Search Results for keywords:"guidance document"

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The U.S. Nuclear Regulatory Commission (NRC) is asking for public comments on a draft guidance document titled "Content of Risk Assessment and Severe Accident Information in Light-Water Power Reactor Construction Permit Applications." This guidance aims to clarify how NRC staff should review risk assessment and severe accident information in construction permit applications for light-water power reactors. The draft provides details on the safety review process but does not change current rules or affect existing licenses. Comments should be submitted by February 18, 2025, and the NRC encourages electronic submissions through the Federal rulemaking website.

The Office of Management and Budget (OMB) is asking for public comments on a draft report that offers initial guidance for classifying environmental-economic statistics. This effort, led by an interagency group of experts, aims to create a framework for including environmental data in national economic accounts, such as measuring assets like land, water, and forests. The goal is to develop consistent statistical categories that align with national and international standards. The feedback from this request will help shape future guidelines, with final guidance expected in 2028.