Results 151 - 200 of 497,441
Determination of Regulatory Review Period for Purposes of Patent Extension; OPTIMIZER
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OPTIMIZER 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 medical device.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
The Food and Drug Administration (FDA or we) 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.
Notice of Public Meetings of the Tennessee Advisory Committee
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Tennessee Advisory Committee (Committee) will hold a meeting via web-conference on Thursday, June 17, 2021, at 12:00 p.m. Central Time. The purpose of the meeting is for the committee to discuss proposed civil rights topics of study.
Determination of Regulatory Review Period for Purposes of Patent Extension; SARCLISA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SARCLISA 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 biological product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey
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.
Regular Meeting; Farm Credit System Insurance Corporation Board
Notice is hereby given, in accordance with the provisions of Article VI of the Bylaws of the Farm Credit System Insurance Corporation (FCSIC), of a forthcoming regular meeting of the Board that a regular meeting of the Board of Directors of FCSIC will be held.
Service Standard Changes
The Commission is providing notice of a hearing on the Postal Service's direct case in this proceeding. This notice informs the public of the hearing dates and times.
Large Power Transformers From the Republic of Korea: Final Results of Antidumping Duty Administrative Review, Final Determination of No Shipments, and Final Successor-in-Interest Determination; 2018-2019
The Department of Commerce (Commerce) determines that Hyosung Heavy Industries Corporation (Hyosung) made sales of large power transformers from the Republic of Korea (Korea) at less than normal value during the period of review (POR) August 1, 2018, through July 31, 2019.
Revision of Categorical Eligibility in the Supplemental Nutrition Assistance Program (SNAP); Withdrawal
This document informs the public that the Food and Nutrition Service (FNS) of the U.S. Department of Agriculture (USDA) is withdrawing the proposed rule titled Revision of Categorical Eligibility in the Supplemental Nutrition Assistance Program (SNAP) that published in the Federal Register on July 24, 2019. This rule would have refined how receipt of the Temporary Assistance for Needy Families (TANF) benefits may confer categorical eligibility for SNAP. The rule would have also required State agencies to include in their SNAP State Plan of Operations all non-cash TANF benefits and certain cash TANF benefits that confer categorical eligibility. After reviewing and considering the comments received, the proposed rule is being withdrawn.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Factoring Criteria for Firearms With Attached “Stabilizing Braces”
The Department of Justice (``Department'') proposes amending Bureau of Alcohol, Tobacco, Firearms, and Explosives (``ATF'') regulations to clarify when a rifle is ``intended to be fired from the shoulder.'' The Department proposes factors ATF considers when evaluating firearms equipped with a purported ``stabilizing brace'' to determine whether these weapons would be considered a ``rifle'' or ``short-barreled rifle'' under the Gun Control Act of 1968 (``GCA'') or a ``rifle'' or ``firearm'' subject to regulation under the National Firearms Act (``NFA''). This proposed rule is a separate action from the Notice on the Objective Factors for Classifying Weapons with ``Stabilizing Braces'' published on December 18, 2020, and withdrawn on December 31, 2020. No comments received under the withdrawn notice were considered for this proposed rule, and no comments received pursuant to that notice will be considered as part of this proposed rule. Commenters will need to submit new comments in connection with this proposed rule.
Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 18, 2023, expiration date.
Applications for New Awards; Education Research and Special Education Research Grant Programs
The Department of Education (Department) is issuing a notice inviting applications for new awards for fiscal year (FY) 2022 for the Education Research and Special Education Research Grant Programs, Assistance Listing Numbers (ALNs) 84.305A, 84.305B, 84.305D, 84.305R, 84.305S, and 84.324X. This notice relates to the approved information collection under OMB control number 4040-0001.
Determination of Regulatory Review Period for Purposes of Patent Extension; MAYZENT
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MAYZENT 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.
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.
