Search Results for keywords:"section 529 FD

Union Pacific Railroad Company (UP) has reported that it has gained temporary rights to use a section of track owned by BNSF Railway Company. This particular agreement allows UP to transport ballast trains, which are used for maintenance work, over a 51.7-mile stretch of rail in Oklahoma and Texas. The temporary rights will last until the end of 2021, and UP has stated that these actions are exempt from environmental and historical preservation reviews. If anyone believes this notice contains false information, they can petition to revoke the exemption, but such petitions will not delay the exemption's start date unless filed by a certain deadline.

The Food and Drug Administration (FDA) has released new guidelines for companies submitting information electronically related to drug and biologic license applications. This guidance helps ensure that data is submitted in a standardized format, which the FDA uses to plan and conduct inspections of research sites, known as Bioresearch Monitoring (BIMO) inspections. The guidance also clarifies which trials need to include certain information, aiming to enhance the FDA's inspection process for safety and efficacy claims in drug applications. Additionally, the guidance addresses previous technical issues and provides updated instructions for submissions under specific FDA regulations.

The Food and Drug Administration (FDA) announced the determination of the regulatory review period for the drug SOHONOS, which is used to treat fibrodysplasia ossificans progressiva in certain children and adults. This determination is related to a patent extension application made to the U.S. Patent and Trademark Office (USPTO). FDA found that the drug underwent a lengthy review process, including 6,657 days of testing and 869 days of approval proceedings. People who believe any of the review dates are incorrect can submit comments to FDA, and petitioners can also request a review of the applicant's diligence during this period.

BNSF Railway Company, a major rail carrier, has filed for an exemption to acquire temporary rights to use two rail lines owned by Union Pacific Railroad Company in California. These rights allow BNSF to move trains with ballast materials between locations near Stockton and Keddie. The agreement is set to expire on December 31, 2021, and the transaction can begin after January 27, 2021. BNSF has ensured that its actions meet certain regulatory conditions and has filed a related petition about the temporary nature of these rights.

Central Oregon & Pacific Railroad, Inc. (CORP) plans to lease and operate a section of railroad line from the Union Pacific Railroad Company, totaling about 27.58 miles in Oregon. This transaction is set to occur after February 8, 2025, following the required notice period and certification. CORP's expected annual revenues from this operation will exceed $5 million, necessitating advance notices to affected employees and labor unions. The agreement includes an interchange commitment, and interested parties can file petitions related to the exemption process.

The Department of Justice is inviting public comments on the proposed extension of an existing information collection by the FBI's Hazardous Devices School. This form, known as FD-731, is used to collect information on prospective students' identities and qualifications and to assess their security clearance status. The aim is to ensure these individuals have the necessary access to sensitive law enforcement facilities and information. The public comment period is open for 60 days, concluding on April 30, 2021, and the feedback will help evaluate and improve the collection process.

The Food and Drug Administration (FDA) has proposed a collection of information regarding laboratory accreditation for food analysis and submitted it to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act. The accreditation program aims to ensure food safety by allowing laboratories accredited by recognized bodies to conduct food testing. This program is voluntary, and the FDA estimates a decrease in the number of respondents and burden hours compared to the previous collection data. The public can submit comments by January 21, 2025, through the specified online portal.

Arkansas Louisiana & Mississippi Railroad Co. (ALM) has filed a notice to discontinue rail service on a 9.32-mile line in Morehouse Parish, Louisiana. This decision is due to the line having no local traffic since before 2014, and any other traffic can be rerouted. Employees affected by the discontinuance will be protected under specific conditions, and financial assistance options for continued service are available until February 28, 2025. If there are no objections, the service discontinuance will take effect on March 20, 2025.

The U.S. Department of Health and Human Services has extended the Public Readiness and Emergency Preparedness (PREP) Act Declaration related to COVID-19. This extension, effective January 1, 2025, provides liability immunity to certain individuals and organizations involved in developing, manufacturing, distributing, and using medical countermeasures against COVID-19 and related health threats until December 31, 2029. It also clarifies the roles of licensed pharmacists and other healthcare providers in administering vaccines and therapeutics, ensuring continued access to critical medical interventions even after the formal public health emergency has ended.

The Food and Drug Administration (FDA) is seeking information on the production methods and ingredients used in making high-protein yogurt, including Greek yogurt, due to discrepancies with existing yogurt identity standards. This request aims to understand if different standards are needed to ensure consumer honesty and fair dealing, considering innovations and practices in the yogurt industry. The public can submit comments electronically or in writing until April 15, 2025. The FDA is particularly interested in consumer perceptions, industry practices, and the labeling of these high-protein yogurt products.