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Armstrong Hospitality Group and related companies, known collectively as Armstrong Group, filed a notice to gain control over American Rocky Mountaineer LLC when it becomes a rail carrier. American Rocky Mountaineer is seeking an exemption to run passenger rail services between Moab, Utah, and Denver, Colorado, on Union Pacific lines. The Surface Transportation Board has set March 5, 2021, as the effective date for the exemption. This transaction doesn't involve any Class I carriers, and Armstrong Group assures there will be no rail line connections with Great Canadian Railtour, which it also owns.

The Department of Health and Human Services has issued a notice clarifying that businesses that started producing hand sanitizers during the COVID-19 pandemic are not required to pay certain facility fees under the Food, Drug, and Cosmetic Act. These businesses, many of which normally produce alcoholic beverages, were allowed to make hand sanitizers due to a temporary policy by the FDA to address shortages. The Department emphasizes that imposing such fees would be inconsistent with the intent of the CARES Act and clarifies that these businesses are not considered drug manufacturing facilities under the law, unless they also engage in producing other over-the-counter drugs.

The Food and Drug Administration (FDA) has released a final guidance document for the pharmaceutical industry called the "Advanced Manufacturing Technologies Designation Program." This program aims to encourage the adoption of advanced manufacturing technologies (AMTs) that can enhance drug quality and production efficiency. The guidance outlines eligibility criteria, submission processes, and benefits for obtaining an AMT designation, which supports the development of crucial drugs. Additionally, it finalizes a draft from December 2023 and reaffirms FDA's commitment to improving drug manufacturing processes.

The Food and Drug Administration (FDA) announced the availability of its annual update on the Susceptibility Test Interpretive Criteria web page, part of procedures under the 21st Century Cures Act. This web page lists standards used to determine the effectiveness of antimicrobial drugs, making it easier for device makers to update their testing products. The FDA is requesting public comments and will update the standards based on feedback. The agency recognizes new standards and withdraws others, such as ones from the Clinical and Laboratory Standards Institute, as part of this ongoing update process.

San Joaquin Valley Railroad Co. (SJVR) has filed for an exemption to continue leasing and operating 101.5 miles of rail lines from Union Pacific Railroad Company. This lease, initially established in 1994 and most recently renewed in 2020, has been extended by a Lease Amendment signed in January 2025, allowing operations to continue for another five years. SJVR's notice also requests a waiver for a 60-day advance notice to labor unions, which will be decided separately. Moreover, SJVR confirms that its projected revenues will not exceed the limit set for a Class III carrier, despite current revenues being over $5 million.

The Food and Drug Administration (FDA) is inviting public comments on the proposed collection of specific information related to dietary supplement labeling. Under the Paperwork Reduction Act, federal agencies must publish notices for any information collection activities, allowing 60 days for public feedback. The proposal involves manufacturers, packers, or distributors of dietary supplements notifying the FDA about claims made on supplement labels. Comments can be submitted electronically or in writing by February 18, 2025.

The Food and Drug Administration (FDA) is asking for public feedback on gathering certain data about reprocessed, single-use medical devices under the Paperwork Reduction Act. This public comment period lasts for 60 days, ending on April 26, 2021. The FDA wants to know if the information collection is necessary, how accurate their burden estimates are, and if there are better ways to collect data. This initiative aims to ensure that reprocessed devices clearly show the manufacturer's name or symbol to prevent misbranding, as required by federal law.

The Department of Health and Human Services has released a statement about improving transparency in the drug approval process by the Food and Drug Administration (FDA). They examined how long it takes the FDA to review and approve new drug applications. Historically, Congress set a 180-day limit for this process, but recent reviews show that it often takes longer. To improve transparency and accountability, the FDA will now publish detailed timelines of these reviews on its website so the public and Congress can better understand these processes and their impacts.

The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) are seeking public input regarding food date labeling. They aim to gather information on industry practices, consumer perceptions, and the impact of date labels on food waste. Both agencies are concerned that inconsistent labeling terms like "Sell By" and "Use By" may confuse consumers, leading to unnecessary food waste. They encourage the use of the phrase "Best if Used By" to reduce confusion and are asking for public comments to guide future policies by February 3, 2025.

The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget for review under the Paperwork Reduction Act. This collection involves the De Novo classification process, which evaluates if a medical device can be classified as class I or II, assuring its safety and effectiveness in the absence of a similar marketed device. The process includes regulatory guidelines and electronic submission templates. Feedback on the proposal is welcomed until January 29, 2025, via the OMB's online portal.