FDA Approves VYVGART HYTRULO with Rare Pediatric Disease Priority Review Voucher
The FDA has approved VYVGART HYTRULO, a product redeeming a priority review voucher, following a review of its supplemental application submitted on June 21, 2024.
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FDA Extends Comment Period for Platform Technology Designation Program Draft Guidance
The US Food and Drug Administration (FDA) has extended the comment period for its draft guidance on the Platform Technology Designation Program for Drug Development, following requests from industry stakeholders for more time to submit comments.
USPTO Issues Guidance Update on Patent Subject Matter Eligibility for Artificial Intelligence
The USPTO has released a guidance update to address patent subject matter eligibility for artificial intelligence inventions, following Executive Order 14110 and incorporating feedback from stakeholders and recent Federal Circuit decisions.
USPTO Requests Comments on Patent Maintenance Fees Rules
The USPTO is seeking public comment on proposed changes to the rules governing patent maintenance fees, as required by the Paperwork Reduction Act of 1995, before submitting the revised rules to the Office of Management and Budget (OMB) for review and approval.
EPA Lodges Proposed Amendment to Clean Water Act Consent Decree
The U.S. Environmental Protection Agency (EPA) has lodged a proposed fifth amendment to the existing consent decree and a consolidated fifth amended consent decree under the Clean Water Act, which aims to address ongoing environmental concerns at a specific facility.
State Department Publishes Delegation of Authority for Assistant Secretary to Invoke Deliberative-Process Privilege
The U.S. Department of State has released a document granting authority to the Assistant Secretary for Western Hemisphere Affairs to invoke the deliberative-process privilege, effective July 10, 2024
SGS North America, Inc. Seeks Expanded Recognition as Nationally Recognized Testing Laboratory
OSHA announces SGS North America, Inc.'s application for expanded recognition as a Nationally Recognized Testing Laboratory (NRTL) and its preliminary finding to grant the application.
OSHA Seeks Nominations for NACOSH Membership
The Occupational Safety and Health Administration (OSHA) is soliciting nominations for individuals to join the National Advisory Committee on Occupational Safety and Health (NACOSH), a committee established by the Occupational Safety and Health Act of 1970.
Comment Period Extended for Proposed Exemption for UBS Asset Managers
The US Department of Labor is extending the comment period for a proposed exemption that would allow UBS asset managers to continue relying on a specific rule, despite judgments involving UBS entities, if they meet the exemption's conditions.
SBA and VA Transfer Veteran Small Business Certification Program Responsibility, Propose New Computer Matching Program
As of January 1, 2023, the SBA took over the responsibility for certifying Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-Owned Small Businesses (SDVOSB) from the VA, and proposes a new Computer Matching program to verify applicant eligibility for the SBA's Veteran Small Business Certification Program.
Economic Injury Disaster Loan Declaration for the State of Georgia
The U.S. Small Business Administration has made an Economic Injury Disaster Loan (EIDL) declaration for the state of Georgia, following a water main break incident that occurred from May 31, 2024, through June 6, 2024. The declaration aims to provide financial assistance to affected businesses.
FDIC Requests Public Comment on Renewal of Information Collections
The Federal Deposit Insurance Corporation (FDIC) is seeking public comment on the renewal of three existing information collections, which were previously announced in the Federal Register on May 1 and May 7, 2024, and will be effective after a 60-day comment period.
Agency Information Collection Activities Under OMB Review
The Office of Management and Budget (OMB) is reviewing a request for information collection from the agency, in compliance with the Paperwork Reduction Act of 1995, to assess the nature of the data collection and its associated costs and burden.
Tech Developers Invited to Submit CodeFest 2024 Proposals by August 8
The CodeFest 2024 event is calling on developers to submit proposals that utilize generative AI to improve patent data access and utilization, with submissions due by August 8
Quarterly Update: Quality Dashboard Shows Continued Positive Trend in Grant Findings
The latest update to the quality dashboard indicates a continuation of the positive trend observed in grant-related findings, suggesting ongoing progress in this area.
Increase Flexibility for Tribes in Child Care and Development Fund (CCDF) Eligibility
The US Department of Health and Human Services proposes to amend the Child Care and Development Fund (CCDF) regulations to allow Indian Tribes and Tribal Organizations to establish their own eligibility criteria for CCDF programs.
Notice of Meeting of the Substance Abuse and Mental Health Services Administration, Center for Mental Health Services National Advisory Council
The Substance Abuse and Mental Health Services Administration (SAMHSA) will hold an open meeting of the Center for Mental Health Services National Advisory Council (CMHS NAC) on August 27, 2024, with virtual access available at https://www.samhsa.gov/about-us/advisory-councils/meetings.
Medicare and Medicaid Programs: Application by DNV Healthcare USA Inc. for Continued CMS Approval of Its Psychiatric Hospital Accreditation Program
DNV Healthcare USA Inc. has been approved for continued CMS approval as a national accrediting organization for its psychiatric hospitals participating in Medicare or Medicaid programs.
U.S. Department of Health and Human Services to Hold Advisory Committee Meeting on Blood and Tissue Safety
The U.S. Department of Health and Human Services will hold an open meeting of the Advisory Committee on Blood and Tissue Safety and Availability to discuss tissue biovigilance and recent committee work on blood and organ safety.
Proposed Collection; 60-Day Comment Request; NIH NeuroBioBank Tissue Access Request Form
The National Institutes of Health will publish a proposed project for the NIH NeuroBioBank Tissue Access Request Form, seeking public comment for 60 days.
Announcing the Intent To Award a Single-Source Supplement for the National Paralysis Resource Center (PRC)
The Administration for Community Living (ACL) intends to award a single-source supplement to the Christopher and Dana Reeve Foundation for the National Paralysis Resource Center (NPRC) in the amount of $1,300,000, bringing the total award for FY 2024 to $10,000,000.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Client-Level Data Reporting System
HRSA submitted an Information Collection Request to OMB for review and approval of the Ryan White HIV/AIDS Program Client-Level Data Reporting System, with a 30-day public comment period.
Gulf of Mexico Fishery Management Council; Public Meeting; Correction
The Gulf of Mexico Fishery Management Council will hold a two-day in-person meeting of its Standing, Reef Fish, Socioeconomic, and Ecosystem Scientific and Statistical Committees.
Industrial Advisory Committee to Hold Open Meeting on August 1, 2024
The Industrial Advisory Committee will hold an open meeting on Thursday, August 1, 2024, from 10:00 a.m. to 3:00 p.m. Eastern Time, both in-person and via web conference.
National Artificial Intelligence Advisory Committee to Hold Virtual Briefing Session
The National Artificial Intelligence Advisory Committee will hold a virtual briefing session on August 1, 2024, to have invited guests brief the full Committee on AI-related topics for the workforce.
NMFS Announces Quota Transfer From Virginia to Massachusetts in Summer Flounder Fishery
The National Marine Fisheries Service (NMFS) has announced that the Commonwealth of Virginia is transferring a portion of its 2024 commercial summer flounder quota to the Commonwealth of Massachusetts to comply with the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan quota transfer provisions.
Closure of the Area I, Area II, and New York Bight Scallop Access Areas to General Category Individual Fishing Quota Scallop Vessels
The National Marine Fisheries Service (NMFS) has announced the closure of the Area I, Area II, and New York Bight Scallop Access Areas to Limited Access General Category Individual Fishing Quota scallop vessels for the remainder of the 2024 fishing year.
Foreign-Trade Zone (FTZ) 75, Notification of Proposed Production Activity; LG Energy Solution Arizona, Inc.; (Cylindrical Lithium-Ion Battery Cells and Lithium Iron Phosphate Pouch-Type Batteries); Queen Creek, Arizona
LG Energy Solution Arizona, Inc. has proposed production activity in Foreign-Trade Zone 75 in Queen Creek, Arizona, for the manufacturing of cylindrical lithium-ion battery cells and lithium iron phosphate pouch-type batteries.
Foreign-Trade Zone (FTZ) 78, Notification of Proposed Production Activity; AESC US LLC; (Lithium-Ion Battery Cells); Smyrna, Tennessee
AESC US LLC has proposed production activity for Lithium-Ion Battery Cells in Foreign-Trade Zone 78, located in Smyrna, Tennessee.
Large Top Mount Combination Refrigerator-Freezers From Thailand: Initiation of Less-Than-Fair-Value Investigation
The US Department of Commerce has initiated an investigation into large top mount combination refrigerator-freezers imported from Thailand, citing concerns of less-than-fair-value practices.
Certain Steel Nails From Taiwan: Preliminary Results and Rescission, in Part, of Antidumping Administrative Review; 2022-2023
The U.S. Department of Commerce preliminarily finds that several Taiwanese companies, including Cyuan Hong Enterprise Co. and Hsieh Shun Iron Wire Mfg. Co. Ltd., sold certain steel nails at prices below normal value during the period of review from July 1, 2022, to June 30, 2023.
Certain Low Speed Personal Transportation Vehicles From the People's Republic of China: Initiation of Less-Than-Fair-Value Investigation
The United States Department of Commerce has initiated an investigation into low-speed personal transportation vehicles imported from the People's Republic of China, alleging less-than-fair-value practices.
Certain Low Speed Personal Transportation Vehicles From the People's Republic of China: Initiation of Countervailing Duty Investigation
The United States Department of Commerce has initiated a countervailing duty investigation into low-speed personal transportation vehicles imported from China.
In the Matter of: Robert Wise, 145 Cliff Avenue, Pelham, NY 10803; Order Denying Export Privileges
The U.S. Department of Commerce's Bureau of Industry and Security has issued an order denying export privileges to Robert Wise, a resident of Pelham, New York.
US Denies Export Privileges to Ruben Arnulfo Chavarin
The US has denied export privileges to Ruben Arnulfo Chavarin, a resident of Douglas, Arizona, due to unspecified reasons.
Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Atlantic Highly Migratory Species Individual Bluefin Quota (IBQ) Tracking and Appeals
The Department of Commerce invites public comment on proposed information collections to assess their impact and minimize the public's reporting burden.
Department of Commerce Invites Public Comment on Proposed Information Collections for National Estuarine Research Reserve System
The Department of Commerce invites the public and other Federal agencies to comment on proposed information collections for the National Estuarine Research Reserve System, as required by the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Pacific Islands Region Seabird-Fisheries Interaction Recovery Reporting
The Department of Commerce invites public comment on proposed information collections to assess their impact and minimize reporting burden, with a 60-day comment period preceding submission to OMB.
Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: HIBIKI (Motor); Invitation for Public Comments
The Maritime Administration (MARAD) is seeking public comments on a coastwise endorsement eligibility determination for the foreign-built vessel HIBIKI, which will carry no more than twelve passengers for hire.
U.S. Department of Transportation, Maritime Administration Announces U.S. Merchant Marine Academy Board of Visitors Public Meeting
The U.S. Department of Transportation, Maritime Administration has announced a public meeting of the U.S. Merchant Marine Academy Board of Visitors to discuss programs and priorities, including governance and academic updates.
Great Lakes St. Lawrence Seaway Development Corporation Announces Public Meeting of Advisory Board
The Great Lakes St. Lawrence Seaway Development Corporation is holding a public meeting of its Advisory Board.
National Hazardous Materials Route Registry Revisions for April 1, 2023, through March 31, 2024
The National Hazardous Materials Route Registry has reported revisions from April 1, 2023, through March 31, 2024, listing designated and restricted roads for hazardous materials transportation.
U.S. Department of Energy Extends Public Comment Period for Fusion Energy Public-Private Consortium Framework
The U.S. Department of Energy has extended the public comment period for a proposed fusion energy public-private consortium framework, allowing comments to be submitted until August 6, 2024.
Submission for OMB Review; Comment Request; Extension: Form N-6
The US Department of the Treasury is requesting an extension for the OMB review of Form N-6, a comment request for the submission of the form.
Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Launch Proximity-On-Demand, a Managed Colocation Solution
Nasdaq MRX, LLC has filed a proposed rule change to launch Proximity-On-Demand, a managed colocation solution, with immediate effectiveness.
Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Launch Proximity-On-Demand, a Managed Colocation Solution
Nasdaq ISE, LLC has filed a proposed rule change to launch Proximity-On-Demand, a managed colocation solution, with immediate effectiveness.
Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Launch Proximity-On-Demand, a Managed Colocation Solution
Nasdaq GEMX, LLC has filed a proposed rule change to launch Proximity-On-Demand, a managed colocation solution, with immediate effectiveness.
Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To Decommission the DTCC Limit Monitoring Risk Management Tool
The Securities and Exchange Commission has approved a proposed rule change by the National Securities Clearing Corporation to decommission the DTCC Limit Monitoring Risk Management Tool.
Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Withdrawal of a Proposed Rule Change To Amend the Exchange's Rules Relating to Position and Exercise Limits
Cboe Exchange, Inc. has withdrawn a proposed rule change to amend its rules relating to position and exercise limits.
Endangered and Threatened Wildlife and Plants; 90-Day Finding and 12-Month Determination on a Petition To Revise Critical Habitat for Sonora Chub
The U.S. Fish and Wildlife Service announces its 90-day finding and 12-month determination on a petition to revise critical habitat for the Sonora chub in Arizona, with plans to assess critical habitat during the 2027 5-year status review.