2020 – Federal Register Recent Federal Regulation Documents
Results 7,601 - 7,650 of 27,998
Revised Geographic Eligibility for Federal Office of Rural Health Policy Grants
HRSA's Federal Office of Rural Health Policy (FORHP) has sought to identify clear, consistent, and data-driven methods of defining rural areas in the United States. FORHP uses the Office of Management and Budget (OMB)'s list of counties designated as part of a Metropolitan Statistical Area (MSA) as the basis for determining eligibility to apply for or receive services funded by its rural health grant programs. FORHP designates all counties that are not part of a MSA as ``rural'' and eligible for rural health grant funding or services. In addition, FORHP designates census tracts within MSAs as rural for grant purposes using Rural-Urban Commuting Area (RUCA) codes. FORHP is proposing modifications to how it designates areas to be eligible for its rural health grant programs so that community organizations serving rural populations within MSAs will be able to apply for resources and allow more of the rural populations within MSAs to access services provided using grant funds. This notice seeks comments on the proposed methodology for designating areas eligible for rural health grant programs.
Draft Guidance for Cannabidiol; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry, entitled ``Draft Guidance for Cannabidiol.'' The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for cannabidiol oral solution.
Environmental Impact Statement for Army Training Land Retention at Pōhakuloa Training Area in Hawai'i; Correction
The Department of the Army (Army) published a document in the Federal Register of September 4, 2020, concerning its continuing intent to prepare an Environmental Impact Statement to address the Army's proposed retention of up to approximately 23,000 acres of land currently leased to the Army by the state of Hawai[revaps]i (``State- owned land'') at P[omacr]hakuloa Training Area (PTA) on the island of Hawai[revaps]i. The document referenced two in-person comment stations previously associated with the Virtual Scoping Open House to be held Wednesday, September 23, 2020. Now, however, because of the national and local orders and proclamations in response to the coronavirus (COVID-19) pandemic in the United States, including: The County of Hawai[revaps]i Mayor's COVID-19 Emergency Rule No. 11 dated August 25, 2020, and the Office of the Governor, State of Hawaii Office Twelfth Proclamation Related to the COVID-19 Emergency dated August 20, 2020, the Army is canceling the in-person comment stations. Only the in- person comment stations will be cancelled; the EIS Scoping Virtual Open House will be held as planned.
Determination That PREXXARTAN (Valsartan) Oral Solution, 20 Milligrams/5 Milliliters and 80 Milligrams/20 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that PREXXARTAN (valsartan) oral solution, 20 milligrams (mg)/5 milliliters (mL) and 80 mg/20 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for valsartan oral solution, 20 mg/5 mL and 80 mg/20 mL, if all other legal and regulatory requirements are met.
Interim Storage Partners Consolidated Interim Storage Facility Project
On May 8, 2020, the U.S. Nuclear Regulatory Commission (NRC) published in the Federal Register a notice issuing the draft Environmental Impact Statement (EIS) for Interim Storage Partners LLC's (ISP's) license application to construct and operate a consolidated interim storage facility (CISF) for spent nuclear fuel and Greater-Than Class C waste, along with a small quantity of mixed oxide fuel for public comment. The NRC is announcing four public comment webinars to receive oral comments on the draft EIS. The meetings will allow interested members of the public to submit their comments.
Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders
FMCSA announces its decision to exempt five individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have ``no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.'' The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Hearing
FMCSA announces its decision to exempt 11 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Hearing
FMCSA announces receipt of applications from 21 individuals for an exemption from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. If granted, the exemptions would enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.
Agency Information Collection Activities; Proposed Collection; Comment Request; Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics
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 information collection associated with FDA recognition of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics.
Senior Executive Service Performance Review Board Membership
This notice sets forth the names and titles of the current membership of the Council of the Inspectors General on Integrity and Efficiency (CIGIE) Performance Review Board as of October 1, 2020.
Clean Water Act: Maryland-City of Annapolis and Anne Arundel County Vessel Sewage No-Discharge Zone for Thirteen Waters-Tentative Affirmative Determination
Notice is hereby given that an application for a no-discharge zone has been received from the Secretary of Natural Resources and Secretary of the Environment on behalf of the State of Maryland requesting a determination by the Regional Administrator, U.S. Environmental Protection Agency (EPA), Region 3, that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for thirteen waters located in the City of Annapolis and Anne Arundel County, Maryland, pursuant to the Clean Water Act. The EPA is requesting comments on this application and whether EPA should finalize its tentative affirmative determination, or make a negative determination, on the proposed designation of a no-discharge zone for all and/or any of the thirteen waters located in the City of Annapolis and Anne Arundel County as provided in the Clean Water Act. The application is available upon request from EPA (at the email address below) or at https:// dnr.maryland.gov/boating/Documents/AANDZApplication.pdf.
Clean Water Act: Virginia-Sarah Creek and Perrin River Vessel Sewage No-Discharge Zone-Final Affirmative Determination
On behalf of the Commonwealth of Virginia (the Commonwealth), the Secretary of the Virginia Department of Natural Resources requested that the Regional Administrator, U.S. Environmental Protection Agency, Region 3 approve a no-discharge zone for Sarah Creek and Perrin River, Gloucester County, Virginia pursuant to the Clean Water Act. After review of Virginia's application, the EPA determined that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for the entirety of Sarah Creek and Perrin River. The application is available upon request from the EPA (at the email address below) or at https:// www.deq.virginia.gov/Programs/Water/WaterQualityInformationTM DLs/TMDL/ NoDischargeZoneDesignations.aspx.
Notice of Teleconference Meeting of the Exxon Valdez Oil Spill Public Advisory Committee
In accordance with the Federal Advisory Committee Act, the Department of the Interior, Office of the Secretary, is announcing that the Exxon Valdez Oil Spill (EVOS) Trustee Council's Public Advisory Committee will meet by teleconference as noted below.
QAI Laboratories, Ltd.: Grant of Expansion of Recognition
In this notice, OSHA announces the final decision to expand the scope of recognition for QAI Laboratories, Ltd., as a Nationally Recognized Testing Laboratory (NRTL).
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Concrete and Masonry Construction Standard
The Department of Labor (DOL) is submitting this Occupational Safety and Health Administration (OSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Logging Operations Standards
The Department of Labor (DOL) is submitting this Occupational Safety and Health Administration (OSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Producer Price Index Survey
The Department of Labor (DOL) is submitting this Bureau of Labor Statistics (BLS)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Endangered Species; Receipt of Recovery Permit Application
We, the U.S. Fish and Wildlife Service, have received an application for a permit to conduct activities intended to enhance the propagation and survival of endangered species under the Endangered Species Act of 1973, as amended. We invite the public and local, State, Tribal, and Federal agencies to comment on this application. Before issuing the requested permit, we will take into consideration any information that we receive during the public comment period.
Agency Information Collection Activities; Geological and Geophysical Explorations of the Outer Continental Shelf
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Ocean Energy Management (BOEM) is proposing to renew an information collection request with revisions.
Availability of a Final Environmental Assessment and Finding of No Significant Impact for Cogongrass Control Efforts in Alabama, Georgia, Mississippi, and South Carolina
We are advising the public that we have prepared a final environmental assessment and finding of no significant impact relative to establishing an integrated management strategy to control cogongrass, a noxious weed, in Alabama, Georgia, Mississippi, and South Carolina. Based on our finding of no significant impact, we have determined that an environmental impact statement need not be prepared.
Meeting of the Council on Graduate Medical Education
The Council on Graduate Medical Education (COGME) meeting scheduled on Tuesday, December 8, 2020, and Wednesday, December 9, 2020, has changed its format and time. The meeting will now be a 2-day webinar and conference call only on Tuesday, December 8, 2020, from 10:00 a.m.-5:00 p.m. Eastern Time (ET) and Wednesday, December 9, 2020, from 10:00 a.m.-2:00 p.m. ET. The webinar link, conference dial in number, meeting materials, and updates will be available on the COGME website: https://www.hrsa.gov/advisory-committees/graduate-medical-edu / meetings/.
Quarterly Rail Cost Adjustment Factor
The Board approves the fourth quarter 2020 Rail Cost Adjustment Factor (RCAF) and cost index filed by the Association of American Railroads. The fourth quarter 2020 RCAF (Unadjusted) is 0.941. The fourth quarter 2020 RCAF (Adjusted) is 0.394. The fourth quarter 2020 RCAF-5 is 0.372.
Funding Opportunity Title: Notice of Allocation Availability (NOAA) Inviting Applications for the Calendar Year (CY) 2020 Allocation Round of the New Markets Tax Credit (NMTC) Program
This NOAA is issued in connection with the CY 2020 allocation round (Allocation Round) of the New Markets Tax Credit Program (NMTC Program), as authorized by Title I, subtitle C, section 121 of the Community Renewal Tax Relief Act of 2000 (Pub. L. 106-554) as amended. (26 U.S.C. 45D). Through the NMTC Program, the Community Development Financial Institutions Fund (CDFI Fund) provides authority to certified CDEs to offer an incentive to investors in the form of tax credits over seven years, which is expected to stimulate the provision of private investment capital that, in turn, will facilitate economic and community development in Low-Income Communities. Through this NOAA, the CDFI Fund announces the availability of $5 billion of NMTC Allocation authority in this Allocation Round. In this NOAA, the CDFI Fund specifically addresses how a CDE may apply to receive an allocation of NMTCs, the competitive procedure through which NMTC Allocations will be made, and the actions that will be taken to ensure that proper allocations are made to appropriate entities.
Airworthiness Directives; MD Helicopters Inc. (MDHI), Helicopters
The FAA is adopting a new airworthiness directive (AD) for certain MD Helicopters Inc. (MDHI) Model 369A, 369D, 369E, 369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters. This AD was prompted by reports of abrasion strips departing the main rotor (MR) blade in- flight. This AD requires tap inspecting each MR blade leading edge abrasion strip. The FAA is issuing this AD to address the unsafe condition on these products.
Secretary of Energy Advisory Board
This notice announces an open meeting of the Secretary of Energy Advisory Board (SEAB). The SEAB was reestablished pursuant to the Federal Advisory Committee Act. This notice is provided in accordance with the Act.
Electricity Advisory Committee
This notice announces a meeting of the Electricity Advisory Committee. The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.
Removal of Colored Federal Airways Amber 7 (A-7), Green 11 (G-11), and Amendment of Amber 1 (A-1); Alaska
This action removes two Colored Federal airways, A-7 and G-11, and amends one Colored Federal airway, A-1 in Alaska. The modifications are necessary due to the planned decommissioning of the Campbell Lake Non-Directional Beacon (NDB) in Anchorage, AK, which provides navigation guidance for portions of the affected routes. The Campbell Lake NDB is to be decommissioned due to ongoing maintenance problems.
Amendment of Phoenix Sky Harbor Class B Legal Description
This action amends the Phoenix Sky Harbor Class B legal description by accurately reflecting the name of the geographical reference point, I-10/Squaw Peak Stack to I-10/Stack contained in the Area A and Area D legal description. The FAA is taking this action because the local community removed Squaw Peak from the geographical reference point and to ensure accurate information is reflected.
Solicitation of Written Comments by the National Security Commission on Artificial Intelligence
The National Security Commission on Artificial Intelligence (``the Commission) is publishing this notice to request comments from small- and medium-sized AI firms to help the Commission understand different views on working with the federal government. Responses will assist in identifying critical areas for improvement and recommended changes in the government's approach to technology procurement and support for commercial innovation.
Airworthiness Directives; Bell Helicopter Textron Canada Limited Helicopters
The FAA is adopting a new airworthiness directive (AD) for certain Bell Helicopter Textron Canada Limited (Bell) Model 505 helicopters. This AD requires inspecting each swashplate assembly bearing (bearing), and depending on the inspection results, removing the bearing from service. This AD was prompted by a report of a bearing that migrated out of the swashplate inner ring. The actions of this AD are intended to address an unsafe condition on these products.
Proposed Amendment of Class D and E airspace; Helena, MT
This action proposes to modify Class D airspace at Helena Regional Airport. This action also proposes to modify Class E airspace, designated as a surface area. Additionally, this action proposes to establish Class E airspace, designated as an extension to a Class D or Class E surface area. Further, this action proposes to modify Class E airspace, extending upward from 700 feet above the surface. Also, this action proposes to modify the Class E airspace extending upward from 1,200 feet above the surface. This action also proposes to remove the Helena VORTAC from the airspace legal descriptions. Lastly, this action proposes administrative corrections to the airspaces' legal descriptions. This action would ensure the safety and management of instrument flight rules (IFR) operations at the airport.
Amendment of Class E Airspace; Frankfort, MI
This action amends the Class E airspace extending upward from 700 feet above the surface at Frankfort Dow Memorial Field Airport, Frankfort, MI. This action as the result of an airspace review caused by the cancellation of instrument procedures at the airport. The geographic coordinates of the airport are also being updated to coincide with the FAA's aeronautical database.
Regulations Regarding “Intended Uses”
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its medical product ``intended use'' regulations. This action, if finalized, will amend FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether an approved or cleared medical product is intended for a new use. This action will also repeal and replace the portions of a final rule issued on January 9, 2017, that never became effective. This action is intended to provide direction and clarity to regulated industry and other stakeholders.
Endangered and Threatened Wildlife and Plants; Removal of the Nashville Crayfish From the Federal List of Endangered and Threatened Wildlife
We, the U.S. Fish and Wildlife Service (Service), proposed to remove the Nashville crayfish (Orconectes shoupi) from the Federal List of Endangered and Threatened Wildlife (List). This determination is based on the best available scientific and commercial data, which indicate that the threats to the species have been eliminated or reduced to the point that the species has recovered and no longer meets the definition of an endangered species or a threatened species under the Endangered Species Act of 1973, as amended (Act). We announced a 60-day public comment period on the proposed rule, ending January 27, 2020. We now reopen the public comment period on the proposed rule to allow all interested parties additional time to comment on the proposed rule. Comments previously submitted need not be resubmitted and will be fully considered in preparation of the final rule. We also announce a public informational meeting and public hearing on the proposed rule.
Direct Grant Programs, State-Administered Formula Grant Programs, Non Discrimination on the Basis of Sex in Education Programs or Activities Receiving Federal Financial Assistance, Developing Hispanic-Serving Institutions Program, Strengthening Institutions Program, Strengthening Historically Black Colleges and Universities Program, and Strengthening Historically Black Graduate Institutions Program
In response to Executive Order 13864 (Improving Free Inquiry, Transparency, and Accountability at Colleges and Universities), the Department of Education revises its current regulations to encourage institutions of higher education to foster environments that promote open, intellectually engaging, and diverse debate, including through compliance with the First Amendment to the U.S. Constitution for public institutions and compliance with stated institutional policies regarding freedom of speech, including academic freedom, for private institutions. These regulations also require a public institution to not deny a religious student organization any of the rights, benefits, or privileges that are otherwise afforded to other student organizations. In response to recent decisions from United States Supreme Court's decisions, the Department revises its current regulations regarding grant programs authorized under titles III and V of the Higher Education Act of 1965, as amended (HEA), and the eligibility of students to obtain certain benefits under those programs. The Department also revises its current regulations to clarify how educational institutions may demonstrate that they are controlled by a religious organization to qualify for the exemption provided under Title IX, 20 U.S.C. 1681(a)(3), to the extent Title IX or its implementing regulations would not be consistent with the religious tenets of such organization.
Requirements for Additional Traceability Records for Certain Foods
The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule would require these entities to establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods. The proposed requirements are intended to help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this proposed rule in accordance with the FDA Food Safety Modernization Act (FSMA).
Assessment and Collection of Regulatory Fees for Fiscal Year 2020
In this document, the Commission revises its Schedule of Regulatory Fees to recover an amount of $339,000,000 that Congress has required the Commission to collect for fiscal year 2020. Section 9 of the Communications Act of 1934, as amended, provides for the annual assessment and collection of regulatory fees under sections 9(b)(2) and 9(b)(3), respectively.
Air Quality Implementation Plan; California; Northern Sierra Air Quality Management District; Stationary Source Permits
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Northern Sierra Air Quality Management District (NSAQMD or ``District'') portion of the California State Implementation Plan (SIP). In this action, we are proposing to approve a rule submitted by the NSAQMD that governs the issuance of permits for stationary sources, which focuses on the preconstruction review and permitting of major sources and major modifications under part D of title I of the Clean Air Act (CAA or ``the Act''). We are taking comments on this proposal and a final action will follow.
Project Management Oversight
This final rule amends FTA regulations implementing project management oversight. FTA is modifying the regulation to make it consistent with statutory changes and to modify the scope and applicability of project management oversight.
Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants
The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is proposing to amend the margin requirements for uncleared swaps for swap dealers (``SDs'') and major swap participants (``MSPs'') for which there is no prudential regulator (``CFTC Margin Rule''). In particular, the Commission is proposing to revise the calculation method for determining whether certain entities come within the scope of the initial margin (``IM'') requirements under the CFTC Margin Rule beginning on September 1, 2021, and the timing for compliance with the IM requirements after the end of the phased compliance schedule. The proposed amendment would align certain aspects of the CFTC Margin Rule with the Basel Committee on Banking Supervision and Board of the International Organization of Securities Commissions' (``BSBS/IOSCO'') Framework for margin requirements for non-centrally cleared derivatives (``BCBS/IOSCO Framework''). The Commission is also proposing to allow SDs and MSPs subject to the CFTC Margin Rule to use the risk-based model calculation of IM of a counterparty that is a CFTC-registered SD or MSP to determine the amount of IM to be collected from the counterparty and to determine whether the IM threshold amount for the exchange of IM has been exceeded such that documentation concerning the collection, posting, and custody of IM would be required.
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