Search Results for keywords:"Centers for Medicare

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Considerations for Complying With 21 CFR 211.110." This draft guidance aims to help manufacturers ensure the uniformity and integrity of drug products by complying with specific regulations. It also provides insight into how advanced manufacturing techniques, like 3D printing and continuous manufacturing, can be incorporated into manufacturing processes. The FDA encourages industry representatives who are interested in using innovative control strategies to contact them for further guidance.

The Food and Drug Administration (FDA) is extending the period for public comments on a concept paper titled "Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed." Originally, the comment period was set to end on April 12, 2021, but it has been extended by 60 days to June 11, 2021, to give people more time to share their thoughts. The concept paper was published on January 11, 2021, and this extension is in response to requests for more time to provide comprehensive feedback. Interested parties can submit their comments electronically or in written form by the new deadline.

The Department of Homeland Security (DHS) and the Transportation Security Administration (TSA) have issued a final rule regarding the enforcement of REAL ID requirements for driver's licenses and identification cards used for federal purposes. Starting May 7, 2025, federal agencies must begin enforcing these requirements but can do so using a phased approach until May 5, 2027, if they consider factors like security, operational feasibility, and public impact. This rule aims to provide flexibility for a smoother transition since not all individuals currently possess REAL ID-compliant IDs. Agencies that choose phased enforcement must coordinate with DHS and publicly share their plans.

The Environmental Protection Agency (EPA) has submitted a request to renew its information collection on solvent extraction for vegetable oil production. This renewal is subject to approval by the Office of Management and Budget (OMB) and follows previous public comments from May 2020. The EPA invites additional public comments by February 10, 2021. This proposal affects facilities with vegetable oil production processes, and compliance involves regular reporting and recordkeeping to meet federal standards.

The Internal Revenue Service (IRS), part of the Treasury Department, is seeking public comments on its existing information collection process related to the Safe Harbor for Valuation and Mark to Market Accounting Method for Dealers under section 475. This involves no changes to current regulations but aims to renew approval under the Paperwork Reduction Act of 1995. The public and other federal agencies are invited to send their feedback by May 5, 2025, focusing on the necessity, accuracy, and potential improvements of this information collection. The safe harbor allows dealers in securities and commodities to use financial statement values for certain positions, helping reduce compliance burdens.

The Office of Management and Budget (OMB) is asking for public input on which regulations should be eliminated to reduce unnecessary barriers for businesses and foster innovation. People can suggest which rules to get rid of and explain why they think these rules are problematic. Comments need to be submitted by May 12, 2025, via the regulations.gov website. It's important to note that any comments submitted could be posted publicly.

The Administration for Native Americans (ANA) is inviting the public to comment on proposed changes to their funding opportunities for Fiscal Year 2021. These changes involve updates to existing programs like Environmental Regulatory Enhancement and Native American Language Preservation, among others. They include new guidelines for intellectual property protection, eligibility criteria, and application requirements. The ANA plans to implement these changes unless significant feedback is received before March 22, 2021.

The Securities and Exchange Commission (SEC) is seeking an extension on the approval for collecting information via Form ID, as required by the Paperwork Reduction Act of 1995. Individuals and companies use Form ID to gain access to file on the SEC's EDGAR system, which is crucial for making certain disclosures under federal securities laws. Each year, about 73,600 Form ID submissions are expected, with each taking about 0.6 hours to complete, resulting in a total of 44,160 hours of effort annually. The public can review and comment on this information collection request through the provided online link or via email by March 27, 2025.

The Office of Personnel Management (OPM) is seeking public comments on a new plan to collect feedback about its services. This effort aims to improve customer experiences by gathering voluntary input from users through various methods like surveys and focus groups. The information collected will be used to enhance service quality but will not affect policy decisions. The public has until February 18, 2025, to submit their comments on this proposal.

The National Oceanic and Atmospheric Administration (NOAA), under the Department of Commerce, announced a pilot program for matching funds to support hydrographic surveys, encouraging partnerships with non-Federal entities like state governments and universities. The program aims to enhance ocean and coastal mapping, contributing to safe navigation, climate adaptation, and more. NOAA will match funds provided by partners and ensure all data collected is publicly accessible. Interested parties must submit proposals by February 26, 2021, highlighting their project plans and funding sources. This initiative is part of NOAA's broader efforts to map U.S. waters by 2040.