June 10, 2021 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 123
Airworthiness Directives; Gulfstream Aerospace LP Airplanes
The FAA proposes to adopt a new airworthiness directive (AD) for certain Gulfstream Aerospace LP Model Gulfstream G280 airplanes. This proposed AD was prompted by a report that during full-scale fatigue testing, a crack was found in the area of the attachment of the wing rib 0 to the front spar. This proposed AD would require non-destructive testing on the forward (front) spar vertical stiffener and rib 0 for any cracking, installation of a doubler to the forward (front) spar and rib 0 attachment, and repair if necessary, as specified in a Civil Aviation Authority of Israel (CAAI) AD, which is proposed for incorporation by reference. The FAA is proposing this AD to address the unsafe condition on these products.
Special Local Regulation; Breton Bay, McIntosh Run, Leonardtown, MD
The Coast Guard is proposing to establish special local regulations for certain waters of Breton Bay and McIntosh Run. This action is necessary to provide for the safety of life on these navigable waters located at Leonardtown, MD, during a high-speed power boat demonstration event on July 31, 2021, and August 1, 2021. This proposed rulemaking would prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Maryland-National Capital Region or the Event Patrol Commander. We invite your comments on this proposed rulemaking.
Determination of Regulatory Review Period for Purposes of Patent Extension; XPOVIO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XPOVIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Core Patient-Reported Outcomes in Cancer Clinical Trials; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Core Patient-Reported Outcomes in Cancer Clinical Trials.'' This draft guidance provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. This guidance focuses on patient-reported outcome (PRO) measures and is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy. The draft guidance recommendations supplement previous guidance on use of PRO measures in clinical trials by providing additional considerations specific to the cancer clinical trial setting. The draft guidance is intended to facilitate generation of high-quality data on a core set of patient-reported symptom and functional impacts that are important contributors to a patient's health-related quality of life.
Exelon Generation Company, LLC; Braidwood Station, Units 1 and 2
The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an amendment to Renewed Facility Operating License Nos. NPF-72 and NPF-77, issued to Exelon Generation Company, LLC, for operation of the Braidwood Station, Units 1 and 2. The proposed amendment is contained in the licensee's letter dated May 27, 2021, and would change Technical Specification (TS) Surveillance Requirement (SR) 3.7.9.2 to allow an ultimate heat sink (UHS) temperature of less than or equal to 102.8 degrees Fahrenheit ([deg]F) through September 30, 2021.
Mutual Savings Association Advisory Committee
The OCC announces a meeting of the Mutual Savings Association Advisory Committee (MSAAC).
Cooperative Research and Development Agreement: Evaluating Unmanned Surface Vessel Characteristics for Coast Guard Platforms
The Coast Guard is announcing its intent to enter into a Cooperative Research and Development Agreement (CRADA) with Sea Machines Robotics. Sea Machines Robotics will work with the USCG Research and Development Center (RDC) to modify the currently existing SM300 system installed on the USCG RDC unmanned surface vessel (USV) to determine what parameters and behaviors would be beneficial for USCG mission sets. Additionally, the agreement will investigate the current state of collision avoidance in autonomous unmanned surface vessels (USVs), to develop a better understanding of how these capabilities should be evaluated/regulated in the future. The Coast Guard invites other potential non-Federal participants, who have the interest and capability to bring similar contributions to this type of research, to submit proposals for consideration in similar CRADAs.
Petitions for Modification of Application of Existing Mandatory Safety Standards
This notice includes the summaries of three petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the party listed below.
Proposed Extension of Information Collection; Notification of Methane Detected in Underground Metal and Nonmetal Mine Atmospheres
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance request for comment to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This request helps to ensure that: Requested data can be provided in the desired format; reporting burden (time and financial resources) is minimized; collection instruments are clearly understood; and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Notification of Methane Detected in Underground Metal and Nonmetal Mine Atmospheres.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Pipeline Safety: Statutory Mandate To Update Inspection and Maintenance Plans To Address Eliminating Hazardous Leaks and Minimizing Releases of Natural Gas From Pipeline Facilities
PHMSA is issuing this advisory bulletin to remind each owner and operator of a pipeline facility that the ``Protecting our Infrastructure of Pipelines and Enhancing Safety Act of 2020'' (PIPES Act of 2020) contains a self-executing mandate requiring operators to update their inspection and maintenance plans to address eliminating hazardous leaks and minimizing releases of natural gas (including intentional venting during normal operations) from their pipeline facilities. Operators must also revise their plans to address the replacement or remediation of pipeline facilities that are known to leak based on their material, design, or past operating and maintenance history. The statute requires pipeline operators to complete these updates by December 27, 2021.
New Postal Products
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Primary Health Care-Program Management Resource Compendium, 0906-XXXX, New
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
New Implementation Date for Patent Practitioner Registration Statement and Continuing Legal Education Certification
The United States Patent and Trademark Office (USPTO or Office) is delaying the implementation of the biennial mandatory registration statement required from registered patent practitioners and individuals granted limited recognition to practice before the USPTO in patent matters until November 1, 2024. However, beginning in the spring of 2022, registered patent practitioners and individuals granted recognition to practice before the USPTO in patent matters may voluntarily certify that they have completed six credit hours of continuing legal education (CLE) in the preceding 24 months.
Determination of Regulatory Review Period for Purposes of Patent Extension; WAKIX
The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for WAKIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Notice of Request for Revision of a Currently Approved Information Collection
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Utilities Service's (RUS) intention to request a revision of a currently approved information collection package and invites comments.
Agency Information Collection Activities: Supplemental Nutrition Assistance Program Forms: Applications, Periodic Reporting, and Notices
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on the proposed information collection. This is a revision of the currently approved collection for the applications, periodic reporting, and notices burden calculations for the Supplemental Nutrition Assistance Program (SNAP).
Airworthiness Directives; CFM International, S.A. Turbofan Engines
The FAA is adopting a new airworthiness directive (AD) for certain CFM International, S.A. (CFM) LEAP-1A model turbofan engines. This AD was prompted by a report of a manufacturing quality escape found during an inspection of a high-pressure turbine (HPT) case. This AD requires the removal from service of the affected HPT case. The FAA is issuing this AD to address the unsafe condition on these products.
Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Reporting of Sea Turtle Incidental Take in Virginia Chesapeake Bay Pound Net Operations
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
Information Collection; Certain Federal Acquisition Regulation Part 36 Construction Contract Requirements
In accordance with the Paperwork Reduction Act of 1995, and the Office of Management and Budget (OMB) regulations, DoD, GSA, and NASA invite the public to comment on a revision and an extension concerning certain Federal Acquisition Regulation (FAR) part 36 construction contract requirements. DoD, GSA, and NASA invite comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of Federal Government acquisitions, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. OMB has approved this information collection for use through September 30, 2021. DoD, GSA, and NASA propose that OMB extend its approval for use for three additional years beyond the current expiration date.
Changes in Flood Hazard Determinations
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
Proposed Flood Hazard Determinations
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.
Proposed Flood Hazard Determinations
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.
Proposed Flood Hazard Determinations
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
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
Proposed Flood Hazard Determinations; Correction
On May 7, 2021, FEMA published in the Federal Register a proposed flood hazard determination notice that contained an erroneous table. This notice provides corrections to that table to be used in lieu of the erroneous information. The table provided here represents the proposed flood hazard determinations and communities affected for Dallas County, Texas and Incorporated Areas.
Notice of First Amendment to Compact With the Republic of Ghana
In accordance with the Millennium Challenge Act of 2003, as amended, the Millennium Challenge Corporation is publishing a summary, justification, and full text of the proposed First Amendment to Millennium Challenge Compact between the United States of America, acting through the Millennium Challenge Corporation, and the Republic of Ghana. Representatives of the United States Government and the Government of Ghana plan to conclude the Amendment in June 2021.
Collaborative Forest Landscape Restoration Advisory Committee
The Collaborative Forest Landscape Restoration Advisory Committee (Committee) will hold a virtual meeting. The committee is authorized under Title IV of Omnibus Public Land Management Act of 2009. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Secretary of Agriculture (Secretary) on the selection of collaborative forest landscape restoration proposals as provided in section 8629 of the Agriculture Improvement Act of 2018. Committee information can be found at the following website: https://www.fs.fed.us/restoration/ CFLRP/advisory-panel.shtml.
Marine Mammals and Endangered Species
Notice is hereby given that permits have been issued to the following entities under the Marine Mammal Protection Act (MMPA) and the Endangered Species Act (ESA), as applicable.
Open Meeting of the Taxpayer Advocacy Panel's Tax Forms and Publications Project Committee
An open meeting of the Taxpayer Advocacy Panel's Tax Forms and Publications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
Open Meeting of the Taxpayer Advocacy Panel's Tax Forms and Publications Project Committee
An open meeting of the Taxpayer Advocacy Panel's Tax Forms and Publications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
Privacy Act of 1974; System of Records
The Export-Import Bank of the United States (EXIM) proposes to add a new electronic system of records, EXIM CRM (Customer Relationship Management), subject to the Privacy Act of 1974, as amended. This notice is necessary to meet the requirements of the privacy act which is to publish in the Federal Register a notice of the existence and character of records maintained by the agency. Included in this notice is the system of records notice (SORN) for EXIM CRM.
Aquatic Nuisance Species Task Force Meeting
The U.S. Fish and Wildlife Service gives notice of a teleconference/web meeting of the Aquatic Nuisance Species (ANS) Task Force, in accordance with the Federal Advisory Committee Act.
Restoring Affirmatively Furthering Fair Housing Definitions and Certifications
The Department of Housing and Urban Development (HUD) publishes this interim final rule to restore certain definitions and certifications that have been through notice-and-comment scrutiny and that are grounded in legal precedent to its regulations implementing the Fair Housing Act's requirement to affirmatively further fair housing (AFFH) and reinstate a process by which HUD will provide technical assistance and other support to funding recipients who are engaged in fair housing planning to support their certifications. No program participant will be required to participate in this process, which is for the benefit of those who want assistance in fulfilling their statutory obligations. HUD will provide these services prior to the effective date of this interim final rule. HUD determined that it is necessary for this narrowly focused rule to go into effect on July 31, 2021, because HUD funding recipients must certify compliance with their duty to AFFH on an annual basis and HUD itself has a continuous statutory obligation to ensure that the Fair Housing Act's AFFH obligations are followed. HUD finds that the definitions in the current regulation, which was promulgated in 2020 without notice-and-comment procedures, are at odds with the statutory AFFH duty as described in decades of judicial precedent and agency practice. This risks confusing funding recipients, who are certifying compliance with a regulatory definition that does not in fact satisfy their statutory AFFH obligation. While HUD therefore has determined that this rule will go into effect on July 31, it nonetheless solicits comments on this action so that it may consider public views before the effective date. HUD promulgates this interim final rule to ensure that program participants have regulatory certainty, while delaying the effective date long enough to provide time for HUD to review comments and, if necessary, act on them prior to the effective date.
Agency Information Collection Request; 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
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