FDA Releases Draft Guidance for Bioresearch Monitoring Inspections
The FDA has issued a draft guidance to describe processes and practices for bioresearch monitoring inspections, in compliance with the Food and Drug Omnibus Reform Act of 2022.
BUSINESS NEWS
Find articles by title or summary.
The FDA has issued a draft guidance to describe processes and practices for bioresearch monitoring inspections, in compliance with the Food and Drug Omnibus Reform Act of 2022.
The Food and Drug Administration (FDA) is seeking public input on a proposed collection of information related to its Medical Device Recall Authority, as required by the Paperwork Reduction Act of 1995.
The US Food and Drug Administration (FDA) has released a draft document outlining the standardized format for electronic submission of marketing applications content for biologics and drug inspections by the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs (ORA).
The Department of Justice's Money Laundering and Asset Recovery Section is seeking OMB approval for a revised information collection request related to the Equitable Sharing Agreement and Certification Report, a process used to share assets recovered from illicit activities.
The International Security Advisory Board (ISAB) has scheduled a closed meeting, and a notice has been issued to inform relevant parties of the upcoming event.
The U.S. Department of the Treasury is conducting a mandatory survey of foreign residents' holdings of U.S. securities as of June 28, 2024, and is requiring all eligible U.S. persons to respond and comply with the survey. Additional information and forms can be found on the Treasury's website at https://home.treasury.gov/data/treasury-international-capital-tic-system-home-page/tic-forms-instructions/forms-shl.
The Internal Revenue Service (IRS) is making corrections to a System of Record Notice (SORN) related to Insider Risk Management Records, which was published in the Federal Register on May 3, 2024, to include Potential Risk Identifiers (PRIs) and align exemptions correctly with the Notice of Proposed Rulemaking.
The Department of Labor is seeking public comment on an Occupational Safety & Health Administration-sponsored information collection request related to construction and general industry standards for electric power generation, transmission, and distribution, as well as electrical protective equipment.
The Department of Labor is requesting public comment on an Office of Workers' Compensation Programs information collection request for the authorization and certification of compounded drugs, which must be submitted to the Office of Management and Budget for review and approval under the Paperwork Reduction Act of 1995.
The Federal Emergency Management Agency (FEMA) has issued a public assistance declaration for the state of Nebraska following severe storms, straight-line winds, and tornadoes that occurred from April 25 to April 27, 2024.
The President has declared a major disaster for the state of Arkansas, following severe storms, straight-line winds, tornadoes, and flooding that occurred from May 24 to May 27, 2024, as documented by FEMA-4788-DR, dated May 30, 2024.
The finalists of the Young Inventors Prize 2024, representing Tunisia, Ukraine, and the Netherlands, are working on innovative projects that focus on sustainability, healthcare, and technological advancements in mobility aids.
CBN's response to false allegations of license withdrawals
This document corrects technical and typographical errors in the proposed rule that appeared in the May 2, 2024 Federal Register.
Shaker Mousa, a former Professor and Executive Vice President of the Pharmaceutical Research Institute, has been found guilty of research misconduct in studies funded by the National Cancer Institute and the National Institute of Diabetes and Digestive and Kidney Diseases.
The National Institutes of Health's National Cancer Institute will publish proposed data collection projects for public comment, in compliance with the Paperwork Reduction Act of 1995.
The Centers for Disease Control and Prevention invites public comment on a proposed information collection project titled Lung Function Screening of Construction Workers with Exposure to Dusts and Chemicals, as required by the Paperwork Reduction Act of 1995.
The Centers for Disease Control and Prevention (CDC) invites public comment on a proposed information collection project titled Annual Progress Reports for Injury Control Research Centers (ICRC), focusing on research and prevention of various issues including child abuse and neglect.
The Centers for Disease Control and Prevention invites the public and other Federal agencies to comment on a proposed information collection project titled Health Message Testing System (HMTS). The HMTS enables programs across CDC to test proposed health messages before dissemination.
The Centers for Disease Control and Prevention invites public comment on a proposed information collection project titled Contact Investigation Outcome Reporting Forms.
The Centers for Disease Control and Prevention invites public comment on a proposed data collection project titled Information Collection for Tuberculosis Data from Panel Physicians, which aims to collect tuberculosis data from U.S.--bound immigrants and refugees.
The Centers for Disease Control and Prevention invites the public and other Federal agencies to comment on a proposed data collection for the Paul Coverdell National Acute Stroke Program, aiming to improve stroke care in the United States.
The Centers for Disease Control and Prevention invites public comment on a proposed data collection project titled National Healthcare Safety Network (NHSN) Coronavirus (COVID-19) Surveillance in Healthcare Facilities, as required by the Paperwork Reduction Act of 1995.
The charter of the United States Manufacturing Council was renewed for a two-year period, ending March 22, 2026.
Petrogas Pacific, LLC has requested authorization from NMFS to take marine mammals incidental to Ferndale Pier Maintenance Activities in Ferndale, Washington, and NMFS is seeking public comments on the proposal.
The National Institute of Standards and Technology (NIST) is planning a workshop to assess the state-of-the-art of environmental sensors and seeking public input on agenda topics and priorities.
The Judges Panel will meet in closed session on June 20, 2024, to review Baldrige Award applications and vote on site visits for applicants.
The US Customs and Border Protection has made a decision on the application for duty-free entry of scientific instruments submitted by Fermi Research Alliance, et al.
The U.S. Department of Commerce published a list of scope rulings and circumvention determinations made from October 1, 2023, through December 31, 2023.
The National Conference on Weights and Measures will hold its 109th Annual Meeting at the Hotel Cleveland in Cleveland, Ohio from July 14 to July 18, 2024.
The National Marine Fisheries Service (NMFS) has implemented an accountability measure for the commercial harvest of snowy grouper in South Atlantic Federal waters, closing the area until the July through December season begins.
The Pacific Fishery Management Council's Ad-hoc Sacramento River Fall Chinook Workgroup will hold a 2-day meeting in June 2024.
The National Marine Fisheries Service (NMFS) has issued regulations to implement amendments 54 and 55 to the Fishery Management Plan for Bering Sea and Aleutian Islands King and Tanner Crabs, revising provisions of the Crab Rationalization Program.
The Federal Motor Carrier Safety Administration (FMCSA) corrected a notice regarding exemptions for 12 individuals with epilepsy or seizure disorders to drive commercial motor vehicles in interstate commerce.
MFT Energy US Power LLC has applied for authorization to export electric energy from the United States to Mexico.
Puget Sound Energy, Inc. has applied for renewed authorization to transmit electric energy from the United States to Canada.
ATNV Energy, LP has applied for authorization to transmit electric energy from the United States to Canada under the Federal Power Act.
ATNV Energy, LP has applied for authorization to transmit electric energy from the United States to Mexico.
The Loveland Area Projects, Western Area Colorado Missouri Balancing Authority, and Colorado River Storage Project have confirmed and approved an interim extension of their existing formula rates, which will now expire on September 30, 2026.
The National Securities Clearing Corporation has filed a proposed rule change to decommission its DTCC Limit Monitoring Risk Management Tool.
The Cboe BZX Exchange, Inc. has filed a proposed rule change to amend the Franklin Bitcoin ETF.
Cboe EDGA Exchange, Inc. has withdrawn its proposed rule change to amend its fees schedule and adopt fees for dedicated cores.
Jeffrey Management Company has submitted a notice of application, but details of the application are not specified.
The Federal Energy Regulatory Commission (FERC) is soliciting public comment on the information collection FERC-566, which involves the Annual Report of a Utility's 20 Largest Purchasers.
Great Lakes Hydro America, LLC has made available a draft environmental assessment for public review and comment.
The Federal Energy Regulatory Commission is soliciting public comment on approved information collections FERC-65, FERC-65A, and FERC-65B, in compliance with the Paperwork Reduction Act of 1995.
The US Coast Guard has established a temporary safety zone in Little Connection Slough near Stockton, CA to protect personnel, vessels, and the marine environment from potential hazards during salvage and pollution removal operations.
U.S. Customs and Border Protection is renewing the Automated Commercial Environment (ACE) Export Manifest for Air Cargo Test, a National Customs Automation Program test concerning ACE export manifest capability.
The US Coast Guard is proposing to adjust the safety zone radius and location for a fireworks event on the Oswego River in Oswego, NY, to protect personnel, vessels, and the marine environment.
The US Coast Guard has updated its Certificate of Number requirements to allow digital certificates, aligning with the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023.