ``volatile organic compounds'' (VOC) to be consistent with state and Federal regulations. The portion of the SIP revision that EPA is approving is consistent with the requirements of the Clean Air Act (CAA or Act). EPA will act on the other portions of the June 25, 2008, submittal in a separate action.
Revisions to Procedural Rules Governing Practice Before the Occupational Safety and Health Review Commission
On September 7, 2018, the Occupational Safety and Health Review Commission solicited recommendations for amendments to the Commission's rules of procedure. The comment period, which was set to expire on October 9, 2018, has been extended to November 16, 2018.
Environmental Protection Agency Acquisition Regulation (EPAAR); Scientific Integrity
The Environmental Protection Agency (EPA) is issuing a proposed rule to address scientific integrity requirements in the creation of a contract clause for inclusion in solicitations and contracts when the contractor may be required to perform, communicate, or supervise scientific activities or use scientific information to perform advisory and assistance services. This clause will complement the EPA scientific integrity policy to ensure all scientific work developed and used by the Government is accomplished with scientific integrity.
Amendment of the NEPA Official Under Procedures for Implementing the National Environmental Policy Act
This final rule amends the Environmental Protection Agency's (``EPA'') responsibility of the NEPA Official under its existing regulations for ``Implementing the National Environmental Policy Act and Assessing the Environmental Effects Abroad of EPA Actions.'' This amendment is a result of an agency reorganization that only impacts a title change of the designated NEPA Official under the existing regulations. This amendment is procedural in nature and none of these changes are intended to substantively alter the Agency's compliance with the National Environmental Policy Act for the EPA's actions.
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